Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients

Study on the Effectiveness and Safety of Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in Patients With Mayer-Rokitansky-Kuster-Hauser Syndrome

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mayer Rokitansky Kuster Hauser Syndrome
• Intervention / Treatment: Procedure: neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel; Procedure: neovaginoplasty and vaginal mold

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keqin Hua, Doctor; Phone Number: +86-021-33189900; Email: huakeqinjiaoshou@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; After neovaginoplasty, a vaginal mold spreaded with photoinduced-imine-crosslink hydrogel was placed in the neovagina.	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.
Other: Arm 2; After neovaginoplasty, a vaginal mold was placed in the neovagina directly without anything spreaded.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of vaginal squamous epithelialization	Percentage of squamous epithelialization of neovagina	1 month
Degree of vaginal squamous epithelialization	Percentage of squamous epithelialization of neovagina	3 months
Degree of vaginal squamous epithelialization	Percentage of squamous epithelialization of neovagina	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of neovagina	length in centimetre, measured by a ruler	1 month
length of neovagina	length in centimetre, measured by a ruler	3 months
length of neovagina	length in centimetre, measured by a ruler	6 months
width of neovagina	width in centimetre, measured by ruler	1 month
width of neovagina	width in centimetre, measured by ruler	3 months
width of neovagina	width in centimetre, measured by ruler	6 months
Sexual life quality	Female Sexual Function Index, a self-reported questionnaire to measure sexual life quality	6 months
Sexual life quality	Female Sexual Function Index, a self-reported questionnaire to measure sexual life quality	1 year

Collaborators and Investigators

• Sponsor: Obstetrics & Gynecology Hospital of Fudan University
• Investigators: Principal Investigator: Keqin Hua, Doctor, Obstetrics & Gynecology Hospital of Fudan University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Photoinduced-imine-crosslink hydrogel; MRKH syndrome; Neovaginoplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Disease; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Syndrome; 46, XX Disorders of Sex Development
• Other Study ID Numbers: 2024-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No