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

13. července 2026 aktualizováno: Qilu Hospital of Shandong University

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

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

70

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
    • Shangdong
      • Jinan, Shangdong, Čína
        • Qilu Hospital of Shandong University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Experimental:BT(A)

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.
Behaviorální: 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.
Experimentální: Experimental:TTNS+BT(B)

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.
Behaviorální: 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.
Přístroj: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The frequency of daily urination over a period of three days
Časové okno: From enrollment to the end of treatment at 12 weeks
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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overactive Bladder Symptom Score (OABSS)
Časové okno: From enrollment to the end of treatment at 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
The urgency severity、nocturia frequency and number of incontinence episodes over a period of three days
Časové okno: From enrollment to the end of treatment at 12 weeks
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
Patient Perception of Bladder Condition Scale (PPBC-S)
Časové okno: From enrollment to the end of treatment at 12 weeks
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
Časové okno: From enrollment to the end of treatment at 12 weeks
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)
Časové okno: From enrollment to the end of treatment at 12 weeks
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)
Časové okno: From enrollment to the end of treatment at 12 weeks
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
Časové okno: From enrollment to the end of treatment at 12 weeks
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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Qilu Hospital of Shandong University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

20. června 2026

Primární dokončení (Odhadovaný)

31. ledna 2027

Dokončení studie (Odhadovaný)

31. ledna 2027

Termíny zápisu do studia

První předloženo

13. července 2026

První předloženo, které splnilo kritéria kontroly kvality

13. července 2026

První zveřejněno (Aktuální)

17. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. července 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • KYLL-2026-04-039-1

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Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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