NCT01134588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2.7 years

First QC Date

June 1, 2010

Last Update Submit

March 24, 2015

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Presence / absence of a completely filled out questionnaire

    6 months post-op

Study Arms (2)

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

Paper questionnaireOTHER
Reference group
Touch screen questionnaireOTHER
Experimental group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • the patient refuses to participate
  • the patient is under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Vincent Letouzey, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 2, 2010

Study Start

May 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

FR(1)