Assessment of Quality of Life in Disorders of the Pelvic... | NCT01134588

Studies
Assessment of Quality of Life in Disorders of the Pelvic Floor

NCT01134588

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Mar 25, 2015Estimated

Enrollment

129Actual

Phase

Not Applicable

Conditions

Pelvic Organ Prolapse

Interventions

Paper questionnaire
Touch screen questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Jun 1, 2010

First Submission Date that Met QC Criteria

Jun 1, 2010

First Posted Date

Jun 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2015

Last Update Posted Date

Mar 25, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

129Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reference group	Active Comparator	This group will fill out paper questionnaires.	Other: Paper questionnaire
Experimental group	Experimental	This group will fill out touch-screen questionnaires.	Other: Touch screen questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paper questionnaire	Other		Reference group
Touch screen questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence / absence of a completely filled out questionnaire		6 months post-op

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent Letouzey, MD	Centre Hospitalier Universitaire de Nīmes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Nîmes		Nîmes		30029	France

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided