NCT01023269

Brief Summary

The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
6 countries

8 active sites

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

First Submitted

Initial submission to the registry

November 30, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

January 31, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

2.5 years

First QC Date

November 30, 2009

Results QC Date

May 18, 2016

Last Update Submit

January 30, 2019

Conditions

Neurogenic Overactive BladderUrinary IncontinenceDetrusor Overactivity

Keywords

Neurogenic overactive bladderUrinary incontinence due to incomplete spinal cord injuryNeuromodulationNeuromodulation for treatment of neurogenic overactive bladderPatients with Urge urinary incontinence and detrusor overactivity

Outcome Measures

Primary Outcomes (1)

  • Functional Bladder Capacity

    Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.

    Baseline, 4 weeks after implant, 8 weeks after implant

Study Arms (2)

ON / OFF

OTHER

Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks.

Device: InterStim Therapy

OFF / ON

OTHER

Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks.

Device: InterStim Therapy

Interventions

InterStim TherapyDEVICE

Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.

OFF / ONON / OFF

Eligibility Criteria

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

You may qualify if:

  • Incomplete upper motor neuron lesion
  • Detrusor overactivity
  • Two leaks or two notices of leaks per day
  • Mean functional bladder capacity (volume voided per episode) of ≥100 ml

You may not qualify if:

  • Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves.
  • Degenerative disease of the central nervous system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

Centre Hospitalier Universitaire de Lyon-Sud

Lyon, France

Location

Hôpital de la Pitié Salpétrière

Paris, France

Location

Marienhospital Herne, Klinikum der Ruhr-Universitaet Bochum

Herne, 44627, Germany

Location

Klinik für Urologie Oberarzt-Sekretaria

Tübingen, Germany

Location

Niguarda Ospedale Ca' Granda

Milan, 20162, Italy

Location

Academisch Ziekenhuis

Maastricht, Netherlands

Location

National Hospital for Neurology and Neurosurgery

London, United Kingdom

Location

MeSH Terms

Conditions

Urinary IncontinenceUrinary Bladder, Overactive

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 SymptomsUrinary Bladder Diseases

Results Point of Contact

Title
Alexandra Delacour, Clinical Research Manager
Organization
Medtronic International Trading Sarl
alexandra.delacour@medtronic.com
0041218027622

Study Officials

  • Michele Spinelli, MD

    Ospedale Niguarda Ca' Granda, Milan, Italy

    PRINCIPAL INVESTIGATOR

  • Karel Everaert, MD

    University Ghent

    PRINCIPAL INVESTIGATOR

  • Philip Van Kerrebroeck, MD

    Academisch Ziekenhuis, Maastricht, The Netherlands

    PRINCIPAL INVESTIGATOR

  • Emmanuel Chartier-Kastler, MD

    Hôpital de la Pitié Salpétrière, Paris, France

    PRINCIPAL INVESTIGATOR

  • Arndt Van Ophoven, MD

    Marienhospital Herne Klinikum der Ruhr-Universität, Herne, Germany

    PRINCIPAL INVESTIGATOR

  • Karl Sievert, MD

    Klinik für Urologie Oberarzt-Sekretariat, Tübingen, Germany

    PRINCIPAL INVESTIGATOR

  • Suzy Elneil, MD

    National Hospital for Neurology and Neurosurgery, London, UK

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

December 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

January 31, 2019

Results First Posted

January 31, 2019

Record last verified: 2019-01

Locations

BE(1)IT(1)FR(2)GB(1)DE(2)NL(1)