Pelvic Organ Prolapse, Prolapse
Conditions
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 200 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.
Interventions
DEVICEReia System
Reia pessary
DEVICEStandard of Care Pessary
Gellhorn pessary or ring with/without support without knob pessary
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with treatment | 6 months | The primary outcome will be measured by participant response to the question "How satisfied or unsatisfied are you with your ability to use and manage the pessary provided to you?" with response collected via VAS ranging from "0mm = very unsatisfied" to "100mm = very satisfied" with 50mm = neutral (neither satisfied nor unsatisfied). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total self-management events | 6 months | Defined as removing the pessary ≥ one time per 24-hour period over the six-month follow-up period, this outcome will be summed and divided by actual days of follow-up to accommodate minor variation across participants in the exact length of follow-up. |
| Patient Global Impression of Severity (PGI-S) | 6 months | A single item questionnaire to assess the patient's impression of disease severity. For purposes of this trial, the investigators have adapted the PGI-I to specifically ask about "prolapse" severity. It will ask participants to "Check the one number that best describes how the participant's prolapse condition is now" on a 4-point Likert scale ranging from (1) normal to (4) severe |
| Patient Global Impression of Improvement (PGI-I) | 6 months | A single item questionnaire to assess a patient's impression of change. For purposes of this trial, the investigators have adapted the PGI-I to specifically ask about "prolapse symptoms." It will ask participants to "Check the one number that best describes how the participant's prolapse condition is now, compared with how it was before the participant began this study" on a 7-point Likert scale ranging from (1) very much better to (7) very much worse |
| Pelvic Floor Distress Inventory-20 (PFDI-20) | 6 months | A 20-item condition-specific quality-of-life instrument with three scales (6-item Urinary Distress Inventory, 6-item Pelvic Organ Prolapse Distress Inventory, and 8-item Colorectal-Anal Distress Inventory) used to evaluate the impact of pelvic floor disorders on quality of life with a response scale from 0 (not present) to 4 (quite a bit bothersome). |
| Pelvic Floor Impact Questionnaire-7 (PFIQ-7) | 6 months | A 7-item condition-specific quality-of-life instrument with three scales (Urinary, Pelvic Organ Prolapse, and Colorectal-Anal). The PFIQ-7 is a validated instrument that is widely utilized in research in conjunction with the PFDI-20 to provide a comprehensive evaluation of the impact of pelvic floor disorders on quality of life, specifically how they affect activities, relationships, and feelings on a scale from not at all to quite a bit. |
| Patient Global Symptoms Control Rating Scale (PGSC) | 6 months | A a single item adapted for purposes of this trial. It will state "My current treatment is giving me adequate control of my prolapse" and participants will be asked to select a response on a 5-point Likert scale ranging from (1) disagree strongly to (5) agree strongly |
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) | 6 months | A validated instrument to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence with 21 questions for sexually active women and 12 questions for non-sexually active women |
| Pessary outcomes | 6 months | Will include continued use of pessary and number of unintentional pessary expulsions |
| Behavioral Outcomes | 6 months | Will include a 5-point Likert scale ranging from (1) disagree strongly to (5) agree strongly about participants' ease of self-administered pessary insertion, ease of self-administered pessary removal, discomfort with self-administration of pessary insertion, and discomfort with self-administration of pessary removal |
| Participant view of importance of ability to self-maintain pessary | 6 months | This outcome will be measured by the question "How important is it to you to be able to self-manage your pessary?" with response options on a 5-point Likert scale of 1-not at all important, 2-slightly important, 3-neutral, 4-moderately important, 5-very important. |
Countries
United States
Outcome results
None listed