NCT00919048

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

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

September 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
Last Updated

December 16, 2009

Status Verified

December 1, 2009

Enrollment Period

Same day

First QC Date

June 10, 2009

Last Update Submit

December 15, 2009

Conditions

Urogynecology

Outcome Measures

Primary Outcomes (1)

  • Voiding variables of patients will be compared to those of healthy female volunteers collected from another study.

Study Arms (1)

Urodynamic patients

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

Eligibility Criteria

Age25 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Urogynecology clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Study Officials

  • Gunhilde Buchsbaum, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 12, 2009

Study Start

September 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 16, 2009

Record last verified: 2009-12

Locations

US(1)