Trial Outcomes & Findings for PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB (NCT NCT02857816)

Last Updated: 2019-01-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

154 participants

Primary outcome timeframe

12 Weeks

Results posted on

2019-01-14

Participant Flow

One hundred fifty-four subjects were enrolled (consented) to participate in the trial from September 15, 2016 through August 14, 2017 from 12 US centers.

Out of 154 enrolled subjects, 120 were qualified and 121 subjects received PTNM therapy, with 1 not meeting eligibility criteria.

Participant milestones

Participant milestones
Measure	NURO System PTNM Therapy Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system to receive PTNM Therapy
Overall Study STARTED	154
Overall Study Subjects Qualified and Treated With PTNM	120
Overall Study COMPLETED	116
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Reasons for withdrawal
Measure	NURO System PTNM Therapy Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system to receive PTNM Therapy
Overall Study Screen Failure	33
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	1

Baseline Characteristics

One subject did not have evaluable diary data at baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NURO System PTNM Therapy n=120 Participants Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system. NURO System PTNM Therapy
Age, Continuous	64.8 years STANDARD_DEVIATION 11.6 • n=120 Participants
Sex: Female, Male Female	103 Participants n=120 Participants
Sex: Female, Male Male	17 Participants n=120 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=120 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	110 Participants n=120 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=120 Participants
Region of Enrollment United States	120 participants n=120 Participants
Years since OAB diagnosis	3.4 years STANDARD_DEVIATION 5.1 • n=120 Participants
Baseline UUI episodes/day	3.5 episodes STANDARD_DEVIATION 2.5 • n=119 Participants • One subject did not have evaluable diary data at baseline.
Baseline voids/day	11.5 episodes STANDARD_DEVIATION 2.9 • n=86 Participants • Baseline voids/day is only summarized on UF subjects (defined as at least 8 voids/day at baseline). This was not required for study eligibility.

PRIMARY outcome

Timeframe: 12 Weeks

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

Outcome measures

Outcome measures
Measure	NURO System PTNM Therapy n=116 Participants Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system. NURO System PTNM Therapy
Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline	-2.4 UUI episodes per day Standard Deviation 2.1

SECONDARY outcome

Timeframe: 12 Weeks

Population: This objective was assessed in qualified subjects with \> 8 voids per day at baseline, who had diary data at both baseline and following the 12th PTNM session.

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.

Outcome measures

Outcome measures
Measure	NURO System PTNM Therapy n=84 Participants Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system. NURO System PTNM Therapy
Change in Number of Voids Per Day After the 12th PTNM Therapy Sessions From Baseline in UF Subjects	-1.7 Number of voids per day Standard Deviation 2.5

SECONDARY outcome

Timeframe: 12 Weeks

Population: This objective was assessed in all qualified subjects who received PTNM therapy and had OABq questionnaire data available at both baseline and 12th PTNM session.

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.

Outcome measures

Outcome measures
Measure	NURO System PTNM Therapy n=116 Participants Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system. NURO System PTNM Therapy
Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline Sleep	30.5 score on a scale Standard Deviation 26.9
Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline Social	15.3 score on a scale Standard Deviation 21.8
Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline HRQL	30.7 score on a scale Standard Deviation 20.9
Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline Symptom Bother	-43.9 score on a scale Standard Deviation 22.5
Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline Concern	40 score on a scale Standard Deviation 25.8
Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline Coping	32.5 score on a scale Standard Deviation 23.9

Adverse Events

NURO System PTNM Therapy

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NURO System PTNM Therapy n=121 participants at risk Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system to receive PTNM Therapy. In the summary of serious AEs below, none of the serous AEs were found to be related to device, therapy or study procedure. The other events reported in this study were non-serious device related and/or therapy/procedure related.
Infections and infestations Diarrhoea infectious	0.83% 1/121 • Number of events 1 • Adverse events report collected starting from the time of enrollment until completion of the final study visit (approximately 16 weeks). The following adverse events were considered reportable in accordance with the Clinical Investigational Plan: serious, device related, and/or therapy/procedure related.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.83% 1/121 • Number of events 1 • Adverse events report collected starting from the time of enrollment until completion of the final study visit (approximately 16 weeks). The following adverse events were considered reportable in accordance with the Clinical Investigational Plan: serious, device related, and/or therapy/procedure related.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.83% 1/121 • Number of events 1 • Adverse events report collected starting from the time of enrollment until completion of the final study visit (approximately 16 weeks). The following adverse events were considered reportable in accordance with the Clinical Investigational Plan: serious, device related, and/or therapy/procedure related.

Other adverse events

Other adverse events
Measure	NURO System PTNM Therapy n=121 participants at risk Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system to receive PTNM Therapy. In the summary of serious AEs below, none of the serous AEs were found to be related to device, therapy or study procedure. The other events reported in this study were non-serious device related and/or therapy/procedure related.
General disorders Medical device site pain	3.3% 4/121 • Number of events 4 • Adverse events report collected starting from the time of enrollment until completion of the final study visit (approximately 16 weeks). The following adverse events were considered reportable in accordance with the Clinical Investigational Plan: serious, device related, and/or therapy/procedure related.
Musculoskeletal and connective tissue disorders Pain in extremity	3.3% 4/121 • Number of events 5 • Adverse events report collected starting from the time of enrollment until completion of the final study visit (approximately 16 weeks). The following adverse events were considered reportable in accordance with the Clinical Investigational Plan: serious, device related, and/or therapy/procedure related.

Additional Information

Beth Michaud / Sr. Principal Clinical Research Specialist

Medtronic Pelvic Health & Gastric Therapies

Phone: 763.526.8102

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place