Peripheral Electrical Stimulation for the Treatment of Overactive Bladder
NCT ID: NCT01783392
Last Updated: 2015-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2013-03-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Unilateral Posterior Tibial Nerve Stimulation
Transcutaneous posterior tibial nerve stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode electrode above, and the anode electrode behind, the medial malleolus, over the posterior tibial nerve and sets the stimulation intensity to a comfortable level.
Transcutaneous Electrical Nerve Stimulation
Bilateral Posterior Tibial Nerve Stimulation
Transcutaneous posterior tibial nerve stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode electrode above, and the anode electrode behind, the medial malleolus, over the posterior tibial nerve on both legs and sets the stimulation intensity to a comfortable level.
Transcutaneous Electrical Nerve Stimulation
Shoulder stimulation
Stimulation applied 40 minutes every day for a duration of 4 weeks. The patient places the cathode and the anode electrodes on the lateral side of the left shoulder.
Transcutaneous Electrical Nerve Stimulation
Interventions
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Transcutaneous Electrical Nerve Stimulation
Eligibility Criteria
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Inclusion Criteria
* Documented symptoms of idiopathic overactive bladder for at least 3 months
* Failure on primary OAB treatment, such as behavior modification or fluid/diet management
* Patients can remain on stable medication
* Willing and capable of understanding and complying with all requirements of the protocol
* Signed Informed Consent to participate in the study after full discussion of the research nature of the treatment and its risks and benefits
Exclusion Criteria
* Clinically significant bladder outlet obstruction
* Stress predominant mixed urinary incontinence
* Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury.
* Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months
* Denovo OAB following pelvic surgery sub-urethral sling Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 6 months
* Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 6 months
* Any form of electric stimulation to the pelvis or lower limbs within 4 weeks
* Vaginal prolapse greater than Stage II in the anterior compartment of the vagina using International Continence Society (ICS) Pelvic Organ ProlapseQuantification (POPQ) criteria.
* Prior periurethral or transurethral bulking agent injections for bladder problems within the past 12 months.
* History of pelvic radiation therapy
* Any skin conditions affecting treatment sites
* Lacking dexterity to properly utilize the components of the stimulator system.
* Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.),
* Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
* Recurrent Urinary Tract Infections UTI (\>3 UTI's in the past year)
* History of, or current, lower tract genitourinary malignancies
* Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study
* Any other clinical trial within 6 months
18 Years
ALL
No
Sponsors
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Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Christopher Chapple
Role: PRINCIPAL_INVESTIGATOR
Sheffield Teaching Hospitals NHS Foundation Trust
Locations
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Sheffield Teaching Hospitals NHS foundation Trust, Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom
Countries
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Other Identifiers
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STH16245
Identifier Type: -
Identifier Source: org_study_id
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