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

NCT ID: NCT06742489

Last Updated: 2024-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

Percutaneous tibial nerve stimulation device

Intervention Type: 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 group

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

Group Type: SHAM_COMPARATOR

Sham group device

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Zhu Yiping

OTHER

Sponsor Role: lead

Responsible Party

Zhu Yiping

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2024218

Identifier Type: -

Identifier Source: org_study_id