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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT01632839

Collaborator

(none)

298

Enrollment

Locations

51.1

Actual Duration (Months)

21.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Sexuality Pelvic Organ Prolapse Urinary Incontinence Fecal Incontinence

Study Design

Study Type:

Observational

Actual Enrollment :

298 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 18, 2013

Actual Primary Completion Date :

Apr 21, 2017

Actual Study Completion Date :

Apr 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Vaginal surgery +prothesis +sexuality 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 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 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 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 The 50 patients included in this group will have undergone abdominal surgery for pelvic organ prolapse; these patients are sexually active.
Abdominal surgery -sexuality 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 The 50 patients included in this group will have surgery for urinary incontinence; these patients are sexually active.
Urinary incontinence surgery - sexuality The 25 patients included in this group will have surgery for urinary incontinence; these patients are NOT sexually active.

Outcome Measures

Primary Outcome Measures

PISQ-R questionnaire [12 months + 1 week]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	APHP - Hôpital Antoine Beclere	Clamart Cedex	France	92141
2	CHU de Clermont Ferrand - Hôpital Estaing	Clermont Ferrand	France	63003
3	G.C.S. Flandre Maritime - site Polyclinique de Grande-Synthe	Grande Synthe	France	59760
4	CH de la Rochelle	La Rochelle Cedex	France	17019
5	APHP - Centre Hospitalier Universitaire de Bicêtre	Le Kremlin Bicêtre Cedex	France	94275
6	CHRU de Lille - Hôpital Jeanne de Flandre	Lille Cedex	France	59037
7	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9	France	30029
8	APHP - Hôpital Bichat - Claude Bernard	Paris Cedex 18	France	75877
9	Groupe Hospitalier Dioconesses - Site Reuilly	Paris	France	75012
10	CHU de Poitiers	Poitiers Cedex	France	86021
11	CH de la Région d'Annecy	Pringy Cedex	France	74374
12	CH de Poissy - Saint-Germain-en-Laye	Saint-Germain-en-Laye	France	78100
13	CHRU de Strasbourg - Hôpital de Hautepierre	Strasbourg	France	67098
14	Hôpital Foch	Suresnes	France	92151

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Study Director: Renaud de Tayrac, MD PhD, Centre Hospitalier Universitaire de Nîmes
Principal Investigator: Brigitte Fatton, MD, Centre Hospitalier Universitaire de Nîmes