Back to resultsEarly Feasibility Study of the Reia Vaginal Pessary
Primary Purpose
Pelvic Organ Prolapse, Prolapse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reia Vaginal Pessary
Sponsored by
About this trial
This is an interventional device feasibility trial for Pelvic Organ Prolapse
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
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Reia Vaginal Pessary
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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].
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].
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04275089
Brief Title
Early Feasibility Study of the Reia Vaginal Pessary
Official Title
Early Feasibility Prospective Open-Label Study to Assess the Function of a Novel Pessary for the Non-Surgical Management of Pelvic Organ Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
January 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reia, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Prolapse
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reia Vaginal Pessary
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Reia Vaginal Pessary
Intervention Description
Reia Vaginal Pessary
Primary Outcome Measure Information:
Title
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)
Description
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
Title
The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination)
Description
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
Secondary Outcome Measure Information:
Title
Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination)
Description
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
Title
Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination)
Description
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
Title
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]
Description
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
Title
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]
Description
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
Title
Global Comfort Associated With Use of the Study Pessary (by Verbal Description)
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kris Strohbehn, MD
Organizational Affiliation
Dartmouth-Hitchcock Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Feasibility Study of the Reia Vaginal Pessary
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