Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients

NANot yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2026

Conditions
Mayer Rokitansky Kuster Hauser Syndrome
Interventions
PROCEDURE

neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel

Under general anesthesia and catheterized bladder, the patient was in the lithotomy position. In the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. With the index finger in the rectum as a direction and protection, Hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. After that, a double-barreled canal appeared. Then, the raphe between the canals was incised. The neovagina was created. According to the randomization, a vaginal mold spreaded with hydrogel or not was placed in the neovagina for 6 months. The patients were suggested to wear the vaginal mold continuously over the following 6 months. After that, they were allowed to have the first sexual intercourse. Otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week.

PROCEDURE

neovaginoplasty and vaginal mold

Under general anesthesia and catheterized bladder, the patient was in the lithotomy position. In the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. With the index finger in the rectum as a direction and protection, Hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. After that, a double-barreled canal appeared. Then, the raphe between the canals was incised. The neovagina was created. According to the randomization, a vaginal mold spreaded with hydrogel or not was placed in the neovagina for 6 months. The patients were suggested to wear the vaginal mold continuously over the following 6 months. After that, they were allowed to have the first sexual intercourse. Otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week.

All Listed Sponsors
lead

Obstetrics & Gynecology Hospital of Fudan University

OTHER

NCT06508151 - Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients | Biotech Hunter | Biotech Hunter