Overactive Bladder Clinical Trial
Official title:
Effects of Transcutaneous and Percutaneous Posterior Tibial Nerve Stimulation on Idiopathic Overactive Bladder Syndrome: Randomized Clinical Trial
Verified date | August 2017 |
Source | Instituto Médico Tecnológico SL |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | March 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 - Central or peripheral neurologic disorders such as Multiple Sclerosis, Parkinson's disease, spina bifida, or other spinal cord lesion - Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (sacrum or ankle/leg). - Uncontrolled diabetes and diabetes with peripheral nerve involvement - Anticoagulants treatment - Current use of anticholinergics or use within the last 4 weeks - Current use of botox bladder injections or bladder botox injection within the last year - Current use of interstim therapy or currently implanted interstim device or leads - Urinary retention or gastric retention - Painful Bladder Syndrome/Interstitial Cystitis - Previous PTNS treatment |
Country | Name | City | State |
---|---|---|---|
Spain | Inés Ramírez | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Instituto Médico Tecnológico SL | University Ramon Llull |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of participants that request for continuous chronic treatment to keep the obtained response after receiving 12 PTNS/TENS sessions for OAB complaints | A number of at least 50% was regarded significant | 12 weeks | |
Other | Number of complaints OR adverse effects registered during treatments | complaints and side effects were registered | From Baseline to week 12 | |
Primary | Reduction from Baseline in Urinary Frequency Scores on 3-day voiding diaries at 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 | 12 weeks | |
Secondary | Reduction from Baseline in the number of leakage episodes diaries at 6 weeks and at 12 weeks | A reduction in the number of leakage episodes of at least 30% on 3-day voiding was regarded significant | 6 and 12 weeks | |
Secondary | Change from Baseline in Mean, Moderate to Severe Urgency episodes on 3-day voiding diaries at 6 and at 12 weeks | A reduction in number of urgency episodes at 6 weeks and 12 weeks | 6 and 12 weeks | |
Secondary | Reduction from Baseline in Mean Nocturia Episodes on 3-day voiding diaries at 6 and at 12 weeks | A reduction of at least 25% was regarded significant | 6 and 12 weeks | |
Secondary | Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL) | An improvement of at least 10 points was regarded significant | 6 and 12 weeks | |
Secondary | Improved Bladder Symptom Severity Score via Overactive Bladder Questionnaire (OAB-q) at 6 and at 12 weeks | An improvement of at least 10 points was regarded significant | 6 and 12 weeks | |
Secondary | Degree of Satisfaction Score on the Treatment Benefit Scale (TBS) at 6 and at 12 weeks | A score of 1 or 2 was regarded significant | 6 and 12 weeks |
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