Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorObstetrics & Gynecology Hospital of Fudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with MRKH syndrome;
Without previous related treatments; 3)18-35 years old;
Disqualifiers
With any previous artificial colpoplasty or other related treatment;
With history of diabetes or systemic immune system disease.
Trial design
Design model
Parallel
Treatments tested in this trial
neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel
Procedure/SurgeryUnder 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.
neovaginoplasty and vaginal mold
Procedure/SurgeryUnder 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Other 1 intervention
Trial outcomes
Primary outcomes
1
Degree of vaginal squamous epithelialization
Percentage of squamous epithelialization of neovagina
Time frame
1 month2
Degree of vaginal squamous epithelialization
Percentage of squamous epithelialization of neovagina
Time frame
3 months3
Degree of vaginal squamous epithelialization
Percentage of squamous epithelialization of neovagina
Time frame
6 monthsSecondary outcomes
1
length of neovagina
length in centimetre, measured by a ruler
Time frame
1 month2
length of neovagina
length in centimetre, measured by a ruler
Time frame
3 months3
length of neovagina
length in centimetre, measured by a ruler
Time frame
6 months4
width of neovagina
width in centimetre, measured by ruler
Time frame
1 monthLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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