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

Overactive Bladder Clinical Trial

— RESET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857816
• Other study ID #: 1679
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: November 21, 2017

Study information

• Verified date: December 2018
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the NURO system for the treatment of OAB in drug naïve patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: November 21, 2017
• Est. primary completion date: November 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• NURO System PTNM Therapy

Locations

Country	Name	City	State
United States	Mount Auburn Hospital	Cambridge	Massachusetts
United States	Advanced Urogynecology of Michigan, P.C.	Dearborn	Michigan
United States	Urology Center Research Institute, LLC	Englewood	New Jersey
United States	NorthShore University Health System	Evanston	Illinois
United States	Alliance Urology Specialists	Greensboro	North Carolina
United States	SSM Health Dean Medical Group	Madison	Wisconsin
United States	NYU Urology Associates	New York	New York
United States	Hospital of University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pinellas Urology, Inc.	Saint Petersburg	Florida
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Metro Urology	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 Weeks
Secondary	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.	12 Weeks
Secondary	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.	12 Weeks