Newly Designed Vaginal Stent to Improve Patient Comfort and Healing Following Vaginal Surgery or Vaginal Radiation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Newly-designed Vaginal Stent to Improve Tissue Healing for Girls and Women With Congenital and Reproductive Anomalies

Conditions
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Vaginal Stricture

Intervention / Treatment
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* Device: Vaginal Stent A
* Device: Vaginal Stent B
* Device: Vaginal Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (healthy participants): 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 No prior history of vaginal surgery or radiation Inclusion Criteria (pediatric participants): 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 Inclusion Criteria (adult radiation participants): 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 Exclusion Criteria (all arms): Non-English or Spanish speaker Pregnant BMI > 45 Diabetic neuropathy limiting use of hands Other limited mobility of hands Vaginismus Urinary retention Vaginal bacterial infection Vaginal fungal infection Allergies to stent materials Seizure disorder Pain with sexual intercourse or tampon insertion

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy participants: acute<br>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. | Device: Vaginal Stent A<br>* Ring stent<br>Device: Vaginal Stent B<br>* Flower stent<br>|
| Experimental: Healthy participants: chronic<br>Healthy participants will wear the stent chosen to be the more comfortable for 2 weeks without removal. | Device: Vaginal Stent<br>* Vaginal stent chosen from A or B that is the most comfortable<br>|
| Experimental: Pediatric participants: post vaginal surgery<br>Pediatric participants will wear the vaginal stent for 2 weeks after undergoing vaginal surgery. | Device: Vaginal Stent<br>* Vaginal stent chosen from A or B that is the most comfortable<br>|
| Experimental: Adult participants: post vaginal brachytherapy<br>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. | Device: Vaginal Stent<br>* Vaginal stent chosen from A or B that is the most comfortable<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting vaginal stent as comfortable. | Participants will report daily on stent comfort and any disruption to normal daily activities. | 24 hours - 4 weeks from stent placement | 
| Number of participants able to retain vaginal stent | Participants will report daily if stent is retained in vaginal canal. | 24 hours - 4 weeks from stent placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who develop vaginal stenosis | Using retrospective data, will compare to the number of enrolled subjects that develop vaginal stenosis | 1 year from stent placement | 
| Number of required subsequent medical interventions | Retrospective study evaluating if requirement of additional medical interventions (i.e. vaginal dilation, corrective surgery, etc) were changed with stent use. | 1 year from stent placement |