Randomized Trial for Botox Urinary Incontinence

This study has been completed.

Study NCT00178191 Information provided by University of Rochester

First Received on September 12, 2005. Last Updated on September 27, 2011 History of Changes

Results First Received: June 12, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Urinary Incontinence
Interventions:	Other: Bladder diary Other: Questionnaires Procedure: Urodynamics Other: Pad weight

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment started June, 2005 and completed Dec, 2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
200 Units Botox	200 units Botulinum-A toxin
300 Units Botox	300 units Botulinum-A toxin
Placebo	Placebo

Participant Flow: Overall Study

	200 Units Botox	300 Units Botox	Placebo
STARTED	11	10	7
COMPLETED	11	10	7
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
200 Units Botox	200 units Botulinum-A toxin
300 Units Botox	300 units Botulinum-A toxin
Placebo	Placebo

Baseline Measures

	200 Units Botox	300 Units Botox	Placebo	Total
Number of Participants [units: participants]	10	11	7	28
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	2	8	2	12
>=65 years	8	3	5	16
Age [units: years] Mean ± Standard Deviation	76.20 ± 10.65	61.72 ± 13	74.14 ± 11.01	70 ± 13.19
Gender [units: participants]
Female	10	11	7	28
Male	0	0	0	0
Region of Enrollment [units: participants]
United States	10	11	7	28

Outcome Measures

1. Primary:

Episodes/Day [ Time Frame: 9 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Please see published manuscripts for additional details

Results Point of Contact:

Name/Title: Michael Flynn
Organization: University of Rochester
phone: 585-273-3232
e-mail: Michaelk_flynn@urmc.rochester.edu

No publications provided

Responsible Party:	Michael Flynn, University of Rochester
ClinicalTrials.gov Identifier:	NCT00178191 History of Changes
Other Study ID Numbers:	10466, 1R21AG025490-01
Study First Received:	September 12, 2005
Results First Received:	June 12, 2009
Last Updated:	September 27, 2011
Health Authority:	United States: Food and Drug Administration