Clinical trial NCT06634459: POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
Official title: The POMEGRANATE Trial: A Randomized Controlled Trial Comparing Pessary Home Management of Reia Pessary Versus Standard of Care Pessary for Treatment of Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Prolapse
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in a 1:1 ratio to receive either (1) the Reia System (RS) or (2) standard pessary care (SPC).
Primary purpose: TREATMENT

Brief summary: This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with/without support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 182 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be satisfaction measured at the six-month time point. Secondary outcomes will include validated surveys to assess quality of life, number of self-management events, ease/difficulty of pessary insertion/removal, importance of ability to self-manage pessary, and adverse events.

Specific Aims

Aim 1: To compare satisfaction with pessary use and management between subjects randomized to the Reia System and those randomized to standard of care pessary.

Aim 2: To assess successful fitting, number of refitting visits, number of self-management events and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.

Aim 3: To compare ease/difficulty of pessary use and importance of ability to self-manage, as well as quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.

Aim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.


Eligibility criteria: Inclusion Criteria:

* English-speaking natal females ≥ 18 years of age
* Willing to self-maintain (insert/remove) pessary
* Pessary naïve with Stage II-IV POP desiring conservative management with a pessary
* Primary indication for use of pessary is treatment of pelvic organ prolapse

Exclusion Criteria:

* Primary indication for pessary use is for management of stress urinary incontinence
* Prior mesh-augmented prolapse repair (i.e. transvaginal mesh, sacrocolpopexy)
* Short vaginal length (TVL \< 8cm) or subjective vaginal narrowing
* Vaginal fistula (e.g. rectovaginal, vesicovaginal or any type of fistula involving the vagina)
* Vaginal, rectal or bladder malignancy
* Genitourinary infection requiring treatment (See below 1)
* Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis) (See below 2)
* Inflammatory bowel disease (Crohn's or ulcerative colitis)
* Pelvic or anorectal chronic pain
* Pelvic floor surgery within the past 6 months or planning to undergo pelvic floor surgery
* Congenital malformation of the bladder, rectum or vagina
* Pregnant or planning pregnancy in the next 6 months
* Prior failure of pessary for POP
* History of hydroureter, hydronephrosis, or impaired renal function secondary to prolapse

  1. Patients with acute vaginal infections will be eligible for enrollment 2 weeks after completing treatment with resolution of symptoms
  2. OK to be on prophylactic/suppressive therapy for HSV

Primary outcomes:
measure: Satisfaction with treatment
timeFrame: 6 months
Secondary outcomes:
measure: Total self-management events
timeFrame: 6 months
measure: Patient Global Impression of Severity (PGI-S)
timeFrame: 6 months
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 6 months
measure: Pelvic Floor Distress Inventory-20 (PFDI-20)
timeFrame: 6 months
measure: Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
timeFrame: 6 months
measure: Patient Global Symptoms Control Rating Scale (PGSC)
timeFrame: 6 months
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
timeFrame: 6 months
measure: Pessary outcomes
timeFrame: 6 months
measure: Behavioral Outcomes
timeFrame: 6 months
measure: Participant view of importance of ability to self-maintain pessary
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Washington
country: United States
facility: MedStar Health
state: District of Columbia
city: Northbrook
country: United States
facility: The University of Chicago
state: Illinois
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Providence
country: United States
facility: Women & Infants Hospital in Rhode Island
state: Rhode Island
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
citation: Constantine ML, Pauls RN, Rogers RR, Rockwood TH. Validation of a single summary score for the Prolapse/Incontinence Sexual Questionnaire-IUGA revised (PISQ-IR). Int Urogynecol J. 2017 Dec;28(12):1901-1907. doi: 10.1007/s00192-017-3373-9. Epub 2017 Jun 6.
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citation: Pinhero J, Bates D. Mixed Effects Models in S and S-plus: Springer; 2000.
citation: Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available.
citation: Health UDo, Services H. Common Terminology Criteria for Adverse Events. Version 5.0. Published November 27, 2017. 2020.
citation: Strohbehn K, Wadensweiler P, Hanissian P. A novel, collapsible, space-occupying pessary for the treatment of pelvic organ prolapse. Int Urogynecol J. 2023 Jan;34(1):317-319. doi: 10.1007/s00192-022-05415-y. Epub 2022 Dec 3. No abstract available.