Prospective, randomized, placebo controlled trial to evaluate the efficacy of transcutaneous stimulation of n. tibialis posterior in treatment of idiopathic overactive bladder

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2021
INTERVENTION: Intervention 1: Stimulation of the tibial posterior nerve 5 x 15 min a week with the device contic+ and 20 Hz Intervention 2: Stimulation of the fibular superficial nerve 5 x 15 min a week with the device contic+ and 20 Hz. After unblinding on week 6, verum stimulation at tibial posterior nerve will be performed in same setting CONDITION: N31.82 ‐ [generalization N31.8: Other neuromuscular dysfunction of bladder] N39.42 ‐ [generalization N39.4: Other specified urinary incontinence] PRIMARY OUTCOME: Change in Patient Global Impression of Improvement (PGI‐I) SECONDARY OUTCOME: Kings Health Questionnaire; OAB‐SS; Quality of life (QoL); ICIQ‐SF; Reduction of the average frequency of micturition / day; Reduction of average urine loss / day:; ‐ padweight 24h; ‐ Incontinence episodes 24h INCLUSION CRITERIA: 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
Epistemonikos ID: bd72e38a0d3f5fdc69766776581454b4d6c9007c
First added on: Dec 20, 2022