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

NCT04923217 | Completed DMC

• 1 other identifier: 50/HĐĐĐ-ĐHYD
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Mayer Rokitansky Kuster Hauser Syndrome; Quality of Life; Sexual Function Disturbances

Outcome Measures

Primary Outcomes (2)

• Quality of Life of women with vaginal agenesis after Davydov procedure

  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.

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

• Sexual Function of women with vaginal agenesis after Davydov procedure

  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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• School of Medicine - Vietnam National University at Ho Chi Minh city: lead
• Tu Du Hospital: collaborator
• University of Medicine and Pharmacy at Ho Chi Minh City: collaborator

Study Sites (1)

Tu Du Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Mullerian aplasia; Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Lan TN Vuong, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 11, 2021
• Study Start: December 13, 2021
• Primary Completion: February 28, 2022
• Study Completion: November 10, 2022
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)