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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: Percutaneous tibial nerve stimulation device; Device: Sham group device

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants have been fully informed of the potential benefits and risks associated with the trial and have provided written consent to participate.
2. Male participants between the ages of 45 and 80 are eligible to participate in the trial.
3. Participants with a confirmed diagnosis of Benign Prostatic Hyperplasia, a maximum urinary flow rate of ≤ 15 ml/sec, undergoing surgical treatment (Thulium laser vapoenucleation) and fulfilling any one of the following conditions according to the International Prostate Symptom Score (IPSS): a) any single IPSS urinary storage subscore (urinary frequency, urgency, nocturia frequency) greater than or equal to 3 points; b) a total IPSS storage subscore of 9 points or greater;
4. Participants who are able to discontinue relevant medications (M-blockers and β3 agonists) for a period of at least one week prior to enrolment;
5. Participants with autonomy, self-care, self-control, and the ability to use the toilet independently.

Exclusion Criteria:

1. Subjects presenting with urinary incontinence due to reduced sphincter function, or subjects evaluated for neurogenic bladder;
2. Subjects with urethral strictures or bladder neck contractures that make insertion of devices difficult;
3. Subjects with pacemakers, buried cardioverter-defibrillators, or other therapeutic electronic medical devices (including sacral neuromodulation).
4. Subjects with implanted devices in the body;
5. Subjects with untreated urinary tract infections;
6. Subjects with urinary stones that cause lower urinary tract symptoms;
7. Subjects with previous pelvic surgery; and
8. Subjects with a history of previous pelvic surgery, or colorectal surgery (except polypectomy and haemorrhoidectomy);
9. Subjects with untreated malignant tumors;
10. Subjects with neurological or cerebrovascular lesions or injuries, or medical conditions affecting cognition, bladder function, sphincter function, or urethral muscle function;
11. Subjects with skin breakdown, malignant tumors, or acute purulent inflammation on the surface of the plantar foot at the location where the electrode pads are to be placed;11. Subjects who have participated in a clinical trial of another drug within three months or a clinical trial of another medical device within 30 days;
12. Other conditions that the investigator deems unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Participants in this group will receive T-PTNS three times a week for 30 minutes every time.	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.
Sham Comparator: Sham group; The sham group will use the same device without therapeutic effect as a blank control.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptoms Score improvement percentage	The study will use International Prostate Symptoms Score (IPSS) questionnaire to evaluate the effectiveness of the treatment. IPSS improvement percentage is defined as dividing the difference between preoperative and postoperative IPSS by preoperative IPSS, which varies from 0% to 100%. If the score is over 50%, the treatment will be considered as effective.	2,4,6,8,12 weeks after surgery
Quality of Life change	The study will use International Prostate Symptoms Score (IPSS) questionnaire to evaluate the effectiveness of the treatment. Quality of Life (QoL) is the last question of the questionnaire. QoL change is defined as the difference between preoperative and postoperative QoL, which varies from 0 to 6. If the score is over 3, the treatment will be considered as effective.	2,4,6,8,12 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum urinary flow change	The study will use free uroflow to assess objective change, with maximum urinary flow (Qmax) as the primary outcome measure. Qmax change is defined as the difference between preoperative and postoperative Qmax. The score is not capped, but the higher the score, the better the outcome.	6,12 weeks after surgery
Overactive Bladder Symptom Score change percentage	The study will use Overactive Bladder Symptom Score (OABSS) questionnaire to evaluate the effectiveness of the treatment. OABSS change percentage is defined as dividing the difference between preoperative and postoperative OABSS by preoperative OABSS, which varies from 0 to 15. If the score is over 50%, the treatment will be considered as effective.	2,4,6,8,12 weeks after surgery

Collaborators and Investigators

• Sponsor: Zhu Yiping

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 2024218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No