Clinical trial NCT06508151: Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients
Official title: Study on the Effectiveness and Safety of Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in Patients With Mayer-Rokitansky-Kuster-Hauser Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mayer Rokitansky Kuster Hauser Syndrome
Keywords: Photoinduced-imine-crosslink hydrogel
MRKH syndrome
Neovaginoplasty
Lead sponsor: Obstetrics & Gynecology Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating the effectiveness and safety of neovaginoplasty using photoinduced-imine-crosslink hydrogel in patients with MRKH syndrome by comparing the differences in the degree of squamous epithelialization, vaginal length and width, and sexual life quality.

Detailed description: This is a randomized controlled trial. Patients meeting the inclusion criteria will be enrolled in this study: 1)Diagnosed with MRKH syndrome; 2)Without previous treatments; 3)Age: 18-35 years old; 4)Voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up.

A centralized block randomization will be used to randomly assign patients to ensure that there will be an equal number of patients (1:1) in the hydrogel group and control group. The sample size is 20.

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. 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.

The primary endpoint is the degree of vaginal squamous epithelialization 1 month, 3 months, 6 months after surgery. The secondary endpoints include neovaginal length and width, sexual life quality, and surgical complications.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with MRKH syndrome;
2. Without previous related treatments; 3)18-35 years old;

4)Voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up.

Exclusion Criteria:

1. With any previous artificial colpoplasty or other related treatment;
2. With history of diabetes or systemic immune system disease.

Primary outcomes:
measure: Degree of vaginal squamous epithelialization
timeFrame: 1 month
measure: Degree of vaginal squamous epithelialization
timeFrame: 3 months
measure: Degree of vaginal squamous epithelialization
timeFrame: 6 months
Secondary outcomes:
measure: length of neovagina
timeFrame: 1 month
measure: length of neovagina
timeFrame: 3 months
measure: length of neovagina
timeFrame: 6 months
measure: width of neovagina
timeFrame: 1 month
measure: width of neovagina
timeFrame: 3 months
measure: width of neovagina
timeFrame: 6 months
measure: Sexual life quality
timeFrame: 6 months
measure: Sexual life quality
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Obstetrics & Gynecology Hospital of Fudan University
name: Keqin Hua, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang X, Qiu J, Ding J, Hua K. Comparison of neovaginoplasty using acellular porcine small intestinal submucosa graft or Interceed in patients with Mayer-Rokitansky-Kuster-Hauser syndrome. Arch Gynecol Obstet. 2019 Dec;300(6):1633-1636. doi: 10.1007/s00404-019-05352-0. Epub 2019 Oct 30.
citation: Bao B, Zeng Q, Li K, Wen J, Zhang Y, Zheng Y, Zhou R, Shi C, Chen T, Xiao C, Chen B, Wang T, Yu K, Sun Y, Lin Q, He Y, Tu S, Zhu L. Rapid fabrication of physically robust hydrogels. Nat Mater. 2023 Oct;22(10):1253-1260. doi: 10.1038/s41563-023-01648-4. Epub 2023 Aug 21.
citation: Zhang W, Bao B, Jiang F, Zhang Y, Zhou R, Lu Y, Lin S, Lin Q, Jiang X, Zhu L. Promoting Oral Mucosal Wound Healing with a Hydrogel Adhesive Based on a Phototriggered S-Nitrosylation Coupling Reaction. Adv Mater. 2021 Dec;33(48):e2105667. doi: 10.1002/adma.202105667. Epub 2021 Oct 4.
citation: Hong Y, Zhou F, Hua Y, Zhang X, Ni C, Pan D, Zhang Y, Jiang D, Yang L, Lin Q, Zou Y, Yu D, Arnot DE, Zou X, Zhu L, Zhang S, Ouyang H. A strongly adhesive hemostatic hydrogel for the repair of arterial and heart bleeds. Nat Commun. 2019 May 14;10(1):2060. doi: 10.1038/s41467-019-10004-7.