NCT01042119

Brief Summary

The neurotoxin Botox (botulinum neurotoxin type A) is shown to be effective in the treatment of therapy refractory overactive bladder syndrome. Our data suggests a longer during efficacy than known from the use in striated muscle. The aim of our study is to analyze short- and longterm efficacy after Botox treatment and to evaluate risk factors for non-responders and side effects such as urinary retention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 24, 2010

Status Verified

June 1, 2010

Enrollment Period

5 months

First QC Date

January 4, 2010

Last Update Submit

June 23, 2010

Conditions

Overactive Bladder Syndrome

Keywords

botulinum neurotoxin type ABoNT/ABotoxoveractive bladder syndrome

Outcome Measures

Primary Outcomes (1)

  • duration of effect of Botox

    1 year

Study Arms (1)

Botox

patients who received intravesical injections of botulinum neurotoxin type A

Eligibility Criteria

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

patients who received at our clinic treatment with intravesical injection of Botox for idiopathic overactive bladder syndrome

You may qualify if:

  • intravesical treatment with Botox at our clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich, Clinic for Gynaecology

Zurich, 8091, Switzerland

Location

Study Officials

  • David A Scheiner, MD

    University Hospital of Zurich, Clinic for Gynaecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 24, 2010

Record last verified: 2010-06

Locations

CH(1)