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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2029-04-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT

NCT02808377

Pelvic Organ Prolapse

UNKNOWN NA

Obstetric and Proctology Support of Patients With Perineums Suits

NCT02823717

Obstetric Complications Muscle Tear

UNKNOWN

Comparison of Overlap and End-to-end Repair in Anal Sphincter Rupture During Delivery

NCT00439907

Rupture Childbirth

COMPLETED NA

Retrospective Evaluation of Functional and Sexological Results of Surgical Perineal Repair

NCT04835311

Complications; Perineal Repair

COMPLETED

Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele

NCT04502953

Rectocele

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prolapse Genital Vulvovaginal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sagittal plication of the puborectal muscles reconstruction

Anatomical reconstruction of the vulvovaginal gape by sagittal plication of the puborectal muscles

Group Type EXPERIMENTAL

Anatomical reconstruction of the vulvovaginal gape

Intervention Type PROCEDURE

Anatomical reconstruction of the vulvovaginal gape with two different surgeries

Questionnaires

Intervention Type OTHER

Questionnaires of quality of sexual life (PPSSQ), of anal incontinence and constipation

MRI

Intervention Type RADIATION

MRI of the genital hiatus

Perineorrhaphy ± transverse myorrhaphy of the puborectal muscles reconstruction

Anatomical reconstruction of the vulvovaginal gape by perineorrhaphy ± transverse myorrhaphy of the puborectal muscles

Group Type ACTIVE_COMPARATOR

Anatomical reconstruction of the vulvovaginal gape

Intervention Type PROCEDURE

Anatomical reconstruction of the vulvovaginal gape with two different surgeries

Questionnaires

Intervention Type OTHER

Questionnaires of quality of sexual life (PPSSQ), of anal incontinence and constipation

MRI

Intervention Type RADIATION

MRI of the genital hiatus

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anatomical reconstruction of the vulvovaginal gape

Anatomical reconstruction of the vulvovaginal gape with two different surgeries

Intervention Type PROCEDURE

Questionnaires

Questionnaires of quality of sexual life (PPSSQ), of anal incontinence and constipation

Intervention Type OTHER

MRI

MRI of the genital hiatus

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No