Peripheral Electrical Stimulation for the Treatment of Overactive Bladder (PESTOB)

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

Study Overview

• Status: Completed
• Conditions: Idiopathic Overactive Bladder
• Intervention / Treatment: Procedure: Transcutaneous Electrical Nerve Stimulation

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Transcutaneous Electrical Nerve Stimulation
Active Comparator: 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.	Procedure: Transcutaneous Electrical Nerve Stimulation
Active Comparator: 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.	Procedure: Transcutaneous Electrical Nerve Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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		baseline, 4 weeks
Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire	Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire from baseline to after 4 weeks of the treatment	baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Christopher Chapple, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 4, 2013

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: overactive bladder; transcutaneous posterior tibial nerve stimulation; placebo PTNS
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: STH16245