NCT00770406

Brief Summary

A pilot study to examine efficacy and safety of intravesical botulinum toxin type A.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.4 years 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

August 4, 2009

Status Verified

August 1, 2009

Enrollment Period

1.4 years

First QC Date

October 9, 2008

Last Update Submit

August 3, 2009

Conditions

Urge Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Incontinence episode frequency

    1 year

Interventions

botulinum toxin type ADRUG

100 or 200 units intravesically

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • refractory urge urinary incontinence

You may not qualify if:

  • neurological disease
  • pregnant or lactating
  • bladder neoplasias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup Hospital

Glostrup Municipality, Copenhagen, DK-2600, Denmark

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination 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

Central Study Contacts

Soren Brostrom, MD, PhD

CONTACT

+45-43232243soren@brostrom.dk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

January 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 4, 2009

Record last verified: 2009-08

Locations

DK(1)