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Vulvovaginal incompetence is generally associated with prolapse and contributes to the pathogenesis of the latter. The perineum and the perineal body (PB) are structures frequently injured throughout life, leading to vesicourethral and rectoanal dysfunction, which are the main focus of study. Other symptoms, such as periorificial dyspareunia and vulvovaginal incompetence, appear to be less verbalized by women. The resulting sexual discomfort is linked, on the one hand, to physical anatomical trauma, with, in some cases, vulvovaginal incompetence contributing to a vaginal sensitivity decreased, and, on the other hand, to psychological trauma with damage to self-image. Vulvoperineoplasty is a surgical repair procedure that aims to optimally reconstruct the introital anatomy by correcting the vulvovaginal incompetence in order to restore normal anatomy, restore self-image, and treat the symptoms of vaginal laxity (feeling of a vagina that is too large and loss of vaginal sensitivity).
Conventional surgical techniques for treating vulvar incompetence, such as levator myorrhaphy and perineorrhaphy, are currently being questioned because they cause functional sequelae, particularly regarding to sexual quality of life. The pubo-rectal muscle plication (PPR) technique is based on the anatomical observation of puborectalis muscle lengthening (PMR) observed on MRI scans in patients with vaginal incompetence. This technique could be an interesting alternative in the surgical treatment of vulvovaginal incompetence.
The main objective of this study is to evaluate the effectiveness of anatomical reconstruction of vulvovaginal incompetence by sagittal plication of the puborectalis muscles vs. by perineorrhaphy ± transverse myorrhaphy of the puborectalis muscles at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sagittal plication of the puborectal muscles reconstruction | Experimental | Anatomical reconstruction of the vulvovaginal gape by sagittal plication of the puborectal muscles |
|
| Perineorrhaphy ± transverse myorrhaphy of the puborectal muscles reconstruction | Active Comparator | Anatomical reconstruction of the vulvovaginal gape by perineorrhaphy ± transverse myorrhaphy of the puborectal muscles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anatomical reconstruction of the vulvovaginal gape | Procedure | Anatomical reconstruction of the vulvovaginal gape with two different surgeries |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of anatomical reconstruction of vulvovaginal gaping | The effectiveness of anatomical reconstruction of the vulvovaginal gap will be assessed at 12 months using a composite criterion. The reconstruction will be considered successful if the following three criteria are met:
| 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-François Oudet, M. | Contact | 0033683346567 | jf.oudet@ecten.eu | |
| Marie-Hélène Barba | Contact | mh.barba@ecten.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital privé Dijon Bourgogne | Recruiting | Dijon | 21000 | France |
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| Questionnaires | Other | Questionnaires of quality of sexual life (PPSSQ), of anal incontinence and constipation |
|
| MRI | Radiation | MRI of the genital hiatus |
|
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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