NCT06742489

Research for the Efficacy and Safety of Percutaneous Tibial Nerve Stimulation to Promote Storage Symptoms Postoperative Recovery for Patients With Benign Prostatic Hyperplasia

Research for the Efficacy and Safety of Percutaneous Tibial Nerve Stimulation to Promote Storage Symptoms Postoperative Recovery for Patients With Benign Prostatic Hyperplasia(Randomised, Double-blind, Prospective, Single-centre Clinical Trial)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Zhu Yiping · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to guide and promote the clinical application of T-PTNS in promoting the postoperative recovery of urinary storage symptoms in patients with BPH. The main question is to evaluate the effectiveness and safety of T-PTNS in promoting the improvement of postoperative urinary storage symptoms in patients with BPH through a single-center randomized double-blind controlled trial, and to propose standard parameters for use such as frequency and power, and ultimately to establish a standard process of T-PTNS treatment and form a replicable and promotable therapeutic specification. Participants will receive T-PTNS three times a week for 30 minutes every time. T-PTNS will be discontinued after 6 weeks. The study will last for 12 weeks, and subjects will be followed up periodically during the study period by the relevant researchers.

Conditions

• Benign Prostatic Hyperplasia
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DEVICE	Percutaneous tibial nerve stimulation device	T-PTNS primarily delivers electrical stimulation to the sacral voiding center via the tibial nerve through the S2-S4 sacral plexus via skin-surface electrodes to improve patients' symptoms of urinary frequency, urgency, and urge incontinence.
DEVICE	Sham group device	The device in the sham group is manufactured by the same company and has the same appearance, display interface, and operation method as the device in the treatment group. These devices have the output circuit disconnected and no actual current output.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-11-01
• Completion: 2027-01-01
• First posted: 2024-12-19
• Last updated: 2024-12-19