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

Launched by ZHU YIPING · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called T-PTNS (transcutaneous percutaneous tibial nerve stimulation) to help men recover from urinary problems after surgery for benign prostatic hyperplasia (BPH), a condition that causes urinary difficulties. The main goal is to see if T-PTNS can improve symptoms like frequent urination or urgency after surgery. Men aged 45 to 80 who have been diagnosed with BPH and are undergoing a specific surgical treatment may be eligible to participate. They’ll need to be able to follow instructions and stop taking certain medications before joining the study.

Participants in the trial will receive T-PTNS three times a week for 30 minutes over six weeks, and the entire study will last for 12 weeks. Throughout this time, researchers will check in with participants to monitor their progress and gather information about the treatment's effectiveness and safety. It’s important to note that certain health conditions, like urinary incontinence from muscle issues or having certain medical devices implanted, may prevent someone from participating. This study aims to establish a clear and effective treatment process that can help many men manage their urinary symptoms better after surgery.

Gender

MALE

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.