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

Rokitansky Syndrome Clinical Trial

— MRKH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911884
• Other study ID #: P110124
• Secondary ID: ID RCB : 2011-A0
• Status: Completed
• Phase: N/A
• Start date: October 11, 2012
• Est. completion date: April 10, 2015

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: April 10, 2015
• Est. primary completion date: April 10, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient affected with Rokitansky syndrome

• Patient over 18 years old

• Patient care with dilatations or by surgery since 1995

• Patient having started dilatations or having had surgery since at least one year

• Patient who signed the consent

• French patient

• Women with social welfare

Exclusion Criteria:

• Patient with a serious chronic disease interfering with analysis to be performed in this project.

• Patient can't reading or writing

• Patient with legal protection

Related Conditions & MeSH terms

• Aneurysm
• Rokitansky Syndrome
• Surgical or Vaginal Dilatation of Vaginal Aplasia
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Service d'Endocrinologie et Gynécologie Pédiatriques Hôpital Necker Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Cheikhelard A, Bidet M, Baptiste A, Viaud M, Fagot C, Khen-Dunlop N, Louis-Sylvestre C, Sarnacki S, Touraine P, Elie C, Aigrain Y, Polak M; French MRKH Study Group. Surgery is not superior to dilation for the management of vaginal agenesis in Mayer-Rokita — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of quality of global life	To fill a self-administered questionnaire: the World Health Organization Quality Of Life (general scale WHOQOL)	Day 0
Secondary	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)	Day 0
Secondary	Assessment of anatomic results	Gynaecological examination	Day 0
Secondary	Assessment of social integration	To fill a self-administered questionnaire (marital status, occupational group, education level, employment status)	Day 0