Mayer Rokitansky Kuster Hauser Syndrome
Conditions
Keywords
Photoinduced-imine-crosslink hydrogel, MRKH syndrome, Neovaginoplasty
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.
Interventions
PROCEDUREneovaginoplasty 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.
PROCEDUREneovaginoplasty 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.
Sponsors
Obstetrics & Gynecology Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of vaginal squamous epithelialization | 1 month | Percentage of squamous epithelialization of neovagina |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of neovagina | 1 month | length in centimetre, measured by a ruler |
| width of neovagina | 1 month | width in centimetre, measured by ruler |
| Sexual life quality | 6 months | Female Sexual Function Index, a self-reported questionnaire to measure sexual life quality |
Contacts
Primary ContactKeqin Hua, Doctor
Outcome results
None listed