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

NCT01632839 | Completed

• 2 other identifiers: LOCAL/2011/BF-032012-A00303-40
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 14

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).

Conditions

Sexuality; Pelvic Organ Prolapse; Urinary Incontinence; Fecal Incontinence

Keywords

PISQ-R; new sexuality questionnaire

Outcome Measures

Primary Outcomes (1)

• PISQ-R questionnaire

  12 months + 1 week

Secondary Outcomes (19)

• 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

Study Arms (8)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing vaginal, abdominal or urinary incontinence surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (14)

APHP - Hôpital Antoine Beclere

Clamart, 92141, France

Location

CHU de Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, 63003, France

Location

G.C.S. Flandre Maritime - site Polyclinique de Grande-Synthe

Grande-Synthe, 59760, France

Location

CH de la Rochelle

La Rochelle, 17019, France

Location

APHP - Centre Hospitalier Universitaire de Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

CHRU de Lille - Hôpital Jeanne de Flandre

Lille, 59037, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Groupe Hospitalier Dioconesses - Site Reuilly

Paris, 75012, France

Location

APHP - Hôpital Bichat - Claude Bernard

Paris, 75877, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CH de la Région d'Annecy

Pringy, 74374, France

Location

CH de Poissy - Saint-Germain-en-Laye

Saint-Germain-en-Laye, 78100, France

Location

CHRU de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Hôpital Foch

Suresnes, 92151, France

Location

Related Publications (1)

• Fatton B, Hermieu JF, Lucot JP, Debodinance P, Cour F, Alonso S, de Tayrac R. French validation of the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA revised (PISQ-IR). Int Urogynecol J. 2021 Dec;32(12):3183-3198. doi: 10.1007/s00192-020-04625-6. Epub 2021 Jan 5.

  PMID: 33399902 RESULT

MeSH Terms

Conditions

Sexuality; Pelvic Organ Prolapse; Urinary Incontinence; Fecal Incontinence

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Renaud de Tayrac, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

• Brigitte Fatton, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 3, 2012
• Study Start: January 18, 2013
• Primary Completion: April 20, 2017
• Study Completion: April 20, 2017
• Last Updated: November 19, 2025

Record last verified: 2017-07

Locations

FR (14)