Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder
NCT ID: NCT01023269
Last Updated: 2019-01-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
17 participants
INTERVENTIONAL
2009-12-31
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bladder and TranscUtaneous Tibial Nerve Stimulation for nEurogenic Lower Urinary Tract Dysfunction
NCT04315142
Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control
NCT00225966
Previously Implanted Pudendal Nerve Stimulation
NCT04473469
Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)
NCT01125722
Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS): an Observational Study
NCT02186041
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ON / OFF
Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks.
InterStim Therapy
Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.
OFF / ON
Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks.
InterStim Therapy
Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
InterStim Therapy
Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Detrusor overactivity
* Two leaks or two notices of leaks per day
* Mean functional bladder capacity (volume voided per episode) of ≥100 ml
Exclusion Criteria
* Degenerative disease of the central nervous system
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MedtronicNeuro
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michele Spinelli, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale Niguarda Ca' Granda, Milan, Italy
Karel Everaert, MD
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Philip Van Kerrebroeck, MD
Role: PRINCIPAL_INVESTIGATOR
Academisch Ziekenhuis, Maastricht, The Netherlands
Emmanuel Chartier-Kastler, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital de la Pitié Salpétrière, Paris, France
Arndt Van Ophoven, MD
Role: PRINCIPAL_INVESTIGATOR
Marienhospital Herne Klinikum der Ruhr-Universität, Herne, Germany
Karl Sievert, MD
Role: PRINCIPAL_INVESTIGATOR
Klinik für Urologie Oberarzt-Sekretariat, Tübingen, Germany
Suzy Elneil, MD
Role: PRINCIPAL_INVESTIGATOR
National Hospital for Neurology and Neurosurgery, London, UK
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitair Ziekenhuis Gent
Ghent, , Belgium
Centre Hospitalier Universitaire de Lyon-Sud
Lyon, , France
Hôpital de la Pitié Salpétrière
Paris, , France
Marienhospital Herne, Klinikum der Ruhr-Universitaet Bochum
Herne, , Germany
Klinik für Urologie Oberarzt-Sekretaria
Tübingen, , Germany
Niguarda Ospedale Ca' Granda
Milan, , Italy
Academisch Ziekenhuis
Maastricht, , Netherlands
National Hospital for Neurology and Neurosurgery
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1.02.7004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.