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PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB (RESET)

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NURO System PTNM Therapy
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

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

Inclusion Criteria:

  1. 18 years of age or older
  2. Diagnosis of OAB and associated symptoms of UUI and qualify with at least 3 episodes of mild, moderate, or severe urgency demonstrated on a 3-day urinary voiding diary
  3. Experiencing UUI symptoms for at least 3 months
  4. No prior treatment with anticholinergics/antimuscarinics or beta 3-agonists medications to treat OAB
  5. Willing and able to accurately complete voiding diaries and questionnaires, attend visits, and comply with the study protocol
  6. Willing and able to provide signed and dated informed consent

Exclusion Criteria:

  1. Have received anticholinergics/antimuscarinics or beta 3-agonists medications to treat OAB or advanced therapy treatment options for OAB (botulinum toxin injections, sacral neuromodulation, or percutaneous tibial nerve stimulation/neuromodulation)
  2. Primary stress incontinence or mixed incontinence where the stress component overrides the urge component
  3. Have implantable pacemakers or implantable defibrillators
  4. Use of transcutaneous electrical nerve stimulation (TENS) in pelvic region, back or legs
  5. Women who are pregnant or planning to become pregnant during the course of the study
  6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol
  7. Nerve damage that could impact either tibial nerve or pelvic floor function.
  8. Subjects prone to excessive bleeding
  9. Inadequate skin integrity in the area of PTNM needle placement
  10. History of diabetes unless the diabetes is well-controlled through diet and/or medications
  11. Have symptomatic urinary tract infection (UTI)
  12. Participation in any research study involving or impacting gynecologic, urinary or renal function within the 4-week period prior to or plans to participate during study enrollment

Sites / Locations

  • Pinellas Urology, Inc.
  • NorthShore University Health System
  • Mount Auburn Hospital
  • Advanced Urogynecology of Michigan, P.C.
  • Metro Urology
  • Urology Center Research Institute, LLC
  • NYU Urology Associates
  • Alliance Urology Specialists
  • Hospital of University of Pennsylvania
  • Virginia Mason Medical Center
  • SSM Health Dean Medical Group

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

NURO System PTNM Therapy

Arm Description

Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system.

Outcomes

Primary Outcome Measures

Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline
Number of UUI episodes were collected at baseline and following the 12th PTNM therapy session. For each subject in the analysis, change in UUI episodes per day was calculated as UUI episodes per day after 12th PTNM session minus baseline. A negative change indicates the improvement in UUI symptom.

Secondary Outcome Measures

Change in Number of Voids Per Day After the 12th PTNM Therapy Sessions From Baseline in UF Subjects
Number of voids were collected at baseline and following the 12th PTNM therapy session. For each UF subject in the analysis, a change in number of voids per day was calculated as number of voids per day after 12th PTNM session minus baseline. A negative change indicates improvement in UF symptoms.
Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline
This objective was to assess the change after12 PTNM therapy sessions from baseline in quality of life as measured by the OABq Questionnaire. OABq consists of a symptom bother scale and four health related quality of life (HRQL) subscales (Coping, Concern, Sleep and Social interaction). The symptom bother scale and 4 HRQL subscales are measured as 0-100 using a range percentile transformation on the summed value from individual listed items. The HRQL score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from 4 subscales (Coping, Concern, Sleep and Social). A change was calculated as the score after 12th PTNM minus the score at baseline. A positive change in HRQL and its subscales (Coping, Concern, Sleep and Social) indicates improvement in QOL; a negative change in symptom bother score indicates improvement in QOL.

Full Information

First Posted
August 3, 2016
Last Updated
December 21, 2018
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT02857816
Brief Title
PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB
Acronym
RESET
Official Title
PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation (PTNM) System in Patients With OAB
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 21, 2017 (Actual)
Study Completion Date
November 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the NURO system for the treatment of OAB in drug naïve patients.
Detailed Description
The purpose of this prospective, multicenter, single arm study is to evaluate the NURO system for the treatment of OAB in drug naïve patients. The study will assess change from baseline through 12 PTNM therapy sessions in UUI (urge urinary incontinence) episodes, voiding episodes, and patient reported outcomes. The study is expected to last approximately 14 weeks per subject following the enrollment visit. Subjects will be exited from the study after the final study visit is complete.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NURO System PTNM Therapy
Arm Type
Other
Arm Description
Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system.
Intervention Type
Device
Intervention Name(s)
NURO System PTNM Therapy
Primary Outcome Measure Information:
Title
Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline
Description
Number of UUI episodes were collected at baseline and following the 12th PTNM therapy session. For each subject in the analysis, change in UUI episodes per day was calculated as UUI episodes per day after 12th PTNM session minus baseline. A negative change indicates the improvement in UUI symptom.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change in Number of Voids Per Day After the 12th PTNM Therapy Sessions From Baseline in UF Subjects
Description
Number of voids were collected at baseline and following the 12th PTNM therapy session. For each UF subject in the analysis, a change in number of voids per day was calculated as number of voids per day after 12th PTNM session minus baseline. A negative change indicates improvement in UF symptoms.
Time Frame
12 Weeks
Title
Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline
Description
This objective was to assess the change after12 PTNM therapy sessions from baseline in quality of life as measured by the OABq Questionnaire. OABq consists of a symptom bother scale and four health related quality of life (HRQL) subscales (Coping, Concern, Sleep and Social interaction). The symptom bother scale and 4 HRQL subscales are measured as 0-100 using a range percentile transformation on the summed value from individual listed items. The HRQL score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from 4 subscales (Coping, Concern, Sleep and Social). A change was calculated as the score after 12th PTNM minus the score at baseline. A positive change in HRQL and its subscales (Coping, Concern, Sleep and Social) indicates improvement in QOL; a negative change in symptom bother score indicates improvement in QOL.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Diagnosis of OAB and associated symptoms of UUI and qualify with at least 3 episodes of mild, moderate, or severe urgency demonstrated on a 3-day urinary voiding diary Experiencing UUI symptoms for at least 3 months No prior treatment with anticholinergics/antimuscarinics or beta 3-agonists medications to treat OAB Willing and able to accurately complete voiding diaries and questionnaires, attend visits, and comply with the study protocol Willing and able to provide signed and dated informed consent Exclusion Criteria: Have received anticholinergics/antimuscarinics or beta 3-agonists medications to treat OAB or advanced therapy treatment options for OAB (botulinum toxin injections, sacral neuromodulation, or percutaneous tibial nerve stimulation/neuromodulation) Primary stress incontinence or mixed incontinence where the stress component overrides the urge component Have implantable pacemakers or implantable defibrillators Use of transcutaneous electrical nerve stimulation (TENS) in pelvic region, back or legs Women who are pregnant or planning to become pregnant during the course of the study Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol Nerve damage that could impact either tibial nerve or pelvic floor function. Subjects prone to excessive bleeding Inadequate skin integrity in the area of PTNM needle placement History of diabetes unless the diabetes is well-controlled through diet and/or medications Have symptomatic urinary tract infection (UTI) Participation in any research study involving or impacting gynecologic, urinary or renal function within the 4-week period prior to or plans to participate during study enrollment
Facility Information:
Facility Name
Pinellas Urology, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710-1925
Country
United States
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Mount Auburn Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Facility Name
Advanced Urogynecology of Michigan, P.C.
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123
Country
United States
Facility Name
Metro Urology
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Urology Center Research Institute, LLC
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
NYU Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Alliance Urology Specialists
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Hospital of University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
SSM Health Dean Medical Group
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB

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