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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01632839
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Tracking Information
First Submitted Date June 29, 2012
First Posted Date July 3, 2012
Last Update Posted Date March 26, 2018
Actual Study Start Date January 18, 2013
Actual Primary Completion Date April 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 29, 2012)
PISQ-R questionnaire [ Time Frame: 12 months + 1 week ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01632839 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 29, 2012)
  • PISQ-R questionnaire [ Time Frame: baseline; day 0 ]
  • PISQ-R questionnaire [ Time Frame: 6 months ]
  • PISQ-R questionnaire [ Time Frame: 12 months ]
  • New sexuality questionnaire [ Time Frame: baseline; day 0 ]
  • New sexuality questionnaire [ Time Frame: 6 months ]
  • New sexuality questionnaire [ Time Frame: 12 months ]
  • New sexuality questionnaire [ Time Frame: 12 months + 1 week ]
  • PFDI questionnaire [ Time Frame: baseline; day 0 ]
  • PFDI questionnaire [ Time Frame: 6 months ]
  • PFDI questionnaire [ Time Frame: 12 months ]
  • ICI-Q questionnaire [ Time Frame: baseline; day 0 ]
  • ICI-Q questionnaire [ Time Frame: 6 months ]
  • ICI-Q questionnaire [ Time Frame: 12 months ]
  • FSFI questionnaire [ Time Frame: baseline; day 0 ]
  • FSFI questionnaire [ Time Frame: 6 months ]
  • FSFI questionnaire [ Time Frame: 12 months ]
  • PGI-I questionnaire [ Time Frame: baseline; day 0 ]
  • PGI-I questionnaire [ Time Frame: 6 months ]
  • PGI-I questionnaire [ Time Frame: 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychometric Validation of a French Version of the PISQ-R and a New Questionnaire About Sexuality
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
Brief 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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing vaginal, abdominal or urinary incontinence surgery.
Condition
  • Sexuality
  • Pelvic Organ Prolapse
  • Urinary Incontinence
  • Fecal Incontinence
Intervention Not Provided
Study Groups/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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 5, 2016)
298
Original Estimated Enrollment
 (submitted: June 29, 2012)
300
Actual Study Completion Date April 21, 2017
Actual Primary Completion Date April 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01632839
Other Study ID Numbers LOCAL/2011/BF-03
2012-A00303-40 ( Other Identifier: RCB number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor Centre Hospitalier Universitaire de Nīmes
Collaborators Not Provided
Investigators
Study Director: Renaud de Tayrac, MD PhD Centre Hospitalier Universitaire de Nîmes
Principal Investigator: Brigitte Fatton, MD Centre Hospitalier Universitaire de Nîmes
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date July 2017