Clinical trial NCT05527665: Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Official title: Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress Urinary Incontinence
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the sexual discomfort in the medium term in patients who have undergone surgery for stress urinary incontinence by placing a suburethral sling.
timeFrame: 2 to 7 years after the surgery
Secondary outcomes:
measure: To evaluate the quality of sexual life of patients who have undergone surgery for stress urinary incontinence using a suburethral sling.
timeFrame: 2 to 7 years after the surgery
measure: Analyze the causes of discomfort and the characteristics of pain experienced by patients during intercourse.
timeFrame: 2 to 7 years after the surgery
measure: To analyze the rate of non-sexually active patients after surgery, and the causes of this lack of sexuality.
timeFrame: 2 to 7 years after the surgery
measure: Compare sexual discomfort and quality of sexual life before/after suburethral sling surgery.
timeFrame: 2 to 7 years after the surgery
Other outcomes:
Locations:
Study officials:
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