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Compares treatment options for Prolapse Genital
Official title Randomized Study Evaluating the Treatment of Vulvovaginal Gaping by Plication of the Puborectalis Muscles Versus Perineorrhaphy ± Transverse Myorrhaphy of the Puborectalis Muscles at 12 Months. (HERA)
ClinicalTrials.gov ID: NCT07245823
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, women only
You may be able to join if
- 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...
- Prolapse
- Candidate for surgery for anatomical reconstruction of the vulvovaginal incompetence
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.