Not Yet RecruitingNot Applicable

Transcutaneous Tibial Nerve Stimulation (TTNS) Patch in the Treatment of Patients With Lower Urinary Tract Symptoms (LUTS) After Benign Prostatic Hyperplasia (BPH) Surgery

China70 participantsStarted 2026-06-20

Plain-language summary

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.

Who can participate

Age range

50 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\. Male, aged 50 to 80 years. 2. Diagnosis of benign prostatic hyperplasia (BPH) confirmed by IPSS, imaging, PSA, pathology, or other relevant assessments. 3\. Previous treatment with transurethral laser enucleation of the prostate for BPH. 4\. Persistent overactive bladder symptoms one month after surgery, defined as an average of ≥8 voids per 24 hours documented on a 72-hour voiding diary. 5\. Not currently using, or having discontinued at least 14 days prior to enrollment, all related medications (e.g., β3-adrenoceptor agonists, non-selective β-adrenoceptor agonists, or anticholinergics). 6\. Medically stable and not requiring hospitalization. 7. Voluntary participation in this clinical study, with written informed consent signed by the participant before study initiation. Exclusion Criteria: * 1\. History of urinary tract infection, urinary tract malformation, obstruction, anatomical abnormality, or neurological disorder. 2\. Known allergy to electrode gel or skin breakdown that precludes the use of surface electrodes. 3\. Presence of psychiatric or cognitive impairment that renders the patient unable to cooperate with the study procedures. 4\. Any serious comorbidity or condition that may hinder the patient's participation or increase the risk associated with surgical procedures. 5\. Participation in another clinical trial within 3 months prior to screening that could potentially affect the results of this study. 6\. O…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The frequency of daily urination over a period of three days

Timeframe: From enrollment to the end of treatment at 12 weeks

Trial details

NCT IDNCT07710794

SponsorQilu Hospital of Shandong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Yan Li

+8618560089113 yanli@sdu.edu.cn

View on ClinicalTrials.gov More Lower Urinary Tract Symptoms (LUTS) trials