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

NCT06742489 | Not Yet Recruiting

• 1 other identifier: 2024218
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• maximum urinary flow change

  6,12 weeks after surgery

• Overactive Bladder Symptom Score change percentage

  2,4,6,8,12 weeks after surgery

Study Arms (2)

Treatment group

EXPERIMENTAL

Participants in this group will receive T-PTNS three times a week for 30 minutes every time.

Device: Percutaneous tibial nerve stimulation device

Sham group

SHAM COMPARATOR

The sham group will use the same device without therapeutic effect as a blank control.

Device: Sham group device

Interventions

Percutaneous tibial nerve stimulation device 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.

Treatment group

Sham group device 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.

Sham group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants have been fully informed of the potential benefits and risks associated with the trial and have provided written consent to participate.
• Male participants between the ages of 45 and 80 are eligible to participate in the trial.
• 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;
• Participants who are able to discontinue relevant medications (M-blockers and β3 agonists) for a period of at least one week prior to enrolment;
• Participants with autonomy, self-care, self-control, and the ability to use the toilet independently.

You may not qualify if:

• Subjects presenting with urinary incontinence due to reduced sphincter function, or subjects evaluated for neurogenic bladder;
• Subjects with urethral strictures or bladder neck contractures that make insertion of devices difficult;
• Subjects with pacemakers, buried cardioverter-defibrillators, or other therapeutic electronic medical devices (including sacral neuromodulation).
• Subjects with implanted devices in the body;
• Subjects with untreated urinary tract infections;
• Subjects with urinary stones that cause lower urinary tract symptoms;
• Subjects with previous pelvic surgery; and
• Subjects with a history of previous pelvic surgery, or colorectal surgery (except polypectomy and haemorrhoidectomy);
• Subjects with untreated malignant tumors;
• Subjects with neurological or cerebrovascular lesions or injuries, or medical conditions affecting cognition, bladder function, sphincter function, or urethral muscle function;
• 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;
• Other conditions that the investigator deems unsuitable for participation in the study.

Sponsors & Collaborators

• Zhu Yiping: lead

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Model Details: This trial will include patients with storage symptoms as the main manifestation and undergo surgical treatment for benign prostatic hyperplasia. There is still a lack of similar products on the market to be used as a control, and thus the sham group will use the same device without therapeutic effect as a blank control.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: January 1, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 19, 2024

Record last verified: 2024-12