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| ID | Type | Description | Link |
|---|---|---|---|
| 90IFRE0002 | Other Grant/Funding Number | NIDRR/ACL/HHS |
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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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A non-randomized study evaluating the efficacy of intravesical gentamicin on the occurrence rate of urinary tract infections and bladder complications in patients after spinal cord injury (SCI), and to assess its effectiveness in promoting overall quality of life (QOL), community living, and participation.
Intervention: Participants' number of UTIs during the six-month treatment period will be compared to the number they incurred during the six months prior to treatment. Participants complete a baseline visit which consists of medical history, informed consent, urinalysis/culture indicating no active UTIs, metabolic panel, and self-reported measures about complications, symptoms, community participation and quality of life. Similar information is collected at the end of treatment. At a 3-month follow up visit, all available data is obtained through phone interviews and/or medical chart reviews except for self-report measures. Participants begin active treatment using Gentamicin plus saline solution after they have completed all requirements. Instillations of treatment solution occur nightly after the participant's last evening catheterization. Bi-weekly calls are conducted to ensure compliance, answer questions and document adverse events. Participants will stop the trial if they develop an UTI. After receiving treatment for the UTI by their physician, they will go into a washout period of a week before resuming the trial with Gentamicin instillations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gentamicin sulfate | Experimental | Participants initiate Gentamicin instillations every night for a treatment period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment for this UTI, they resume the Gentamicin instillations. After baseline screening and being consented, they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug from syringes are to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentamicin Sulfate | Drug | Gentamicin is compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Pharmacy mails participants treatment drug. Once received, participants will do daily instillations of 30 milliliters of solution after catheterizing their bladder at night. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Urinary Tract Infections (UTI) Over Time | Number of reported urinary tract infections (UTI) by participants and documented in medical chart, per person across months pre and post treatment. The number of UTIs over time was determined by establishing a per person-month rate made up of the total number of UTIs pre and during treatment (numerator) for the sample divided by the total number of persons/ 6 months (11 participants over 6 months period = 66) as the denominator. The unit of measure is defined as pre and during treatment number of UTI events per person months. These appear below under outcome measure data table. | 6 months prior to treatment and 6 months during treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score of Neurogenic Bladder Symptom Severity (NBSS) Scale | Self-reported bladder symptoms on a scale from 0 (no symptoms) to 74 (maximum symptoms). The NBSS is a patient reported 22 item scale designed to assess symptoms and bladder related consequences among persons with neurogenic bladder dysfunction. NBSS scores are calculated across three domains with higher scores being worse and reflecting more symptoms or complications. Incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23). An additional question of happiness (points) was not used for this outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise G Tate, PhD | University of Michigan | Principal Investigator |
| Anne Pelletier-Cameron, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health System | Ann Arbor | Michigan | 48103 | United States |
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Of 23 eligible persons who consented, only 19 started on treatment due to several reasons including changes in necessary study procedures associated with the COVID outbreak, changes in medical status due to complications and personal decisions to proceed with treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gentamicin Sulfate | Participants initiate Gentamicin instillations every night for a period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment for the UTI and a one week washout period, they can resume their Gentamicin instillations. After screening, being consented and completing baseline interview, participants are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug in the syringe is to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed. Gentamicin Sulfate: Gentamicin is compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Baseline data is provided for all participants who started treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Gentamicin Sulfate | Participants initiate Gentamicin instillations every night for a period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment they can continue with the Gentamicin instillations. After baseline and consented they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug is to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed. Gentamicin Sulfate: Gentamicin will be compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Urinary Tract Infections (UTI) Over Time | Number of reported urinary tract infections (UTI) by participants and documented in medical chart, per person across months pre and post treatment. The number of UTIs over time was determined by establishing a per person-month rate made up of the total number of UTIs pre and during treatment (numerator) for the sample divided by the total number of persons/ 6 months (11 participants over 6 months period = 66) as the denominator. The unit of measure is defined as pre and during treatment number of UTI events per person months. These appear below under outcome measure data table. | Eleven participants with spinal cord injury or disease and neurogenic bladder with recurrent urinary track infections (2 or more) during the 6 months prior to treatment. | Posted | Number | 95% Confidence Interval | UTI events per person months. | 6 months prior to treatment and 6 months during treatment |
|
AE data was gathered for 30 days after 6 months of treatment, a total of approximately 7 months.
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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 | Gentamicin Sulfate | Participants initiate Gentamicin instillations every night for a period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment they can continue with the Gentamicin instillations. After baseline and consented they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug is to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed. Gentamicin Sulfate: Gentamicin will be compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal stone removal | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinically significant labs | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Denise Tate | University of Michigan | (734) 647-5195 | dgtate@umich.edu |
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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 | Mar 9, 2023 | Feb 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2023 | Apr 16, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D013119 | Spinal Cord Injuries |
| D013118 | Spinal Cord Diseases |
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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For each participant, six month pre-treatment data is compared to data collected during treatment (count of UTIs) and immediately after treatment (self-reported measures).
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|
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| Baseline to 6 months |
| Change in Score of Neurogenic Bowel Dysfunction (NBD) | Self-reported bowel symptoms on a scale from 0 (very minor) to 14+ (severe). The NBD is a 10 item validated measure that assesses frequency of defecation and methods of bowel management and complications. Thus negative numbers in "score change" represent decrease in symptom severity. | Baseline to 6 months |
| Withdrawal by Subject |
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| Lost to Follow-up |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Type of spinal lesions | Count of Participants | Participants |
|
Participants initiate Gentamicin instillations every night for a period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment they can continue with the Gentamicin instillations. After baseline and consented they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug is to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed. Gentamicin Sulfate: Gentamicin will be compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution |
|
|
|
| Secondary | Change in Score of Neurogenic Bladder Symptom Severity (NBSS) Scale | Self-reported bladder symptoms on a scale from 0 (no symptoms) to 74 (maximum symptoms). The NBSS is a patient reported 22 item scale designed to assess symptoms and bladder related consequences among persons with neurogenic bladder dysfunction. NBSS scores are calculated across three domains with higher scores being worse and reflecting more symptoms or complications. Incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23). An additional question of happiness (points) was not used for this outcome. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 months |
|
|
|
|
| Secondary | Change in Score of Neurogenic Bowel Dysfunction (NBD) | Self-reported bowel symptoms on a scale from 0 (very minor) to 14+ (severe). The NBD is a 10 item validated measure that assesses frequency of defecation and methods of bowel management and complications. Thus negative numbers in "score change" represent decrease in symptom severity. | 11 participants with spinal cord injury or disease (SCI/D) with neurogenic bladder and recurrent UTIs during 6 months prior to treatment. They completed the NBD survey. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 6 months |
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|
|
|
| 0 |
| 19 |
| 4 |
| 19 |
| 17 |
| 19 |
| Gross hematuria | Renal and urinary disorders | Systematic Assessment |
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| Post-COVID 19 pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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| Serratia tissue infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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| bladder spasms | Renal and urinary disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| nasal discharge | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| urinary discharge | Renal and urinary disorders | Systematic Assessment |
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| abdominal stoma issue | Infections and infestations | Systematic Assessment |
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| bladder irritation | Renal and urinary disorders | Systematic Assessment |
|
| sweating | General disorders | Systematic Assessment |
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| heel wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| air in bladder | Renal and urinary disorders | Systematic Assessment |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| bleeding from catheter site | Renal and urinary disorders | Systematic Assessment |
|
| muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
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| pneumonia | Infections and infestations | Systematic Assessment |
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| flu-like symptoms | Infections and infestations | Systematic Assessment |
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| bone infection | Infections and infestations | Systematic Assessment |
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| hematuria | Renal and urinary disorders | Systematic Assessment |
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| bladder stone | Renal and urinary disorders | Systematic Assessment |
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| cystolitholapaxy | Renal and urinary disorders | Systematic Assessment |
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| GI upset | Gastrointestinal disorders | Systematic Assessment |
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| loose stool | Gastrointestinal disorders | Systematic Assessment |
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| conjunctivitis | Infections and infestations | Systematic Assessment |
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| parotitis | Infections and infestations | Systematic Assessment |
|
| vaginitis | Infections and infestations | Systematic Assessment |
|
| inguinal pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D001745 | Urinary Bladder Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| NBSS Domain score for storage and voiding; pre-post comparison. Due to small sample size (n=11) no power calculations were conducted. | t-test, 2 sided | <0.39 | a priori threshold p<0.05 | Mean Difference (Final Values) | -1.1 | Standard Deviation | 4.09 | 2-Sided | 95 | -3.8 | 1.7 | (higher numbers represent more symptoms or complications) | Superiority |
| Pre and post test comparisons of mean NBSS scores for the consequences domain. Power calculations were not conducted due to small sample size. | t-test, 2 sided | <0.14 | Mean Difference (Final Values) | -1.9 | Standard Deviation | 3.99 | 2-Sided | 95 | -4.6 | 0.8 | Higher numbers represent more symptoms or complications referred as consequences. | Superiority |