Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients

NCT06508151 | Not Yet Recruiting

• 1 other identifier: 2024-16
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mayer Rokitansky Kuster Hauser Syndrome

Keywords

Photoinduced-imine-crosslink hydrogel; MRKH syndrome; Neovaginoplasty

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• length of neovagina

  1 month

• length of neovagina

  3 months

• length of neovagina

  6 months

• width of neovagina

  1 month

• width of neovagina

  3 months

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Arm 2

OTHER

After neovaginoplasty, a vaginal mold was placed in the neovagina directly without anything spreaded.

Procedure: neovaginoplasty and vaginal mold

Interventions

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

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.

Arm 1

neovaginoplasty and vaginal mold PROCEDURE

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.

Arm 2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with MRKH syndrome;
• Without previous related treatments; 3)18-35 years old;
• )Voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up.

You may not qualify if:

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

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: lead

Related Publications (4)

• 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.

  PMID: 31667605 RESULT

• 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.

  PMID: 37604908 RESULT

• 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.

  PMID: 34605063 RESULT

• 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.

  PMID: 31089131 RESULT

MeSH Terms

Conditions

Mullerian aplasia

Study Officials

• Keqin Hua, Doctor

  Obstetrics & Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keqin Hua, Doctor

CONTACT

+86-021-33189900; huakeqinjiaoshou@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 18, 2024
• Study Start: August 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share