NCT00213577

Brief Summary

The purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus 500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

3.8 years

First QC Date

September 13, 2005

Last Update Submit

March 23, 2015

Conditions

Overactive Bladder

Keywords

overactive neurogenic bladder

Outcome Measures

Primary Outcomes (1)

  • complete urinary continence at baseline, and days 30, 90, 180, and 360

Secondary Outcomes (4)

  • number of mictions or self catheterizations a day

  • number of leakages, urgency adverse events

  • guarding times

  • urodynamics: bladder capacity, reflex volume, residual maximal capacity detrusor pressure, flow detrusor pressure

Interventions

type A botulinum toxinDRUG

Eligibility Criteria

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

You may qualify if:

  • Neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic

You may not qualify if:

  • Pregnancy
  • Bladder cancer
  • Symptomatic urinary infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU-Rouen

Rouen, 76031, France

Location

Related Publications (1)

  • Grise P, Ruffion A, Denys P, Egon G, Chartier Kastler E. Efficacy and tolerability of botulinum toxin type A in patients with neurogenic detrusor overactivity and without concomitant anticholinergic therapy: comparison of two doses. Eur Urol. 2010 Nov;58(5):759-66. doi: 10.1016/j.eururo.2010.06.035. Epub 2010 Jul 3.

    PMID: 20674149DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic 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

Study Officials

  • Philippe GRISE, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

December 1, 2003

Primary Completion

September 1, 2007

Study Completion

October 1, 2007

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

FR(1)