Clinical trial NCT06742489: Research for the Efficacy and Safety of Percutaneous Tibial Nerve Stimulation to Promote Storage Symptoms Postoperative Recovery for Patients With Benign Prostatic Hyperplasia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 160
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: International Prostate Symptoms Score improvement percentage
timeFrame: 2,4,6,8,12 weeks after surgery
measure: Quality of Life change
timeFrame: 2,4,6,8,12 weeks after surgery
Secondary outcomes:
measure: maximum urinary flow change
timeFrame: 6,12 weeks after surgery
measure: Overactive Bladder Symptom Score change percentage
timeFrame: 2,4,6,8,12 weeks after surgery
Other outcomes:
Locations:
Study officials:
References: