18 and older, female only, with Pelvic Organ Prolapse or Prolapse. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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· During treatment - within 1 hour
The subject will be asked to Valsalva with their current pessary in place, and the distance from the leading edge of the current pessary to the hymen will be measured in centimeters. After the current pessary is removed and with the study pessary in place, the subject will be asked to Valsalva again. The distance from the leading edge of the study pessary to the hymen will be measured in centimeters. In order to assess the ability of the study pessary to function and be retained, the measurements will be compared.
Group
Value
95% CI
Reia Vaginal Pessary
0
± 1.7
The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination)Primary· During treatment - within 1 hour
With the study pessary in place, the subject will be asked to ambulate for 10 minutes and attempt to void. Following these activities, whether the pessary was retained or expelled will be recorded.
pessary retained
Group
Value
95% CI
Reia Vaginal Pessary
14
pessary expelled
Group
Value
95% CI
Reia Vaginal Pessary
0
Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination)Secondary· During treatment - within 1 hour
The subject will be asked to Valsalva. If the study device is expelled during Valsalva, whether the study device was expelled fully deployed or whether it prematurely folded to its collapsed state will be recorded.
Group
Value
95% CI
Reia Vaginal Pessary
14
Reia Vaginal Pessary
0
Reia Vaginal Pessary
0
Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination)Secondary· During treatment - within 1 hour
Following ambulation and attempting to void and prior to removing the study pessary, it will be recorded if the study device's stem rotated out of its original inserted position.
Rotated
Group
Value
95% CI
Reia Vaginal Pessary
1
Not rotated
Group
Value
95% CI
Reia Vaginal Pessary
13
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]Secondary· During treatment - within 1 hour
To indicate discomfort, the subject will be shown and asked to mark a visual analogue scale (VAS) after removal of her current pessary and before using the study pessary. The VAS will be a 10 centimeter linear continuum in which 0 represents no pain and 10 represents worst pain. After use of the study pessary and upon removal of the study pessary, the subject will be shown and asked to mark another VAS. In order to assess the discomfort experienced during removal of the study pessary, the distance from 0 to the subject's mark will be measured and compared between the two scales. The outcome me
Group
Value
95% CI
Reia Vaginal Pessary
1.4
-1.3 – 4.3
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]Secondary· During treatment - within 1 hour
To indicate discomfort, the subject will be shown and asked to mark a VAS after insertion of the study pessary. The VAS will be a 10 centimeter linear continuum in which 0 represents no pain and 10 represents worst pain. After use of the study pessary and upon insertion of the subject's current pessary, the subject will also be shown and asked to mark another VAS. In order to assess the discomfort experienced during insertion of the study pessary, the distance from 0 to the subject's mark will be measured and compared between the two scales. The outcome measure is \[VAS after insertion of curr
Group
Value
95% CI
Reia Vaginal Pessary
1.3
-1.2 – 5.7
Global Comfort Associated With Use of the Study Pessary (by Verbal Description)Secondary· Post treatment - within or at 1 hour
Following insertion of the subject's current pessary, and after the subject is dressed, she will be asked whether the study pessary was more, less, or as comfortable as her current pessary when it was in situ. If she responds it was more or less comfortable, she will be asked to describe why.
Study pessary more comfortable
Group
Value
95% CI
Reia Vaginal Pessary
2
Equal comfort
Group
Value
95% CI
Reia Vaginal Pessary
6
Current pessary more comfortable
Group
Value
95% CI
Reia Vaginal Pessary
5
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Reia, LLC
Last refreshed: 28 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04275089.