|- candidate number||7693|
|- NTR Number||NTR2192|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-jan-2010|
|- Secondary IDs||09030 METC|
|- Public Title||Blaastraining en PTNS bij overactieve blaas.|
|- Scientific Title||Bladder Training with or without PTNS (Posterior Tibial Nerve Stimulation) in the treatment of Overactive Bladder.|
|- ACRONYM||PTOAB study|
|- hypothesis||An combination therapy of Bladder Training with PTNS will significantly reduce the symptoms of overactive bladder in comparison with a Bladder Training program alone|
|- Healt Condition(s) or Problem(s) studied||Urge incontinence, Overactive bladder|
|- Inclusion criteria||All patients diagnosed with OAB syndrome will be included.
Criteria for diagnosis are as follow:|
1. Urgency and frequency: more than 8 voids per 24 hours and the sudden urge to void can hardly be suppressed;
2. Urge incontinence: urgency leading to urinary leakage occurring at least three times weekly;
3. Age > 18yrs.
|- Exclusion criteria||1. Symptoms existing for less than 6 months;|
3. Active urinary tract or recurrent urinary tract infection;
4. Severe cardiopulmonary disease;
5. Diabetes with peripheral nerve involvement;
6. Neurological disorders;
7. Flowmetrie < 15mm/sec;
8. Had already treatment for overactive bladder.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2009|
|- planned closingdate||1-okt-2010|
|- Target number of participants||60|
|- Interventions||1. PTNS (Posterior tibial nerve stimulation);|
2. Bladder training.
1. Bladder training;
2. Bladder training and PTNS.
|- Primary outcome||ICIQ-ui-sf scores: Percentage of 70% improvement on the ICIQ-ui-sf scores.
H0 hypothesis: There will be no difference in the ICIQ-sf scores of the two arms.
Scores ranging from 0-21.
|- Secondary outcome||1. Incontinence episodes per week;|
2. Frequency of micturition per 24h.
|- Timepoints||1. Baseline;|
2. 6 weeks;
3. 12 weeks.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Johanna Biemans|
|- CONTACT for SCIENTIFIC QUERIES|| Johanna Biemans|
|- Sponsor/Initiator ||Nederlandse Vereniging voor Acupunctuur (NVA)|
(Source(s) of Monetary or Material Support)
|NVA Dutch Organisation of Acupuncture|
|- Brief summary||In the guidelines of Overactive Bladder , PTNS is prescribed when all other treatments have failed. In the trial we want to investigate the efectiveness when given primarily. And particularly when it is given in combination with the now already given bladder training.|
|- Main changes (audit trail)|
|- RECORD||26-jan-2010 - 17-feb-2010|