Trial record 12 of 92 for:    Open Studies | "Urinary Bladder, Overactive"

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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014