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Completed

NCT Number: NCT01632839

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

APHP - Hôpital Antoine Beclere, Clamart, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 3, 2012
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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