Clinical trial NCT01783392: Peripheral Electrical Stimulation for the Treatment of Overactive Bladder
Official title: Peripheral Electrical Stimulation for the Treatment of Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Overactive Bladder
Keywords: overactive bladder
transcutaneous posterior tibial nerve stimulation
placebo PTNS
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial testing three different sites of transcutaneous electrical nerve stimulation for the treatment of overactive bladder (OAB).


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

Primary outcomes:
measure: Change in frequency of voiding
timeFrame: baseline, 4 weeks
measure: Change in Patient Perception of Bladder Condition (PPBC)
timeFrame: baseline, 4 weeks
Secondary outcomes:
measure: Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire
timeFrame: baseline, 4 weeks
measure: Changes in the mental/physical scores of RAND36
timeFrame: baseline, 4 weeks
measure: Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire
timeFrame: baseline, 4 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS foundation Trust, Royal Hallamshire Hospital
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Christopher Chapple
role: PRINCIPAL_INVESTIGATOR
References: