Trial Outcomes & Findings for Early Feasibility Study of the Reia Vaginal Pessary (NCT NCT04275089)

NCT ID: NCT04275089

Last Updated: 2023-07-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: During treatment - within 1 hour
• Results posted on: 2023-07-28

Participant Flow

Participant milestones

Measure	Reia Vaginal Pessary Reia Vaginal Pessary: Reia Vaginal Pessary
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Reia Vaginal Pessary Reia Vaginal Pessary: Reia Vaginal Pessary
Overall Study Unable to be fit with Reia pessary	1

Baseline Characteristics

Early Feasibility Study of the Reia Vaginal Pessary

Baseline characteristics by cohort

Measure	Reia Vaginal Pessary n=15 Participants Reia Vaginal Pessary: Reia Vaginal Pessary
Age, Continuous	78 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Pessary type Gellhorn	8 Participants n=5 Participants
Pessary type Ring	7 Participants n=5 Participants
BMI <20	1 Participants n=5 Participants
BMI 20-30	9 Participants n=5 Participants
BMI >30	5 Participants n=5 Participants
Menopause status Post menopause	15 Participants n=5 Participants
Menopause status Pre menopause	0 Participants n=5 Participants
Prolapse severity Stage II	8 Participants n=5 Participants
Prolapse severity Stage III	5 Participants n=5 Participants
Prolapse severity Stage IV	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Reia Vaginal Pessary n=14 Participants 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)	0 cm Standard Deviation 1.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Reia Vaginal Pessary n=14 Participants Reia Vaginal Pessary: Reia Vaginal Pessary
The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination) pessary retained	14 participants
The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination) pessary expelled	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Reia Vaginal Pessary n=14 Participants Reia Vaginal Pessary: Reia Vaginal Pessary
Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination) Not expelled	14 Participants
Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination) Expelled in collapsed state	0 Participants
Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination) Expelled in deployed state	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Reia Vaginal Pessary n=14 Participants Reia Vaginal Pessary: Reia Vaginal Pessary
Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination) Rotated	1 participants
Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination) Not rotated	13 participants

SECONDARY outcome

Timeframe: During treatment - within 1 hour

Population: 1 subject arrived without current pessary in place, so no current pessary VAS removal score was recorded.

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].

Outcome measures

Measure	Reia Vaginal Pessary n=13 Participants Reia Vaginal Pessary: 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 cm Interval -1.3 to 4.3

SECONDARY outcome

Timeframe: During treatment - within 1 hour

Population: 1 subject did not have current pessary reinserted due to discomfort with insertion of the current 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].

Outcome measures

Measure	Reia Vaginal Pessary n=13 Participants Reia Vaginal Pessary: 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 cm Interval -1.2 to 5.7

SECONDARY outcome

Timeframe: Post treatment - within or at 1 hour

Population: Data was not collected by the study team for 1 subject.

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.

Outcome measures

Measure	Reia Vaginal Pessary n=13 Participants Reia Vaginal Pessary: Reia Vaginal Pessary
Global Comfort Associated With Use of the Study Pessary (by Verbal Description) Study pessary more comfortable	2 Participants
Global Comfort Associated With Use of the Study Pessary (by Verbal Description) Equal comfort	6 Participants
Global Comfort Associated With Use of the Study Pessary (by Verbal Description) Current pessary more comfortable	5 Participants

Adverse Events

Reia Vaginal Pessary

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kaitlin Maier

Reia, LLC

Phone: 2032742886

Email: kaitlin@reiahealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place