Ultrasonographic Bladder Wall Thickness and Different For... | NCT01003457

Studies
Ultrasonographic Bladder Wall Thickness and Different Forms of Detrusor Overactivity

NCT01003457

Sponsor

Università degli Studi dell'Insubria

Status

Completed

Last Update Posted

Oct 28, 2009Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Detrusor Overactivity

Interventions

ultrasonography

Countries

Italy

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

Oct 2009

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

Jan 2005

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Oct 27, 2009

First Submission Date that Met QC Criteria

Oct 27, 2009

First Posted Date

Oct 28, 2009Estimated

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

Oct 27, 2009

Last Update Posted Date

Oct 28, 2009Estimated

Description Module

Brief Summary

In the last decade, several authors proposed ultrasound measurement of Bladder wall thickness (BWT) for the screening of the voiding dysfunction and of the detrusor overactivity (DO). The aims of the investigator prospective study were:

to compare the ultrasonographic measurement of BWT in women with DO vs women with other urodynamic diagnosis in a very large population.
to verify whether the BWT in women with DO can be different in the clinically or urodinamically different forms of DO.

Detailed Description

Not provided

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

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
detrusor overactivity			Other: ultrasonography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasonography	Other	transvaginal ultrasonography of bladder wall thickness	detrusor overactivity

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All women referred to our Urogynecology Unit from January 2005 to December 2008 for symptoms of OAB, stress urinary incontinence or mixed incontinence and sottoposte a prove urodinamiche complete were included in this prospective study

Exclusion Criteria:

The investigators excluded women with documented recurrent urinary tract infections
Previous antimuscarinic treatment
Previous pelvic surgery
Neurological disease
Vaginal prolapse > I stage
Symptoms or clinical and/or urodynamic signs of voiding dysfunction
Patients included in other ongoing clinical trials during the same study period.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

all women with urinary dysfunction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Insubria		Varese	varese	21100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20535449	Derived	Serati M, Salvatore S, Cattoni E, Soligo M, Cromi A, Ghezzi F. Ultrasound measurement of bladder wall thickness in different forms of detrusor overactivity. Int Urogynecol J. 2010 Nov;21(11):1405-11. doi: 10.1007/s00192-010-1194-1. Epub 2010 Jun 10.

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation