Prolapse GenitalHERANCT07245823
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)
A study testing Anatomical reconstruction of the vulvovaginal gape, Questionnaires and MRI in people with Prolapse Genital and Vulvovaginal Disease, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Prolapse Genital, Vulvovaginal Disease
- What is being tested?
- Anatomical reconstruction of the vulvovaginal gape, Questionnaires and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2025to 25 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Hopital privé Dijon Bourgogne
Dijon, 21000
Aurélie Guyomard, Dr, 0033676382990, docteurguyomard@gmail.com
About this study
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.
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.
- Conditions
- Prolapse Genital, Vulvovaginal Disease
- Being tested
- Anatomical reconstruction of the vulvovaginal gape, Questionnaires, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical reconstruction of the vulvovaginal gapeProcedure or surgery
Anatomical reconstruction of the vulvovaginal gape with two different surgeries
QuestionnairesOther
Questionnaires of quality of sexual life (PPSSQ), of anal incontinence and constipation
MRIRadiation
MRI of the genital hiatus
| Study group | Role | What they receive |
|---|---|---|
| Sagittal plication of the puborectal muscles reconstruction | Experimental | Anatomical reconstruction of the vulvovaginal gape by sagittal plication of the puborectal muscles Receives: Procedure: Anatomical reconstruction of the vulvovaginal gape; Other: Questionnaires; Radiation: MRI |
| Perineorrhaphy ± transverse myorrhaphy of the puborectal muscles reconstruction | Active comparator | Anatomical reconstruction of the vulvovaginal gape by perineorrhaphy ± transverse myorrhaphy of the puborectal muscles Receives: Procedure: Anatomical reconstruction of the vulvovaginal gape; Other: Questionnaires; Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion20 Apr 2029 (estimated)
- Study completion25 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse GenitalStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245823
- Sponsor's protocol ID
- 2024-A01362-45
- Acronym
- HERA
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07245823
- Acronym / sponsor ID
- HERA / 2024-A01362-45
- Conditions
- Prolapse Genital, Vulvovaginal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 20 Apr 2029 (estimated)
- Study completion
- 25 Apr 2029 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sagittal plication of the puborectal muscles reconstruction | Experimental | Procedure: Anatomical reconstruction of the vulvovaginal gape, Other: Questionnaires, Radiation: MRIAnatomical reconstruction of the vulvovaginal gape by sagittal plication of the puborectal muscles |
| Perineorrhaphy ± transverse myorrhaphy of the puborectal muscles reconstruction | Active comparator | Procedure: Anatomical reconstruction of the vulvovaginal gape, Other: Questionnaires, Radiation: MRIAnatomical reconstruction of the vulvovaginal gape by perineorrhaphy ± transverse myorrhaphy of the puborectal muscles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomical reconstruction of the vulvovaginal gapeAnatomical reconstruction of the vulvovaginal gape with two different surgeries | Procedure or surgery | Perineorrhaphy ± transverse myorrhaphy of the puborectal muscles reconstruction, Sagittal plication of the puborectal muscles reconstruction |
| QuestionnairesQuestionnaires of quality of sexual life (PPSSQ), of anal incontinence and constipation | Other | Perineorrhaphy ± transverse myorrhaphy of the puborectal muscles reconstruction, Sagittal plication of the puborectal muscles reconstruction |
| MRIMRI of the genital hiatus | Radiation | Perineorrhaphy ± transverse myorrhaphy of the puborectal muscles reconstruction, Sagittal plication of the puborectal muscles reconstruction |
Primary outcome
Effectiveness of anatomical reconstruction of vulvovaginal gaping
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomical reconstruction of the vulvovaginal gape, Questionnaires and MRI in people with Prolapse Genital and Vulvovaginal Disease, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet, M. (0033683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of anatomical reconstruction of vulvovaginal gaping (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.