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

Sponsor
Medtecx Co Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04999657
Collaborator
(none)
106
Enrollment
7
Locations
2
Arms
12.2
Anticipated Duration (Months)
15.1
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Non-invasive low-frequency tibial nerve stimulator (TNS-01)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Prospective, Multi-center, Randomized Controlled, Double-blind, Superiority Clinical Trial Evaluating the Safety and Efficacy of a Non-invasive Low-frequency Tibial Nerve Stimulator for the Treatment of Overactive Bladder
Actual Study Start Date :
Aug 26, 2021
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active

Device: Non-invasive low-frequency tibial nerve stimulator

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

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)
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.

Outcome Measures

Primary Outcome Measures

  1. The change of overactive bladder symptom score (OABSS) after 12-week treatment compared with baseline [12 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Women and men aged between 18 and 80 years old (including 18 and 80 years old)；

  2. 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 .

  1. 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;

  2. 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;

  3. The subject has autonomy and can go to the toilet independently;

  4. Individual is ambulatory and able to use the toilet independently;

  5. Individual is capable and willing to participate in the study and provide the written informed consent.

Exclusion Criteria:

  1. Woman is pregnant or lactating, or woman of childbearing age who plans to become pregnant during the study period;

  2. Individual has Stress Urinary Incontinence (SUI);

  3. Individual has obvious urinary obstruction due to various reasons accompanied by residual urine volume> 100 ml;

  4. Individual has an implanted pacemaker, embedded cardioverter defibrillator, or other electrical medical devices (including sacral neuromodulation (SNM) devices)

  5. Individual has uncured urinary system infection;

  6. Individual has urinary calculus resulting in lower urinary tract symptoms;

  7. Individual has congenital urinary tract malformations causing uncured lower urinary tract symptoms;

  8. Individual has uncured cancers;

  9. Individual had undergone lower urinary tract surgery within 3 months;

  10. Individual has neurological diseases or injuries accompanied with uncured lower urinary tract symptoms;

  11. Individual has skin breakage, malignant tumor or acute purulent inflammation on the surface of the plantar where the electrode pads are to be placed;

  12. Individual has participated in other drug clinical trials medical dev within 3 months, or participated in other ice clinical trials within 30 days;

  13. Individual is deemed unsuitable for enrollment in the study by investigator.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Hospital Beijing Beijing China
2 West China Hospital Chengdu China
3 Nan Fang Hospital Guangzhou China
4 Zhejiang Provincial People's Hospital Hangzhou China
5 Shanghai Fifth People's Hospital Shanghai China
6 Shanghai General Hospital Shanghai China
7 The First Affiliated Hospital of XI'AN JiaoTong University Xi'an China

Sponsors and Collaborators

  • Medtecx Co Ltd.

Investigators

  • Principal Investigator: Yaoguang Zhang, MD, Beijing Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medtecx Co Ltd.
ClinicalTrials.gov Identifier:
NCT04999657
Other Study ID Numbers:
  • EMK03025P
First Posted:
Aug 11, 2021
Last Update Posted:
Sep 16, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urinary Bladder, Overactive

Study Results

No Results Posted as of Sep 16, 2021