Prospective, randomized, placebo controlled trial to evaluate the efficacy of transcutaneous stimulation of n. tibialis posterior in treatment of idiopathic overactive bladder
- Conditions
- N39.42N31.82
- Registration Number
- DRKS00021250
- Lead Sponsor
- niversitätsklinikum Münster
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 116
Idiopathic overactive bladder
Age 18 to 70 years
Ability to give consent
Oral drug treatment of OAB should be discontinued 4 weeks before the start of treatment or continued for the duration of the study
pregnancy
Children <18 LJ.
Age> 80.LJ
Taking psychotropic drugs, antiepileptics, antidepressants
Interruption of antimuscarinergics within the last 4 weeks before entering the study
Presence of a any pacemaker
recent other neuromodulative procedures (sacral neuromodulation, percutaneous tibial nerve stimulation) Sacral neuromodulation
recent Injection treatment with botox in the detrusor
Neurogenic genesis of urinary symptoms (e.g. apoplex, multiple sclerosis, Parkinson disease, paraplegia)
? obstructive micturition complaints
TRUS: prostate size> 40 cc, uroflowmetry: maximum urine flow <15 ml / s
? urogenital descensus> 2 °, any symptomatic urogenital descensus
Stress incontinence> 1 °
Bladder pain syndrome / interstitial cystitis
any history of bladder tumor
recurrent urinary tract infections (> 3 / year or> 2 / half year)
anatomical abnormalities of the urinary bladder and urethra such as Bladder diverticulum, bladder wall thickening (> 2.5mm with 250 ml bladder filling), urethral stricture
residual urine over 20% of the micturition volume or> 100 ml
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Patient Global Impression of Improvement (PGI-I)
- Secondary Outcome Measures
Name Time Method Kings Health Questionnaire<br>OAB-SS<br>Quality of life (QoL)<br>ICIQ-SF<br>Reduction of the average frequency of micturition / day<br>Reduction of average urine loss / day:<br> - padweight 24h<br> - Incontinence episodes 24h