Overview

This trial is active, not recruiting.

Conditions sexuality, pelvic organ prolapse, urinary incontinence, fecal incontinence
Sponsor Centre Hospitalier Universitaire de Nīmes
Start date January 2013
End date March 2017
Trial size 298 participants
Trial identifier NCT01632839, 2012-A00303-40, LOCAL/2011/BF-03

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
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.
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.
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.
The 50 patients included in this group will have undergone abdominal surgery for pelvic organ prolapse; these patients are sexually active.
The 25 patients included in this group will have undergone abdominal surgery for pelvic organ prolapse; these patients are NOT sexually active.
The 50 patients included in this group will have surgery for urinary incontinence; these patients are sexually active.
The 25 patients included in this group will have surgery for urinary incontinence; these patients are NOT sexually active.

Primary Outcomes

Measure
PISQ-R questionnaire
time frame: 12 months + 1 week

Secondary Outcomes

Measure
PISQ-R questionnaire
time frame: baseline; day 0
PISQ-R questionnaire
time frame: 6 months
PISQ-R questionnaire
time frame: 12 months
New sexuality questionnaire
time frame: baseline; day 0
New sexuality questionnaire
time frame: 6 months
New sexuality questionnaire
time frame: 12 months
New sexuality questionnaire
time frame: 12 months + 1 week
PFDI questionnaire
time frame: baseline; day 0
PFDI questionnaire
time frame: 6 months
PFDI questionnaire
time frame: 12 months
ICI-Q questionnaire
time frame: baseline; day 0
ICI-Q questionnaire
time frame: 6 months
ICI-Q questionnaire
time frame: 12 months
FSFI questionnaire
time frame: baseline; day 0
FSFI questionnaire
time frame: 6 months
FSFI questionnaire
time frame: 12 months
PGI-I questionnaire
time frame: baseline; day 0
PGI-I questionnaire
time frame: 6 months
PGI-I questionnaire
time frame: 12 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Brigitte Fatton, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes.