An interventional study of NURO System PTNM Therapy in Overactive Bladder, sponsored by MedtronicNeuro. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-14.
Sponsored by MedtronicNeuro · Not applicable, Interventional, and Treatment
To evaluate the NURO system for the treatment of OAB in drug naïve patients.
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 154 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →MedtronicNeuro is the lead sponsor of 69 studies on the registry; 2 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system.
Device: NURO System PTNM Therapy
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
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
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
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.
| Milestone | NURO System PTNM Therapy |
|---|---|
| Started | 154 |
| Subjects qualified and treated with ptnm | 120 |
| Completed | 116 |
| Not completed | 38 |
| Withdrew: Screen failure | 33 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lost to follow-up | 1 |
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.
| UUI episodes per day | 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 ± 2.1 |
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.
| Number of voids per day | NURO System PTNM Therapy |
|---|---|
| Change in Number of Voids Per Day After the 12th PTNM Therapy Sessions From Baseline in UF Subjects | -1.7 ± 2.5 |
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.
| score on a scale | NURO System PTNM Therapy |
|---|---|
| Concern | 40 ± 25.8 |
| Coping | 32.5 ± 23.9 |
| Sleep | 30.5 ± 26.9 |
| Social | 15.3 ± 21.8 |
| HRQL | 30.7 ± 20.9 |
| Symptom Bother | -43.9 ± 22.5 |
Collected over Adverse events report collected starting from the time of enrollment until completion of the final study visit (approximately 16 weeks).. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NURO System PTNM Therapy | 0/121 (0%) | 3/121 (2.5%) | 8/121 (6.6%) |
| Event | NURO System PTNM Therapy |
|---|---|
| Diarrhoea infectiousInfections and infestations | 1/121 |
| Breast cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/121 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 1/121 |
| Event | NURO System PTNM Therapy |
|---|---|
| Medical device site painGeneral disorders | 4/121 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 4/121 |
One hundred twenty subjects were qualified for study participation and received PTNM therapy.
| Age, Continuous(years) | NURO System PTNM Therapy |
|---|---|
| Mean | 64.8 ± 11.6 |
| Sex: Female, Male(Participants) | NURO System PTNM Therapy |
|---|---|
| Female | 103 |
| Male | 17 |
| Ethnicity (NIH/OMB)(Participants) | NURO System PTNM Therapy |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 110 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | NURO System PTNM Therapy |
|---|---|
| United States | 120 |
| Years since OAB diagnosis(years) | NURO System PTNM Therapy |
|---|---|
| Mean | 3.4 ± 5.1 |
| Baseline UUI episodes/day(episodes) | NURO System PTNM Therapy |
|---|---|
| Mean | 3.5 ± 2.5 |
| Baseline voids/day(episodes) | NURO System PTNM Therapy |
|---|---|
| Mean | 11.5 ± 2.9 |
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