Quality of Life and Sexual Function in Vaginal Aplasia Patients After Davydov Procedure

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.

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Key information

Conditions

Mayer Rokitansky Kuster Hauser Syndrome Mental Disorders Mullerian aplasia Quality of Life Sexual Dysfunctions, Psychological Sexual Function Disturbances

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Tu Du Hospital

Ho Chi Minh City, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Quality of Life of women with vaginal agenesis after Davydov procedure

Time frame: From six months after surgery up to the initiation of the study, assessed up to 1 month

The psychological doctor uses the questionnaire named World Health Organization Quality of Life Scale(WHOQoL-BREF) in the interview to ask patient. The patient's Quality of Life will be assessed based on the WHOQoL-BREF questionnaire 's score. All the results will be collected and calculated subsequently. The raw scores are converted to transformation scores. The first transformation converts scores to range of 4-20 and the second transformation converts domain scores to 0-100 scale. Higher scores reflect better Quality of Life.
Sexual Function of women with vaginal agenesis after Davydov procedure

Time frame: From six months after surgery up to the initiation of the study, assessed up to 1 month

The psychological doctor uses the questionnaire named Female Sexual Function Index Scale (FSFI) in the interview to ask patient. The patient's sexual function will be assessed based on the FSFI questionnaire 's score. All the results will be collected and calculated subsequently. The FSFI's minimum total score is 2 and the FSFI's maximum total score is 36. The patient is diagnosed to have sexual dysfunction when the FSFI's total score is less than 26,55.

Sponsors and collaborators

Lead sponsor

School of Medicine - Vietnam National University at Ho Chi Minh city

Other

Collaborators

Tu Du Hospital
University of Medicine and Pharmacy at Ho Chi Minh City

Registry information

Official study title

Assessing Quality of Life and Sexual Function in Vaginal Aplasia Patients After Neovaginal Surgical Procedure by Davydov Method

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 11, 2021
Registry last updated: Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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