Randomised crossover-controlled evaluation of simultaneous-bilateral transcutaneous electrostimulation of the posterior tibial nerve during urodynamic studies on patients with lower urinary tract symptoms

Randomised crossover-controlled evaluation of simultaneous-bilateral transcutaneous electrostimulation of the posterior tibial nerve during urodynamic studies on patients with lower urinary tract symptoms - UroTENS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00020402

Enrollment

Registered

2020-01-10

Start date

2016-07-01

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

N32.8 N31.8

Interventions

Group 1: Verumstimulation (roughly 20-40min, electrode placement around medial ankle, intensity below pain threshold, 20Hz) during the first cystometric examination. Placebo stimulation (roughly 20-4

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Neurogenic or non-neurogenic bladder dysfunction, which requires a urodynamic examination.

Exclusion criteria

Exclusion criteria: nonage; pregnancy; epilepsy; patients with electronic or metallic implants; any affected condition (e. g. skin lesion) at stimulation site (foot/ankle/calf)

Design outcomes

Primary

Measure	Time frame
statistically significant improvements of functional bladder capacity, bladder compliance, urine flowrate and reduction of residual urine volumes	—

Secondary

Measure	Time frame
Detection of subjects who respond very well to PTNS. Evaluation (phone interview after 8 weeks) of the subjectively perceived therapeutic effect after teaching said patients daily self-administration of PTNS	—

Countries

Germany

Contacts

Public ContactFlorian Girtner

Abteilung für Urologie, Universität Regensburg

florian.girtner@ukr.de09417823511

Outcome results

None listed

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