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

NCT04807387 | Terminated Results DMC FDA Device

• 2 other identifiers: H-455495R44HD092156-03
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Stricture

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Vaginal Stent as Comfortable.

  Participants will report daily on stent comfort and any disruption to normal daily activities.

  24 hours from stent placement

Study Arms (4)

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.

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.

Device: Vaginal Stent

Pediatric participants: post vaginal surgery

EXPERIMENTAL

Pediatric participants will wear the vaginal stent for 2 weeks after undergoing vaginal surgery.

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.

Device: Vaginal Stent

Interventions

Vaginal Stent A DEVICE

Ring stent

Healthy participants: acute

Vaginal Stent B DEVICE

Flower stent

Healthy participants: acute

Vaginal Stent DEVICE

Vaginal stent chosen from A or B that is the most comfortable

Adult participants: post vaginal brachytherapy; Healthy participants: chronic; Pediatric participants: post vaginal surgery

Eligibility Criteria

• Age: 13 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• BioTex, Inc.: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr Julie Hakim
• Organization: Baylor College of Medicine

julie.hakim@bcm.edu

832-826-7464

Study Officials

• Julie CE Hakim, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 19, 2021
• Study Start: May 5, 2022
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)