Complications; Perineal RepairSEX-RPCNCT04835311
Retrospective Evaluation of Functional and Sexological Results of Surgical Perineal Repair
An observational study of Complications; Perineal Repair, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Vaginal laxity" syndrome is an increasingly frequent reason for gynecological consultations. Patients complain above all of a sensation of excessive vaginal looseness. This syndrome can be isolated or associated with genital prolapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Complications; Perineal Repair
- What is being tested?
- surgical perineal repair
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Adult, Older adult
Study population: All women who underwent surgical perineal repair (CCAM codes JMMA002 and/or HKCA005) between July 2012 and September 2020 at Nîmes University Hospital.
Who may be able to join
- women who underwent surgical perineal repair (CCAM codes JMMA002 and/or HKCA005) between July 2012 and September 2020 at Nîmes University Hospital.
- Adult patient (≥18 years old)
- Enrolled in a social security plan
- Patient does not object to the study
Who cannot join
- Prolapse surgery without perineal repair
- Perineal repair without levator myorrhaphy
- Patient who objected to the use of their data.
- Pregnancy since the operation
- Persons under court protection,
- Person participating in another research study with an ongoing exclusion period,
- Severely impaired physical and/or psychological health that, in the opinion of the investigator, may affect the participant's compliance with the study
Trial locations and contacts
1 site in 1 country.
About this study
Vaginal laxity" syndrome is an increasingly frequent reason for gynecological consultations. Patients complain above all of a sensation of excessive vaginal looseness. This syndrome can be isolated or associated with genital prolapse. Women with vaginal laxity may experience sexual dysfunction manifested by hypersensitivity during penetration and vaginal gas, resulting in decreased libido. Among urogynecology patients, vaginal laxity has been reported in up to 24% of cases, with a mean discomfort of 5.7 (on a scale of 0 to 10). Vaginal laxity is more common in younger women who have given birth vaginally. Gynecologic examination usually finds widening of the urogenital hiatus during the Valsalva maneuver, suggesting that vaginal laxity may be a manifestation of hyperdistensibility or disinsertion of the levator ani muscles. Campbell et al. noted that vaginal laxity was reported by 38% of 22621 women attending a urogynecology clinic and was associated with vaginal parity, prolapse symptoms, stress, and urinary urgency incontinence, reduced sensation on the ePAQ-PF questionnaire. In an IUGA survey of member physicians, 83% of respondents felt that vaginal laxity was underreported by patients.
The most common clinical definition of vaginal laxity is a urinary meatus to vulvar fork distance (GH measure of the POP-Q classification) > or = 4cm.
Read more
The first-line treatment for vaginal laxity is perineal rehabilitation. If this fails, surgical perineal repair, combining posterior perineorrhaphy and myorrhaphy of the pubo-rectal bundles of the levator ani muscles, can be performed with the aim of narrowing the introital vaginal caliber and improving the symptoms of laxity. This procedure is poorly evaluated in the literature.
The purpose of this study is to evaluate the functional and sexological results of surgical perineal repair.
- Conditions
- Complications; Perineal Repair
- Being tested
- surgical perineal repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical perineal repairProcedure or surgery
women who have undergone surgical perineal repair (codes CCAM JMMA002 and/or HKCA005)
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the sexological results of surgical perineal repair.
Validated questionnaire (Pelvi-Perineal Surgery Sexuality Questionnaire). Sexual health = score minimum 2 / maximum 29 (29 = very good sexual health) Discomfort and pain = score minimum 0 / maximum 15 (15 = important discomfort or pain)
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start26 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications; Perineal RepairStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835311
- Sponsor's protocol ID
- LOCAL/2021/THESE/RDT-01
- Acronym
- SEX-RPC
- Status last verified
- Sep 2022
- First submitted
- 2 Apr 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al Salehi A, Zemmache MZ, Allegre L, Fatton B, de Tayrac R. Functional and sexual outcomes following surgical vaginal introital reduction. Prog Urol. 2023 Jul;33(7):370-376. doi: 10.1016/j.purol.2023.05.003. Epub 2023 May 30.
PubMed 37263901
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Functional and Sexological Results of Surgical Perineal Repair
- ClinicalTrials.gov ID
- NCT04835311
- Acronym / sponsor ID
- SEX-RPC / LOCAL/2021/THESE/RDT-01
- Conditions
- Complications; Perineal Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Apr 2021 (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.
Vaginal laxity" syndrome is an increasingly frequent reason for gynecological consultations. Patients complain above all of a sensation of excessive vaginal looseness. This syndrome can be isolated or associated with genital prolapse. Women with vaginal laxity may experience sexual dysfunction manifested by hypersensitivity during penetration and vaginal gas, resulting in decreased libido. Among urogynecology patients, vaginal laxity has been reported in up to 24% of cases, with a mean discomfort of 5.7 (on a scale of 0 to 10). Vaginal laxity is more common in younger women who have given birth vaginally. Gynecologic examination usually finds widening of the urogenital hiatus during the Valsalva maneuver, suggesting that vaginal laxity may be a manifestation of hyperdistensibility or disinsertion of the levator ani muscles. Campbell et al. noted that vaginal laxity was reported by 38% of 22621 women attending a urogynecology clinic and was associated with vaginal parity, prolapse symptoms, stress, and urinary urgency incontinence, reduced sensation on the ePAQ-PF questionnaire. In an IUGA survey of member physicians, 83% of respondents felt that vaginal laxity was underreported by patients.
The most common clinical definition of vaginal laxity is a urinary meatus to vulvar fork distance (GH measure of the POP-Q classification) > or = 4cm.
The first-line treatment for vaginal laxity is perineal rehabilitation. If this fails, surgical perineal repair, combining posterior perineorrhaphy and myorrhaphy of the pubo-rectal bundles of the levator ani muscles, can be performed with the aim of narrowing the introital vaginal caliber and improving the symptoms of laxity. This procedure is poorly evaluated in the literature.
The purpose of this study is to evaluate the functional and sexological results of surgical perineal repair.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- All women who underwent surgical perineal repair (CCAM codes JMMA002 and/or HKCA005) between July 2012 and September 2020 at Nîmes University Hospital.
Key inclusion criteria (4 listed)
- women who underwent surgical perineal repair (CCAM codes JMMA002 and/or HKCA005) between July 2012 and September 2020 at Nîmes University Hospital.
- Adult patient (≥18 years old)
- Enrolled in a social security plan
- Patient does not object to the study
Key exclusion criteria (7 listed)
- Prolapse surgery without perineal repair
- Perineal repair without levator myorrhaphy
- Patient who objected to the use of their data.
- Pregnancy since the operation
- Persons under court protection,
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 |
|---|---|---|
| surgical perineal repairwomen who have undergone surgical perineal repair (codes CCAM JMMA002 and/or HKCA005) | Procedure or surgery | – |
Primary outcome
To evaluate the sexological results of surgical perineal repair.
Time frame: Day 30
Validated questionnaire (Pelvi-Perineal Surgery Sexuality Questionnaire). Sexual health = score minimum 2 / maximum 29 (29 = very good sexual health) Discomfort and pain = score minimum 0 / maximum 15 (15 = important discomfort or pain)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 37263901Al Salehi A, Zemmache MZ, Allegre L, Fatton B, de Tayrac R. Functional and sexual outcomes following surgical vaginal introital reduction. Prog Urol. 2023 Jul;33(7):370-376. doi: 10.1016/j.purol.2023.05.003. Epub 2023 May 30.
- Individual participant dataSharing planned: No
Related trials for Complications; Perineal Repair
Not yet recruiting
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal Trauma, Postpartum Pain
RecruitingObservational study
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Perineum; Wound, Postoperative Complications
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications; Perineal Repair, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 4 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the sexological results of surgical perineal repair. (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04835311, which also lists 1 linked publication.
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 4 Dec 2025.