N/A
N=15
Early Feasibility Study of the Reia Vaginal Pessary
Pelvic Organ Prolapse · Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT04275089 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: The Ability of the Study Device to be Retained During Valsalva Compared to the Ability of the Subject's Current Pessary to be Retained During Valsalva (Change in Distance Between Current Pessary and Study Pessary to Leading Edge to the Hymen) — 0 cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reia Vaginal Pessary (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Reia, LLC
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Ability of the Study Device to be Retained During Valsalva Compared to the Ability of the Subject's Current Pessary to be Retained During Valsalva (Change in Distance Between Current Pessary and Study Pessary to Leading Edge to the Hymen) |
— | — |
| PRIMARY The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination) |
14; 0 | — |
| SECONDARY Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination) |
14; 0; 0 | — |
| SECONDARY Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination) |
1; 13 | — |
| SECONDARY Discomfort Experienced With Removal of the Study Pessary Subtracted From the Discomfort Experienced With Removal of the Subject's Current Pessary (Change in VAS) [Positive Score Indicates Lower Discomfort With Study Pessary] |
1.4 | — |
| SECONDARY Discomfort Experienced With Insertion of the Study Pessary Subtracted From the Discomfort Experienced With Insertion of the Subject's Current Pessary (Change in VAS) [Positive Score Indicates Lower Discomfort With Study Pessary] |
1.3 | — |
| SECONDARY Global Comfort Associated With Use of the Study Pessary (by Verbal Description) |
2; 6; 5 | — |
Summary
This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse (POP). Recruited patients will have Stage II POP or greater and will be current users of a legally marketed vaginal pessary. In a single visit, data will be collected on the performance and comfort of the subject's current pessary. After placement of a study pessary, comparative data will be collected between subject's current pessary and the study pessary on ability to support prolapse. The study pessary's function will be assessed under controlled circumstances. The patient will have her current pessary replaced at the conclusion of the visit. Results will be used to inform future design modifications of the study pessary.
Eligibility Criteria
Inclusion Criteria
- Women with Stage II pelvic organ prolapse or greater
- Current ring style or Gellhorn pessary users inclusive of sizes 1.5"-3.5"
- Capable of giving informed consent
Exclusion Criteria
- Pregnancy
- Deep vaginal erosion noted with removal of current pessary
- Presence of vesicovaginal fistula
- Presence of rectovaginal fistula
- Vaginal, rectal, or bladder tumor
- Inflammatory Bowel Disease
- Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary
- Current vaginal or urinary infection requiring treatment
- Previous pelvic floor surgery in last 12 months
- Congenital malformation of bladder, rectum, or vagina
- Significant medical condition interfering with study participation (psychologic, neurologic, active drug/alcohol abuse, etc.)
- Planning pregnancy in next 6 months
Data sourced from ClinicalTrials.gov (NCT04275089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.