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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NURO System PTNM Therapy | Other | Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NURO System PTNM Therapy | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinellas Urology, Inc. | St. Petersburg | Florida | 33710-1925 | United States | ||
| NorthShore University Health System |
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Out of 154 enrolled subjects, 120 were qualified and 121 subjects received PTNM therapy, with 1 not meeting eligibility criteria.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | NURO System PTNM Therapy | Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system to receive PTNM Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2016 | Oct 18, 2018 |
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| 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. | 12 Weeks |
| Evanston |
| Illinois |
| 60201 |
| United States |
| Mount Auburn Hospital | Cambridge | Massachusetts | 02138 | United States |
| Advanced Urogynecology of Michigan, P.C. | Dearborn | Michigan | 48123 | United States |
| Metro Urology | Woodbury | Minnesota | 55125 | United States |
| Urology Center Research Institute, LLC | Englewood | New Jersey | 07631 | United States |
| NYU Urology Associates | New York | New York | 10016 | United States |
| Alliance Urology Specialists | Greensboro | North Carolina | 27403 | United States |
| Hospital of University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| SSM Health Dean Medical Group | Madison | Wisconsin | 53715 | United States |
| Subjects Qualified and Treated With PTNM | This includes those subjects that met eligibility criteria and received PTNM therapy in the study. |
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| COMPLETED |
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| NOT COMPLETED |
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One hundred twenty subjects were qualified for study participation and received PTNM therapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | NURO System PTNM Therapy | Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system. NURO System PTNM Therapy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Years since OAB diagnosis | Mean | Standard Deviation | years |
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| Baseline UUI episodes/day | One subject did not have evaluable diary data at baseline. | Mean | Standard Deviation | episodes |
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| Baseline voids/day | 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. | Mean | Standard Deviation | episodes |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Subjects with diary data from both baseline and the 12th PTNM therapy session | Posted | Mean | Standard Deviation | UUI episodes per day | 12 Weeks |
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| 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. | 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. | Posted | Mean | Standard Deviation | Number of voids per day | 12 Weeks |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NURO System PTNM Therapy | 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. | 0 | 121 | 3 | 121 | 8 | 121 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea infectious | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical device site pain | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
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Study had a single arm with all subjects treated with PTNM Therapy.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Michaud / Sr. Principal Clinical Research Specialist | Medtronic Pelvic Health & Gastric Therapies | 763.526.8102 | beth.m.michaud@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2017 | Oct 18, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Participants |
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