- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01911884
Assessment of Quality of Global and Sexual Life and Impact of Surgical and Non Surgical Vaginal Aplasia in Patients With a Rokitansky Syndrome (MRKH)
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.
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Paris, France, 75015
- Service d'Endocrinologie et Gynécologie Pédiatriques Hôpital Necker Enfants Malades
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Patients with a Rokitansky Syndrome
|
protocol designed to evaluate quality of life of surgical and non surgical vaginal aplasia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of quality of global life
Time Frame: Day 0
|
To fill a self-administered questionnaire: the World Health Organization Quality Of Life (general scale WHOQOL)
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Day 0
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Assessment of anatomic results
Time Frame: Day 0
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Gynaecological examination
|
Day 0
|
Assessment of social integration
Time Frame: Day 0
|
To fill a self-administered questionnaire (marital status, occupational group, education level, employment status)
|
Day 0
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michel POLAK, PUPH, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P110124
- ID RCB : 2011-A01517-34
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