Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)

Primary outcomes

1. Degree of Neovaginal Epithelialization

   Time frame: Six 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

2. Change in Vaginal Diameter

   Time frame: Post-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).

3. Change in Vaginal Depth

   Time frame: Post-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).

4. Change in quality of life as measured by the Short-Form 36 (SF-36)

   Time frame: 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.

5. Change in Pain as measured by the Brief Pain Inventory - Short Form (BPI-SF)

   Time frame: 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.

6. Change in Pain as measured by the The Female Genitourinary Pain Index (GUPI)

   Time frame: 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.

7. Change in overall perception of improvement as measured by the PGI-I (Patient Global Impression of Improvement)

   Time frame: 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.

8. Change in sexual function of improvement as measured by the Female Sexual Function Index (FSFI)

   Time frame: 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.