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

N/ANot Yet RecruitingNCT07710794

Qilu Hospital of Shandong University70 enrolled

Overview

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.

Eligible participants will be screened strictly according to the inclusion and exclusion criteria and enrolled until the required sample size is reached. At enrollment, baseline data will be collected for all participants, including: (1) basic patient information, such as age and sex; (2) a standardized 72-hour voiding diary; (3) a current medication list; (4) the Overactive Bladder Symptom Score (OABSS); (5) the Patient Perception of Bladder Condition Scale (PPBC-S); (6) the Quality of Life scale (QOL); (7) the Self-Rating Anxiety Scale (SAS); (8) the International Prostate Symptom Score (IPSS). Eligible participants will be randomly assigned to Group A or Group B in a 1:1 ratio. Participants 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. Follow-up visits will be conducted at Weeks 1, 4, 8, and 12 after enrollment. At each follow-up visit, the following data will be collected: (1) the standardized 72-hour voiding diary; (2) the current medication list; (3) OABSS; (4) PPBC-S; (5) QOL; (6) SAS; (7) IPSS; and (8) adverse events.

Interventions

Transcutaneous Tibial Nerve Stimulation (TTNS)DEVICE

Participants 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 TreatmentBEHAVIORAL

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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