Evaluation of the The Neuromodulation System for the Treatment of Overactive Bladder Symptoms

NCT04999657 | Completed

• 1 other identifier: EMK03025P
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 7

Brief Summary

To evaluate the efficacy and safety of non-invasive tibial nerve stimulator for the treatment of overactive bladder under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be the improvement value of overactive bladder symptom score (OABSS) after 12-week treatment.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• The change of overactive bladder symptom score (OABSS) after 12-week treatment compared with baseline

  OABSS is evaluated via 3-day voiding diary and urinary voiding events of the previous week at week 0, 4, 8 and 12 after treatment. Evaluate OABSS improvement from baseline after 12 weeks of treatment and compared between the Treatment and the Control groups

  12 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

Device: Non-invasive low-frequency tibial nerve stimulator

Device: Non-invasive low-frequency tibial nerve stimulator (TNS-01)

Sham

SHAM COMPARATOR

Device: Non-invasive low-frequency tibial nerve stimulator (same device operation without real current output)

Device: Non-invasive low-frequency tibial nerve stimulator (TNS-01)

Interventions

Non-invasive low-frequency tibial nerve stimulator (TNS-01) DEVICE

The investigational device is a transcutaneous electrical nerve stimulation (TENS) device that is designed to provide stimulation to the nerves at the site of application via surface electrodes temporarily adhered to the skin.

Active; Sham

Eligibility Criteria

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

You may qualify if:

• Women and men aged between 18 and 80 years old (including 18 and 80 years old)；
• Individual with primary OAB, or with OAB symptoms, satisfies one of the following conditions:
• ① Urinary urgency: sudden and strong desire to urinate, and it is difficult to be subjectively suppressed and delayed urination ;
• ② Urge urinary incontinence: accompanied with urinary urgency or immediately after urinary urgency ;
• ③ Urination frequency: adults urination frequency ≥8 times during the daytime，≥2 times at night, and each urine volume \<200 ml .
• Individual meets the diagnostic criteria of OAB: According to the OABSS questionnaire, urgency score ≥2 points, total score ≥3 points, and symptoms duration ≥3 months;
• Individual newly diagnosed with OAB have not been medicated, or is able to stop taking OAB-related drugs (M receptor block, β3 receptor agonists) for at least 2 weeks prior to enrollment;
• The subject has autonomy and can go to the toilet independently;
• Individual is ambulatory and able to use the toilet independently;
• Individual is capable and willing to participate in the study and provide the written informed consent.

You may not qualify if:

• Woman is pregnant or lactating, or woman of childbearing age who plans to become pregnant during the study period;
• Individual has Stress Urinary Incontinence (SUI);
• Individual has obvious urinary obstruction due to various reasons accompanied by residual urine volume\> 100 ml;
• Individual has an implanted pacemaker, embedded cardioverter defibrillator, or other electrical medical devices (including sacral neuromodulation (SNM) devices)
• Individual has uncured urinary system infection;
• Individual has urinary calculus resulting in lower urinary tract symptoms;
• Individual has congenital urinary tract malformations causing uncured lower urinary tract symptoms;
• Individual has uncured cancers;
• Individual had undergone lower urinary tract surgery within 3 months;
• Individual has neurological diseases or injuries accompanied with uncured lower urinary tract symptoms;
• Individual has skin breakage, malignant tumor or acute purulent inflammation on the surface of the plantar where the electrode pads are to be placed;
• Individual has participated in other drug clinical trials medical dev within 3 months, or participated in other ice clinical trials within 30 days;
• Individual is deemed unsuitable for enrollment in the study by investigator.

Sponsors & Collaborators

• Medtecx Co Ltd.: lead

Study Sites (7)

Beijing Hospital

Beijing, Beijing Municipality, China

Location

West China Hospital

Chengdu, China

Location

Nan Fang Hospital

Guangzhou, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

Shanghai Fifth People's Hospital

Shanghai, China

Location

Shanghai General Hospital

Shanghai, China

Location

The First Affiliated Hospital of XI'AN JiaoTong University

Xi'an, China

Location

Related Publications (1)

• Zhang Z, Liu M, Wang Y, Wu P, Zhu Y, Han B, Xu Z, Li X, Shi C, Zhang J, Luo D, Shi G, Zhang Y. Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder. Eur J Med Res. 2025 Jan 20;30(1):40. doi: 10.1186/s40001-024-02262-z.

  PMID: 39833952 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

Study Officials

• Yaoguang Zhang, MD

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 11, 2021
• Study Start: August 26, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 15, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

CN (7)