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Vaginal Stent for Vaginal Stenosis

N/A
Waitlist Available
Led By Julie CE Hakim, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year from stent placement
Awards & highlights

Study Summary

This trial is testing newly designed vaginal stents, with the hope of replacing the poorly retained and uncomfortable standard of care. The goal is to see if the new stents are more comfortable and stay in place better than the current ones.

Eligible Conditions
  • Vaginal Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year from stent placement
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year from stent placement for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants able to retain vaginal stent
Number of participants reporting vaginal stent as comfortable.
Secondary outcome measures
Number of participants who develop vaginal stenosis
Number of required subsequent medical interventions

Trial Design

4Treatment groups
Experimental Treatment
Group I: Pediatric participants: post vaginal surgeryExperimental Treatment1 Intervention
Pediatric participants will wear the vaginal stent for 2 weeks after undergoing vaginal surgery.
Group II: Healthy participants: chronicExperimental Treatment1 Intervention
Healthy participants will wear the stent chosen to be the more comfortable for 2 weeks without removal.
Group III: Healthy participants: acuteExperimental Treatment2 Interventions
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.
Group IV: Adult participants: post vaginal brachytherapyExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,724 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,246 Total Patients Enrolled
BioTex, Inc.Industry Sponsor
8 Previous Clinical Trials
319 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Newly Designed Vaginal Stent to Improve Patient Comfort and Healing Following Vaginal Surgery or Vaginal Radiation
Julie Hakim 2022. "Newly Designed Vaginal Stent to Improve Patient Comfort and Healing Following Vaginal Surgery or Vaginal Radiation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04807387.
~2 spots leftby Apr 2025
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