Pelvic Organ ProlapseNCT04275089
Early Feasibility Study of the Reia Vaginal Pessary
A study testing Reia Vaginal Pessary in people with Pelvic Organ Prolapse and Prolapse, run by Reia, LLC at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Prolapse
- What is being tested?
- Reia Vaginal Pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 20 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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
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.
- Conditions
- Pelvic Organ Prolapse, Prolapse
- Being tested
- Reia Vaginal Pessary
- Medical subject headings
- Pelvic Organ Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reia Vaginal PessaryDevice
Reia Vaginal Pessary
| Study group | Role | What they receive |
|---|---|---|
| Reia Vaginal Pessary | Experimental | Not described Receives: Device: Reia Vaginal Pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During treatment - within 1 hour
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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].
Measured: 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].
Measured: 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.
Measured: Post treatment - within or at 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start5 Nov 2020
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reia, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kris Strohbehn, MD, Principal investigator, Dartmouth-Hitchcock Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275089
- Sponsor's protocol ID
- CP-001
- Status last verified
- Sep 2022
- First submitted
- 12 Feb 2020
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04275089
- Acronym / sponsor ID
- CP-001
- Conditions
- Pelvic Organ Prolapse, Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Reia, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Posted 28 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reia Vaginal Pessary | Experimental | Device: Reia Vaginal Pessary |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- Pregnancy
- Deep vaginal erosion noted with removal of current pessary
- Presence of vesicovaginal fistula
- Presence of rectovaginal fistula
- Vaginal, rectal, or bladder tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reia Vaginal PessaryReia Vaginal Pessary | Device | Reia Vaginal Pessary |
Primary outcome
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)
Time frame: 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.
The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination)
Time frame: 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.
5 secondary outcomes
Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination)
Time frame: During treatment - within 1 hour
Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination)
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]
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]
Time frame: During treatment - within 1 hour
Global Comfort Associated With Use of the Study Pessary (by Verbal Description)
Time frame: Post treatment - within or at 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kris Strohbehn, MD principal investigator
Dartmouth-Hitchcock Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reia Vaginal Pessary in people with Pelvic Organ Prolapse and Prolapse, run by Reia, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: During treatment - within 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.