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

NHS Foundation Trust

Status: Completed

Conditions: Idiopathic Overactive Bladder

Treatments: Procedure: Transcutaneous Electrical Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01783392

STH16245

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

29 participants in 3 patient groups

Unilateral Posterior Tibial Nerve Stimulation

Active Comparator group

Description:

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.

Treatment:

Procedure: Transcutaneous Electrical Nerve Stimulation

Bilateral Posterior Tibial Nerve Stimulation

Active Comparator group

Description:

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.

Treatment:

Procedure: Transcutaneous Electrical Nerve Stimulation

Shoulder stimulation

Active Comparator group

Description:

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.

Treatment:

Procedure: Transcutaneous Electrical Nerve Stimulation