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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021250

Enrollment

116

Registered

2021-10-04

Start date

2021-10-07

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N39.42 N31.82

Interventions

Group 1: Stimulation of the tibial posterior nerve 5 x 15 min a week with the device contic+ and 20 Hz Group 2: Stimulation of the fibular superficial nerve 5 x 15 min a week with the device contic+ a

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: pregnancy Children 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 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

Design outcomes

Primary

Measure	Time frame
Change in Patient Global Impression of Improvement (PGI-I)	—

Secondary

Measure	Time frame
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	—

Countries

Germany

Contacts

Public ContactClaudia Middeldorf

Universitätsklinikum MünsterAbteilung für Urologie und Kinderurologie

Claudia.Middeldorf@ukmuenster.de0251-83-48344

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026