An interventional study of Reia Vaginal Pessary in Pelvic Organ Prolapse and Prolapse, sponsored by Reia, LLC. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-28.
Sponsored by Reia, LLC · Not applicable, Interventional, and Device feasibility
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.
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's enrollment of 15 is below the median of 74 across 435 interventional studies indexed under Prolapse.
Browse Prolapse studies →Reia, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Reia Vaginal Pessary
Reia Vaginal Pessary
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)
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.
Time frame: During treatment - within 1 hour
The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination)
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.
Time frame: During treatment - within 1 hour
Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination)
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.
Time frame: During treatment - within 1 hour
Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination)
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.
Time frame: During treatment - within 1 hour
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]
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 measure is \[VAS after removal of current pessary\] - \[VAS after removal of study pessary\].
Time frame: During treatment - within 1 hour
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]
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 \[VAS after insertion of current pessary\] - \[VAS after insertion of study pessary\].
Time frame: During treatment - within 1 hour
Global Comfort Associated With Use of the Study Pessary (by Verbal Description)
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.
Time frame: Post treatment - within or at 1 hour
| Milestone | Reia Vaginal Pessary |
|---|---|
| Started | 15 |
| Completed | 14 |
| Not completed | 1 |
| Withdrew: Unable to be fit with reia pessary | 1 |
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.
| cm | Reia Vaginal Pessary |
|---|---|
| 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 ± 1.7 |
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.
| participants | Reia Vaginal Pessary |
|---|---|
| pessary retained | 14 |
| pessary expelled | 0 |
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.
| Participants | Reia Vaginal Pessary |
|---|---|
| Not expelled | 14 |
| Expelled in collapsed state | 0 |
| Expelled in deployed state | 0 |
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.
| participants | Reia Vaginal Pessary |
|---|---|
| Rotated | 1 |
| Not rotated | 13 |
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 measure is \[VAS after removal of current pessary\] - \[VAS after removal of study pessary\].
| cm | Reia Vaginal Pessary |
|---|---|
| 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 (-1.3 to 4.3) |
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 \[VAS after insertion of current pessary\] - \[VAS after insertion of study pessary\].
| cm | Reia Vaginal Pessary |
|---|---|
| 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 (-1.2 to 5.7) |
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.
| Participants | Reia Vaginal Pessary |
|---|---|
| Study pessary more comfortable | 2 |
| Equal comfort | 6 |
| Current pessary more comfortable | 5 |
Collected over Duration of subject's sole study visit - within one hour. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reia Vaginal Pessary | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Reia Vaginal Pessary |
|---|---|
| Mean | 78 (63 to 93) |
| Sex: Female, Male(Participants) | Reia Vaginal Pessary |
|---|---|
| Female | 15 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Reia Vaginal Pessary |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 14 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Reia Vaginal Pessary |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Reia Vaginal Pessary |
|---|---|
| United States | 15 |
| Pessary type(Participants) | Reia Vaginal Pessary |
|---|---|
| Gellhorn | 8 |
| Ring | 7 |
| BMI(Participants) | Reia Vaginal Pessary |
|---|---|
| <20 | 1 |
| 20-30 | 9 |
| >30 | 5 |
| Menopause status(Participants) | Reia Vaginal Pessary |
|---|---|
| Post menopause | 15 |
| Pre menopause | 0 |
1 further baseline measures are reported on the registry.
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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