NCT00282490

Brief Summary

The purpose of this study is to perform a randomized controlled investigation of the effect of surface nerve stimulation on functional daytime incontinence in children with OAB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2006

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

June 17, 2008

Status Verified

June 1, 2008

Enrollment Period

2.1 years

First QC Date

January 25, 2006

Last Update Submit

June 13, 2008

Conditions

Overactive BladderUrinary Incontinence

Keywords

Overactive bladderChildrenNerve stimulationTENS

Outcome Measures

Primary Outcomes (1)

  • Clinical effects evaluated by home registrations of degree of incontinence, VAS score of degree of urgency and frequency volume charts at specified intervals. Acute effect evaluated by urodynamics.

Secondary Outcomes (1)

  • Bladder capacity, voiding frequency and subjective impression of incontinence.

Interventions

Nerve stimulatorDEVICE

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Daytime urinary incontinence with at least 1 episode of at least 1 ml per week
  • Incontinence refractory to treatment
  • Informed consent

You may not qualify if:

  • Severe diseases of the kidneys or urinary tract besides OAB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of pediatrics,Skejby Sygehus, University hospital of Aarhus

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence

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 SymptomsUrination Disorders

Study Officials

  • Soeren Hagstroem, MD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 26, 2006

Study Start

February 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

June 17, 2008

Record last verified: 2008-06

Locations

DK(1)