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

NCT ID: NCT01632839

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

298 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-18

Study Completion Date

2017-04-20

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).

Detailed Description

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Conditions

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Sexuality Pelvic Organ Prolapse Urinary Incontinence Fecal Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Abdominal surgery +sexuality

The 50 patients included in this group will have undergone abdominal surgery for pelvic organ prolapse; these patients are sexually active.

No interventions assigned to this group

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.

No interventions assigned to this group

Urinary incontinence surgery + sexuality

The 50 patients included in this group will have surgery for urinary incontinence; these patients are sexually active.

No interventions assigned to this group

Urinary incontinence surgery - sexuality

The 25 patients included in this group will have surgery for urinary incontinence; these patients are NOT sexually active.

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renaud de Tayrac, MD PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Brigitte Fatton, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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APHP - Hôpital Antoine Beclere

Clamart, , France

Site Status

CHU de Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, , France

Site Status

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

Grande-Synthe, , France

Site Status

CH de la Rochelle

La Rochelle, , France

Site Status

APHP - Centre Hospitalier Universitaire de Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

CHRU de Lille - Hôpital Jeanne de Flandre

Lille, , France

Site Status

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Groupe Hospitalier Dioconesses - Site Reuilly

Paris, , France

Site Status

APHP - Hôpital Bichat - Claude Bernard

Paris, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

CH de la Région d'Annecy

Pringy, , France

Site Status

CH de Poissy - Saint-Germain-en-Laye

Saint-Germain-en-Laye, , France

Site Status

CHRU de Strasbourg - Hôpital de Hautepierre

Strasbourg, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 33399902 (View on PubMed)

Other Identifiers

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2012-A00303-40

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2011/BF-03

Identifier Type: -

Identifier Source: org_study_id

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