Overactive Bladder
Conditions
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.
Interventions
DEVICENURO System PTNM Therapy
Sponsors
MedtronicNeuro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Voids Per Day After the 12th PTNM Therapy Sessions From Baseline in UF Subjects | 12 Weeks | 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 | 12 Weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Out of 154 enrolled subjects, 120 were qualified and 121 subjects received PTNM therapy, with 1 not meeting eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| NURO System PTNM Therapy Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system.
NURO System PTNM Therapy | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Screen Failure | 33 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | NURO System PTNM Therapy |
|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 11.6 |
| Baseline UUI episodes/day | 3.5 episodes STANDARD_DEVIATION 2.5 |
| Baseline voids/day | 11.5 episodes STANDARD_DEVIATION 2.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 110 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Region of Enrollment United States | 120 participants |
| Sex: Female, Male Female | 103 Participants |
| Sex: Female, Male Male | 17 Participants |
| Years since OAB diagnosis | 3.4 years STANDARD_DEVIATION 5.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 121 |
| other Total, other adverse events | 8 / 121 |
| serious Total, serious adverse events | 3 / 121 |
Outcome results
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.
Time frame: 12 Weeks
Population: Subjects with diary data from both baseline and the 12th PTNM therapy session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 |
Comparison: This is a single arm study. The primary objective was to demonstrate a statistically significant reduction between baseline and following the 12th PTNM therapy sessions in the number of UUI episodes per day.p-value: <0.0001Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NURO System PTNM Therapy | 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 |
| NURO System PTNM Therapy | 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 |
| 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 |
| NURO System PTNM Therapy | 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 |
| NURO System PTNM Therapy | 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 |
| NURO System PTNM Therapy | 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 |