CClinicalTrials.gg
Status unknownNCT05527665SEXBSUUpdated Sep 8, 2022

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

An observational study in Stress Urinary Incontinence, sponsored by University Hospital, Grenoble. Status unknown. Open to female participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-08.

Sponsored by University Hospital, Grenoble · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
200
Ages
18 Years to 90 Years
Sex
Female
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Study 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.

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Conditions studied

  • Stress Urinary Incontinence
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In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 200 is above the median of 120 across 305 observational studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • ProcedureMidurethral 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 to 7 years after the surgery

Secondary outcomes

  1. 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.

    Time frame: 2 to 7 years after the surgery

  2. Analyze the causes of discomfort and the characteristics of pain experienced by patients during intercourse.

    Analyse of PPSSQ answers to questions 5 and 6

    Time frame: 2 to 7 years after the surgery

  3. 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

    Time frame: 2 to 7 years after the surgery

  4. 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

    Time frame: 2 to 7 years after the surgery

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05527665
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Sep 2, 2022
Start date
Sep 2022 (estimated)
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Sep 8, 2022

Study contacts

Marie Bugnon
Contact
mar.bugnon@gmail.com
+33684722204

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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