An interventional study of evaluate quality of life of surgical and non surgical vaginal aplasia in Rokitansky Syndrome and Surgical or Vaginal Dilatation of Vaginal Aplasia, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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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.
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 several appointments.
Therapeutic management can be proposed when the girl is ready because the therapeutic is long and difficult. Two therapeutic approaches can be proposed: to create a vagina using dilators or having a surgical procedure. In France, vaginal reconstruction with dilators is the most used. This method consists in dilating the vagina progressively with different sizes of dilators in order to obtain a vaginal opening of 8 cm around 6 months after treatment initiation. This method is successful in about 75% of cases. Complications are exceptional.
Surgery is an option for patients who are unsuccessful with dilatators or patients who prefer surgery. A number of operations are appropriate for the correction of vaginal agenesis. Vecchietti procedure and sigmoid vaginoplasty are the most commonly used techniques in France.
In national and international publications, it is impossible to compare scientifically the results of the different technique because of the small effective in each studies and because of the the lack of standardized assessment. Studies report the functional result for each technique but none compare the techniques used. No studies compared the result in terms of anatomical and function results, complications and quality of life.
The demonstration of a positive correlation between the anatomic criteria and the functional results would help to guide the surgical technique. The lack of correlation would suggest that a perfect anatomical reconstruction is not essential. If it is demonstrated, the management should focus on other criteria like psychological management. Several factors seem to influence the general and sexual quality of life of women affected by the Rokitansky syndrome. Our objective is to evaluate the importance of these factors to improve the treatment of these women.
20 studies on the registry are indexed under Mullerian aplasia; 11 are open to participants now.
This study's enrollment of 138 is above the median of 20 across 13 interventional studies indexed under Mullerian aplasia.
Browse Mullerian aplasia studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
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Exclusion Criteria:
Patients with a Rokitansky Syndrome
Behavioral: evaluate quality of life of surgical and non surgical vaginal aplasia
protocol designed to evaluate quality of life of surgical and non surgical vaginal aplasia
Assessment of quality of global life
To fill a self-administered questionnaire: the World Health Organization Quality Of Life (general scale WHOQOL)
Time frame: Day 0
Assessment of quality of sexual life
To fill 2 self-administered questionnaires : Female Sexual Function Index and Female Sexual Dysfunction Scale-Revised (FSFI and FSDS)
Time frame: Day 0
Assessment of anatomic results
Gynaecological examination
Time frame: Day 0
Assessment of social integration
To fill a self-administered questionnaire (marital status, occupational group, education level, employment status)
Time frame: Day 0
Ran from Oct 2012 to primary completion in Apr 2015, 29 months.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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