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

Primary Purpose

Idiopathic Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Overactive Bladder focused on measuring overactive bladder, transcutaneous posterior tibial nerve stimulation, placebo PTNS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sheffield Teaching Hospitals NHS foundation Trust, Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Unilateral Posterior Tibial Nerve Stimulation

Bilateral Posterior Tibial Nerve Stimulation

Shoulder stimulation

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Changes in the mental/physical scores of RAND36
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

Full Information

First Posted
January 23, 2013
Last Updated
May 21, 2015
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01783392
Brief Title
Peripheral Electrical Stimulation for the Treatment of Overactive Bladder
Acronym
PESTOB
Official Title
Peripheral Electrical Stimulation for the Treatment of Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Overactive Bladder
Keywords
overactive bladder, transcutaneous posterior tibial nerve stimulation, placebo PTNS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unilateral Posterior Tibial Nerve Stimulation
Arm Type
Active Comparator
Arm 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.
Arm Title
Bilateral Posterior Tibial Nerve Stimulation
Arm Type
Active Comparator
Arm 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.
Arm Title
Shoulder stimulation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Primary Outcome Measure Information:
Title
Change in frequency of voiding
Description
The change of urinary frequency from baseline to after 4 weeks of the treatment, measured by a 3 days bladder diary.
Time Frame
baseline, 4 weeks
Title
Change in Patient Perception of Bladder Condition (PPBC)
Description
Change in the patient's bladder condition based on the PPBC questionaire from baseline to after 4 weeks of the treatment.
Time Frame
baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire
Description
Change in symptom severity score and HRQL score from baseline to after 4weeks of the treatment.
Time Frame
baseline, 4 weeks
Title
Changes in the mental/physical scores of RAND36
Time Frame
baseline, 4 weeks
Title
Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire
Description
Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire from baseline to after 4 weeks of the treatment
Time Frame
baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Chapple
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS foundation Trust, Royal Hallamshire Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

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Peripheral Electrical Stimulation for the Treatment of Overactive Bladder

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