Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Retrospective Evaluation of Functional and Sexological Results of Surgical Perineal Repair (SEX-RPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04835311
Recruitment Status : Active, not recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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.


Condition or disease Intervention/treatment
Complications; Perineal Repair Procedure: surgical perineal repair

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Evaluation of Functional and Sexological Results of Surgical Perineal Repair
Actual Study Start Date : March 26, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Procedure: surgical perineal repair
    women who have undergone surgical perineal repair (codes CCAM JMMA002 and/or HKCA005)

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04835311


Locations
Layout table for location information
France
Centre Hospitalier Universitaire
Nîmes, Gard, France, 30000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04835311    
Other Study ID Numbers: LOCAL/2021/THESE/RDT-01
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No