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SexualityNCT01632839

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

An observational study of Sexuality and Pelvic Organ Prolapse, run by Centre Hospitalier Universitaire de Nīmes at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older, women only
How many people
298 participants
Where
14 sitesFrance
Study dates
18 Jan 2013to 20 Apr 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing vaginal, abdominal or urinary incontinence surgery.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • APHP - Hôpital Antoine Beclere

    Clamart, 92141

  • CHU de Clermont Ferrand - Hôpital Estaing

    Clermont-Ferrand, 63003

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

    Grande-Synthe, 59760

  • CH de la Rochelle

    La Rochelle, 17019

  • APHP - Centre Hospitalier Universitaire de Bicêtre

    Le Kremlin-Bicêtre, 94275

  • CHRU de Lille - Hôpital Jeanne de Flandre

    Lille, 59037

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

  • Groupe Hospitalier Dioconesses - Site Reuilly

    Paris, 75012

  • APHP - Hôpital Bichat - Claude Bernard

    Paris, 75877

  • CHU de Poitiers

    Poitiers, 86021

  • CH de la Région d'Annecy

    Pringy, 74374

  • CH de Poissy - Saint-Germain-en-Laye

    Saint-Germain-en-Laye, 78100

  • CHRU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67098

  • Hôpital Foch

    Suresnes, 92151

Other trials in France

About this study

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

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).

Keywords
PISQ-R, new sexuality questionnaire
Medical subject headings
Sexuality, Pelvic Organ Prolapse, Urinary Incontinence, Fecal Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01632839
Study groupRoleWhat they receive
Vaginal surgery +prothesis +sexualityThe 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 -sexualityThe 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 + sexualityThe 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 -sexualityThe 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 +sexualityThe 50 patients included in this group will have undergone abdominal surgery for pelvic organ prolapse; these patients are sexually active.
Abdominal surgery -sexualityThe 25 patients included in this group will have undergone abdominal surgery for pelvic organ prolapse; these patients are NOT sexually active.
Urinary incontinence surgery + sexualityThe 50 patients included in this group will have surgery for urinary incontinence; these patients are sexually active.
Urinary incontinence surgery - sexualityThe 25 patients included in this group will have surgery for urinary incontinence; these patients are NOT sexually active.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PISQ-R questionnaire

    Measured: 12 months + 1 week

Secondary outcomes (19)

  1. PISQ-R questionnaire

    Measured: baseline; day 0

  2. PISQ-R questionnaire

    Measured: 6 months

  3. PISQ-R questionnaire

    Measured: 12 months

  4. New sexuality questionnaire

    Measured: baseline; day 0

  5. New sexuality questionnaire

    Measured: 6 months

  6. New sexuality questionnaire

    Measured: 12 months

  7. New sexuality questionnaire

    Measured: 12 months + 1 week

  8. PFDI questionnaire

    Measured: baseline; day 0

  9. PFDI questionnaire

    Measured: 6 months

  10. PFDI questionnaire

    Measured: 12 months

  11. ICI-Q questionnaire

    Measured: baseline; day 0

  12. ICI-Q questionnaire

    Measured: 6 months

  13. ICI-Q questionnaire

    Measured: 12 months

  14. FSFI questionnaire

    Measured: baseline; day 0

  15. FSFI questionnaire

    Measured: 6 months

  16. FSFI questionnaire

    Measured: 12 months

  17. PGI-I questionnaire

    Measured: baseline; day 0

  18. PGI-I questionnaire

    Measured: 6 months

  19. PGI-I questionnaire

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2012 (estimated)
  2. Study start18 Jan 2013
  3. Primary completion20 Apr 2017
  4. Study completion20 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01632839
Sponsor's protocol ID
LOCAL/2011/BF-03
Other IDs
2012-A00303-40
Status last verified
Jul 2017
First submitted
29 Jun 2012
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33399902

Questions about this trial

What is this clinical trial studying?

An observational study of Sexuality and Pelvic Organ Prolapse, run by Centre Hospitalier Universitaire de Nīmes at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PISQ-R questionnaire (time frame: 12 months + 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01632839, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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