Validation of a French Version of the PISQ-R | NCT01548976

Studies
Validation of a French Version of the PISQ-R

NCT01548976

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Mar 26, 2015Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Pelvic Organ Prolapse
Urinary Incontinence
Fecal Incontinence

Interventions

Not provided

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

ID	Type	Description	Link
2012-A00133-40	Other Identifier	RCB number

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

Apr 2012

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Feb 28, 2012

First Submission Date that Met QC Criteria

Mar 6, 2012

First Posted Date

Mar 8, 2012Estimated

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 25, 2015

Last Update Posted Date

Mar 26, 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 main objective of this study is to perform the linguistic validation of the french version of the PISQ-R questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.

Detailed Description

Step 1: Establish a French translation of the original questionnaire (English> French.

Step 2: Perform a first set of comprehension tests with a panel of 15 patients.

Step 3: Establish a revised questionnaire.

Step 4: Perform a second series of comprehension tests with a panel of 10 other patients.

Step 5: Determine the final questionnaire.

Step 6: Perform a back-translation (French> English.

Step 7: Send the final version of the questionnaire and the questionnaire back-translated to the specific committee of the IUGA for final approval.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The study population		Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence. See inclusion/exclusion criteria.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient comprehension	These tests assess patient understanding of the original formulation and patient understanding of the various terms used: a list of proposed rewording suggested by patients is made.	Baseline (Day 0; transversal study)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient is able to read and understand French
The patient must be insured or beneficiary of a health insurance plan
Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Exclusion Criteria:

Patient is pregnant
The patient is under judicial protection, under tutorship or curatorship
The patient does not understand French

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

Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brigitte Fatton, MD	Centre Hospitalier Universitaire de Nīmes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nîmes - Hôpital Universitaire Carémeau		Nîmes	Gard	30029	France

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse
D014549	Urinary Incontinence
D005242	Fecal Incontinence

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D014555	Urination Disorders

Browse Leaves

Not provided

Browse Branches

Not provided