Stress Urinary IncontinenceSEXBSUNCT05527665
Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
An observational study of Stress Urinary Incontinence, run by University Hospital, Grenoble.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Midurethral sling surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Midurethral sling surgery
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midurethral sling surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 to 7 years after the surgery
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 2 to 7 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527665
- Sponsor's protocol ID
- 38RC21.0301
- Acronym
- SEXBSU
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
- ClinicalTrials.gov ID
- NCT05527665
- Acronym / sponsor ID
- SEXBSU / 38RC21.0301
- Conditions
- Stress Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Procedure: Midurethral sling surgeryWomen 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 |
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midurethral sling surgeryThis 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. | Procedure or surgery | Patient group |
Primary outcome
Evaluate the sexual discomfort in the medium term in patients who have undergone surgery for stress urinary incontinence by placing a suburethral sling.
Time frame: 2 to 7 years after the surgery
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.
4 secondary outcomes
To evaluate the quality of sexual life of patients who have undergone surgery for stress urinary incontinence using a suburethral sling.
Time frame: 2 to 7 years after the surgery
Analyze the causes of discomfort and the characteristics of pain experienced by patients during intercourse.
Time frame: 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.
Time frame: 2 to 7 years after the surgery
Compare sexual discomfort and quality of sexual life before/after suburethral sling surgery.
Time frame: 2 to 7 years after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Bugnon (+33684722204, mar.bugnon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the sexual discomfort in the medium term in patients who have undergone surgery for stress urinary incontinence by placing a suburethral sling. (time frame: 2 to 7 years after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.