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

Stress Urinary Incontinence Clinical Trial

— SEXBSU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05527665
• Other study ID #: 38RC21.0301
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: December 2022

Study information

• Verified date: September 2022
• Source: University Hospital, Grenoble
• Contact: Marie Bugnon
• Phone: +33684722204
• Email: mar.bugnon[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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