Prolapse Genital, Vulvovaginal Disease
Conditions
Brief summary
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.
Interventions
PROCEDUREAnatomical reconstruction of the vulvovaginal gape
Anatomical reconstruction of the vulvovaginal gape with two different surgeries
OTHERQuestionnaires
Questionnaires of quality of sexual life (PPSSQ), of anal incontinence and constipation
RADIATIONMRI
MRI of the genital hiatus
Sponsors
Ramsay Générale de Santé
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female patient between 18 and 80 years-old. * Genital hiatus at rest ≥ 4 cm by POP-Q * Sexually active woman without pain (never/rarely scored) during penetration and who has stopped sexual activity due to vulvovaginal incompetence without pain (never/rarely scored) during penetration * Prolapse * Candidate for surgery for anatomical reconstruction of the vulvovaginal incompetence * Patient affiliated with a social security scheme or beneficiary of such a scheme, according to Article L.1124-1 of the Public Health Code * Free, informed and signed consent
Exclusion criteria
* Resting GH \< 4 cm (POP-Q classification) * Women not sexually active and not planning to become sexually active * Chronic perineal pain syndrome * Anal sphincter injury with concomitant indication for sphincterorrhaphy * Cognitive or language impairment of the patient unable to complete the study questionnaires * Contraindications to surgery or anesthesia * Adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision, hospitalized without consent * Pregnant, breastfeeding, or parturient woman * Patient planning to become pregnant during the study period * Immediate postpartum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of anatomical reconstruction of vulvovaginal gaping | 12 months | 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: * Resting GH \< 4 cm, * AND PGI-I overall condition improved or greatly improved, * AND pain during intercourse rated never or rarely (question 6 of the PPSSQ) |
Countries
France
Contacts
Primary ContactJean-François Oudet, M.
Backup ContactMarie-Hélène Barba
Outcome results
None listed