Assessment of Quality of Life in Disorders of the Pelvic Floor

NCT ID: NCT01134588

Last Updated: 2015-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Reference group

This group will fill out paper questionnaires.

Group Type ACTIVE_COMPARATOR

Paper questionnaire

Intervention Type OTHER

Experimental group

This group will fill out touch-screen questionnaires.

Group Type EXPERIMENTAL

Touch screen questionnaire

Intervention Type OTHER

Interventions

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Paper questionnaire

Intervention Type OTHER

Touch screen questionnaire

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent Letouzey, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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Centre Hospitalier Universitaire de Nîmes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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LOCAL/2009/VL-01

Identifier Type: -

Identifier Source: org_study_id

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