search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Blaastraining en PTNS bij overactieve blaas.


- candidate number7693
- NTR NumberNTR2192
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jan-2010
- Secondary IDs09030 METC
- Public TitleBlaastraining en PTNS bij overactieve blaas.
- Scientific TitleBladder Training with or without PTNS (Posterior Tibial Nerve Stimulation) in the treatment of Overactive Bladder.
- ACRONYMPTOAB study
- hypothesisAn 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) studiedUrge incontinence, Overactive bladder
- Inclusion criteriaAll 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 criteria1. Symptoms existing for less than 6 months;
2. Pregnancy;
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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2009
- planned closingdate1-okt-2010
- Target number of participants60
- Interventions1. PTNS (Posterior tibial nerve stimulation);
2. Bladder training.

Two arms:
1. Bladder training;
2. Bladder training and PTNS.
- Primary outcomeICIQ-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 outcome1. Incontinence episodes per week;
2. Frequency of micturition per 24h.
- Timepoints1. Baseline;
2. 6 weeks;
3. 12 weeks.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Johanna Biemans
- CONTACT for SCIENTIFIC QUERIES Johanna Biemans
- Sponsor/Initiator Nederlandse Vereniging voor Acupunctuur (NVA)
- Funding
(Source(s) of Monetary or Material Support)
NVA Dutch Organisation of Acupuncture
- PublicationsN/A
- Brief summaryIn 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)
- RECORD26-jan-2010 - 17-feb-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl