Vaginal StrictureNCT04807387
Newly Designed Vaginal Stent to Improve Patient Comfort and Healing Following Vaginal Surgery or Vaginal Radiation
A study testing Vaginal Stent A, Vaginal Stent B and Vaginal Stent in people with Vaginal Stricture, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Each year, females need surgery to create a vaginal canal or pelvic radiation to treat cancer. The result is often a narrowing or scarring of their vagina. To aid in healing a stent is often placed. However, current stents are poorly designed. Read more about this study
- Who is it for?
- Ages 13 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Stricture
- What is being tested?
- Vaginal Stent A, Vaginal Stent B and Vaginal Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2022to 18 Jan 2023
- 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 13 to 64 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Not pregnant
- participant consent or parent/guardian consent \& participant assent
- Understand requirements of study
- Agree to abide by study restrictions
- Able to travel to Houston
- Understand English or Spanish to a 5th grade level
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- No prior history of vaginal surgery or radiation
- Not pregnant
- participant consent or parent/guardian consent \& participant assent
- Understand requirements of study
- Agree to abide by study restrictions
- Able to travel to Houston
- Understand English or Spanish to a 5th grade level
- Undergoing vaginal surgery
- Not pregnant
- participant consent or parent/guardian consent \& participant assent
- Understand requirements of study
- Agree to abide by study restrictions
- Able to travel to Houston
- Understand English or Spanish to a 5th grade level
- Undergoing vaginal brachytherapy
Who cannot join
- Non-English or Spanish speaker
- Pregnant
- BMI > 45
- Diabetic neuropathy limiting use of hands
- Other limited mobility of hands
- Vaginismus
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- Urinary retention
- Vaginal bacterial infection
- Vaginal fungal infection
- Allergies to stent materials
- Seizure disorder
- Pain with sexual intercourse or tampon insertion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Newly-designed Vaginal Stent to Improve Tissue Healing for Girls and Women With Congenital and Reproductive Anomalies
Each year, females need surgery to create a vaginal canal or pelvic radiation to treat cancer. The result is often a narrowing or scarring of their vagina. To aid in healing a stent is often placed. However, current stents are poorly designed. The goal of this trial is to test newly designed vaginal stents, with the hope of replacing the poorly retained and uncomfortable standard of care. This trial has two aims. In the first aim, healthy participants will evaluate two newly designed vaginal stents for retention, comfort, and safety over 24 hours. The preferred stent will then be worn by the healthy participants for 2 weeks, again evaluating retention, comfort, and safety. In the second aim, the stents will be evaluated by two different patient populations. Adolescent participants undergoing vaginal surgery for genetic anomalies, will have a stent placed following surgery for continuous wear for 2 weeks. Adult participants undergoing vaginal brachytherapy will have the stent placed following the final brachytherapy treatment. These participants will wear the stent continuously for 2 weeks, followed by an additional 2 weeks of continuous wear. Each participant will evaluate the stent for retention, comfort, and safety. We hypothesize the newly designed stents will be retained longer and be more comfortable compared to current standards of care.
Read the detailed description
After surgery or radiation to the vaginal area, a common patient risk is that their vaginal tissue sticks together and scars. This can cause the vaginal canal to narrow or shorten. This can occur in up to 73% of patients and to fix the scarring, more surgery or uncomfortable procedures may be needed to widen the canal. To prevent the problem of scarring after surgery or radiation, patients should wear a stent to hold open the vaginal canal. Unfortunately, the current stents are poorly made and not very advanced. The result can be a poor fit to the vagina, movement of the stent, and patients not being able to wear the stent for a long enough time to keep the vaginal tissue from scarring.
The first aim of this trial is for healthy participants to evaluate two newly designed stents. Each participant will have a stent placed for 24 hours, removed for 24 hours, and the second stent placed for 24 hours. The participants will evaluate the stent on comfort (during insertion, wearing, and removal), retention, any impact on daily functions, and chose which stent performed better overall. That stent will then be placed in the healthy participants for 2 weeks of continuous wear. Participants will answer daily questionnaires on comfort, retention, and any adverse effects. Physicians will also be asked to complete questionnaires at each appointment related to stent performance.
The second aim of the trial is for two different patient populations to evaluate the preferred stent chosen by the healthy participants. Adolescent girls undergoing vaginal reconstructive surgery for vaginal anomalies will have a stent placed following surgery. During the two weeks of continuous wear, participants will be asked to answer daily questionnaires on comfort, retention, and adverse effects. The stent will be removed at two weeks, and participants will be asked to complete a follow-up questionnaire at each of their standard of care appointments, 2, 4, and 6 weeks, 3, 6, and 12 months. Adult females undergoing vaginal brachytherapy will have a stent placed after their last brachytherapy treatment. The participants will wear the stent continuously for 2 weeks and be asked to answer daily questionnaires on comfort, retention, and adverse effects. Participants will have a 2-week follow-up, during which the stent will be removed, they will be examined, and the stent will be replaced for 2 more weeks of continuous wear. At the 4-week follow-up, the stent will be removed and subsequent standard of care follow-ups will continue at 3, 6, and 12 months. Physicians will also be asked to complete questionnaires at each appointment related to stent performance.
During all phases of the trial, the data safety monitoring board will meet at regularly scheduled meetings and immediately after any severe or unanticipated adverse event. After our 12 months of follow up, data collected from both participant and physician questionnaires will be analyzed by the study bio-statistician and compared to retrospective data.
- Conditions
- Vaginal Stricture
- Being tested
- Vaginal Stent A, Vaginal Stent B, Vaginal Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Stent ADevice
Ring stent
Vaginal Stent BDevice
Flower stent
Vaginal StentDevice
Vaginal stent chosen from A or B that is the most comfortable
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants: acute | Experimental | Healthy participants will wear one of two vaginal stents for 24 hours, followed by a 24 hour wash out period. They will then wear the second vaginal stent for 24 hours. After both stents have been worn, the participants will choose the most comfortable stent. Receives: Device: Vaginal Stent A; Device: Vaginal Stent B |
| Healthy participants: chronic | Experimental | Healthy participants will wear the stent chosen to be the more comfortable for 2 weeks without removal. Receives: Device: Vaginal Stent |
| Pediatric participants: post vaginal surgery | Experimental | Pediatric participants will wear the vaginal stent for 2 weeks after undergoing vaginal surgery. Receives: Device: Vaginal Stent |
| Adult participants: post vaginal brachytherapy | Experimental | Adult participants undergoing vaginal brachytherapy for cancer treatment will wear the stent for 2 weeks, be evaluated by a physician, and wear the stent for an additional 2 weeks. Receives: Device: Vaginal Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Vaginal Stent as Comfortable.
Participants will report daily on stent comfort and any disruption to normal daily activities.
Measured: 24 hours from stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start5 May 2022
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Why it stopped: After enrolling 6 healthy participants the study is being put on halted due to funding and personnel gap. All participants have been informed, per study IRB, of study status.
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 Vaginal StrictureStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), BioTex, Inc.
- Responsible party
- Principal investigator, Julie Hakim, Baylor College of Medicine
- Investigators
- Julie CE Hakim, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807387
- Sponsor's protocol ID
- H-45549
- Other IDs
- 5R44HD092156-03
- Status last verified
- Jul 2024
- First submitted
- 3 Mar 2021
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newly-designed Vaginal Stent to Improve Tissue Healing for Girls and Women With Congenital and Reproductive Anomalies
- ClinicalTrials.gov ID
- NCT04807387
- Acronym / sponsor ID
- H-45549
- Conditions
- Vaginal Stricture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After enrolling 6 healthy participants the study is being put on halted due to funding and personnel gap. All participants have been informed, per study IRB, of study status.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), BioTex, Inc.
- Study start
- 5 May 2022 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Posted 6 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Each year, females need surgery to create a vaginal canal or pelvic radiation to treat cancer. The result is often a narrowing or scarring of their vagina. To aid in healing a stent is often placed. However, current stents are poorly designed. The goal of this trial is to test newly designed vaginal stents, with the hope of replacing the poorly retained and uncomfortable standard of care. This trial has two aims. In the first aim, healthy participants will evaluate two newly designed vaginal stents for retention, comfort, and safety over 24 hours. The preferred stent will then be worn by the healthy participants for 2 weeks, again evaluating retention, comfort, and safety. In the second aim, the stents will be evaluated by two different patient populations. Adolescent participants undergoing vaginal surgery for genetic anomalies, will have a stent placed following surgery for continuous wear for 2 weeks. Adult participants undergoing vaginal brachytherapy will have the stent placed following the final brachytherapy treatment. These participants will wear the stent continuously for 2 weeks, followed by an additional 2 weeks of continuous wear. Each participant will evaluate the stent for retention, comfort, and safety. We hypothesize the newly designed stents will be retained longer and be more comfortable compared to current standards of care.
Detailed description
After surgery or radiation to the vaginal area, a common patient risk is that their vaginal tissue sticks together and scars. This can cause the vaginal canal to narrow or shorten. This can occur in up to 73% of patients and to fix the scarring, more surgery or uncomfortable procedures may be needed to widen the canal. To prevent the problem of scarring after surgery or radiation, patients should wear a stent to hold open the vaginal canal. Unfortunately, the current stents are poorly made and not very advanced. The result can be a poor fit to the vagina, movement of the stent, and patients not being able to wear the stent for a long enough time to keep the vaginal tissue from scarring.
The first aim of this trial is for healthy participants to evaluate two newly designed stents. Each participant will have a stent placed for 24 hours, removed for 24 hours, and the second stent placed for 24 hours. The participants will evaluate the stent on comfort (during insertion, wearing, and removal), retention, any impact on daily functions, and chose which stent performed better overall. That stent will then be placed in the healthy participants for 2 weeks of continuous wear. Participants will answer daily questionnaires on comfort, retention, and any adverse effects. Physicians will also be asked to complete questionnaires at each appointment related to stent performance.
The second aim of the trial is for two different patient populations to evaluate the preferred stent chosen by the healthy participants. Adolescent girls undergoing vaginal reconstructive surgery for vaginal anomalies will have a stent placed following surgery. During the two weeks of continuous wear, participants will be asked to answer daily questionnaires on comfort, retention, and adverse effects. The stent will be removed at two weeks, and participants will be asked to complete a follow-up questionnaire at each of their standard of care appointments, 2, 4, and 6 weeks, 3, 6, and 12 months. Adult females undergoing vaginal brachytherapy will have a stent placed after their last brachytherapy treatment. The participants will wear the stent continuously for 2 weeks and be asked to answer daily questionnaires on comfort, retention, and adverse effects. Participants will have a 2-week follow-up, during which the stent will be removed, they will be examined, and the stent will be replaced for 2 more weeks of continuous wear. At the 4-week follow-up, the stent will be removed and subsequent standard of care follow-ups will continue at 3, 6, and 12 months. Physicians will also be asked to complete questionnaires at each appointment related to stent performance.
During all phases of the trial, the data safety monitoring board will meet at regularly scheduled meetings and immediately after any severe or unanticipated adverse event. After our 12 months of follow up, data collected from both participant and physician questionnaires will be analyzed by the study bio-statistician and compared to retrospective data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy participants: acute | Experimental | Device: Vaginal Stent A, Device: Vaginal Stent BHealthy participants will wear one of two vaginal stents for 24 hours, followed by a 24 hour wash out period. They will then wear the second vaginal stent for 24 hours. After both stents have been worn, the participants will choose the most comfortable stent. |
| Healthy participants: chronic | Experimental | Device: Vaginal StentHealthy participants will wear the stent chosen to be the more comfortable for 2 weeks without removal. |
| Pediatric participants: post vaginal surgery | Experimental | Device: Vaginal StentPediatric participants will wear the vaginal stent for 2 weeks after undergoing vaginal surgery. |
| Adult participants: post vaginal brachytherapy | Experimental | Device: Vaginal StentAdult participants undergoing vaginal brachytherapy for cancer treatment will wear the stent for 2 weeks, be evaluated by a physician, and wear the stent for an additional 2 weeks. |
Who may qualify
- Ages
- 13 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- Not pregnant
- participant consent or parent/guardian consent \& participant assent
- Understand requirements of study
- Agree to abide by study restrictions
- Able to travel to Houston
Key exclusion criteria (12 listed)
- Non-English or Spanish speaker
- Pregnant
- BMI > 45
- Diabetic neuropathy limiting use of hands
- Other limited mobility of hands
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 |
|---|---|---|
| Vaginal Stent ARing stent | Device | Healthy participants: acute |
| Vaginal Stent BFlower stent | Device | Healthy participants: acute |
| Vaginal StentVaginal stent chosen from A or B that is the most comfortable | Device | Adult participants: post vaginal brachytherapy, Healthy participants: chronic, Pediatric participants: post vaginal surgery |
Primary outcome
Number of Participants Reporting Vaginal Stent as Comfortable.
Time frame: 24 hours from stent placement
Participants will report daily on stent comfort and any disruption to normal daily activities.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Julie CE Hakim, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Stent A, Vaginal Stent B and Vaginal Stent in people with Vaginal Stricture, run by Baylor College of Medicine 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 21 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: stopped early, as of the sponsor's last update on 6 Aug 2024. 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 6 Aug 2024). 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?
Number of Participants Reporting Vaginal Stent as Comfortable. (time frame: 24 hours from stent placement). 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 6 Aug 2024.