Feasibility Study of the Reia Vaginal Pessary
Public ClinicalTrials.gov record NCT04508335. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Assessment of Effectiveness and Safety of a Novel Pessary for the Non-Surgical Treatment of Pelvic Organ Prolapse
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal pessary design for the use in women who suffer from symptoms of pelvic organ prolapse (POP) and have already opted for non-surgical management. Recruited patients will have Stage II POP or greater and will be current users of a Gellhorn or ring style pessary. Following enrollment, each subject will enter a 1-month wash out period in which they will continue using their current pessary so that baseline subjective and objective data can be collected. They will then be fit with a study pessary and enter a 3-month treatment phase. Comparative, subjective, and objective data will be collected at the conclusion of the study.
Study identification
- NCT ID
- NCT04508335
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 78 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 20, 2021
- Primary completion
- Jun 15, 2023
- Completion
- Jun 15, 2023
- Last update posted
- Nov 26, 2024
2021 – 2023
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Boston Urogynecology Associates | Cambridge | Massachusetts | 02138 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| New York Medical College | Hawthorne | New York | 10532 | — |
| Main Line Health | Media | Pennsylvania | 19063 | — |
| Women & Infants Hospital | Providence | Rhode Island | 02905 | — |
| UTHealth | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04508335, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 26, 2024 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04508335 live on ClinicalTrials.gov.