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

NCT ID: NCT05527665

Last Updated: 2022-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stress Urinary Incontinence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Midurethral sling surgery

Intervention Type PROCEDURE

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

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Marie Bugnon

Role: CONTACT

+33684722204

Other Identifiers

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38RC21.0301

Identifier Type: -

Identifier Source: org_study_id

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