Clinical trial NCT04923217: Quality of Life and Sexual Function in Vaginal Aplasia Patients After Davydov Procedure
Official title: Assessing Quality of Life and Sexual Function in Vaginal Aplasia Patients After Neovaginal Surgical Procedure by Davydov Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mayer Rokitansky Kuster Hauser Syndrome
Quality of Life
Sexual Function Disturbances
Lead sponsor: School of Medicine - Vietnam National University at Ho Chi Minh city
Sponsor class: OTHER
Collaborators: name: Tu Du Hospital
name: University of Medicine and Pharmacy at Ho Chi Minh City
First posted: 2021-06-11
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample is patients who underwent Davydov procedure to create neovagina at Tu Du hospital, Ho Chi Minh city, Vietnam.

Brief summary: Mayer-Rokitansky-Kuster-Hauser(MRKH) syndrome is described as absence or underdevelopment of vagina and uterus. This condition is extremely rare congenital malformation that affects one in every 5000 female births. Medical management of MRKH syndrome includes the creation of a neovagina using nonsurgical or surgical procedure. In Vietnam, since 2014, Davydov technique has been used to create neovagina for patients with MRKH syndrome at Tu Du hospital which is the biggest obstetric and gynecological hospital in south of Vietnam. However, the effectiveness of this surgical approach on patient's life and sexual activity hasn't been assessed. The objective of this study is to assess the quality of life, the psychological impact and the sexual function of Vietnamese women with MRKH syndrome after Davydov surgical procedure.

Detailed description: This study will be conducted at Tu Du Hospital, Ho Chi Minh City, Vietnam. Female patients diagnosed with Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome were performed the Davydov procedure to create neovagina at the Anaesthesia and Intensive care department, Tu Du hospital. Based on the Department of Anaesthesia and Intensive care data, a list of potentially eligible patients who underwent Davydov surgery at least six months was made. Because of the impact of the Covid 19 pandemic, the patients could not come to the hospital, so the research team decided to interview the participants online. According to this list, patients will be contacted by telephone to set up an online appointment to assess the effectiveness of the Davydov procedure. The informed consent will be sent by email or mail to the patients who accepted to participate in our research before the enrolment. On appointment day, the investigator will make group telecommunication by an application on cell phone or computer. Efficacy of Davydov procedure according to the functional aspect: the psychological doctors assess the impact of patient's neovagina on life and sexual function through questionnaires involving World Health Organization Quality of life Scale (WHOQoL-BREF), Female Sexual Function Index (FSFI) and self-composed qualitative questionnaire. The interview with a patient will be held individually and conducted by the psychological doctor. The participants will be requested to record the conversation. Because MRKH syndrome is a rare condition, the investigators take all patients who are suitable to inclusion criteria and accept participating in our research.

Eligibility criteria: Inclusion Criteria:

* Aged equal or more than 18.
* Diagnosed vaginal agenesis and underwent Davydov procedure to create neovagina at least 6 months.
* Able to listen, understand and answer questions.

Exclusion Criteria:

* Disagreed to participate the research.
* Having any conditions that make patient unable to listen, understand and answer questions.
* Having psychological disturbance.

Primary outcomes:
measure: Quality of Life of women with vaginal agenesis after Davydov procedure
timeFrame: From six months after surgery up to the initiation of the study, assessed up to 1 month
measure: Sexual Function of women with vaginal agenesis after Davydov procedure
timeFrame: From six months after surgery up to the initiation of the study, assessed up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Tu Du Hospital
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Lan TN Vuong, PhD
role: PRINCIPAL_INVESTIGATOR
References: