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NCT01134588 Clinical Trial

Assessment of Quality of Life in Disorders of the Pelvic Floor

Pelvic Organ Prolapse Clinical Trial

— U-GYN-QOL  

Official title:
Assessment of Quality of Life in Disorders of the Pelvic Floor

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01134588
Other study ID # LOCAL/2009/VL-01
Secondary ID
Status Completed
Phase N/A
First received June 1, 2010
Last updated March 24, 2015
Start date May 2010
Est. completion date January 2013

Study information
Verified date March 2015
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority France: Commission Nationale de L'Information et des Libertés
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 129
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Other:
• Paper questionnaire

• Touch screen questionnaire

Locations
Country Name City State
France Centre Hospitalier Universitaire de Nîmes Nîmes

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence / absence of a completely filled out questionnaire 6 months post-op No
See also
  Status Clinical Trial Phase
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Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Recruiting NCT04807920 - BOTOX® at the Time of Prolapse Surgery for OAB Phase 4
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
Recruiting NCT02919852 - Laparoscopic Retrovesical Colpopectinopexia N/A
Completed NCT02925585 - Vaginal Tactile Imaging for Pelvic Floor Prolapse
Not yet recruiting NCT02536001 - Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes N/A
Recruiting NCT02113969 - Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol N/A
Completed NCT02383199 - Polypropylene Mesh in Prolapse Surgery N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A