Effects of Transcutaneous and Percutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder Syndrome: Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Instituto Médico Tecnológico SL
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Reduction from Baseline in Urinary Frequency Scores on 3-day voiding diaries at 12 weeks
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to determine if Transcutaneous Tibial Nerve Stimulation (TENS) is as effective as Percutaneous Tibial Nerve Stimulation (PTNS) as therapeutic option for subjects with Idiopathic Overactive Bladder (OAB) who have failed conventional therapy.
Detailed Description
Both therapies have been proven to be effective, but very few times have been compared. PTNS and TENS SNS have been proven effective modifying bladder diary scores (change in the frequency of day and night urination, and urge incontinence), and improving subject's quality of life. Only PTNS has shown changes in urodynamic data while undergoing therapy. The investigators hypothesize that short-term effectiveness and benefit reported, is not lower in the TENS group, if we compare both therapies in a randomized control trial. Secondary goals are to evaluate changes in bladder diary scores (frequency of urination, nocturia, number of urgency and leakage episodes ), participants quality of life improvement scores and treatment benefit score at TBS scale, while undergoing these therapies.
Investigators
Inés Ramírez García
Physiotherapist, MSc
Instituto Médico Tecnológico SL
Eligibility Criteria
Inclusion Criteria
- •Female and male
- •Age \>18 years
- •Complaint urge urinary incontinence (3 or more episodes per week) OR overactive bladder (8 or more voids per day, and/or 2 or more voids per night)
- •Urodynamic data of overactive detrusor
- •Failed trial of conservative therapy (bladder training, fluid modification, diet modification, caffeine restriction, pelvic floor training)
- •Failed trial of anticholinergic either due to inability to take the medication, adverse reaction to medication, or no improvement on medication
- •Willing to complete study questionnaires and informed consent study
Exclusion Criteria
- •Presence of bladder obstruction (prostate or prolapse)
- •Neurogenic bladder overactivity
- •Previous pelvic organ prolapse surgery
- •Unwilling and mentally incompetent to participate in study
- •Pregnancy or planning to become pregnant during the study
- •Presence of urinary fistula
- •Recurrent or current urinary tract infection (5 or more infections in the last 12 months)
- •Bladder stones
- •Bladder cancer or suspected bladder cancer
- •Hematuria
Outcomes
Primary Outcomes
Reduction from Baseline in Urinary Frequency Scores on 3-day voiding diaries at 12 weeks
Time Frame: 12 weeks
A reduction in urinary frequency was regarded clinically significant when a normal voiding pattern of less than 8 voids per 24 hours could be obtained
Secondary Outcomes
- Reduction from Baseline in the number of leakage episodes diaries at 6 weeks and at 12 weeks(6 and 12 weeks)
- Change from Baseline in Mean, Moderate to Severe Urgency episodes on 3-day voiding diaries at 6 and at 12 weeks(6 and 12 weeks)
- Reduction from Baseline in Mean Nocturia Episodes on 3-day voiding diaries at 6 and at 12 weeks(6 and 12 weeks)
- Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)(6 and 12 weeks)
- Improved Bladder Symptom Severity Score via Overactive Bladder Questionnaire (OAB-q) at 6 and at 12 weeks(6 and 12 weeks)
- Degree of Satisfaction Score on the Treatment Benefit Scale (TBS) at 6 and at 12 weeks(6 and 12 weeks)