A Novel Wearable Transcutaneous Tibial Nerve Stimulation (TTNS) Device in the Treatment of Patients With Overactive Bladder (OAB) and Nocturia

NCT07635251 | Not Yet Recruiting DMC

• 1 other identifier: KYLL-2026-04-013-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Overactive bladder (OAB) is a syndrome with urgency as the main symptom, usually accompanied by frequent urination, nocturia, and sometimes urge urinary incontinence. Globally, the prevalence of OAB in the general population has been reported to be about 20%. Nocturia was defined as the patient waking up at least once during the night to urinate. Among lower urinary tract symptoms, nocturia can significantly affect daily life and quality of life. Reported causes of nocturia include nocturnal polyuria, sleep disorders, circadian rhythm disruption (e.g., circadian rhythm sleep disorders), and reduced bladder capacity. Because overactive bladder (OAB) may be associated with reduced bladder capacity, anticholinergic agents are used as standard therapy in the management of nocturia associated with OAB. However, anticholinergic medications are associated with poor adherence, such as inadequate efficacy and adverse effects (e.g., dry mouth, constipation, and cognitive impairment). Therefore, it is imperative to find alternative therapies for anticholinergic drugs. Previous studies have shown that transcutaneous tibial nerve stimulation (TNS) can also significantly improve lower urinary tract symptoms, such as frequency, urgency, incontinence, and nocturia, and is also one of the options for the treatment of OAB. A previous study also demonstrated its improvement in sleep quality in women with nocturia. However, the efficacy of tibial nerve stimulation in the treatment of active bladder with nocturia is still a blank, and further studies are needed.

Conditions

Overactive Bladder (OAB); Nocturia

Keywords

transcutaneous tibial nerve stimulation; overactive bladder; nocturia

Outcome Measures

Primary Outcomes (2)

• Standardized 72-hour voiding diary

  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

• Overactive Bladder Symptom Score (OABSS)

  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

Secondary Outcomes (2)

• Pittsburgh Sleep Quality Index (PSQI)

  From enrollment to the end of treatment at 12 weeks

• Nocturia quality of life (NQOL) score

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

TTNS+BT (A)

EXPERIMENTAL

The selected study participants were randomly divided into group A and group B with a ratio of 1:1. Participants in group A were treated with A new wearable transcutaneous tibial nerve stimulation (TTNS) device combined with behavioral therapy (BT), while participants in group B were treated with behavioral therapy alone. Participants were followed up at 4, 8, and 12 weeks after enrollment. The improvement of voiding symptoms (frequent urination, urgency, urge incontinence, etc.) and sleep quality were analyzed at different stages. Treatment assignments: Group A, participants received tibial nerve stimulation three times a week (30 minutes each time) in combination with daily behavioral therapy. Group B: The study participants received daily behavioral therapy, and the improvement of symptoms was observed in the study participants at all stages.

Device: A new wearable transcutaneous tibial nerve stimulation (TTNS) device; Behavioral: behavioral therapy

BT (B)

EXPERIMENTAL

The selected study participants were randomly divided into group A and group B with a ratio of 1:1. Participants in group A were treated with A new wearable transcutaneous tibial nerve stimulation (TTNS) device combined with behavioral therapy (BT), while participants in group B were treated with behavioral therapy alone. Participants were followed up at 4, 8, and 12 weeks after enrollment. The improvement of voiding symptoms (frequent urination, urgency, urge incontinence, etc.) and sleep quality were analyzed at different stages. Treatment assignments: Group A, participants received tibial nerve stimulation three times a week (30 minutes each time) in combination with daily behavioral therapy. Group B: The study participants received daily behavioral therapy, and the improvement of symptoms was observed in the study participants at all stages.

Behavioral: behavioral therapy

Interventions

behavioral therapy BEHAVIORAL

Treatment assignments: Group A, participants received tibial nerve stimulation three times a week (30 minutes each time) in combination with daily behavioral therapy. Group B: The study participants received daily behavioral therapy, and the improvement of symptoms was observed in the study participants at all stages.

BT (B); TTNS+BT (A)

A new wearable transcutaneous tibial nerve stimulation (TTNS) device DEVICE

Group A: participants received tibial nerve stimulation three times a week (30 minutes each time) in combination with daily behavioral therapy. Group B: The study participants received daily behavioral therapy, and the improvement of symptoms was observed in the study participants at all stages.

TTNS+BT (A)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥20 years old, ≤80 years old, female;
• the patient's physical condition is stable and can be treated at home;
• All participants volunteered to participate in the study and provided written informed consent before the study began.

You may not qualify if:

• Residual urine volume ≥100 mL;
• difficulty walking;
• urethral stricture;
• bladder stones;
• bladder cancer;
• urinary tract infection;
• pregnant, lactating women, women of childbearing age who plan to become pregnant during the study or who do not use safe contraception;
• pelvic organ prolapse;
• neuropsychiatric disorders (including cerebrovascular diseases) associated with neurogenic bladder;
• taking medications for urinary system diseases within 2 weeks before enrollment;
• patients with mental and cognitive impairment who are unable to cooperate with treatment;
• other conditions considered by the investigator to be inappropriate for study participation.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Related Publications (5)

• Furtado-Albanezi D, Jurgensen SP, Avila MA, Correia GN, Driusso P. Effects of two nonpharmacological treatments on the sleep quality of women with nocturia: a randomized controlled clinical trial. Int Urogynecol J. 2019 Feb;30(2):279-286. doi: 10.1007/s00192-018-3584-8. Epub 2018 Mar 6.

  PMID: 29508046 BACKGROUND

• Liao L, Li X, Chong T, Chen Q, Xu Z, Huang B, Chen M, Li H, Wei Z, Shao Y, Lu J, Pang R, Li X, Wang Y. Efficacy and safety of tibial nerve stimulation using a wearable device for overactive bladder. BJU Int. 2024 Jun;133(6):760-769. doi: 10.1111/bju.16330. Epub 2024 Mar 11.

  PMID: 38468422 BACKGROUND

• van Balken MR, Vandoninck V, Gisolf KW, Vergunst H, Kiemeney LA, Debruyne FM, Bemelmans BL. Posterior tibial nerve stimulation as neuromodulative treatment of lower urinary tract dysfunction. J Urol. 2001 Sep;166(3):914-8. doi: 10.1097/00005392-200109000-00025.

  PMID: 11490245 BACKGROUND

• Yokoyama O, Yamaguchi O, Kakizaki H, Itoh N, Yokota T, Okada H, Ishizuka O, Ozono S, Gotoh M, Sugiyama T, Seki N, Yoshida M, Yamada S. Efficacy of solifenacin on nocturia in Japanese patients with overactive bladder: impact on sleep evaluated by bladder diary. J Urol. 2011 Jul;186(1):170-4. doi: 10.1016/j.juro.2011.02.2700. Epub 2011 May 14.

  PMID: 21575976 BACKGROUND

• Weiss JP, Jumadilova Z, Johnson TM 2nd, Fitzgerald MP, Carlsson M, Martire DL, Malhotra A. Efficacy and safety of flexible dose fesoterodine in men and women with overactive bladder symptoms including nocturnal urinary urgency. J Urol. 2013 Apr;189(4):1396-401. doi: 10.1016/j.juro.2012.11.067. Epub 2012 Nov 15.

  PMID: 23159276 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Nocturia

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Yan Li, Doctor

CONTACT

18560089113; 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: June 3, 2026
• First Posted: June 9, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): June 10, 2027
• Study Completion (Estimated): June 10, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-05

Locations

CN (1)