Peripheral Electrical Stimulation for the Treatment of Overactive Bladder

Idiopathic Overactive Bladder Clinical Trial

— PESTOB  

Official title:

Peripheral Electrical Stimulation for the Treatment of Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783392
• Other study ID #: STH16245
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: May 21, 2015
• Start date: March 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Procedure:
• Transcutaneous Electrical Nerve Stimulation

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS foundation Trust, Royal Hallamshire Hospital	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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.	baseline, 4 weeks	No
Secondary	Changes in the mental/physical scores of RAND36		baseline, 4 weeks	No
Secondary	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	baseline, 4 weeks	No