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Not Yet Recruiting NCT07710794

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

Conditions: Lower Urinary Tract Symptoms (LUTS), BPH (Benign Prostatic Hyperplasia)

Sex: Male
Ages: 50 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: Qilu Hospital of Shandong University

Location: Qilu Hospital of Shandong University Jinan Shangdong

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.

Eligibility Criteria

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\. Other conditions deemed unsuitable for participation by the investigator.

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Source: ClinicalTrials.gov (NCT07710794). StuddyBuddy aggregates publicly available trial information.