Overactive BladderRESETNCT02857816

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

A study testing NURO System PTNM Therapy in people with Overactive Bladder, run by MedtronicNeuro at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the NURO system for the treatment of OAB in drug naïve patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder
What is being tested?: NURO System PTNM Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 11 sitesUnited States
Study dates: Sep 2016to 21 Nov 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Mount Auburn Hospital
Cambridge, Massachusetts, 02138
Advanced Urogynecology of Michigan, P.C.
Dearborn, Michigan, 48123
Urology Center Research Institute, LLC
Englewood, New Jersey, 07631
NorthShore University Health System
Evanston, Illinois, 60201
Alliance Urology Specialists
Greensboro, North Carolina, 27403
SSM Health Dean Medical Group
Madison, Wisconsin, 53715
NYU Urology Associates
New York, New York, 10016
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Virginia Mason Medical Center
Seattle, Washington, 98101
Pinellas Urology, Inc.
St. Petersburg, Florida, 33710-1925
Metro Urology
Woodbury, Minnesota, 55125

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Overactive Bladder
Being tested: NURO System PTNM Therapy
Medical subject headings: Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NURO System PTNM TherapyDevice

Study groups in NCT02857816
Study group	Role	What they receive
NURO System PTNM Therapy	Other	Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system. Receives: Device: NURO System PTNM Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 Weeks

Secondary outcomes (2)

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.
Measured: 12 Weeks
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.
Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201621 Nov 2017

First posted5 Aug 2016 (estimated)
Study startSep 2016
Primary completion21 Nov 2017
Study completion21 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Overactive BladderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02857816
Sponsor's protocol ID: 1679
Acronym: RESET
Status last verified: Dec 2018
First submitted: 3 Aug 2016
Last updated: 14 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation (PTNM) System in Patients With OAB
ClinicalTrials.gov ID: NCT02857816
Acronym / sponsor ID: RESET / 1679
Conditions: Overactive Bladder
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: Sep 2016
Primary completion: 21 Nov 2017 (actual)
Study completion: 21 Nov 2017 (actual)
First posted: 5 Aug 2016 (estimated)
Results: Posted 12 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NURO System PTNM Therapy	Other	Device: NURO System PTNM TherapySubjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NURO System PTNM Therapy	Device	NURO System PTNM Therapy

Primary outcome

Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline
Time frame: 12 Weeks
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.

2 secondary outcomes

Change in Number of Voids Per Day After the 12th PTNM Therapy Sessions From Baseline in UF Subjects
Time frame: 12 Weeks
Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline
Time frame: 12 Weeks

Results and safety

Results posted to the registry on 12 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NURO System PTNM Therapy	154	116

Primary outcome: Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline

Time frame: 12 Weeks. Mean (Standard Deviation). Unit: UUI episodes per day

Measure	NURO System PTNM Therapy n = 116
Value	-2.4 (2.1)

NURO System PTNM Therapy: p <0.0001, Wilcoxon (Mann-Whitney)

Population analysed: Subjects with diary data from both baseline and the 12th PTNM therapy session

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events report collected starting from the time of enrollment until completion of the final study visit (approximately 16 weeks).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NURO System PTNM Therapy	3 of 121 (2.5%)	8 of 121 (6.6%)	0 of 121

Limitations and caveats (from the sponsor): Study had a single arm with all subjects treated with PTNM Therapy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Overactive Bladder

RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
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Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
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Parasacral TENS Project
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Active, not recruiting
INTIBIA Pivotal Study
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Recruiting
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NURO System PTNM Therapy in people with Overactive Bladder, run by MedtronicNeuro at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02857816.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.