NCT00345332

Brief Summary

The purpose of the study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

October 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

July 11, 2017

Completed
Last Updated

July 11, 2017

Status Verified

June 1, 2017

Enrollment Period

5.6 years

First QC Date

June 27, 2006

Results QC Date

April 4, 2016

Last Update Submit

June 7, 2017

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Incontinent Episodes Per Day

    The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.

    week 13

Secondary Outcomes (1)

  • Number of Incontinence Pads Used Per Day

    week 13

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

EXPERIMENTAL

Botox

Drug: Botox

Interventions

BotoxDRUG

Injected

2
PlaceboDRUG

Injected

1

Eligibility Criteria

Age21 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female subjects 21-90 years of age
  • subjects has urinary incontinence on 3 day bladder diary
  • subject has severe incontinence
  • urine dipstick or urine culture negative for urinary tract infection
  • cystometrogram without stress urinary leakage
  • must have failed at least one anti-cholinergic medication
  • negative urine pregnancy test on day of administration of study medication

You may not qualify if:

  • history of carcinoma of the bladder
  • presence of foreign body in the bladder, cystitis or other correctable etiology for Urge Urinary Incontinance
  • gross fecal incontinence
  • known allergy to sulfa or ciprofloxacin or to lidocaine
  • any medical condition that may put the subject at increased risk with exposure to Botox
  • females who are pregnant, breast-feeding, or planning a pregnancy during the study or who are of child-bearing potential
  • known allergy to any of the components in the study medication
  • prior documented resistance to Botox
  • evidence of recent alcohol or drug abuse
  • concurrent participation in another investigational drug or device study within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California at Davis

Sacramento, California, 95817, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Flynn MK, Webster GD, Amundsen CL. The effect of botulinum-A toxin on patients with severe urge urinary incontinence. J Urol. 2004 Dec;172(6 Pt 1):2316-20. doi: 10.1097/01.ju.0000143889.00681.3f.

    PMID: 15538257RESULT

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
Division of Urogynecology
Organization
University of Rochester
amy_keller@urmc.rochester.edu
585-273-3232

Study Officials

  • Michael K Flynn, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 28, 2006

Study Start

October 1, 2005

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 11, 2017

Results First Posted

July 11, 2017

Record last verified: 2017-06

Locations

US(3)