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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The urgency severity、nocturia frequency and number of incontinence episodes over a period of three days | Standardized 72-hour voiding diary, record 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) |
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Li | Contact | +8618560089113 | yanli@sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35688702 | Background | 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. | |
| 22581511 | 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. |
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| 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. |
|
The OABSS score is mainly used for initial severity grading, with total scores ranging from 0 to 15: 0-5 as mild, 6-11 as moderate, and 12-15 as severe. |
| From enrollment to the end of treatment at 12 weeks |
| Patient Perception of Bladder Condition Scale (PPBC-S) | The PPBC-S is a single-item, self-reported scale used to assess the patient's global perception of their bladder condition. The score ranges from 1 to 6, with higher scores indicating greater bother caused by the bladder condition. A score of 1 or 2 is generally regarded as mild, 3 or 4 as moderate, and 5 or 6 as severe. | From enrollment to the end of treatment at 12 weeks |
| Quality of Life (QOL) Scale | The QOL scale used is the International Prostate Symptom Score quality of life question (IPSS-QoL). It is a single-item, self-reported assessment that asks: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" The score ranges from 0 (delighted) to 6 (terrible), with higher scores indicating a poorer quality of life due to urinary symptoms. A score of 0-1 is generally considered good, 2-3 as mixed, and 4-6 as poor. | From enrollment to the end of treatment at 12 weeks |
| International Prostate Symptom Score (IPSS) | The IPSS is a validated, self-administered questionnaire used to assess the severity of lower urinary tract symptoms. It consists of seven questions covering incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is scored from 0 to 5, yielding a total score ranging from 0 to 35. Severity is graded as mild (0-7), moderate (8-19), and severe (20-35). | From enrollment to the end of treatment at 12 weeks |
| Self-Rating Anxiety Scale (SAS) | The SAS is a self-administered questionnaire designed to assess the level of anxiety in patients. It consists of 20 items, each scored on a 4-point scale (1-4) based on the frequency of symptoms over the past week. The raw total score is multiplied by 1.25 to obtain a standardized score ranging from 25 to 100. Higher scores indicate greater anxiety severity. A standardized score of 50 or above suggests clinically significant anxiety, with 50-59 classified as mild, 60-69 as moderate, and ≥70 as severe. | From enrollment to the end of treatment at 12 weeks |
| Safety endpoints and the occurrence of adverse events | including pain and infection at the stimulation site, tibial nerve injury (e.g., motor dysfunction, neuralgia), and urological complications. | From enrollment to the end of treatment at 12 weeks |
| 24091072 | 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. |
| 27889591 | 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. |
| 8996367 | 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. |
| 23766642 | 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. |
| 2454326 | 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. |
| 18765127 | 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. |
| 25037906 | 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. |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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