Idiopathic Overactive Bladder
Conditions
Keywords
overactive bladder, transcutaneous posterior tibial nerve stimulation, placebo PTNS
Brief summary
This clinical trial testing three different sites of transcutaneous electrical nerve stimulation for the treatment of overactive bladder (OAB).
Interventions
PROCEDURETranscutaneous Electrical Nerve Stimulation
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in frequency of voiding | baseline, 4 weeks | 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) | baseline, 4 weeks | Change in the patient's bladder condition based on the PPBC questionaire from baseline to after 4 weeks of the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire | baseline, 4 weeks | Change in symptom severity score and HRQL score from baseline to after 4weeks of the treatment. |
| Changes in the mental/physical scores of RAND36 | baseline, 4 weeks | — |
| Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire | baseline, 4 weeks | Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire from baseline to after 4 weeks of the treatment |
Countries
United Kingdom
Outcome results
None listed