Clinical Trial: Assessment of Quality of Global and Sexual Life and Impact of Surgical and Non Surgical Vaginal Aplasia in Patients With a Rokitansky Syndrome

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Assessment of Quality of Global and Sexual Life and Impact of Surgical and Non Surgical Vaginal Aplasia in Patients With a Rokitansky Syndrome

Brief Summary:

The principal objective is to assess the general health status and the sexual health status of women with Rokitansky syndrome having received a surgical or non surgical treatment.

The secondary purpose is to assess the anatomical aspect and the quality of sexual life. To search a correlation between the anatomical result, the general and sexual quality of life. To compare the different techniques of medical follow-up in terms of anatomic results, general quality of life, sexual quality of life, complications and morbidities.

To evaluate social inclusion of these women with their family situation, social and professional category and their job.

At the same time, we propose an evaluation with a psychologist to study the impact of the announcement of the diagnosis. This impact study is conducted at a distance from diagnosis.

Detailed Summary:

The MRKH syndrome is a congenital disorder characterized by absence of uterus and at least the two thirds of the vagina, a female phenotype and a normal karyotype XX.

These patients have normal ovaries and fallopian tubes. The external genitalia are normal. This syndrome was described by Mayer (1829), Rokitansky ( 1838), Kuster ( 1910) and Hauser ( 1961). About one in every 4500 female babies has this condition. This syndrome represents 85% of congenital vagina aplasia and is the second cause of primary amenorrhea after disorders of sexual development. These women are unfertile.

The malformation can be isolated or associated with other malformations called MURCS (Müllerian duct aplasia, renal aplasia, and cervicothoracic somite dysplasia), as kidney ( 30%), bone ( 10%) or cardiac malformations ( 1%).

The most common age for MRKH to be diagnosed is when the woman hasn't started her period ( 85%).Some girls may find out at an earlier age when there is a severe malformation , during a systematic gynaecological examination or during an pelvic ultrasound. When the women are older, the syndrome can be diagnosed during studies for infertility.

A pelvic ultrasound is usually the first test performed to assess presence of uterus. A magnetic resonance imaging may be used to complete the investigations. These tests can also confirm if there are two ovaries and two kidneys. Sometimes, a very small uterus can be seen, it's a uterine horn.

The psychological management is essential to take care of the women affected.It seeks to understand the impact of the diagnosis announcement and the various treatments offered. The follow-up can be different for each girl and her parents during seve
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Assessment of quality of global life [ Time Frame: Day 0 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Assessment of quality of sexual life [ Time Frame: Day 0 ]
  To fill 2 self-administered questionnaires : Female Sexual Function Index and Female Sexual Dysfunction Scale-Revised (FSFI and FSDS)
• Assessment of anatomic results [ Time Frame: Day 0 ]
  Gynaecological examination
• Assessment of social integration [ Time Frame: Day 0 ]
  To fill a self-administered questionnaire (marital status, occupational group, education level, employment status)

Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: July 26, 2013
Date Started: October 2012
Date Completion: October 2015
Last Updated: July 2, 2015
Last Verified: June 2015