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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Non-invasive low-frequency tibial nerve stimulator (TNS-01)
Sponsored by
Medtecx Co Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

  3. 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;
  4. 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;
  5. The subject has autonomy and can go to the toilet independently;
  6. Individual is ambulatory and able to use the toilet independently;
  7. 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.

Sites / Locations

  • Beijing Hospital
  • West China Hospital
  • Nan Fang Hospital
  • Zhejiang Provincial People's Hospital
  • Shanghai Fifth People's Hospital
  • Shanghai General Hospital
  • The First Affiliated Hospital of XI'AN JiaoTong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active

Sham

Arm Description

Device: Non-invasive low-frequency tibial nerve stimulator

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 2, 2021
Last Updated
January 16, 2023
Sponsor
Medtecx Co Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04999657
Brief Title
Evaluation of the The Neuromodulation System for the Treatment of Overactive Bladder Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 26, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtecx Co Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
Device: Non-invasive low-frequency tibial nerve stimulator
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Device: Non-invasive low-frequency tibial nerve stimulator (same device operation without real current output)
Intervention Type
Device
Intervention Name(s)
Non-invasive low-frequency tibial nerve stimulator (TNS-01)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of overactive bladder symptom score (OABSS) after 12-week treatment compared with baseline
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaoguang Zhang, MD
Organizational Affiliation
Beijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
West China Hospital
City
Chengdu
Country
China
Facility Name
Nan Fang Hospital
City
Guangzhou
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
Country
China
Facility Name
Shanghai Fifth People's Hospital
City
Shanghai
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
Country
China
Facility Name
The First Affiliated Hospital of XI'AN JiaoTong University
City
Xi'an
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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