Observational Study of Vaginoplasty with Kerecis™ for Gender Affirmation
This study is observing the results of gender-affirming vaginoplasty surgery using the Tubularized Augmented Peritoneal Cap (TAPCap) technique. During this surgery, a special fish skin graft called Kerecis™ is used to line a portion of the newly created vagina. Researchers want to see how well the new vaginal lining forms (epithelialization) and measure changes in vaginal depth and width over time. This study is for transgender women aged 19 to 99 who are planning to have this specific type of gender-affirming surgery. The goal is to understand the outcomes of this standard surgical approach, which aims to improve quality of life and reduce gender dysphoria.
- Study design
- This is an observational study involving 20 participants. It is not specified if it's randomized or blinded.
- What's involved
- You would undergo the TAPCap vaginoplasty procedure. Biopsies will be taken from the neovagina at 6 months after surgery, and vaginal measurements will be taken at 2 weeks, 12 weeks, 6 months, and 1 year post-surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 1 year after surgery to measure vaginal diameter and depth. Neovaginal epithelialization will be measured at 6 months post-op.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Shubham Gupta, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Degree of Neovaginal EpithelializationSix months post-op
Degree of epithelialization of each sample biopsy. Biopsies are obtained from the proximal segment (peritoneal portion), middle segment (Xenograft portion), and, distal segment (penile skin portion) of the neovagina. Grade 0: No epithelialization Grade 1 : Minimal epithelialization Grade 2: Moderate epithelialization Grade 3: Significant epithelialization
- Change in Vaginal DiameterPost-op week 2, week, 12, month 6, and year 1
The participants' vaginal diameter is calculated based on the largest tolerated vaginal dilator size (Soul Source; CA, USA) . Measurements are reported in centimeters (cm).
- Change in Vaginal DepthPost-op week 2, week, 12, month 6, and year 1
The participants' vaginal depth are calculated based on the largest tolerated vaginal dilator (Soul Source, CA, USA). Measurements are reported in centimeters (cm).
- Change in quality of life as measured by the Short-Form 36 (SF-36)Week 2, Week 12, Month 6, and year 1 post-op
This is a validated questionnaire measuring health-related quality of life through eight domains, covering physical and mental well-being. It's widely used in healthcare to assess overall health perception and functional status. With higher scores indicating greater quality of life.
- Change in Pain as measured by the Brief Pain Inventory - Short Form (BPI-SF)Week 2, Week 12, Month 6, and year 1 post-op
This is a concise validated questionnaire used to evaluate the severity and impact of pain experienced by individuals. It consists of questions that assess the intensity of pain at its worst, least, average, and current levels, as well as its interference with various aspects of daily life such as general activity, mood, walking ability, work, relationships, and enjoyment of life. Higher scores indicate worse outcomes.
- Change in Pain as measured by the The Female Genitourinary Pain Index (GUPI)Week 2, Week 12, Month 6, and year 1 post-op
This is a validated questionnaire used to assess symptoms related to genitourinary pain in women. It includes questions covering pain severity, urinary symptoms, and impact on quality of life, providing clinicians with a standardized tool to evaluate and monitor participants' symptoms and treatment responses in these chronic pain conditions. Higher scores indicate worse outcomes.
- Change in overall perception of improvement as measured by the PGI-I (Patient Global Impression of Improvement)Week 2, Week 12, Month 6, and year 1 post-op
This is a patient-reported scale that measures how individuals perceive their overall improvement after treatment, offering clinicians insight into treatment effectiveness from the participant's viewpoint. Lower scores indicate better outcomes.
- Change in sexual function of improvement as measured by the Female Sexual Function Index (FSFI)Month 6, and year 1 post-op
This is a validated 19-item questionnaire assessing six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain is scored, and the total score reflects overall sexual function, with higher scores indicating better function. It is used in clinical and research settings to evaluate sexual health and the impact of treatments. Higher scores indicate better outcomes.