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CompletedNCT01632839Updated Nov 19, 2025

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

An observational study in Sexuality, Pelvic Organ Prolapse and Urinary Incontinence, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 14 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
298
Ages
18 Years and older
Sex
Female
01

Study 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).

02

Conditions studied

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

Keywords

  • PISQ-R
  • new sexuality questionnaire
03

In context

Sexuality

130 studies on the registry are indexed under Sexuality; 26 are open to participants now.

This study's enrollment of 298 is above the median of 100 across 47 observational studies indexed under Sexuality.

Browse Sexuality studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Browse Centre Hospitalier Universitaire de Nīmes studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing vaginal, abdominal or urinary incontinence surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
298 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. PISQ-R questionnaire

    Time frame: 12 months + 1 week

Secondary outcomes

  1. PISQ-R questionnaire

    Time frame: baseline; day 0

  2. PISQ-R questionnaire

    Time frame: 6 months

  3. PISQ-R questionnaire

    Time frame: 12 months

  4. New sexuality questionnaire

    Time frame: baseline; day 0

  5. New sexuality questionnaire

    Time frame: 6 months

  6. New sexuality questionnaire

    Time frame: 12 months

  7. New sexuality questionnaire

    Time frame: 12 months + 1 week

  8. PFDI questionnaire

    Time frame: baseline; day 0

  9. PFDI questionnaire

    Time frame: 6 months

  10. PFDI questionnaire

    Time frame: 12 months

  11. ICI-Q questionnaire

    Time frame: baseline; day 0

  12. ICI-Q questionnaire

    Time frame: 6 months

  13. ICI-Q questionnaire

    Time frame: 12 months

  14. FSFI questionnaire

    Time frame: baseline; day 0

  15. FSFI questionnaire

    Time frame: 6 months

  16. FSFI questionnaire

    Time frame: 12 months

  17. PGI-I questionnaire

    Time frame: baseline; day 0

  18. PGI-I questionnaire

    Time frame: 6 months

  19. PGI-I questionnaire

    Time frame: 12 months

07

Study locations

14 sites
  • APHP - Hôpital Antoine Beclere
    Clamart, 92141, France
  • CHU de Clermont Ferrand - Hôpital Estaing
    Clermont-Ferrand, 63003, France
  • G.C.S. Flandre Maritime - site Polyclinique de Grande-Synthe
    Grande-Synthe, 59760, France
  • CH de la Rochelle
    La Rochelle, 17019, France
  • APHP - Centre Hospitalier Universitaire de Bicêtre
    Le Kremlin-Bicêtre, 94275, France
  • CHRU de Lille - Hôpital Jeanne de Flandre
    Lille, 59037, France
  • CHU de Nîmes - Hôpital Universitaire Carémeau
    Nîmes, 30029, France
  • Groupe Hospitalier Dioconesses - Site Reuilly
    Paris, 75012, France
  • APHP - Hôpital Bichat - Claude Bernard
    Paris, 75877, France
  • CHU de Poitiers
    Poitiers, 86021, France
  • CH de la Région d'Annecy
    Pringy, 74374, France
  • CH de Poissy - Saint-Germain-en-Laye
    Saint-Germain-en-Laye, 78100, France
  • CHRU de Strasbourg - Hôpital de Hautepierre
    Strasbourg, 67098, France
  • Hôpital Foch
    Suresnes, 92151, France
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2013 to primary completion in Apr 2017, 51 months.

Of 15 observational studies under Sexuality, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 51. This study's 51 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2012
First posted
Jul 3, 2012
StartActual
Jan 18, 2013
Primary completionActual
Apr 20, 2017
CompletionActual
Apr 20, 2017
Last update
Nov 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01632839
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Jul 3, 2012
Start date
Jan 18, 2013
Primary completion
Apr 20, 2017
Completion
Apr 20, 2017
Last update
Nov 19, 2025

Study contacts

Renaud de Tayrac, MD PhD
study director · Centre Hospitalier Universitaire de Nīmes
Brigitte Fatton, MD
principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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