Uroflow Measurements in Urogynecology Patients Compared to Healthy Female Volunteers

This study has been completed.

Sponsor:

Information provided by:

University of Rochester

ClinicalTrials.gov Identifier:

NCT00919048

First received: June 10, 2009

Last updated: December 15, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 10, 2009

Last Updated Date

December 15, 2009

Start Date ^ICMJE

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Voiding variables of patients will be compared to those of healthy female volunteers collected from another study. [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00919048 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Uroflow Measurements in Urogynecology Patients Compared to Healthy Female Volunteers

Official Title ^ICMJE

Uroflow Measurements in Urogynecology Patients Compared to Healthy Female Volunteers

Brief Summary

To compare uroflowmetry measurements of patients undergoing urodynamic testing as part of an incontinence work-up in an urogynecology practice to healthy female volunteers.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Urogynecology clinic

Condition ^ICMJE

Urogynecology

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Urodynamic patients

Uroflow studies of patients who underwent urodynamics as part of an incontinence work-up.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All patients who underwent urodynamics at the urogynecology clinic during the past 12 months
Voids larger than 50 mls.

Exclusion Criteria:

History of pelvic organ prolapse, incomplete bladder emptying, and voids less than 50cc.

Gender

Female

Ages

25 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00919048

Other Study ID Numbers ^ICMJE

25597

Has Data Monitoring Committee

Responsible Party

Gunhilde Buchsbaum, MD, University of Rochester

Study Sponsor ^ICMJE

University of Rochester

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gunhilde Buchsbaum, MD

University of Rochester

Information Provided By

University of Rochester

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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