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

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632839
• Other study ID #: LOCAL/2011/BF-03
• Secondary ID: 2012-A00303-40
• Status: Completed
• First received: June 29, 2012
• Last updated: March 23, 2018
• Start date: January 18, 2013
• Est. completion date: April 21, 2017

Study information

• Verified date: July 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: April 21, 2017
• Est. primary completion date: April 21, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Fecal Incontinence
• Pelvic Organ Prolapse
• Prolapse
• Sexuality
• Urinary Incontinence

Locations

Country	Name	City	State
France	APHP - Hôpital Antoine Beclere	Clamart Cedex
France	CHU de Clermont Ferrand - Hôpital Estaing	Clermont Ferrand
France	G.C.S. Flandre Maritime - site Polyclinique de Grande-Synthe	Grande Synthe
France	CH de la Rochelle	La Rochelle Cedex
France	APHP - Centre Hospitalier Universitaire de Bicêtre	Le Kremlin Bicêtre Cedex
France	CHRU de Lille - Hôpital Jeanne de Flandre	Lille Cedex
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9
France	Groupe Hospitalier Dioconesses - Site Reuilly	Paris
France	APHP - Hôpital Bichat - Claude Bernard	Paris Cedex 18
France	CHU de Poitiers	Poitiers Cedex
France	CH de la Région d'Annecy	Pringy Cedex
France	CH de Poissy - Saint-Germain-en-Laye	Saint-Germain-en-Laye
France	CHRU de Strasbourg - Hôpital de Hautepierre	Strasbourg
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PISQ-R questionnaire		12 months + 1 week
Secondary	PISQ-R questionnaire		baseline; day 0
Secondary	PISQ-R questionnaire		6 months
Secondary	PISQ-R questionnaire		12 months
Secondary	New sexuality questionnaire		baseline; day 0
Secondary	New sexuality questionnaire		6 months
Secondary	New sexuality questionnaire		12 months
Secondary	New sexuality questionnaire		12 months + 1 week
Secondary	PFDI questionnaire		baseline; day 0
Secondary	PFDI questionnaire		6 months
Secondary	PFDI questionnaire		12 months
Secondary	ICI-Q questionnaire		baseline; day 0
Secondary	ICI-Q questionnaire		6 months
Secondary	ICI-Q questionnaire		12 months
Secondary	FSFI questionnaire		baseline; day 0
Secondary	FSFI questionnaire		6 months
Secondary	FSFI questionnaire		12 months
Secondary	PGI-I questionnaire		baseline; day 0
Secondary	PGI-I questionnaire		6 months
Secondary	PGI-I questionnaire		12 months