Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ (SEXBSU)

Evaluation of the sexual quality of life of women who had a sub-urethral sling several years ago, using a recently validated questionnaire: the PPSSQ (Pelvi-Perineal Surgery Sexuality Questionnaire).

This questionnaire is specifically oriented for women who have undergone surgery for stress urinary incontinence or prolapse. It contains questions specific to post-surgical issues that are not present in other sexual quality of life questionnaires. The questionnaire will also be administered to a group of control women who have not had suburethral sling surgery in order to compare their responses to those of women who have had surgery.

The hypothesis is that the placement of a suburethral sling for stress urinary incontinence increases the quality of sexual life of the women.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: Midurethral sling surgery

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Marie Bugnon; Phone Number: +33684722204; Email: mar.bugnon@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients who have received a sub-urethral sling at CHUGA in the gynecology and urology departments between January 2015 and June 2020.

Healthy volunteers who agreed to answer the questionnaire fitted on age and menopausal status.

Description

Inclusion Criteria:

Patient group

• Women who have received a suburethral sling at CHUGA in the gynecology or urology departments between January 2015 and June 2020.
• Women who agreed to complete the PPSSQ

Healthy volunteers group

• Adult women matched on age and menopausal status to the patient group
• Women who have never undergone surgery for stress urinary incontinence by placing a sub-urethral tape.
• Women who agreed to complete the PPSSQ

Exclusion Criteria:

Patient group

• Tape removal.
• Death since surgery.
• Factors that make it impossible to understand the questionnaires: neurological or psychiatric pathology that limits the understanding of the questions, lack of mastery of the French language, illiteracy.
• Absence of perineal sensation.
• Persons referred to in articles L1121-5 to L1121-8 of the CSP.

Healthy volunteers group

• Factors that make it impossible to understand the questionnaires: neurological or psychiatric pathology that limits the understanding of the questions, lack of mastery of the French language, illiteracy.
• Absence of perineal sensation.
• Persons referred to in articles L1121-5 to L1121-8 of the CSP.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient group; Women over 90 years of age Women who have received a suburethral sling at CHUGA in the gynecology or urology departments between January 2015 and June 2020. Women who agreed to complete the PPSSQ	Procedure: Midurethral sling surgery; This treatment consists of the placement of a sub-urethral sling, usually made of polypropylene, in order to support the urethra during efforts and thus to avoid leaks linked to its hyper mobility. This is a frequent and rapid surgery, which is performed on an outpatient basis. The sling is placed under the patient's urethra with the help of an awl.
Healthy volunteers group; -Adult women under 90 years of age, matched on age and menopausal status to the patient group Women who have never had surgery for stress urinary incontinence with a sub-urethral sling. Women who agreed to complete the PPSSQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the sexual discomfort in the medium term in patients who have undergone surgery for stress urinary incontinence by placing a suburethral sling.	The primary endpoint of the research is the comparison of medians of the PPSSQ "discomfort and pain" score between women who underwent suburethral sling surgery and healthy female volunteers of the same age and menopausal status.	2 to 7 years after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the quality of sexual life of patients who have undergone surgery for stress urinary incontinence using a suburethral sling.	Comparison of medians of the PPSSQ "sexual health" score between women with suburethral sling surgery and healthy female volunteers.	2 to 7 years after the surgery
Analyze the causes of discomfort and the characteristics of pain experienced by patients during intercourse.	Analyse of PPSSQ answers to questions 5 and 6	2 to 7 years after the surgery
To analyze the rate of non-sexually active patients after surgery, and the causes of this lack of sexuality.	Analyse of PPSSQ answers to question 1	2 to 7 years after the surgery
Compare sexual discomfort and quality of sexual life before/after suburethral sling surgery.	Comparison of medians of the PPSSQ scores in the patient group before and after surgery	2 to 7 years after the surgery

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 38RC21.0301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No