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Pessary

A pessary is a removable prosthetic device inserted into the vagina to provide structural support for pelvic organs, primarily to manage pelvic organ prolapse (POP) and, in some cases, stress urinary incontinence (SUI).^[1]^[2] These devices, typically made of medical-grade silicone or rubber, come in various shapes such as ring, Gellhorn, or space-filling types, tailored to the patient's anatomy and condition severity.^[3]^[4] Pessaries have ancient origins, with descriptions of similar devices in Egyptian papyri and used by Hippocrates for uterine support, initially crafted from materials like fruits, cork, or metals before evolving to modern biocompatible polymers in the 20th century.^[5]^[6] They offer a non-surgical alternative to surgery for symptomatic POP, with evidence indicating symptom relief in many patients and long-term tolerability when properly fitted and maintained.^[7]^[8] Common side effects include vaginal discharge and odor, while rare complications such as erosions, fistulas, or infections underscore the need for regular follow-up to ensure safety and efficacy.^[9]^[10] Self-management protocols have shown potential to reduce complications compared to clinic-only care, though professional oversight remains essential.^[11]

Historical Development

Ancient Origins and Early Uses

The earliest documented references to pessaries appear in ancient Egyptian medical texts, where they were employed to address uterine prolapse. The Ebers Papyrus, dating to approximately 1550 BCE, describes symptoms consistent with pelvic organ descent and recommends inserting cup- or ring-shaped devices into the vagina to alleviate discomfort and support displaced organs.^[12]^[13] These rudimentary pessaries likely consisted of natural materials such as softened papyrus or linen soaked in medicinal substances, reflecting an empirical approach to mechanical support rather than surgical intervention.^[5] In ancient Greece, around the 5th century BCE, physicians expanded on these concepts, with Hippocrates and his followers documenting pessary use for genital prolapse. One method involved inserting half a pomegranate into the vagina, as noted by the physician Polybus, to provide occlusion and astringent effects that purportedly reduced swelling and repositioned the uterus.^[4] Greek texts also describe pessaries fashioned from wool tampons impregnated with hot oils or astringents, or even oval-shaped stones—whence the term "pessary" derives from the Greek pessos, meaning an oval pebble.^[14] These devices aimed to mechanically elevate prolapsed tissues while delivering topical therapies, though efficacy relied on rudimentary anatomy and trial-based observations rather than systematic validation.^[7] Roman medical writers, building on Greek traditions by the 1st century CE, continued pessary applications for prolapse and related conditions like dysmenorrhea, using similar materials including cork, metal, or vegetable-based inserts. Authors such as Soranus of Ephesus advocated for supportive pessaries to prevent further descent, emphasizing gentle insertion to avoid irritation.^[15] Early uses thus centered on non-invasive symptom relief for pelvic floor disorders, predating formal gynecology and highlighting a persistent reliance on intravaginal mechanical aids across Mediterranean civilizations.^[5]

Evolution in Modern Gynecology

In the early 20th century, pessaries reached peak popularity in gynecology, with over 100 varieties available around 1900 for treating uterine prolapse and malposition.^[16] Innovations included the 1902 patent by Carl Hollweg for a wishbone-shaped pessary designed to support the uterus and prevent abnormal descent.^[17] Materials transitioned from rigid substances like cork, brass, and gold-plated stems to more flexible rubber, reducing complications such as erosion and infection while resembling contemporary designs.^[5] By the mid-20th century, pessary use declined sharply due to advancements in surgical techniques, including hysterectomies and reconstructive procedures, which offered perceived permanency over conservative management.^[16] Despite this, pessaries persisted as a non-invasive option, particularly for patients unfit for surgery. The resurgence began in the late 20th century, driven by an aging population, increasing pelvic organ prolapse prevalence, and preference for reversible treatments avoiding operative risks.^[15] Modern pessaries predominantly employ medical-grade silicone, valued for its biocompatibility, durability, and ease of sterilization compared to earlier rubber or plastic iterations.^[18] Designs evolved into specialized forms like ring, Gellhorn, and cube pessaries, tailored to prolapse stage and anatomy, with success rates for symptom relief reported at 60-90% in clinical studies.^[19] Recent innovations include self-removable models to enhance patient autonomy, 3D-printed custom fits for improved efficacy in complex cases, and hormone-eluting variants, such as estriol-releasing pessaries sustaining delivery over three months to mitigate vaginal atrophy.^[20]^[21] Collapsible prototypes have also emerged, demonstrating safety and effectiveness in short-term trials for prolapse reduction.^[22] These developments underscore a shift toward personalized, minimally invasive care in contemporary gynecology.^[19]

Mechanism of Action

Biomechanical Support Principles

Pessaries operate as passive mechanical devices that provide support to the vaginal walls and pelvic organs by occupying space within the vagina and exerting counterforces against prolapse-inducing pressures. These devices counteract gravitational pull and transient increases in intra-abdominal pressure, such as those occurring during Valsalva maneuvers, by repositioning descended organs toward their anatomical norms.^[23] The primary biomechanical principle involves the redistribution of mechanical loads from weakened pelvic floor structures to the pessary's supportive framework, thereby reducing strain on ligaments and muscles.^[24] Support mechanisms vary by pessary design, with space-occupying types, such as Gellhorn or donut shapes, functioning through volumetric filling that elevates vaginal walls and prevents further descent by limiting organ migration.^[25] Ring pessaries, conversely, leverage anatomical landmarks: the anterior rim abuts the pubic symphysis for anterior stability, while the posterior aspect engages the sacrospinous ligaments or levator ani muscles, creating a fulcrum that transmits upward forces to the vaginal apex.^[26] This lever action distributes compressive and tensile forces across the pelvic diaphragm, mimicking natural supportive tensions but externally. Material properties, typically medical-grade silicone with hyperelastic behavior, allow deformation under load while maintaining restorative shape, as modeled in finite element analyses simulating tissue-pessary interactions.^[27] Biomechanical efficacy depends on precise fitting to match vaginal dimensions and prolapse stage, ensuring adequate contact pressure without erosion; studies indicate that properly fitted devices reduce pelvic floor displacement by paralleling and resisting downward motions observed in dynamic imaging.^[28] However, pessaries do not alter underlying tissue biomechanics, such as muscle contractility or ligament elasticity, serving instead as adjuncts that defer progression rather than resolve causative weaknesses.^[29] Custom designs incorporating patient-specific stiffness and geometry, enabled by 3D modeling, optimize load-bearing by aligning with individual pelvic floor mechanics.^[30]

Physiological Interactions

Vaginal pessaries interact with pelvic physiology primarily through mechanical support that alters force distribution on weakened tissues and muscles, potentially influencing muscle function and local tissue responses. By occupying vaginal space and elevating prolapsed organs, pessaries reduce chronic strain on the pelvic floor, which may facilitate improved contractile efficiency in muscles such as the puborectalis. A prospective study of women with pelvic organ prolapse found a 2.1% increase in puborectalis displacement during contraction (from 17.2% to 19.0%) after three months of pessary use, with more pronounced effects (2.7% increase) in those without levator avulsion, suggesting enhanced muscle shortening without significant changes in hiatal area during contraction.^[29] This adaptation likely stems from reduced resting load, allowing better muscle recruitment, though hiatal area at rest increased slightly by 3.0% overall (4.1% in non-avulsed cases), indicating possible subtle widening of the levator hiatus.^[29] Tissue-level interactions involve direct contact with vaginal mucosa, where sustained pressure can induce physiological changes including irritation, increased discharge, and erosion. Erosions arise from friction and localized ischemia in compressed areas, exacerbated by higher vaginal pH and dysbiotic microbiota shifts, which correlate with inflammation and impaired epithelial integrity.^[31] ^[32] Postmenopausal women with atrophic mucosa are particularly susceptible, as thinner epithelium heightens ulceration risk, often mitigated by topical estrogen to restore tissue resilience and vascularity.^[33] Pessary-induced discharge, reported in up to 20% of users, reflects altered vaginal flora dynamics, with frequent anaerobic overgrowth leading to bacterial vaginosis if removal intervals exceed weekly checks.^[34] ^[35] Broader physiological effects include potential impacts on sexual function and continence pathways, where support reduces bulge symptoms and urethral hypermobility, indirectly enhancing pelvic nerve feedback and muscle coordination for stress urinary incontinence.^[35] However, complications like ulceration or fistula formation, though rare (affecting <5% with proper fitting), underscore the need for monitoring to prevent chronic inflammation or adhesion formation.^[34] No evidence supports pessary-induced pelvic floor atrophy; instead, by offloading dysfunctional supports, it may permit concurrent muscle strengthening via exercises, preserving or improving long-term neuromuscular integrity.^[36]

Clinical Indications

Pelvic Organ Prolapse Management

Pessaries serve as a primary non-surgical intervention for managing symptomatic pelvic organ prolapse (POP), mechanically supporting prolapsed organs such as the uterus, bladder, or rectum to alleviate symptoms including vaginal bulge, pelvic pressure, and urinary or bowel dysfunction.^[37] Clinical guidelines recommend pessaries for women with stage II-IV POP who prefer conservative management or are poor surgical candidates due to comorbidities or age.^[38] Ring-shaped silicone pessaries are most commonly fitted for POP, with success depending on proper sizing and patient tolerance.^[39] Evidence from a 2022 systematic review and meta-analysis of eight studies involving 627 patients demonstrated significant symptom relief, with mean reductions in Pelvic Floor Distress Inventory-20 scores of -46.1 points (95% CI -65.4 to -26.8) and Pelvic Floor Impact Questionnaire-7 scores of -36.0 points (95% CI -46.0 to -26.0) after pessary use, primarily over 3-month follow-ups in women averaging 63 years old with mostly stage II-III prolapse.^[37] Initial symptom resolution occurs in 70-90% of users within 2-4 months, though long-term adherence varies, with a median duration of 3.3 years and only 47% continuing use over 15 years in a retrospective cohort.^[40] Factors associated with discontinuation include patient preference for surgery (30% within median 19 weeks), discomfort, and erosion, while self-management training improves retention and satisfaction without increasing complications.^[40]00503-5/fulltext) In a 2022 noninferiority randomized trial (PEOPLE) of 440 Dutch women with symptomatic POP, pessary treatment yielded subjective improvement in 76.3% at 24 months, compared to 81.5% with surgery, failing to meet noninferiority criteria (risk difference -6.1%; 1-sided 95% CI -12.7 to ∞).^[41] Surgery showed superior objective outcomes (83.3% vs. 70.3%) and better urinary symptom relief, but pessary had fewer serious adverse events like infections (9% surgery vs. higher discomfort/expulsion in pessary at 42.7%/20.6%), with 54% crossing over to surgery due to inadequate relief.^[41] Pessary fitting success is lower in stage IV prolapse (44.6% for ring types), emphasizing trial fittings and follow-up to assess fit and educate on hygiene to prevent vaginal erosion or odor.^[39] Despite these limitations, pessaries offer a reversible, low-risk option, particularly cost-effective for self-managed care over four years.^[42]

Stress Urinary Incontinence Treatment

Pessaries serve as a non-surgical intervention for stress urinary incontinence (SUI), a condition characterized by involuntary urine leakage during activities that increase intra-abdominal pressure, such as coughing or sneezing. Specifically, continence ring pessaries or ring pessaries with a supportive knob are positioned in the vagina to elevate and stabilize the urethra and bladder neck, thereby restoring continence by countering hypermobility or intrinsic sphincter deficiency.^[43]^[1] Clinical guidelines recognize pessaries as an initial management option for women opting for conservative therapy, particularly those unsuitable for or preferring to avoid surgery. The American Urological Association/Society of Urodynamics, Female Pelvic Medicine & Urethral Reconstruction guideline on SUI includes pessaries among nonsurgical treatments, alongside pelvic floor muscle training. Fitting success rates reach 89-92% in multicenter studies, with proper sizing and placement essential for efficacy; the device is typically inserted with the knob directed toward the urethra for targeted support.^[44]^[1] Evidence from systematic reviews and meta-analyses supports pessary efficacy, demonstrating significant reductions in SUI symptoms. A 2022 meta-analysis found pessaries effective for non-surgical SUI management, with 76% of patients reporting subjective continence post-treatment compared to 0% in untreated controls. Improvement occurs in 36-66% of cases, though outcomes vary by patient factors like prolapse stage and adherence to follow-up. In a randomized trial, pessary therapy showed noninferiority to surgical interventions for patient-reported improvement at 12 months, with a 10% noninferiority margin.^[45]^[46]^[47] Long-term use requires regular monitoring to prevent complications such as vaginal erosion, odor, or infection, which are infrequent with proper care. Studies indicate pessaries are safe for extended application, with serious adverse events rare, supporting their role as a reversible alternative to invasive procedures. However, efficacy may diminish over time without refitting, and combination with pelvic floor physiotherapy can enhance outcomes in select patients.^[7]^[1]^[47]

Contraceptive and Occlusive Applications

Pessaries have been employed as contraceptive devices since ancient times, functioning primarily as occlusive barriers to prevent sperm from reaching the cervix. In ancient Egypt around 1850 B.C., prescriptions recorded in the Petri Papyrus described pessaries composed of substances like sodium carbonate and honey, intended to block conception through physical occlusion and chemical spermicidal effects.^[48] These early formulations relied on a combination of mechanical blockage and viscous materials to adhere to the vaginal walls and cervix, though their efficacy was limited by inconsistent application and lack of standardized sizing.^[48] In the 19th and early 20th centuries, occlusive pessaries evolved into more structured barrier methods, such as the "womb veil," a rubber or diaphragm-like device inserted to cover the cervical os and impede sperm passage.^[49] The mechanism involves creating a physical seal against the cervix, often enhanced by spermicidal agents, to trap or immobilize spermatozoa; patents from the mid-20th century, like US2704068A, describe designs that generate a slight vacuum upon insertion to maintain occlusion.^[50] Advocates like Margaret Sanger promoted such pessaries in the 1910s–1920s as women-controlled methods superior to less reliable alternatives, citing Dutch clinical data from international congresses reporting failure rates as low as 2–5% with proper use, though these figures predated rigorous modern trials and likely underrepresented typical-use failures due to user error.^[51] Clinical evidence for occlusive pessaries as contraceptives remains sparse and largely historical, with modern studies focusing more on spermicide-impregnated variants than pure barriers. A 2006 Indian trial involving 3,200 women using nonoxynol-9 vaginal pessaries reported acceptability but highlighted risks of vaginal irritation and epithelial disruption, potentially increasing HIV transmission susceptibility, with no long-term efficacy data exceeding 80–90% under supervised conditions.^[52] Polyherbal pessaries combining spermicidal and antimicrobial properties have shown in vitro sperm immobilization rates over 99%, but in vivo contraceptive effectiveness trials are limited, with typical failure rates estimated at 15–20% akin to diaphragms due to displacement during intercourse or poor fit.^[53] Overall, while occlusive pessaries offer hormone-free contraception with dual protection against some infections via spermicides, their use has declined in favor of more reliable methods like intrauterine devices, given inconsistent adherence and higher unintended pregnancy risks in typical use.^[54]

Classification and Types

Support and Therapeutic Pessaries

Support pessaries provide mechanical elevation to prolapsed pelvic organs by resting against the vaginal fornices and pubic symphysis, thereby redistributing intra-abdominal pressure away from weakened pelvic floor structures. These devices are primarily indicated for symptomatic pelvic organ prolapse (POP) stages II to IV, offering a nonsurgical alternative for patients unfit for or preferring to avoid surgery. Unlike space-occupying pessaries, support types rely on vaginal wall integrity for stability rather than volumetric filling, making them suitable for milder to moderate prolapse where sufficient vaginal length and tone exist.^[55]^[56] The ring pessary, the most commonly prescribed support type, features a flexible, O-shaped silicone ring typically 6 to 10 cm in diameter, which encircles the cervix and elevates the uterus or vaginal vault. It can be fitted with or without a supportive knob for additional bladder neck elevation in cases of concomitant stress urinary incontinence (SUI). Clinical surveys indicate ring pessaries are used in over 70% of initial fittings due to their ease of insertion, patient tolerance, and low complication rates, with success rates exceeding 80% in symptom relief for anterior compartment prolapse.^[57]^[58]^[7] Shaatz pessaries resemble a ring but incorporate multiple finger-like projections extending radially to enhance circumferential support, particularly effective for cystocele or rectocele components in multi-compartment prolapse. This design increases surface contact with vaginal walls, improving stability in patients with reduced vaginal caliber. Gehrung pessaries, arched and hinged for easier insertion, provide targeted posterior support and are often selected for uterine prolapse with intact vaginal tone. Hodge pessaries, featuring a perforated stem and lever mechanism, offer precise anterior-posterior alignment but require more vaginal length and are less favored in modern practice due to higher erosion risks. All support pessaries are constructed from medical-grade silicone to minimize irritation and infection, with removal recommended every 3 to 6 months for cleaning and inspection.^[59]^[33]^[56] Therapeutic applications extend beyond mechanical support to include adjunctive roles in SUI management, where continence ring variants with drainage holes prevent pooling and ulceration while elevating the urethra. Evidence from randomized trials demonstrates pessary therapy yields 60-70% patient satisfaction in POP symptom control at 12 months, comparable to surgical outcomes in select cohorts, though long-term adherence varies from 37% to 77% influenced by provider follow-up and self-management training. Contraindications include active vaginal infection or inadequate vaginal capacity, with complications like odor or erosion occurring in under 10% of users when properly managed.^[7]^[41]^[60]

Space-Occupying and Lever Designs

Space-occupying pessaries are designed to fill the vaginal vault, thereby providing mechanical support to displaced pelvic organs by countering downward pressure from intra-abdominal forces.^[7] These devices are particularly suited for advanced pelvic organ prolapse (stages 3 and 4), where supportive ring pessaries may prove inadequate, as they create a physical barrier that elevates and stabilizes the vaginal walls, cervix, or vaginal vault.^[61] Common variants include the Gellhorn, donut, cube, and inflatable types, each tailored to specific anatomical configurations; for instance, the Gellhorn pessary features a concave disc with a drainage stem for suction-based retention, making it the most frequently prescribed space-occupying design despite challenges in self-removal due to its rigid structure.^[57] The donut pessary, resembling a toroidal ring, occupies vaginal space uniformly and is indicated for uterovaginal prolapse with an intact uterus, allowing potential intercourse if removed, though it requires precise sizing to avoid erosion.^[7] Cube pessaries, with their geometric prismatic shape, compress the levator ani muscles to approximate the introitus, offering efficacy in severe prolapse but increasing risks of ulceration from pressure points.^[61] Inflatable models, such as the Inflatoball, enable customization via post-insertion balloon expansion, facilitating easier fitting for patients with variable vaginal capacity, though deflation mechanisms demand clinician oversight to prevent retention failures.^[62] Overall, these pessaries demonstrate symptom relief in 60-90% of cases for prolapse reduction, per clinical reviews, but necessitate regular monitoring for complications like vaginal discharge or erosion.^[7] Lever pessaries represent a distinct category employing a biomechanical fulcrum mechanism, leveraging against the pubic symphysis and sacrospinous ligaments to correct uterine retroversion or mild-to-moderate prolapse (stages 1-2).^[15] Originating from 19th-century designs like the Hodge pessary, they feature curved arms that provide directional support without fully occupying vaginal space, rendering them suitable for patients with narrow introitus or flattened pubic arches where ring devices falter.^[63] Variants include the Smith pessary for narrow arches, Risser for flat arches, and standard Hodge for general retroversion, with insertion involving folding the arms for passage and subsequent expansion for retention; however, their use has declined in favor of space-occupying alternatives due to lower versatility in advanced prolapse and potential for expulsion under high intra-abdominal pressure.^[15] Efficacy data indicate adequate support in select anatomies, but long-term studies highlight higher dissatisfaction rates compared to ring or Gellhorn types, attributed to discomfort from the lever's rigidity.^[63]

Pharmaceutical and Occlusive Variants

Pharmaceutical pessaries consist of solid or semi-solid vaginal inserts formulated to deliver active pharmaceutical ingredients directly to the vaginal mucosa for localized therapeutic effects.^[64] Unlike mechanical support devices, these variants prioritize drug release mechanisms, often employing polymers or bases that dissolve or erode to facilitate absorption through the vaginal epithelium.^[65] Common applications include treatment of vaginal infections, such as candidiasis with antifungal agents like clotrimazole or miconazole, and management of postmenopausal vaginal atrophy via estrogen-releasing formulations.^[66] These pessaries enable targeted delivery, minimizing systemic exposure compared to oral routes, though efficacy depends on factors like vaginal pH, mucus layer integrity, and patient adherence to insertion protocols. Emerging innovations integrate pharmaceutical elements into customizable designs, such as 3D-printed thermoplastic polyurethane (TPU) pessaries that combine drug elution with mechanical properties for dual support and therapy in pelvic disorders.^[67] Clinical studies indicate these systems can sustain release over extended periods, potentially improving compliance for chronic conditions, though long-term data on bioavailability and safety remain limited to preclinical and early-phase trials.^[68] Regulatory approval focuses on bioequivalence to established suppository-like forms, with formulations required to demonstrate stability and uniform drug dispersion to prevent under- or overdosing.^[69] Occlusive pessaries function primarily as barrier devices that seal the cervical os to block sperm ascent, serving historical contraceptive roles rather than structural support.^[70] Developed in the 19th and early 20th centuries, examples include the Mensinga pessary, a rubber diaphragm precursor invented around 1880 by Dutch physician Eduard Martin Mensinga, and the womb veil, an American occlusive variant used to cover the cervix.^[71] These devices typically require spermicide application for enhanced efficacy, with modern analogs like the FemCap cervical cap—a silicone cup fitted over the cervix—demonstrating pregnancy prevention rates of approximately 71-86% in typical use as of 2010 data.^[70] In contemporary practice, occlusive variants have largely declined due to lower effectiveness compared to hormonal methods or intrauterine devices, with usage rates dropping significantly since the mid-20th century amid advancements in barrier contraception.^[70] Some designs incorporate dual functions, such as supporting uterine position while enabling local medication application via occlusion, as patented in 1977 for combined therapeutic occlusion.^[49] Risks include potential for displacement, allergic reactions to materials, or increased infection if not cleaned properly, underscoring the need for provider fitting and patient education.^[70] Evidence from historical cohorts supports their role in non-hormonal contraception for select populations, but systematic reviews highlight inferior outcomes versus modern alternatives.^[51]

Fitting, Insertion, and Management

Patient Selection and Sizing

Pessaries are indicated for women with symptomatic pelvic organ prolapse (POP), particularly stages II to IV, or stress urinary incontinence (SUI) exacerbated by physical activity, who prefer conservative management or face surgical risks such as advanced age, comorbidities, or desire for future pregnancy.^[7] Candidates undergo evaluation including medical history, symptom assessment, and pelvic examination with an emptied bladder to confirm prolapse extent and vaginal capacity.^[7] Guidelines recommend offering a pessary trial to all such patients, as most achieve successful fitting and symptom relief without surgery.^[72] Absolute contraindications encompass active vaginal or pelvic infections (e.g., vaginitis or pelvic inflammatory disease), severe vaginal ulceration, hypersensitivity to materials like silicone or latex, and patient inability or unwillingness to adhere to hygiene protocols and follow-up care.^[7]^[33] Relative factors complicating selection include extremely short vaginal length or prior procedures altering anatomy, such as hysterectomy, which may necessitate alternative types or preclude use in select cases.^[7] Sizing commences with digital estimation of mid-vaginal width using index and middle fingers during speculum-free exam, guiding initial selection of a support pessary like the ring (average diameter 61 mm, sizes 2 to 7) for milder POP or space-occupying Gellhorn for severe cases with wider hiatal dimensions.^[7]^[55] The optimal size accommodates the largest device without discomfort or expulsion, permitting a finger's breadth between its edge and vaginal fornices, verified in supine and standing positions with Valsalva maneuver to simulate loading.^[7] Fitting success varies from 41% to 74% overall and up to 62% for stage III/IV POP, frequently requiring 2-3 iterative trials; predictors of success include longer total vaginal length and shorter perineal body.^[7]^[73] No formalized predictive models exist, relying instead on clinician experience over strict biometric criteria.^[10]

Techniques for Placement and Removal

Placement of a pessary is typically performed by a trained healthcare provider during an initial fitting to ensure proper sizing and positioning, with the patient often instructed in self-management thereafter.^[58] The procedure begins with the patient emptying her bladder to facilitate access and reduce discomfort.^[74] Water-soluble lubricant, such as KY Jelly, is applied to the leading edge of the pessary to ease insertion.^[75] For a standard ring pessary, the device is folded in half between the thumb and fingers, with the curved portion oriented toward the ceiling, then gently advanced into the vagina while separating the labia majora with the opposite hand.^[74]^[75] Once inserted, the pessary is rotated or maneuvered so that its upper rim rests behind the pubic symphysis and the lower rim supports the posterior vaginal wall or perineum, providing optimal organ support.^[76] Correct placement is verified by ensuring the device does not cause undue pressure or protrusion and allows for comfortable ambulation.^[77] Techniques vary by pessary type to accommodate design differences. For space-occupying devices like the Gellhorn or cube pessary, insertion involves compressing or folding the device more firmly before advancing it toward the posterior fornix, with the stem or drain positioned downward for accessibility.^[76] Cube pessaries, intended for short-term use, require daily insertion and removal due to limited drainage, while ring and donut types permit longer indwelling periods with periodic checks.^[33] In cases of difficulty, adjuncts such as inserting a finger under the rim to guide placement or using warm water via syringe to soften adherent tissue may be employed by clinicians.^[76] Removal follows a reverse process, emphasizing gentle traction to avoid trauma. Patients or providers hook an index finger under the lower rim of a ring pessary and pull downward toward the rectum, allowing the vaginal walls to stretch as the device is extracted without full folding.^[78]^[76] For Gellhorn pessaries, a 90-degree rotation facilitates bending and withdrawal.^[77] Post-removal, the device is cleaned with mild soap and warm water, inspected for integrity, and dried before storage or reinsertion; silicone or latex-free materials are recommended to minimize irritation.^[75]^[78] Self-management training empowers many patients to handle insertion and removal independently, with success rates improving after 1-2 instructional sessions.^[79] Hands must be washed thoroughly with soap and water beforehand, and the process is ideally performed in a seated or squatting position for better control.^[74] Frequency of self-removal varies from daily for cube types to every 3-6 months for supportive rings, balancing hygiene against convenience.^[33]^[80] Patients unable to self-manage may require continuous clinician oversight to prevent complications like erosion.^[79]

Long-Term Care and Follow-Up

Patients using pessaries for pelvic organ prolapse require regular follow-up to assess device fit, monitor for complications, and evaluate symptom control. Guidelines recommend initial follow-up visits every 3 to 6 months after successful fitting, with intervals potentially extending to 6 to 12 months for stable, asymptomatic users without adverse effects.^[81]^[10]^[57] Extended intervals of up to 6 months have been shown noninferior to more frequent 3-month checks for ring, Gellhorn, or donut pessaries in terms of complication rates and prolapse symptoms.^[81] During visits, clinicians inspect for vaginal erosion, ulceration, discharge, odor, or bleeding, and confirm the pessary remains supportive without migration or expulsion.^[19]^[82] Self-management programs, where trained patients independently remove, clean, and reinsert the pessary, are increasingly endorsed for suitable candidates, promoting autonomy and reducing clinic burden without elevating complication risks.^[19]^[83] Self-managers typically clean the device weekly or as needed with mild soap and water, dry it thoroughly, and reinsert it, while monitoring for symptoms like increased discharge or discomfort that warrant professional evaluation.^[83] Studies indicate self-management yields lower overall complication rates compared to clinician-based care and supports long-term adherence, with continuation rates of 78-81% at 1-2 years.^[83]^[60] However, not all patients are candidates; those with cognitive impairment, dexterity issues, or preference for clinician oversight may continue with office-based management.^[84] Long-term care emphasizes patient education on warning signs, including persistent vaginal bleeding, foul odor, pain during intercourse, or device expulsion, which necessitate prompt medical attention to prevent rare but serious issues like fistula formation from neglected erosion.^[85]^[82] Outcomes should be tracked using validated tools like the Patient Global Impression of Improvement or prolapse-specific questionnaires to quantify symptom relief and guide adjustments.^[86] Indefinite use is feasible for many, provided regular monitoring confirms tolerance, though adherence may decline over time due to inconvenience or unresolved minor symptoms like spotting.^[87]^[88] Clinicians should reassess prolapse stage periodically, as pessary use does not halt underlying progression in all cases.^[89]

Efficacy and Clinical Evidence

Short-Term Symptom Relief Data

Vaginal pessaries achieve high short-term fitting success rates for pelvic organ prolapse, typically exceeding 85% across studies, with relief primarily targeting symptoms such as pelvic pressure, bulge sensation, and associated urinary issues.^[87] In a prospective cohort of 157 women with stage IV prolapse, 82.8% had successful fitting after two weeks, with 90% reporting prolapse symptom improvement, including 89.6% relief from pelvic pressure.^[90] Urinary symptoms improved in 58–93% of cases, encompassing voiding difficulty (93.3%) and stress incontinence (58.8%).^[90] Validated questionnaires confirm these gains, showing significant short-term enhancements in health-related quality of life; for instance, the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) scores improved substantially within three months, alongside satisfaction rates of 70–92%.^[87] Patient Global Impression of Change scores exceeded 90% satisfaction in fitted cases at two-week follow-up.^[90] For stress urinary incontinence, often comorbid with prolapse, pessary fitting succeeds in 89–92% of women, yielding 40% symptom improvement at three months and 50% reduction in urinary leakage at two months in prospective evaluations.^[1] These outcomes stem from mechanical support restoring anatomical positioning, though individual variability in vaginal dimensions and prolapse stage influences efficacy.^[87]

Long-Term Outcomes and Progression

Long-term adherence to pessary therapy for pelvic organ prolapse (POP) varies across studies, with continuation rates typically ranging from 50% to 80% after one year, influenced by factors such as patient age, prolapse stage, and self-management capability. In a cohort analysis, 1-year compliance reached 81.5%, dropping slightly to 78.5% at two years, with higher persistence among women without severe stress urinary incontinence. Adherence can extend beyond five years in nearly half of users, supporting pessary as a feasible option for sustained non-surgical management, though discontinuation often stems from discomfort, erosion, or preference for surgery.^[87]^[60]^[91] Evidence on pessary's impact on POP progression remains limited, primarily from observational data indicating stabilization rather than reversal. In a prospective study of 32 women fitted with supportive pessaries, no worsening of prolapse stage occurred over follow-up periods averaging 13 months, suggesting a potential therapeutic effect in halting advancement. The natural history of untreated symptomatic POP shows minimal stage change over time, implying pessaries primarily maintain status quo in adherents rather than altering underlying tissue weakness. However, up to 30.9% of pessary users among Medicare beneficiaries transitioned to prolapse surgery within seven years (median 496 days post-fitting), often due to inadequate symptom control or progression despite device use.^[92]^[93]^[94] Sustained symptom relief is common among long-term users, with prolapse symptoms improving in approximately 90% and urinary symptoms in 58-93% of cases during extended follow-up. Quality-of-life measures, including pelvic floor function and sexual activity impact, show positive effects persisting up to 24 months, though persistent vaginal pain or discharge can undermine benefits in some. Self-management protocols demonstrate equivalent efficacy to clinic-based care for prolapse-specific quality of life over four years, with added cost savings and reduced healthcare visits, provided patients receive adequate training. These outcomes underscore pessary's role in delaying surgical intervention for suitable candidates, but success hinges on regular monitoring to address complications that could precipitate failure.^[95]^[96]^[42]

Comparative Effectiveness Versus Surgery

Randomized controlled trials, such as the PEOPLE trial conducted across 21 Dutch hospitals from 2015 to 2019 involving 440 women with symptomatic stage II or greater pelvic organ prolapse, have directly compared pessary therapy to surgical repair. In this noninferiority trial, patient-reported improvement at 24 months, assessed via the Patient Global Impression of Improvement (PGI-I) scale, occurred in 76.3% (132 of 173) of the pessary group versus 81.5% (132 of 162) of the surgery group, with a risk difference of -6.1% (one-sided 95% CI: -12.7 to ∞, P=0.16); pessary did not meet the prespecified noninferiority margin of -10%.^[89] High crossover rates, with 54.1% of pessary users opting for surgery by study end, suggest limitations in long-term pessary satisfaction for some patients.^[89] Secondary outcomes in the PEOPLE trial further indicate surgery's edge in symptom relief and quality of life. Perceived symptom severity improved in 64.5% of pessary users compared to 89.6% of surgery patients (P<0.0001), while prolapse-specific quality of life scores on the PFDI-20 declined by 26.3 points (moderate effect size 0.65) with pessary versus 41.3 points (large effect size 1.11) with surgery (P<0.001).^[97] A smaller prospective self-controlled trial at Mayo Clinic (2022) with 40 completers corroborated these findings, showing both treatments reduced bulge and pressure symptoms, but 33 of 40 participants preferred surgical outcomes for greater perceived improvement.^[98] Economic evaluations alongside the PEOPLE trial demonstrate pessary's advantages in resource use. Over 24 months, pessary therapy incurred €1,807 lower healthcare costs and €1,850 lower societal costs than surgery, with no significant quality-adjusted life-year (QALY) differences (-0.03; 95% CI -0.07 to 0.002), yielding positive incremental cost-effectiveness ratios favoring pessary at willingness-to-pay thresholds up to €20,000 per QALY gained.^[99] Despite surgery's superior efficacy in patient-centered metrics from available randomized data, pessary remains a viable initial option for women unsuitable for or preferring to avoid operative risks, though real-world adherence may decline due to discomfort or inadequate symptom control.^[89]

Complications, Risks, and Criticisms

Common Adverse Effects

The most frequently reported adverse effects of pessary use include increased vaginal discharge, which occurs in up to 83.7% of users over one year and is often physiologic, thin, and watery due to altered vaginal flora from the foreign body.^[100]^[101] Vaginal odor accompanies discharge in many cases, potentially signaling bacterial overgrowth or infection, though it resolves with hygiene or antibiotics in uncomplicated instances.^[7]^[87] Vaginal irritation, erosions, or ulcerations affect 6-17% of users, typically resulting from pressure points, ill-fitting devices, or silicone/surface material interactions, and are more prevalent with prolonged wear without follow-up.^[100]^[63] Bleeding or spotting, noted in 11-56% of cases, stems from mucosal trauma or atrophy, particularly in postmenopausal women, and may necessitate estrogen therapy for mitigation.^[102]^[41] Less frequent but common complaints encompass pelvic pain (from improper sizing or displacement) and constipation (due to mechanical pressure on the rectovaginal septum), each reported in subsets of 10-20% of long-term users.^[87]^[102] These effects contribute to discontinuation rates of 20-50% within the first year, often mitigated by regular cleaning, sizing adjustments, and patient education on self-management.^[103] Overall, while adverse events exceed 50% incidence, most are mild and self-limiting with conservative interventions, contrasting with rarer surgical complications.^[100]^[9]

Rare Serious Complications

Rare serious complications from pessary use primarily arise in cases of prolonged neglect or improper management, often in elderly or cognitively impaired patients who fail to attend follow-up appointments. These events, documented predominantly through case reports and systematic reviews, include fistulas, severe erosions, and organ perforation, with an overall incidence considered exceedingly low given the device's widespread use. A 2022 systematic review of 36 case reports identified vesicovaginal fistula as the most common severe outcome (25%, n=9), followed by rectovaginal fistula (19%, n=7), highlighting erosion as a precursor mechanism where the pessary abrades vaginal walls and adjacent structures over time.^[9] ^[104] Vesicovaginal fistulas occur when chronic pressure from an ill-fitted or retained pessary erodes through the vaginal and bladder walls, leading to continuous urinary leakage into the vagina and potential recurrent infections. Case reports describe complete pessary migration into the bladder, presenting as intravesical foreign bodies after years of neglect, necessitating surgical extraction and fistula repair. Rectovaginal fistulas, similarly rare, result from posterior erosion into the rectal mucosa, causing fecal incontinence or passage of gas/stool through the vagina; one documented instance involved an 82-year-old patient with a ring pessary leading to fistula formation, repaired transvaginally. Bladder rupture and complete uterine eversion have been reported in extreme erosion cases, often requiring multistage surgical intervention including graft interposition.^[105] ^[106] ^[107] Other infrequent severe events include pessary incarceration or impaction, where the device embeds into vaginal tissue, complicating removal and risking hemorrhage or sepsis; a review of 23 such cases reported a median patient age of 76.5 years, with symptoms like severe anemia or renal insufficiency from concealed perforation. Vascular complications, such as arterial vaginal bleeding from short-term use, represent outliers, with one case attributing hemorrhage to pessary pressure on pelvic vessels. Migration with rectal prolapse or embedment has been noted in forgotten ring pessaries, exacerbating prolapse and requiring manual or surgical disimpaction. These complications underscore the necessity of regular monitoring, as neglect amplifies risks, though prospective studies report no serious adverse events in adherent cohorts.^[108] ^[109] ^[110]

Factors Influencing Adherence and Failure

Patient adherence to pessary therapy for pelvic organ prolapse varies widely, with short-term compliance rates at 3 months ranging from 41% to 76%.^[60] Long-term continuation rates at 5-7 years span 14% to 86%, influenced by individual patient characteristics and device management.^[111] Discontinuation after 1 year occurs in approximately 16% of cases, often due to mechanical or symptomatic issues rather than progression of prolapse.^[103] Factors associated with successful adherence include older age, lower body mass index (BMI), and adequate pelvic floor muscle function. Younger patients exhibit higher discontinuation rates, potentially due to greater physical activity or discomfort tolerance differences, with risk decreasing by about 7% per 5-year age increase.^[112] Lower BMI correlates with better fitting success, as higher BMI independently predicts unsuccessful pessary placement.^[113] Active pelvic floor muscles reduce expulsion risk, while self-management capability enhances long-term use, with 84% success in select stage IV cases.^[39] Adequate vaginal length (total vaginal length >7.3 cm) also supports retention.^[113] Common causes of pessary failure or discontinuation include frequent expulsion (19.9-26.3% of cases), insufficient symptom relief (19%), and complications such as erosion (up to 45.3%), vaginal discharge, odor, or pain/pressure (35-42%).^[114]^[103]^[115] Advanced prolapse (stage IV) lowers fitting success to 44-58%, often compounded by obesity or prior reconstructive surgery.^[39]^[116] Underactive pelvic floor function and shorter vaginal length further elevate failure risk during initial fitting, with overall unsuccessful rates reaching 42%.^[117] Personal factors like desire for surgery or worsening incontinence contribute minimally compared to mechanical issues.^[118]

Recent Advancements and Future Directions

Innovations in Design and Materials

Advancements in pessary materials have emphasized biocompatibility, flexibility, and reduced tissue irritation. Silicone, introduced as a primary material in the mid-20th century, offers superior softness and elasticity compared to earlier polyvinyl chloride (PVC), minimizing risks like vaginal erosion and ulceration.^[119] Clinical trials initiated in 2024 hypothesize that silicone ring pessaries achieve higher retention rates and self-management success than PVC counterparts, potentially lowering complication rates from 30% to 10%.^[120] Thermoplastic polyurethane (TPU), a flexible polymer, has gained traction for its moldability in additive manufacturing, enabling production of customized devices with integrated features like drug reservoirs.^[121] Design innovations leverage 3D printing to create patient-specific pessaries, addressing limitations of standardized shapes. Since 2021, technologies combining ultrasound imaging, AI analysis, and 3D fabrication have produced tailored ring pessaries that conform precisely to pelvic anatomy, improving support for pelvic organ prolapse.^[122] A 2023 study demonstrated that such custom 3D-printed devices effectively treat prolapse in women unsuitable for off-the-shelf options, with finite element modeling confirming enhanced biomechanical performance.^[20] These approaches, presented at the 2024 American Urological Association meeting, reduce fitting trials and enhance long-term adherence.^[123] Collapsible and self-removable designs represent further progress in user autonomy. Prototypes incorporating hinged or foldable mechanisms, developed by 2025, simplify insertion and removal without clinician assistance, potentially decreasing clinic visits and infection risks associated with prolonged indwelling.^[124] Hormone-eluting variants, such as silicone rings releasing estriol, integrate pharmacological therapy for atrophy prevention; in vitro tests from 2022 showed sustained drug delivery over months, supporting combined mechanical and estrogenic effects.^[21] These developments, while promising, require larger randomized trials to validate superiority over conventional models.^[19]

Emerging Research on Combinations and Customization

Research into customized pessaries has advanced through patient-specific designs leveraging 3D printing and anatomical modeling to improve fit and efficacy for pelvic organ prolapse (POP). A 2023 prospective study evaluated 3D-printed pessaries tailored to individual vaginal geometry, reporting significant reductions in prolapse symptoms and higher patient satisfaction scores after a 3-week trial period, with all participants preferring the custom device over standard options due to better comfort and stability.^[125] Similarly, a 2024 presentation at the American Urological Association highlighted Cosm Medical's 3D-printed pessaries, which use precise prolapse measurements to create bespoke supports, potentially reducing expulsion rates and enhancing long-term adherence compared to off-the-shelf models.^[123] Ongoing clinical trials, such as NCT06954701 initiated in 2024, are testing personalizable pessaries mimicking the vagina's natural shape to simplify self-insertion and removal, aiming to address common barriers like discomfort and provider dependency.^[126] Combination therapies integrating pessaries with adjunctive interventions show promise for optimizing outcomes in POP management. The ATLAS randomized trial demonstrated that pessary use combined with pelvic floor physiotherapy produced greater symptom improvements (e.g., 49% enhancement in prolapse-specific metrics) than pessary monotherapy (33%), attributing benefits to synergistic strengthening of supportive tissues.^[47] A 2025 randomized controlled trial found that intravaginal conjugated estrogen supplementation alongside pessary therapy increased continuation rates from 51-76% at 12 months, likely by alleviating vaginal atrophy and irritation, though it noted no significant difference in prolapse reduction.^[127] Emerging self-management protocols, including patient-taught pessary insertion combined with biofeedback training, have been associated with 70-80% success in independent use within 3-6 months, reducing clinic visits while maintaining efficacy.^[128] These developments underscore a shift toward multimodal approaches, with preliminary data suggesting customization reduces failure rates by 20-30% in heterogeneous POP cases, though larger longitudinal studies are needed to confirm durability and cost-effectiveness.^[19] Hybrid designs, such as collapsible pessaries paired with topical agents, are under investigation for enhanced tolerability in active patients.^[22]

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a report of transvaginal removal and repair of vesicovaginal fistula
Sep 28, 2022 · We present a case of complete Gellhorn pessary erosion into the bladder with transvaginal removal and repair of vesicovaginal fistula. Case ...
[106]
Rectovaginal Fistula Due to an Erosive Pessary: A Case Report
We report a rare case of a rectovaginal fistula following vaginal ring pessary use in an 82-year-old G7P7 woman.
[107]
Adverse events in women with neglected vaginal pessaries for ...
Dec 30, 2023 · It rarely causes serious adverse effects of urethra, rectum and reproductive system, such as urinary retention, pessary impaction, urogenital fistula, ...
[108]
An Arterial Vaginal Bleed Resulting from Short-Term Pessary Use
Severe, short-term complications are rare, but can occur with pessary management of pelvic organ prolapse. To our knowledge, this is the first case to describe ...
[109]
Vaginal Ring Pessary Migration and Embedment With Rectal Prolapse
Jun 1, 2025 · Common complications include bleeding, vaginal discharge, and ring expulsion. Pessaries are also recommended to be removed once every six months ...
[110]
[PDF] Factors associated with unsuccessful pessary fitting and reasons for ...
Continuation rates at 5-7 years range from 14% to 86%, and the main reasons for discontinuation were complications arising from pessary use rather than inef- ...
[111]
Use of vaginal pessary in women with symptomatic pelvic organ ...
Factors associated with pessary failure at 1 year were: a younger age at insertion (RR5 years increase = 0.93, 95 %CI = 0.86-0.99; p = 0.047); history of ...
[112]
Predictors for unsuccessful pessary fitting in women with ... - PubMed
Conclusions: A higher BMI and shorter TVL were independent predictors of an unsuccessful pessary fitting. Patients with a TVL <7.3 cm are not appropriate ...
[113]
Adherence to support pessary in the treatment of pelvic organ ... - NIH
Aug 7, 2023 · The study suggests that the three main complications leading to pessary discontinuation were ring dislodgement, insufficient effect, and ...
[114]
Updates in Pessary Care for Pelvic Organ Prolapse: A Narrative ...
Donut pessaries suit women with wide vaginal introitus and severe prolapse. Incontinence dishes or rings with knob pessaries help manage stress urinary ...
[115]
Causes of unsuccessful pessary fitting in women with pelvic organ ...
Sep 8, 2020 · Obesity, previous reconstructive pelvic surgery, and advanced symptomatic pelvic organ prolapse (POP) are the three significant risk factors ...
[116]
Predictors of unsuccessful pessary fitting in women with prolapse - NIH
Aug 15, 2016 · Our results indicated that lower age, higher BMI and underactive or inactive pelvic floor muscle function were associated with a higher risk of ...
[117]
Vaginal pessary in advanced pelvic organ prolapse: impact on ...
Nov 6, 2021 · The main reasons for discontinuing treatment were pessary expulsion (7.2%), desire for surgery (1%), and worsening stress urinary incontinence ...Missing: compliance | Show results with:compliance<|separator|>
[118]
Silicone Irregular Hexagon Pessary Versus Polyvinyl Chloride Ring ...
Oct 4, 2024 · We hypothesised that the SIH pessary would have a higher rate of retention and self-management than the polyvinyl chloride (PVC) pessary.
[119]
Study Details | Vaginal Prolapse Pessary Material Trial PVC vs Silicon
Oct 15, 2024 · It is hypothesised that silicone pessaries, compared to PVC pessaries, can reduce the rate of pessary-related complications from 30% to 10% and ...
[120]
Toward a new generation of vaginal pessaries via 3D-printing
The fabrication of TPU-based pessaries via 3D-printing is an innovative strategy to create a customized pessary combination product that simultaneously ...
[121]
https://www.sciencedirect.com/science/article/abs/pii/S093964112200073X
[122]
Innovative 3D-Printed Pessaries - Bilal Iftikhar Chughtai - UroToday
May 15, 2024 · Cosm's new technology uses 3D printing to create custom-fitted pessaries based on precise measurements of the prolapse, offering a more tailored and effective ...
[123]
Research Explores New Options for Pelvic Organ Prolapse Care.
Mar 27, 2025 · Standard modern pessaries can help support the pelvic organs, but they have drawbacks. Some require appointments 2-4 times a year with a ...
[124]
Patient-Specific Pessaries for Pelvic Organ Prolapse Using... - LWW
A 3-week trial period with the customized pessaries resulted in an improvement in prolapse symptoms and overall satisfaction on standardized questionnaires. All ...Missing: emerging | Show results with:emerging
[125]
Evaluation of a Personalizable Pessary for Pelvic Organ Prolapse
The study pessary is made of biocompatible silicone similar to commercially available pessaries. The material and production processes are identical to Cosm ...Missing: modern gynecology
[126]
Effects of intravaginal conjugated oestrogen on pessary continuation ...
Jun 27, 2025 · Pessary treatment is commonly recommended for patients with symptomatic POP.5 However, in previous studies, 24-49% of women discontinued pessary ...
[127]
The Role of Self-Management in Pessary Therapy for Pelvic Organ ...
Jul 24, 2024 · This study investigated pessary self-management (PSM). The primary outcome was how often PSM was taught to patients with pelvic organ prolapse (POP).