bTUNED: transcutaneous tibial nerve stimulation for neurogenic lower urinary tract dysfunction

Area of Science:

• Urology
• Neurology
• Clinical Trials

Background:

• Neurogenic lower urinary tract dysfunction (NLUTD) presents significant challenges in managing bladder and bowel function.
• Refractory NLUTD often requires advanced treatment strategies beyond standard therapies.
• Transcutaneous tibial nerve stimulation (TTNS) is an emerging neuromodulation technique with potential for treating lower urinary tract symptoms.

Purpose of the Study:

• To present the protocol for the bTUNED trial, an international multicentre, sham-controlled, double-blind randomized controlled trial (RCT).
• To evaluate the efficacy and safety of TTNS in patients with refractory NLUTD.
• To define primary and secondary outcome measures for assessing TTNS effectiveness.

Main Methods:

• The bTUNED trial will enroll 240 patients with refractory NLUTD, randomized 1:1 to verum or sham TTNS.
• TTNS will be administered twice weekly for 30 minutes over a 6-week period.
• Key outcomes include bladder diary variables, Self-Assessment Goal Achievement (SAGA) questionnaire, urodynamic measures, neurophysiological assessments, and bowel function.

Main Results:

• Primary outcome is defined by improvements in bladder diary variables and SAGA questionnaire scores.
• Secondary outcomes assess the impact of TTNS on urodynamics, neurophysiology, and bowel function.
• Safety data will be meticulously collected throughout the trial.

Conclusions:

• The bTUNED trial protocol provides a robust framework for evaluating TTNS in refractory NLUTD.
• Results will elucidate the efficacy and safety profile of TTNS for this patient population.
• Findings are anticipated to inform clinical practice guidelines for NLUTD management.