NCT00714389

Brief Summary

The goal of this study to determine normal values for certain urinary measurements in order to better understand voiding dysfunction in women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2008

Shorter than P25 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

February 1, 2008

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 29, 2010

Completed
Last Updated

February 6, 2013

Status Verified

January 1, 2013

Enrollment Period

29 days

First QC Date

July 8, 2008

Results QC Date

January 5, 2010

Last Update Submit

January 31, 2013

Conditions

Healthy

Keywords

Urogynecology

Outcome Measures

Primary Outcomes (2)

  • Voided Volume

    Volume of spontaneous void

    March 2008

  • Maximal Flow Rate

    Maximal uroflow of spontaneous subject voids

    March 2008

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Urogynecology clinic

You may qualify if:

  • Healthy volunteers/employees
  • Normal voiding function.
  • Willing to participate.

You may not qualify if:

  • Subjects currently receiving treatment for any lower urinary tract condition or having any voiding difficulty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urogynecology and Reconstructive Pelvic Surgery Center

Rochester, New York, 14623, United States

Location

Limitations and Caveats

Limited number of participants

Results Point of Contact

Title
Gunhilde Buchsbaum, MD
Organization
University of Rochester
gunhilde_buchsbaum@urmc.rochester.edu
585-273-3232

Study Officials

  • Gunhilde Buchsbaum, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 14, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 6, 2013

Results First Posted

January 29, 2010

Record last verified: 2013-01

Locations

US(1)