Effectiveness and safety of a novel, collapsible pessary for management of pelvic organ prolapse

Abstract

Background:

Pessaries are an effective treatment for pelvic organ prolapse, yet currently available pessaries can cause discomfort with removal and insertion. An early feasibility trial of an investigational, collapsible pessary previously demonstrated mechanical feasibility during a brief 15-minute office trial. Longer-term, patient-centered safety and efficacy data is needed.

Objectives:

To assess the effectiveness and safety of the investigational vaginal pessary for pelvic organ prolapse at three months.

Study Design:

This was a prospective, seven-center, open-label equivalence study with participants serving as their own controls. Subjects were current users of a Gellhorn or ring pessary with ≥ Stage II prolapse. Baseline subjective and objective data were collected for one month using their current pessary, and then data were collected through a three-month treatment phase with use of the study pessary. The primary outcome was change in Pelvic Floor Distress Inventory-20 score. Secondary outcome measures included objective assessment of prolapse support, changes in the Pelvic Floor Impact Questionnaire-7, and pain with insertion and removal measured on a Visual Analog Scale. Subjects fitted with study pessary were analyzed as intention to treat and those who dropped out were assigned scores at the upper limit of the predefined equivalence limits. Secondary per protocol analyses included subjects who completed treatment. The study was powered to 80% with a minimal important change equivalence limit of 18.3 points on the Pelvic Floor Distress Inventory-20 scale. Square root transformations were used for non-parametric data and p-values adjusted for multiple comparisons.

Results:

Seventy-eight subjects were enrolled, though 16 withdrew prior to study pessary placement. Sixty-two subjects (50 ring and 12 Gellhorn pessary users) were fitted with the study pessary, and 48 (62%) completed the three-month intervention. The change in Pelvic Floor Distress Inventory-20 scores at three months demonstrated equivalence compared to the subjects’ baseline scores, (mean difference −3.96 (improvement), 90% confidence interval (CI) [−11.99, 4.08], p=0.002). Per protocol analysis of the Pelvic Floor Distress Inventory-20, equivalence was not demonstrated with scores favoring the study pessary (mean difference −10.45, 90% CI, [−20.35, 0.54] (p=0.095)). Secondary outcomes included: objective measures of support which were similar, mean difference Ba=0.54 cm, Bp=0.04 cm, favoring study pessary; improvement in mean Pelvic Floor Impact Questionnaire-7 scores for those who completed the trial (pre=32.23, post=16.86, p=0.019); and pain with insertion and removal, which was lower with the study pessary compared to subject’s own pessary (mean difference Visual Analogue Scale insertion=9.91 mm (p=0.019), removal=11.23 mm (p=0.019)). No serious adverse events related to the pessary were reported.

Conclusions:

Equivalence was demonstrated in the study pessary primary outcome compared to current non-collapsible pessaries for change in severity and bother of pelvic floor symptoms. In participants who completed the trial, the Pelvic Floor Impact Questionnaire-7 improved with the study pessary and change in Pelvic Floor Distress Inventory-20 scores were non-equivalent, favoring the study pessary. Subjects reported significantly lower pain scores with both pessary insertion and removal with the novel collapsible pessary compared with their standard pessary.

Tweetable Statement:

A novel, collapsible investigational pessary is equivalent to ring and Gellhorn pessaries in terms of bother of pelvic floor symptoms (PFDI-20 score) and demonstrated improvement in life impact of symptoms (PFIQ-7 score) and reduction in pain during insertion and removal.

Introduction:

Pelvic organ prolapse (POP) is common, with 40–50% of women having demonstrable prolapse on physical examination.^1–3 POP typically becomes symptomatic if the vaginal wall protrudes to the level of the hymen or beyond,^4,5 and 3–20% or women seek care for POP in their lifetime. POP management options include watchful waiting, pelvic floor exercises, pessary, and surgery.²

The vaginal pessary is an effective treatment option for POP. Among surveyed urogynecologists, 77% recommend a pessary as first-line treatment for patients with POP.⁶ Pessaries may be as effective as reconstructive surgery in improving symptoms of POP,⁷ and many recommend a pessary trial prior to considering surgery.^2,8,9 Most pessaries are made of silicone, some with fixed geometry (such as Gellhorn, cube, donut) and others fold or flex (ring). The ring and Gellhorn are the two most used pessaries. Most practitioners, particularly non-urogynecologists, preferentially start with fitting a ring pessary because it is easier for patients and practitioners to use than fixed geometry pessaries.^10,11 This is despite findings of equivalence in relieving symptom in a randomized, controlled double-blind study. Gellhorn pessaries more effectively reduce life impact of prolapse symptoms,¹² and once fit, have longer continuation rates than the ring with support (10.5 years vs. 1.8 years).¹³ Additionally, the Gellhorn successfully treated 71% of women at 3 months who failed treatment with the ring with support.⁵ For patients who do not self-manage their pessaries, many U.S. practitioners recommend surveillance visits 2–4 times annually to avoid preventable complications associated with long term pessary use.^2,8,14 Adverse effects have been reported as high as 56%,¹⁵ including: discomfort; vaginal erosion, bleeding and discharge; voiding and defecatory dysfunction.¹⁶ Pessary self-management may optimally tailor pessary use to specific times of need, such as strenuous activities, while allowing temporary removal for other activities, including intercourse.

The investigational study pessary [Reia, LLC; Lyme, NH] is engineered with collapsible geometry and a loop removal feature to improve the comfort and ability of pessary removal and reinsertion by physicians and patients.¹⁷ The pessary (Fig. 1) is manufactured from medical grade silicone, in three sizes, 57, 67, 76 mm (2 ¼, 2⁵/₈, and 3 inches) in diameter, and has a structural form like the Gellhorn. An early feasibility study of the investigational pessary confirmed less patient discomfort with insertion and removal during a 15-minute office trial among current ring and Gellhorn pessary users.¹⁷ The objective of the current study is to determine if the investigational pessary is equivalent for treating POP symptom bother compared to traditional pessaries.

Figure 1.

Study pessary in natural resting state (left), when providing support; and in temporary collapsed state (right) during insertion and removal.

Materials and Methods:

This was a prospective, seven-center, open-label equivalence study with participants serving as their own controls. Subjects were current users of a ring or Gellhorn pessary with at least Stage II POP and all provided written consent. Subjects were recruited at seven participating urogynecology clinical trial sites. Institutional Review Board (IRB) approval was obtained through a central IRB (WIRB-Copernicus Group, Inc., Princeton, NJ) and participating sites’ institutional IRBs. Subjects were compensated for participation with three separate $100 gift cards, totaling $300 if they participated in all study visits. Inclusion and exclusion criteria are listed in Table 1. Subjective and objective data were collected for one month using their current pessary, and then through a three-month treatment phase using the study pessary (Fig. 2). The primary outcome was a change in Pelvic Floor Distress Inventory-20 (PFDI-20) score.¹⁸ Secondary outcome measures included objective assessment of prolapse support, changes in the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), and pain with insertion and removal using a visual analog scale (VAS), 0–100 millimeters.¹⁸

Table 1:

Inclusion and Exclusion Criteria

Inclusion	Exclusion
Women 18 years or older, capable of providing informed consent	Current pregnancy or planning pregnancy in next 6 months
Fluency in English or Spanish	Prior treatment failure with pessary.
POP-Q Stage II or greater	Vaginal length < 8 cm or subjective narrowing
Current pessary user for at least 3 months Gellhorn size 2 – 3.25 inches Ring pessary size 2.25 – 3.5 inches	Presence of Current / preexisting: Deep vaginal erosion with removal of current pessary Vesicovaginal or rectovaginal fistula Open wound or tear near the vagina or anus Vaginal, rectal, or bladder tumor Pelvic, vaginal, urinary infection Inflammatory bowel disease; chronic pain syndrome of pelvic or anorectal origin Pelvic surgery in the preceding 12 months Congenital malformation of the bladder, vagina or rectum Medical conditions that would interfere with study participation (psychologic, neurologic, active substance abuse)

Figure 2.

Flow Diagram

Abbreviations: n = number, POP-Q = Pelvic Organ Prolapse Quantification, VAS = Visual Analogue Scale (mm), PFDI-20 = Pelvic Floor Distress Inventory-20, PFIQ-7 = Pelvic Floor Impact Questionnaire −7, PISQ-IR = Prolapse and Incontinence Sexual Questionnaire.

Baseline data collection (Visit 0) was obtained while the patient was using their current pessary. Visit 0 included: abstracting most recently documented POP-Q examination prior to pessary use, if available; a physical examination; assessment of existing adverse symptoms and objective examination findings. After reinsertion of the current pessary, assessment of prolapse support was measured at the anterior and posterior walls (POP-Q points Ba and Bp). At Visit 1, baseline questionnaires were completed, including the Pelvic Floor Distress Inventory-20 (PFDI-20)¹⁸, the Pelvic Floor Impact Questionnaire-7 (PFIQ-7)¹⁸ and the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR).¹⁹ The pelvic examination was repeated, and the subject’s current pessary removed. The study pessary was fitted, with the initial fitting based on current pessary size (Fig. 3). Immediately after removal of the current pessary and again after insertion of the study pessary, the patient recorded level of discomfort on a 0–100 mm VAS scale. With the study pessary in place, POP-Q points Ba and Bp were measured. Visit 2 was initially scheduled to evaluate for adverse events and to change the study pessary size, if necessary. The protocol was revised 14 months after study initiation, allowing for a virtual Visit 2 unless the subject was experiencing side effects. At the final visit (Visit 3), questionnaires, VAS scores and examination were repeated. At each scheduled visit, subjects were queried about discomfort with use of the pessary, displacement of the pessary, vaginal or bleeding, the feeling of obstructed urination, and constipation. Adverse events were recorded at each visit, including subjective symptoms and examiner findings. If the subjective symptom and examiner finding matched, such as vaginal discharge reported by the patient and the examiner, this was recorded as one adverse event. Adverse events were classified as Grade 1 or mild (easily tolerated by the subject no intervention necessary), Grade 2 or moderate (causing discomfort or interrupting usual activities), or Grade 3 or severe (causing considerable interference with usual activities, may be incapacitating, or may require hospitalization).²⁰ At each in-person visit, examination was performed to evaluate for perineal tearing, vaginal irritation, vaginal ecchymosis, vaginal abrasions/superficial cuts, deep vaginal erosions, vaginal bleeding, granulation tissue, or copious vaginal discharge. Adverse events were additionally reported by patients and/or observed by practitioners at each additional visit or phone call. At each site, the entire data set was combined in a master file and resolved into unique events, which were then categorized to conform to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 definitions.²⁰

Figure 3.

Chart for Initial Sizing and Fitting Study Pessary

Statistical analysis was performed using R, version 4.3.2. Equivalence was evaluated using two one-sided t-tests, each with alpha set at 0.05 to test the composite null hypothesis that the mean difference score between the study and current pessary on the PFDI-20, is between the upper and lower equivalence limits, > 18.3 and < −18.3, respectively. Subjects fitted with study pessary were analyzed as intention to treat. Those who dropped out after any treatment with the study pessary and did not attend Visit 3 did not complete the final PFDI-20 survey. Presuming these data were not missing at random, those subjects were assigned a delta PFDI-20 score of 18.3 (the upper limit of the predefined equivalence limits), disfavoring the study pessary. A sensitivity analysis using missing at random (MAR) based multiple imputation and tipping point analysis was performed to verify treatment of these missing data.

Continuous variables were reported as means (ranges or standard deviations) and medians (ranges) depending on the distribution of data. Categorical data was reported as counts (percentages). Comparisons were made with mean difference and reported as mean difference and 90% confidence interval, using t-test, Wilcoxon and chi-square analysis as indicated. Secondary per protocol analyses included subjects who completed treatment. The study was powered to 80% with a minimal clinically important difference (MCID)²¹ equivalence limit of 18.3 points on the PFDI-20 scale as described by Wiegersema using a distribution based method.²² Based on our power calculation, we planned recruitment for 40 subjects to ultimately complete the study. Due to anticipated dropouts, 78 were recruited. Square root transformations were used for non-normally distributed data and p-values adjusted for multiple comparisons. Square root transformations on quantitative variables prior to the t-test because they were moderately positively skewed. Non-parametric tests (Wilcoxon test) on the raw data to confirm conclusions.

Results:

Baseline demographic and clinical data are listed in Table 2. Seventy-eight subjects were initially enrolled to start the study (Visit 0), and baseline data were collected (Fig. 2). Sixteen (21%) of the enrolled subjects withdrew prior to trying to fit a study pessary for varying reasons, including unexpected events, such as contracting Covid-19, logistical reasons related to inconvenience of travel, and changing mind about participation. Of the 62 remaining subjects (50 ring and 12 Gellhorn pessary users), 59 (95%) were successfully fitted with the study pessary with a median of one pessary attempt for all subjects successfully fitted. Forty-eight (77%) completed the full three-month trial. Change in PFDI-20 scores at three months demonstrated equivalence compared to subjects’ baseline scores, (mean difference −3.96 (improvement), [CI: −11.99, 4.08], p=0.002). Comparing per protocol analysis of the PDFI-20, equivalence was not demonstrated, with improvement favoring the study pessary (−10.45, [−20.35, 0.54], (p=0.095)). Secondary outcomes are listed in Table 2. Objective measures of support were similar, mean difference Ba=0.5 cm, Bp=0.0 cm, favoring study pessary. Improvement was seen in mean PFIQ-7 scores for those who completed the trial (pre=32.23, post=16.86, p=0.019). Pain with insertion and removal was lower with the study pessary compared to subject’s own pessary (mean difference VAS insertion=9.91 (p=0.019), removal= 11.23 (p=0.019)) (Fig. 4). There were 25 subjects (all ring pessary users) who self-managed their pessary prior to study enrollment and 24 continued to self-manage while using the study pessary. Thirteen subjects started self-managing (9 ring and 4 Gellhorn users) during the study period. Among self-managers, current pessaries were removed a mean of 3.07 (7.36 Standard Deviation (SD)) times per month, compared to 2.57 (SD 4.86) times per month with the study pessary. Vaginal estrogen cream was used in 18 of 48 (37.5%) subjects completing the study. There was no difference in sexual activity or PISQ-IR scores before and during study pessary use. Overall patient satisfaction scores slightly favored the study pessary but were not statistically different. Adverse events are grouped by anatomic location (Table 3). There were higher reported side effects with the study pessary, including symptoms of vaginal discharge, bleeding and odor; and higher rates of physical examination findings of granulation tissue and abrasions. While not specifically collected at each visit, an informal query of the investigators confirmed that the location of abrasions seemed to be predominantly at the apex, rather than at the distal vagina, similar to the location of abrasions that the investigators have noted with traditional pessaries. There were no serious adverse events attributed to the study pessary.

Table 2:

Demographics and baseline clinical characteristics of study group.

Characteristic	Fitted with Study Pessary (n = 62)	Completed Study (n=48)
Age (years), Mean (SD), [range]	71.1 (9.04), [28–89]	71.4 (9.50), [28–89]
Parity, Median, [range]	2 [0–8]	2 [1–8]
BMI, Mean (SD), [range]	26.6 (4.37), [20–38]	27.1 (4.34), [21–38]
Current pessary type (n, (%))
Ring	50 (80.6)	38 (79.2)
Gellhorn	12 (20.4)	10 (20.8)
Race (n)
American Indian/Alaska Native	0	0
Asian	1	1
Black or African American	3	3
White	57	43
Unknown or not reported	1	1
Ethnicity (n)
Not Hispanic or Latino	60	46
Hispanic or Latino	2	2
Concomitant Pelvic Floor Disorders (n, (%))
Urinary incontinence	31 (50%)	24 (50%)
Fecal incontinence	9 (14.5%)	6 (12.5%)
Prolapse Organ Prolapse Quantification Scores
Stage, Median, [range]	3 [2, 4]	3 [2, 4]
Baseline POP-Q evaluations with current pessary in situ (cm), Median [Range]
Leading edge	1 [−4, 5.5]	0 [−4, 5.5]
Ba	−2 [−3, 3]	−2 [−3, 3]
Bp	−3 [−3, 1]	−3 [−3, 1]
Historic POP-Q evaluation before pessary (cm), Median [Range]
Aa	1 [−3, 3]	1 [−3, 3]
Ba	1 [−2, 7]	2 [−2, 7]
C	−3 [−8, 7]	−3.25 [−7, 7]
D	−4 [−9, 7]	−5 [−8, 7]
TVL	9 [6.5, 12]	9 [6.5, 12]
Ap	−1.75 [−3, 2]	−1.75 [−3, 2]
Bp	−1.5 [−3, 7]	−1.5 [3, 7]
GH	4 [0.5, 7]	4 [0.5, 7]
PB	3 [0, 5]	3 [0, 5]

Abbreviation: POP-Q: Pelvic Organ Prolapse Quantification

Figure 4.

Pain Scores with insertion / removal of current versus study pessary

Abbreviation: VAS: Visual analog scale (0–100mm)

Table 3:

Primary and secondary outcomes comparing current pessary and study pessary PFDI-20 scores, PFIQ-7 scores, pain with pessary insertion and removal, and support.

	Current Pessary		Study Pessary
	Mean (SD)	n	Mean (SD)	n	Mean difference: μstudy – μcurrent (p-value)	Mean difference square root transformation: μstudy – μcurrent (adjusted p-value)
PFDI-20	62.75 (42.31)	62	49.46+ (43.20)	48	−3.96* (0.0021)	−1.97*^ (0.0005)
PFIQ-7	32.23 (49.08)	48	16.86 (21.73)	48	−15.37*	−1.11*^ (0.019)
Pain (VAS Score, 0–100 mm)
Insertion	23.71 (26.58)	62	13.80 (15.82)	62	9.91*	0.973*^ (0.019)
Removal	34.27 (30.04)	53	23.04 (25.32)	53	11.23*	1.172*^ (0.014)
POP-Q Point (cm) with pessary in place
Ba	−1.6 (1.31)	50	−2.1 (0.95)	50	−0.5*
Bp	−2.3 (0.93)	50	−2.3 (0.95)	50	0.0*
Global satisfaction VAS score	69.69 (24.82)	50	72.63 (28.02)	50	−2.95*

PFDI-20 = Pelvic Floor Distress Inventory-20, PFIQ-7 = Pelvic Floor Impact Questionnaire-7, SD = standard deviation, n = number, μ = mean, POP-Q = Pelvic Organ Prolapse Quantification, VAS = Visual Analogue Scale, in mm, range 0–100.

^*All mean differences favored the study pessary.

⁺Mean calculation based on collected data, dropouts were assigned mean difference values.

^{^}The PFIQ-7, pain with insertion, and pain with removal were square root transformed before computing difference scores to minimize skewness.

Comments:

Principle Findings:

In this prospective study it was found that among current ring and Gellhorn pessary users with at least Stage II prolapse, the investigational, collapsible pessary was equivalent to current pessaries with respect to subject symptom and bother relief. There were no serious adverse events attributed to the study pessary, though higher rates mild adverse event such as vaginal discharge, bleeding, abrasions and granulation tissue. The study pessary was less painful to insert and remove and had a greater improvement in pelvic floor symptoms and measures of prolapse support. Most (95%) of subjects were fitted with the first fitting and many subjects were able to learn self-insertion and removal of the study pessary, including those who previously relied on practitioner management.

Results in the Context of What is Known:

It was found that the study pessary demonstrated equivalence for change in PFDI-20 scores and that PFIQ-7 scores were improved compared to the current pessary. Wiegersma established that a MCID on the PFDI-20 of 13.5 – 18.3 points was clinically relevant.²² For this study, we used their suggested more conservative estimate of MCID, 18.3 points. In other studies investigating pessary treatment to pessary-naïve patients, PFDI-20 scores improved by 29.7–51.4 points and PFIQ scores improved by 29.0–42.1 points, comparing pre-treatment to post-treatment after pessary placement.^12,23–26 A systematic review and analysis by Sansone²⁶ found improvement in PFDI-20 scores of 46.1 (95% CI [26.8, 65.4]) and PFIQ-7 scores of 36.0 (95% CI [26.0, 46.0]) after an average of 3-months of pessary use compared to scores prior to pessary intervention. Our findings confirm the study pessary is as effective at improving bother of pelvic floors symptoms among current ring and Gellhorn pessary users measured by post-treatment PFDI-20 scores.

Most subjects were successfully fitted with the study pessary on the first attempt. This was not surprising, given that the study population was a select group of established pessary users. Of those fitted, 77% continued with the study pessary over the three-month duration of the study protocol. Among pessary-naïve patients with prolapse, initial fitting is reported to be successful in 41–85.8%.^15,27–31 Deng successfully fitted a Gellhorn pessaries in 82.3% of subjects who had failed a trial with a ring pessary, and 70.8% continued to use the Gellhorn pessary at 3 months.³⁰

Chan found that successful pessary use at 12 months correlated with the number of pessaries tried, fewer complications, and an indication of prolapse for pessary-fitting.³² Reported continuation rates in the literature 12 months after pessary fitting ranges from 58–84.9%,^13,32–35 with higher rates reported among Gellhorn pessary users, older age, apical prolapse POP-Q Point C > 0, and Genital Hiatus (GH) < 4.³³ Wolff reported that factors associated with long-term (mean 7.0 years) use included age > 65 years, estrogen use, and Gellhorn use (mean 10.5 years).¹³ Other associated factors for pessary discontinuation include vaginal discharge, prior hysterectomy,³⁴ and plans to proceed with surgery. Given that the study pessary is less uncomfortable to remove and insert, it may provide additional opportunity for successful fitting.

Many studies report improvement in bulge symptoms and PFDI-20 and PFIQ-7 scores, but no citations were found regarding anterior and posterior vaginal support measurements (POP-Q points Aa, Ba) with the pessary in place. Ziv et al reported improvement in POP-Q stage with disposable pessary in place.³⁶

Common complications from vaginal pessaries include vaginal discharge, vaginal bleeding, discomfort, and urinary and bowel symptoms.³⁷ Similar side effects attributable to pessary, including abrasions, granulation tissue, bleeding, and vaginal discharge were noted in this study. In most cases, discharge is related to inflammation associated with the pessary rather than infection.² Bleeding can be the consequence of trauma related to pessary insertion or removal, vaginal atrophy with superficial irritation, vaginal erosions, or granulation tissue.² Vaginal discharge rates have been reported between 23.8–41.5%.^{25,26,38–40} Out of 62 treated subjects in this trial, 19 experienced persisting, 18 new or worsening, and 8 improving discharge. van der Vaart reported vaginal bleeding due to pessary therapy in 11.5% of 218 subjects.³⁸ By comparison, 19% (12/62) of the current subjects had improving or persisting bleeding while 27% experienced new or worsening bleeding. Hagen and van der Vaart reported vaginal pain in 9.7% and discomfort in 42.7% of their subjects.^38,39 Rates of pessary complications in the literature are dependent on definitions used, trial duration, the number of data collection events, and whether the event is reported or observed. This trial is unique in that adverse event data were collected twice in the first month after enrollment with subjects using their current pessary and twice over three months of treatment. While the higher rates of some adverse events observed in this trial compared to the literature could be attributed to sampling frequency, the increased rates of discharge and bleeding seen with use of the study pessary may also be related to its geometry. Regardless, all adverse events related to the study pessary were mild or moderate and within the range of those commonly seen with typical pessary use.

In this trial, 13 subjects dependent on practitioner care for pessary management with their current pessary were able to self-manage with the study pessary, including four Gellhorn users. In a scoping review, Dwyer reported that pessary self-management offers benefits to women in terms of comfort, convenience, perceived access to help and support, and feeling of independence. They found overall complication rates for self-managing women of 10–16%, compared with complication rates of 62% for women receiving clinician-led care. They reported that 70% of self-managing patients remove their pessary usually or always before sexual activitity.⁴¹ With these benefits, it is not surprising that 53% of US practitioners offer pessary self-management to their patients.⁴¹ Regardless, in a review of 580 long-term pessary users, only 1/3 of patients are able to manage their pessary independently, and patients who use Gellhorn pessaries were far less likely to self-manage than those who use ring pessaries.⁴² This study pessary may facilitate self-management.

Clinical Implications:

In some form or other, pessaries have been a management option for millennia.³⁷ The lifetime risk for a woman having surgery for POP is 12.6%, or 1:8.⁴³ Composite risks for recurrent apical prolapse within six years have been reported as high as 43– 57%.⁴⁴ Given that pessaries offer relatively low risk for serious adverse events,² optimizing pessary care may reduce the number of patients needing surgical treatment. Patients who self-manage pessaries in general report better outcomes,^41,45 yet pessary insertion and removal is often related to patient discomfort. As the study pessary has acceptable adverse side effects, with equivalent improvement in bother and symptom relief, it may be a promising alternative due to improved pain with insertion and removal.

Research Implications:

Preliminary findings for the collapsible study pessary are encouraging and additional enhancements and studies are planned. An applicator is being developed for the study pessary to further enable patients’ ability for self-management. This will be studied in a future randomized controlled trial in pessary-naïve women. Additional important next steps include determining the percentage of current pessary users who can learn self-care of their pessaries, and how many primary care practitioners can be taught self-care.^41,45–48 Other recent innovations for pessaries include a disposable pessary,³⁶ and 3-D printed “personalized pessaries”.⁴⁹ Additionally, study of cost-effectiveness and effects on vaginal microbiome may be useful.

Strengths and Limitations:

The strengths of this study include that it is a prospective comparison of the study pessary in a multicenter trial, with subjects as their own controls, using the PDFI-20 and other validated tools to measure effectiveness. Limitations of the study include a relatively high rate of loss of subjects after enrollment before the study pessary was fitted. There were few recruited subjects using Gellhorn pessaries, which typically have higher rates of pain with insertion and removal compared to ring pessaries.

Conclusions:

Equivalence was demonstrated in the study pessary primary outcome compared to current non-collapsible pessaries for change in severity and bother of pelvic floor symptoms. Subjects reported significantly lower pain scores with both pessary insertion and removal with the novel collapsible pessary compared with their standard pessary. The study pessary may facilitate pessary users to increase self-management of their pessaries. Further study is needed to determine if side effects of increased vaginal discharge and bleeding may be reduced with more frequent removal and pessary management.

Table 4:

Adverse events reported by patients or examiner.

Reported Adverse Events	Persistent AE with current and study pessary	New AE and/or worsening with study pessary	Improvement in AE with study pessary
Vaginal Symptoms / Signs
Discharge	19	18	8
Bleeding	8	17	4
Granulation tissue / abrasions / erosions / ecchymosis	2	30	8
Vaginal irritation / burning / pain	2	11	5
Odor	0	3	0
Bulge	0	0	2
Subtotal Vaginal Symptoms / Signs	31	79	27
Pain / Discomfort / Pessary malposition
Sensation of displacement	10	16	10
Pain / Discomfort with use / Pressure	12	17	15
Dislodged pessary	0	3	0
Pruritus	0	2	0
Difficulty reinserting	0	1	1
Labial irritation	0	1	0
Pessary rotation causing inability to remove	0	1	0
Perineal tear	1	0	2
Subtotal Pain/ Discomfort / Pessary malposition	23	41	28
Urinary Symptoms
Incontinence	1	4	2
Obstructed urination (subjective and objective)	3	3	12
Frequency / urgency	1	2	0
UTI	0	1	0
Subtotal Urinary Symptoms	5	10	14
Bowel Symptoms
Constipation / incomplete defecation	3	4	10
Fecal incontinence	0	1	0
Removal of pessary to enable bowel movement	0	0	1
Proctitis	1	0	0
Subtotal Bowel Symptoms	4	5	11
Total	70	135	81

Abbreviations: AE = adverse events, UTI = Urinary tract infection

AJOG at a Glance:

A. Why was this study conducted?

This study was conducted to investigate whether a novel, collapsible investigational pessary is a safe and effective option to treat organ prolapse, compared to currently available ring and Gellhorn pessaries.

B. What are the key findings?

The study pessary is effective at supporting prolapse among current ring and Gellhorn pessary users with equivalent change in presence and bother of pelvic floor symptoms measured by post-treatment PFDI-20 scores. Almost all subjects (95%) who attempted fitting with the novel pessary were successful, most on the first attempt. Most participants found the study pessary less painful with insertion and removal but did have increased vaginal discharge and spotting. Many subjects not previously performing self-insertion and removal could do so with the study pessary. There were no serious adverse events related to pessary use.

C. What does this study add to what is already known?

Based on its novel design, the collapsible study pessary may allow more pessary users to self-manage their pessary. Further study is needed to determine if side effects of increased vaginal discharge and bleeding may be reduced with more frequent removal and pessary management.