Peripheral Electrical Stimulation for the Treatment of Ov... | NCT01783392

NCT01783392

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Unilateral Posterior Tibial Nerve Stimulation	Active Comparator	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.	Procedure: Transcutaneous Electrical Nerve Stimulation
Bilateral Posterior Tibial Nerve Stimulation	Active Comparator	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.	Procedure: Transcutaneous Electrical Nerve Stimulation
Shoulder stimulation	Active Comparator	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.	Procedure: Transcutaneous Electrical Nerve Stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcutaneous Electrical Nerve Stimulation	Procedure		Bilateral Posterior Tibial Nerve Stimulation Shoulder stimulation Unilateral Posterior Tibial Nerve Stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in frequency of voiding	The change of urinary frequency from baseline to after 4 weeks of the treatment, measured by a 3 days bladder diary.	baseline, 4 weeks
Change in Patient Perception of Bladder Condition (PPBC)	Change in the patient's bladder condition based on the PPBC questionaire from baseline to after 4 weeks of the treatment.	baseline, 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire	Change in symptom severity score and HRQL score from baseline to after 4weeks of the treatment.	baseline, 4 weeks
Changes in the mental/physical scores of RAND36

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and Females, at least 18 years of age
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:

Urinary retention or post voiding residual greater than 100 ml
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

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation