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

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ClinicalTrials.gov Identifier: NCT04807387
Recruitment Status : Not yet recruiting
First Posted : March 19, 2021
Last Update Posted : October 29, 2021
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
BioTex, Inc.
Information provided by (Responsible Party):
Julie Hakim, Baylor College of Medicine

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Vaginal Stricture Device: Vaginal Stent A Device: Vaginal Stent B Device: Vaginal Stent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Newly-designed Vaginal Stent to Improve Tissue Healing for Girls and Women With Congenital and Reproductive Anomalies
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: Healthy participants: acute
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
Ring stent

Device: Vaginal Stent B
Flower stent

Experimental: Healthy participants: chronic
Healthy participants will wear the stent chosen to be the more comfortable for 2 weeks without removal.
Device: Vaginal Stent
Vaginal stent chosen from A or B that is the most comfortable

Experimental: Pediatric participants: post vaginal surgery
Pediatric participants will wear the vaginal stent for 2 weeks after undergoing vaginal surgery.
Device: Vaginal Stent
Vaginal stent chosen from A or B that is the most comfortable

Experimental: Adult participants: post vaginal brachytherapy
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
Vaginal stent chosen from A or B that is the most comfortable




Primary Outcome Measures :
  1. Number of participants reporting vaginal stent as comfortable. [ Time Frame: 24 hours - 4 weeks from stent placement ]
    Participants will report daily on stent comfort and any disruption to normal daily activities.

  2. Number of participants able to retain vaginal stent [ Time Frame: 24 hours - 4 weeks from stent placement ]
    Participants will report daily if stent is retained in vaginal canal.


Secondary Outcome Measures :
  1. Number of participants who develop vaginal stenosis [ Time Frame: 1 year from stent placement ]
    Using retrospective data, will compare to the number of enrolled subjects that develop vaginal stenosis

  2. Number of required subsequent medical interventions [ Time Frame: 1 year from stent placement ]
    Retrospective study evaluating if requirement of additional medical interventions (i.e. vaginal dilation, corrective surgery, etc) were changed with stent use.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807387


Contacts
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Contact: Julie CE Hakim, MD (832) 826-7464 Julie.Hakim@bcm.edu
Contact: Jennifer M McCracken, PhD (832) 824-5833 jennifer.mccracken@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Contact: Julie CE Hakim, MD    409-292-7579    Julie.Hakim@bcm.edu   
Contact: Jennifer M McCracken, PhD    620-249-3176    jennifer.mccracken@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
BioTex, Inc.
Investigators
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Principal Investigator: Julie CE Hakim, MD Baylor College of Medicine
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Responsible Party: Julie Hakim, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04807387    
Other Study ID Numbers: H-45549
5R44HD092156-03 ( U.S. NIH Grant/Contract )
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical