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

This study is currently recruiting participants.
Verified May 2013 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01783392
First received: January 23, 2013
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Idiopathic Overactive Bladder
Procedure: Transcutaneous Electrical Nerve Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peripheral Electrical Stimulation for the Treatment of Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Change in frequency of voiding [ Time Frame: baseline, 4 weeks ] [ Designated as safety issue: No ]
    The change of urinary frequency from baseline to after 4 weeks of the treatment, measured by a 3 days bladder diary.

  • Change in Patient Perception of Bladder Condition (PPBC) [ Time Frame: baseline, 4 weeks ] [ Designated as safety issue: No ]
    Change in the patient's bladder condition based on the PPBC questionaire from baseline to after 4 weeks of the treatment.


Secondary Outcome Measures:
  • Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire [ Time Frame: baseline, 4 weeks ] [ Designated as safety issue: No ]
    Change in symptom severity score and HRQL score from baseline to after 4weeks of the treatment.

  • Changes in the mental/physical scores of RAND36 [ Time Frame: baseline, 4 weeks ] [ Designated as safety issue: No ]
  • Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire [ Time Frame: baseline, 4 weeks ] [ Designated as safety issue: No ]
    Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire from baseline to after 4 weeks of the treatment


Estimated Enrollment: 36
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783392

Contacts
Contact: Martin Slovak m.slovak@sheffield.ac.uk

Locations
United Kingdom
Sheffield Teaching Hospitals NHS foundation Trust, Royal Hallamshire Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Contact: Martin Slovak       m.slovak@sheffield.ac.uk   
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Christopher Chapple Sheffield Teaching Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01783392     History of Changes
Other Study ID Numbers: STH16245
Study First Received: January 23, 2013
Last Updated: May 14, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
overactive bladder
transcutaneous posterior tibial nerve stimulation
placebo PTNS

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014