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

Official title

Transcutaneous Tibial Nerve Stimulation (TTNS) Patch Combined With Behavioral Therapy (BT) Versus Behavioral Therapy in the Treatment of Patients With Lower Urinary Tract Symptoms (LUTS) After Benign Prostatic Hyperplasia (BPH) Surgery: a Prospective, Randomized Controlled Study

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.

Detailed description

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

• Device Transcutaneous Tibial Nerve Stimulation (TTNS)
  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 Behavioral Treatment
  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.

Primary outcome measures

• The frequency of daily urination over a period of three days [Time frame: From enrollment to the end of treatment at 12 weeks]

Secondary outcome measures (7)

• The urgency severity、nocturia frequency and number of incontinence episodes over a period of three days [Time frame: From enrollment to the end of treatment at 12 weeks]
• Overactive Bladder Symptom Score (OABSS) [Time frame: From enrollment to the end of treatment at 12 weeks]
• Patient Perception of Bladder Condition Scale (PPBC-S) [Time frame: From enrollment to the end of treatment at 12 weeks]
• Quality of Life (QOL) Scale [Time frame: From enrollment to the end of treatment at 12 weeks]
• International Prostate Symptom Score (IPSS) [Time frame: From enrollment to the end of treatment at 12 weeks]
• Self-Rating Anxiety Scale (SAS) [Time frame: From enrollment to the end of treatment at 12 weeks]
• Safety endpoints and the occurrence of adverse events [Time frame: From enrollment to the end of treatment at 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Qilu Hospital of Shandong University — Jinan

Publications

• Sayner AM, Rogers F, Tran J, Jovanovic E, Henningham L, Nahon I. Transcutaneous Tibial Nerve Stimulation in the Management of Overactive Bladder: A Scoping Review. Neuromodulation. 2022 Dec;25(8):1086-1096. doi: 10.1016/j.neurom.2022.04.034. Epub 2022 Jun 8. PMID 35688702
• Burton C, Sajja A, Latthe PM. Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn. 2012 Nov;31(8):1206-16. doi: 10.1002/nau.22251. Epub 2012 May 11. PMID 22581511
• Chancellor MB, Migliaccio-Walle K, Bramley TJ, Chaudhari SL, Corbell C, Globe D. Long-term patterns of use and treatment failure with anticholinergic agents for overactive bladder. Clin Ther. 2013 Nov;35(11):1744-51. doi: 10.1016/j.clinthera.2013.08.017. Epub 2013 Oct 3. PMID 24091072
• Vouri SM, Kebodeaux CD, Stranges PM, Teshome BF. Adverse events and treatment discontinuations of antimuscarinics for the treatment of overactive bladder in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2017 Mar-Apr;69:77-96. doi: 10.1016/j.archger.2016.11.006. Epub 2016 Nov 14. PMID 27889591
• Nitti VW, Kim Y, Combs AJ. Voiding dysfunction following transurethral resection of the prostate: symptoms and urodynamic findings. J Urol. 1997 Feb;157(2):600-3. PMID 8996367
• Hou CP, Chen TY, Chang CC, Lin YH, Chang PL, Chen CL, Hsu YC, Tsui KH. Use of the SF-36 quality of life scale to assess the effect of pelvic floor muscle exercise on aging males who received transurethral prostate surgery. Clin Interv Aging. 2013;8:667-73. doi: 10.2147/CIA.S44321. Epub 2013 Jun 6. PMID 23766642
• Staskin DS, Vardi Y, Siroky MB. Post-prostatectomy continence in the parkinsonian patient: the significance of poor voluntary sphincter control. J Urol. 1988 Jul;140(1):117-8. doi: 10.1016/s0022-5347(17)41501-1. PMID 2454326
• Housami F, Abrams P. Persistent detrusor overactivity after transurethral resection of the prostate. Curr Urol Rep. 2008 Jul;9(4):284-90. doi: 10.1007/s11934-008-0050-z. PMID 18765127

Identifiers

NCT: NCT07710794 · KYLL-2026-04-039-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗