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CompletedNCT01548989Updated Mar 26, 2015

Validation of a New Sexuality Questionnaire for Patients With Urinary Incontinence or Pelvic Organ Prolapse

An observational study in Pelvic Organ Prolapse, Urinary Incontinence and Fecal Incontinence, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-26.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
25
Ages
18 Years and older
Sex
Female
01

Study summary

The main objective of this study is to perform the linguistic validation of a new french questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.

02

Conditions studied

  • Pelvic Organ Prolapse
  • Urinary Incontinence
  • Fecal Incontinence

Keywords

  • linguistic validation of a new questionnaire
03

In context

Fecal Incontinence

312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.

This study's enrollment of 25 is below the median of 100 across 79 observational studies indexed under Fecal Incontinence.

Browse Fecal Incontinence studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

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 suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Inclusion criteria

  • The patient is able to read and understand French
  • The patient must be insured or beneficiary of a health insurance plan
  • Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Exclusion criteria

Exclusion Criteria:

  • Patient is pregnant
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient does not understand French
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
25 participants (actual)

Groups and cohorts

  • The study population

    Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence. See inclusion/exclusion criteria.

06

What researchers measure

Primary outcomes

  1. Patient comprehension

    These tests assess patient understanding of the original formulation and patient understanding of the various terms used: a list of proposed rewording suggested by patients is made.

    Time frame: Baseline (Day 0; transversal study)

07

Study locations

1 site
  • CHU de Nîmes - Hôpital Universitaire Carémeau
    Nîmes Cedex 09, Gard 30029, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01548989
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Mar 8, 2012
Start date
Apr 2012
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Mar 26, 2015

Study contacts

Brigitte Fatton, MD
principal investigator · Centre Hospitalier Universitaire de Nîmes

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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