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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of Minnesota | OTHER |
| University of Michigan | OTHER |
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The investigators goal is to create a better understanding of patient reported outcomes for bladder management strategies (clean intermittent catheterization (CIC), indwelling catheter (IDC) and bladder surgery.
Our study is a longitudinal observational study between bladder management strategies, comparing outcomes measured by patient reported questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clean Intermittent Catheterization | Participants performing intermittent catheterization of their bladder, having not had augmentation cystoplasty or creation of a catheterizable channel |
| |
| Indwelling Catheter | Participants utilizing an Foley catheter or a suprapubic tube (cystostomy) |
| |
| Surgery | Undergoing any of the following surgeries: augmentation cystoplasty with or without a catheterizable channel, creation of catheterizable channel alone, urinary diversion (conduit or continent catheterizable pouch) |
| |
| Voiding | Participants with volitional control, voiding into diapers or a condom catheter via crede, valsalva, or spontaneous leakage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clean Intermittent Catheterization | Other | Clean intermittent self catheterization is a standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurogenic Bladder Symptom Score (NBSS): comparing change in: CIC, IDC, Voiding, and Surgery | The NBSS quantifies bladder symptoms | Baseline and 1 year longitudinal follow up |
| The Spinal Cord Injury Quality of Life Measurement System Bladder Management Difficulties (SCI-QOL Difficulties): comparing change in: CIC, IDC, Voiding, and Surgery | The SCI-QoL Difficulties assesses feelings and psychosocial impact of bladder symptoms | Baseline and 1 year longitudinal follow up |
| The Spinal Cord Injury Quality of Life Measurement System Bladder Complications (SCI-QOL Complications): comparing change in: CIC, IDC, Voiding, and Surgery | The SCI-QoL Complications assesses degree of bladder complications their psychosocial impact | Baseline and 1 year longitudinal follow up |
| Measure | Description | Time Frame |
|---|---|---|
| NBSS Incontinence subdomain | The Incontinence subdomain measures degree of incontinence | Baseline and 1 year longitudinal follow up |
| NBSS Storage and Voiding subdomain | The Storage and Voiding subdomain measures symptoms related to frequency and emptying of the bladder |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with neurogenic bladder with urinary issues and currently being managed by one/ any of various bladder management treatments (clean intermittent catheterization, indwelling catheter, voiding or bladder surgery).
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy O Myers, MD | University of Utah School of Medicine - Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| University of Minnesota |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29017505 | Result | Patel DP, Lenherr SM, Stoffel JT, Elliott SP, Welk B, Presson AP, Jha A, Rosenbluth J, Myers JB; Neurogenic Bladder Research Group. Study protocol: patient reported outcomes for bladder management strategies in spinal cord injury. BMC Urol. 2017 Oct 10;17(1):95. doi: 10.1186/s12894-017-0286-3. | |
| 33035138 | Derived |
| Label | URL |
|---|---|
| Neurogenic Bladder Research Group | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2017 | May 13, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 16, 2017 | May 13, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D057928 | Intermittent Urethral Catheterization |
| D002408 | Catheters, Indwelling |
| D013514 | Surgical Procedures, Operative |
| D014554 | Urination |
| ID | Term |
|---|---|
| D014546 | Urinary Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Indwelling Catheter | Other | Indwelling catheterization is a standard of care. |
|
| Surgery | Other | Bladder surgery is a standard of care. |
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| Voiding | Other | Voiding spontaneously is a standard of care. |
|
| Baseline and 1 year longitudinal follow up |
| NBSS Consequences subdomain | The Consequences subdomain measures bladder related complications | Baseline and 1 year longitudinal follow up |
| NBSS QoL Satisfaction | The final question of the NBSS assesses overall satisfaction with the urinary system | Baseline and 1 year longitudinal follow up |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Crescenze IM, Lenherr SM, Myers JB, Elliott SP, Welk B, O'Dell D, Stoffel JT. Self-Reported Urological Hospitalizations or Emergency Room Visits in a Contemporary Spinal Cord Injury Cohort. J Urol. 2021 Feb;205(2):477-482. doi: 10.1097/JU.0000000000001386. Epub 2020 Oct 9. |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D057785 |
| Catheters |
| D004864 | Equipment and Supplies |
| D014553 | Urinary Tract Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |