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

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Sexuality
Pelvic Organ Prolapse
Fecal Incontinence
Urinary Incontinence

Study type

Observational

Funder types

Other

Identifiers

NCT01632839
2012-A00303-40 (Other Identifier)
LOCAL/2011/BF-03

Details and patient eligibility

About

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).

Enrollment

298 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

298 participants in 8 patient groups

Vaginal surgery +prothesis +sexuality
Description:
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
Description:
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
Description:
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
Description:
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
Description:
The 50 patients included in this group will have undergone abdominal surgery for pelvic organ prolapse; these patients are sexually active.
Abdominal surgery -sexuality
Description:
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
Description:
The 50 patients included in this group will have surgery for urinary incontinence; these patients are sexually active.
Urinary incontinence surgery - sexuality
Description:
The 25 patients included in this group will have surgery for urinary incontinence; these patients are NOT sexually active.

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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