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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
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.
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.
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.
Time frame: 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.
Time frame: 2,4,6,8,12 weeks after surgery
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.
Time frame: 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.
Time frame: 2,4,6,8,12 weeks after surgery
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