NCT01003457

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

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

January 1, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
Last Updated

October 28, 2009

Status Verified

October 1, 2009

Enrollment Period

3.9 years

First QC Date

October 27, 2009

Last Update Submit

October 27, 2009

Conditions

Study Arms (1)

detrusor overactivity

Other: ultrasonography

Interventions

transvaginal ultrasonography of bladder wall thickness

detrusor overactivity

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all women with urinary dysfunction

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Insubria

Varese, varese, 21100, Italy

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Study Start

January 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 28, 2009

Record last verified: 2009-10

Locations