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 of blaastraining plus elektro-acupunctuur als behandeling bij overactieve blaas.


- candidate number5244
- NTR NumberNTR1649
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-feb-2009
- Secondary IDs 
- Public TitleBlaastraining of blaastraining plus elektro-acupunctuur als behandeling bij overactieve blaas.
- Scientific TitleBladder training with or without PTNS(Posterior Tibial Nerve Stimulation) in the treatment of Overactive Bladder.
- ACRONYMBlaastraining en PTNS bij overactieve blaas
- hypothesisA combination therapy of bladder training with PTNS(Posterior Tibial Nerve Stimulation) has a synergistic effect in comparison with bladder training alone in the treatment of over active bladder.
- Healt Condition(s) or Problem(s) studiedOveractive 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. Willingness to fill up a daily bladder diary;
4. Age > 18yrs;
5. Signed informed consent.
- 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate
- Target number of participants60
- InterventionsBladder training and Bladder training with PTNS.
- Primary outcomeThe primary outcome is the percentage of patients with a 70% improvement in the ICIQ-Sf total score.
- Secondary outcome1. Micturition frequency at 12 wks/ daytime/nightime;
2. Number of leakage episodes.
- Timepoints1. Baseline;
2. 6 wks;
3. 12 wks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES J. Biemans
- CONTACT for SCIENTIFIC QUERIES J. Biemans
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryOveractive bladder ia a disabling condition with serious impact on quality of life. Although medication and its side efeects are really diminished in recent years, it isn't always a favorable treatment option. Bladder training and PTNS form a good and well-approved alternative for this condition. What we're trying to investigate is the additive value of the combination of both therapies.
- Main changes (audit trail)
- RECORD1-feb-2009 - 19-sep-2014


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