Psychometric Validation of a French Version of the PISQ-R and a New Questionnaire About Sexuality

Study Overview
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Brief Summary
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The primary objective of this study is the psychometric validation of two questionnaires (PISQ-R and a new questionnaire on sexuality) as compared to a non specific questionnaire on female sexual function (FSFI).

Official Title
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Psychometric Validation of a French Version of the PISQ-R and a New Questionnaire About Sexuality: Tools for Evaluating Sexuality in Patients With From Urinary Incontinence or Pelvic Organ Prolapse

Conditions
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Sexuality, Pelvic Organ Prolapse, Urinary Incontinence, Fecal Incontinence

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is not pregnant Patient can read and understand French The patient must have given her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient has genital prolapse and/or urinary incontinence and/or anal incontinence, and have undergone surgery Exclusion Criteria: The patient is under judicial protection The patient does not understand french Patient has vulvodynia Patient has painful bladder syndrome The patient has had chronic pelvic pain for longer than 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaginal surgery +prothesis +sexuality<br>The 50 patients included in this group will have undergone vaginal surgery for pelvic organ prolapse with placement of a prothesis; these patients are sexually active. | |
| Vaginal surgery +prothesis -sexuality<br>The 25 patients included in this group will have undergone vaginal surgery for pelvic organ prolapse with placement of a prothesis; these patients are NOT sexually active. | |
| Vaginal surgery -prothesis + sexuality<br>The 50 patients included in this group will have undergone vaginal surgery for pelvic organ prolapse WITHOUT placement of a prothesis; these patients are sexually active. | |
| Vaginal surgery -prothesis -sexuality<br>The 25 patients included in this group will have undergone vaginal surgery for pelvic organ prolapse WITHOUT placement of a prothesis; these patients are NOT sexually active. | |
| Abdominal surgery +sexuality<br>The 50 patients included in this group will have undergone abdominal surgery for pelvic organ prolapse; these patients are sexually active. | |
| Abdominal surgery -sexuality<br>The 25 patients included in this group will have undergone abdominal surgery for pelvic organ prolapse; these patients are NOT sexually active. | |
| Urinary incontinence surgery + sexuality<br>The 50 patients included in this group will have surgery for urinary incontinence; these patients are sexually active. | |
| Urinary incontinence surgery - sexuality<br>The 25 patients included in this group will have surgery for urinary incontinence; these patients are NOT sexually active. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PISQ-R questionnaire |  | 12 months + 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PISQ-R questionnaire |  | baseline; day 0 | 
| PISQ-R questionnaire |  | 6 months | 
| PISQ-R questionnaire |  | 12 months | 
| New sexuality questionnaire |  | baseline; day 0 | 
| New sexuality questionnaire |  | 6 months | 
| New sexuality questionnaire |  | 12 months | 
| New sexuality questionnaire |  | 12 months + 1 week | 
| PFDI questionnaire |  | baseline; day 0 | 
| PFDI questionnaire |  | 6 months | 
| PFDI questionnaire |  | 12 months | 
| ICI-Q questionnaire |  | baseline; day 0 | 
| ICI-Q questionnaire |  | 6 months | 
| ICI-Q questionnaire |  | 12 months | 
| FSFI questionnaire |  | baseline; day 0 | 
| FSFI questionnaire |  | 6 months | 
| FSFI questionnaire |  | 12 months | 
| PGI-I questionnaire |  | baseline; day 0 | 
| PGI-I questionnaire |  | 6 months | 
| PGI-I questionnaire |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PISQ-R, new sexuality questionnaire