Back to resultsAssessment of Quality of Life in Disorders of the Pelvic Floor (U-GYN-QOL)
Primary Purpose
Pelvic Organ Prolapse
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Paper questionnaire
Touch screen questionnaire
Sponsored by
About this trial
This is an interventional health services research trial for Pelvic Organ Prolapse
Eligibility Criteria
Inclusion Criteria:
- the patient has pelvic organ prolapse
- the patient requires a surgical intervention within the next 4 to 8 weeks
- the patient understands and reads french
- the patient is affiliated with a social security system
- the patient has given consent
Exclusion Criteria:
- the patient refuses to participate
- the patient is under guardianship
Sites / Locations
- Centre Hospitalier Universitaire de Nîmes
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Reference group
Experimental group
Arm Description
This group will fill out paper questionnaires.
This group will fill out touch-screen questionnaires.
Outcomes
Primary Outcome Measures
Presence / absence of a completely filled out questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT01134588
First Posted
June 1, 2010
Last Updated
March 24, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT01134588
Brief Title
Assessment of Quality of Life in Disorders of the Pelvic Floor
Acronym
U-GYN-QOL
Official Title
Assessment of Quality of Life in Disorders of the Pelvic Floor
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the touch-screen version of the PFDI-20, PFIQ-7, PISQ 12 and SF-36 french questionnaires to their paper versions. The investigators hypothesize that the percentage of completely filled questionnaires will be higher in the touch-screen version.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reference group
Arm Type
Active Comparator
Arm Description
This group will fill out paper questionnaires.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
This group will fill out touch-screen questionnaires.
Intervention Type
Other
Intervention Name(s)
Paper questionnaire
Intervention Type
Other
Intervention Name(s)
Touch screen questionnaire
Primary Outcome Measure Information:
Title
Presence / absence of a completely filled out questionnaire
Time Frame
6 months post-op
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the patient has pelvic organ prolapse
the patient requires a surgical intervention within the next 4 to 8 weeks
the patient understands and reads french
the patient is affiliated with a social security system
the patient has given consent
Exclusion Criteria:
the patient refuses to participate
the patient is under guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Letouzey, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Learn more about this trial
Assessment of Quality of Life in Disorders of the Pelvic Floor
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