The incidence of lower urinary tract symptoms (LUTS) with persistent overactive bladder (OAB) symptoms after benign prostatic hyperplasia (BPH) surgery ranges from approximately 5% to 35%, meaning that roughly one-third of patients remain troubled by symptoms such as urinary frequency, urgency, and increased nocturia following surgery.Current treatment options are limited. Although behavioral therapy (BT) is recommended as first-line treatment, patient compliance is often poor. Pharmacotherapy is associated with insufficient efficacy and adverse effects such as dry mouth, constipation, and cognitive impairment, which lead to low long-term medication adherence.
Transcutaneous tibial nerve stimulation (TTNS) has been proven effective in improving OAB symptoms and is recommended by multiple guidelines as one of the optional treatment modalities. However, research on its application in patients after BPH surgery remains lacking.The novel transcutaneous tibial nerve stimulation patch device offers the advantages of being non-invasive, portable, and suitable for home-based treatment. Whether combining this device with behavioral therapy can provide additional benefits for patients with refractory lower urinary tract symptoms after surgery needs to be verified through clinical research. Therefore, we plan to conduct this randomized controlled study to evaluate the efficacy and safety of the transcutaneous tibial nerve stimulation patch combined with behavioral therapy.
1. Male, aged 50 to 80 years. 2. Diagnosis of benign prostatic hyperplasia (BPH) confirmed by IPSS, imaging, PSA, pathology, or other relevant assessments.
1. History of urinary tract infection, urinary tract malformation, obstruction, anatomical abnormality, or neurological disorder.
Parallel
Transcutaneous Tibial Nerve Stimulation (TTNS)
DeviceParticipants in Group A will receive daily behavioral therapy, while participants in Group B will receive daily behavioral therapy plus transcutaneous tibial nerve stimulation (TTNS) using the patch, three times per week, 30 minutes per session, for a total of 12 weeks.
Behavioral Treatment
BehavioralParticipants in Group A will receive daily behavioral therapy, while participants in Group B will receive daily behavioral therapy plus transcutaneous tibial nerve stimulation (TTNS) using the patch, three times per week, 30 minutes per session, for a total of 12 weeks.
The frequency of daily urination over a period of three days
Standardized 72-hour voiding diary, record the frequency of daily urination over a period of three days
The urgency severity、nocturia frequency and number of incontinence episodes over a period of three days
Standardized 72-hour voiding diary, record the urgency severity、nocturia frequency and number of incontinence episodes over a period of three days
Overactive Bladder Symptom Score (OABSS)
The OABSS score is mainly used for initial severity grading, with total scores ranging from 0 to 15: 0-5 as mild, 6-11 as moderate, and 12-15 as severe.
Patient Perception of Bladder Condition Scale (PPBC-S)
The PPBC-S is a single-item, self-reported scale used to assess the patient's global perception of their bladder condition. The score ranges from 1 to 6, with higher scores indicating greater bother caused by the bladder condition. A score of 1 or 2 is generally regarded as mild, 3 or 4 as moderate, and 5 or 6 as severe.
Quality of Life (QOL) Scale
The QOL scale used is the International Prostate Symptom Score quality of life question (IPSS-QoL). It is a single-item, self-reported assessment that asks: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" The score ranges from 0 (delighted) to 6 (terrible), with higher scores indicating a poorer quality of life due to urinary symptoms. A score of 0-1 is generally considered good, 2-3 as mixed, and 4-6 as poor.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
