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

NCT07710794 | Not Yet Recruiting DMC

• 1 other identifier: KYLL-2026-04-039-1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Urinary Tract Symptoms (LUTS); BPH (Benign Prostatic Hyperplasia)

Keywords

Transcutaneous Tibial Nerve Stimulation; Lower Urinary Tract Symptoms; After Benign Prostatic Hyperplasia (BPH) Surgery

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (7)

• The urgency severity、nocturia frequency and number of incontinence episodes over a period of three days

  From enrollment to the end of treatment at 12 weeks

• Overactive Bladder Symptom Score (OABSS)

  From enrollment to the end of treatment at 12 weeks

• Patient Perception of Bladder Condition Scale (PPBC-S)

  From enrollment to the end of treatment at 12 weeks

• Quality of Life (QOL) Scale

  From enrollment to the end of treatment at 12 weeks

• International Prostate Symptom Score (IPSS)

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Experimental:BT(A)

ACTIVE COMPARATOR

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.

Behavioral: Behavioral Treatment

Experimental:TTNS+BT(B)

EXPERIMENTAL

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.

Device: Transcutaneous Tibial Nerve Stimulation (TTNS); Behavioral: Behavioral Treatment

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.

Experimental:TTNS+BT(B)

Behavioral Treatment BEHAVIORAL

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.

Experimental:BT(A); Experimental:TTNS+BT(B)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male, aged 50 to 80 years. 2. Diagnosis of benign prostatic hyperplasia (BPH) confirmed by IPSS, imaging, PSA, pathology, or other relevant assessments.
• \. Previous treatment with transurethral laser enucleation of the prostate for BPH.
• \. 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.
• \. 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).
• \. Medically stable and not requiring hospitalization. 7. Voluntary participation in this clinical study, with written informed consent signed by the participant before study initiation.

You may not qualify if:

• \. History of urinary tract infection, urinary tract malformation, obstruction, anatomical abnormality, or neurological disorder.
• \. Known allergy to electrode gel or skin breakdown that precludes the use of surface electrodes.
• \. Presence of psychiatric or cognitive impairment that renders the patient unable to cooperate with the study procedures.
• \. Any serious comorbidity or condition that may hinder the patient's participation or increase the risk associated with surgical procedures.
• \. Participation in another clinical trial within 3 months prior to screening that could potentially affect the results of this study.
• \. Other conditions deemed unsuitable for participation by the investigator.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shangdong, China

Location

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Chughtai B, Simma-Chiang V, Kaplan SA. Evaluation and management of post-transurethral resection of the prostate lower urinary tract symptoms. Curr Urol Rep. 2014 Sep;15(9):434. doi: 10.1007/s11934-014-0434-1.

  PMID: 25037906 BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Yan Li

CONTACT

+8618560089113; yanli@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-06

Locations

CN (1)