Peripheral Electrical Stimulation for the Treatment of Overactive Bladder

NCT01783392 | Completed

• 1 other identifier: STH16245
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Idiopathic Overactive Bladder

Keywords

overactive bladder; transcutaneous posterior tibial nerve stimulation; placebo PTNS

Outcome Measures

Primary Outcomes (2)

• 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 (3)

• Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire

  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

  baseline, 4 weeks

Study Arms (3)

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

Transcutaneous Electrical Nerve Stimulation PROCEDURE

Bilateral Posterior Tibial Nerve Stimulation; Shoulder stimulation; Unilateral Posterior Tibial Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS foundation Trust, Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Christopher Chapple

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: February 4, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

GB (1)