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| ID | Type | Description | Link |
|---|---|---|---|
| 12297 | Other Identifier | Kaiser Permanente Southern California IRB | |
| 191835 | Other Identifier | UC San Diego Health IRB |
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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. This prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in 50 mL of saline versus usual care on the proportion of women treated for UTI within 6 weeks following surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gentamicin Arm | Active Comparator | At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care. |
|
| Control Arm | Sham Comparator | If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gentamicin sulfate | Drug | Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Urinary Tract Infection | Number of participants in each arm treated with antibiotics for urinary tract infection symptoms | Within 6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Hospital readmissions | Within 6 weeks after surgery |
| Number of Participants With Isolated Uropathogen on Post-operative Urine Culture | Within 6 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
All subjects will be female because undergoing surgery for female pelvic organ prolapse and stress urinary incontinence is an inclusion criterion.
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly L Ferrante, M.D., M.A.S. | Kaiser Permanente | Principal Investigator |
| Marianna Alperin, M.D., M.S. | UC San Diego Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Health | La Jolla | California | 92037 | United States | ||
| Kaiser Permanente San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36409639 | Derived | Rieger MM, Shah NM, Ferrante KL, Tan-Kim J, Jacobs MB, Brubaker L, Alperin M. Intraoperative Gentamicin Intravesical Instillation for Prevention of Urinary Tract Infection After Urogynecologic Surgery: A Randomized Controlled Trial. Urogynecology (Phila). 2022 Dec 1;28(12):825-833. doi: 10.1097/SPV.0000000000001233. Epub 2022 Aug 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gentamicin Arm | At completion of surgery but prior to awakening from anesthesia, after ensuring the bladder is fully drained, 80mg of gentamicin in 50 mL of normal saline will be infused by the surgeon into the participants's bladder through the standard-care transurethral catheter. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The participant will then proceed as usual to the postoperative anesthesia care unit. The recovery room nurse will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care. gentamicin sulfate: Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter. |
| FG001 | Control Arm | At the end of the surgery but prior to awakening from anesthesia, after ensuring the bladder is fully drained, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for participants receiving usual care will be to ensure participants are masked to study arm assignment if they wake up and notice their catheter. The participant will then proceed as usual to the postoperative anesthesia care unit. The recovery room nurse will unclamp the catheter after 1 hour. The participant will otherwise have usual pre-operative and post-operative care. Catheter clamping only: Participants in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain participant masking to study arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gentamicin Arm | At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care. gentamicin sulfate: Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter. |
| 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 | Post-operative Urinary Tract Infection | Number of participants in each arm treated with antibiotics for urinary tract infection symptoms | Posted | Count of Participants | Participants | Within 6 weeks after surgery |
|
6 weeks after surgery
Hospital readmission within 6 weeks after surgery as reported by patient or found in electronic medical record
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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 Arm | At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care. gentamicin sulfate: Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Rieger, MD, MAS | Dell Medical School at The University of Texas at Austin | 512-324-7036 | mary.rieger@austin.utexas.edu |
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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 | Jun 9, 2020 | Sep 18, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
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| ID | Term |
|---|---|
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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The subject will be masked as to whether she has been assigned to the gentamicin arm or the control arm. The subject will be unmasked at the completion of the 6 week follow up period.
|
| Catheter clamping only | Other | Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm. |
|
| San Diego |
| California |
| 92123 |
| United States |
| BG001 | Control Arm | If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care. Catheter clamping only: Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | As entered into electronic medical cord | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Study site | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Parity | Median | Full Range | births |
|
| American Society of Anesthesiologists (ASA) Physical Status Classification | ASA 1 - A normal healthy patient, ASA 2 - A patient with mild systemic disease, ASA 3 - A patient with severe systemic disease, ASA 4 - A patient with severe systemic disease that is a constant threat to life, ASA 5 - A moribund patient who is not expected to survive without the operation, ASA 6 - A declared brain-dead patient whose organs are being removed for donor purposes | Median | Full Range | units on a scale |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Current smoker | Count of Participants | Participants |
|
| Postmenopausal | Count of Participants | Participants |
|
| Current vaginal estrogen use | Count of Participants | Participants |
|
| Current menopausal hormone therapy use | Count of Participants | Participants |
|
| Number of culture positive UTIs in 12 months prior to surgery | Number | participants |
|
| Positive urine culture within 4 weeks before surgery | Count of Participants | Participants |
|
| OG001 | Control Arm | If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care. Catheter clamping only: Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm. |
|
|
| Secondary | Adverse Events | Hospital readmissions | Posted | Count of Participants | Participants | Within 6 weeks after surgery |
|
|
|
| Secondary | Number of Participants With Isolated Uropathogen on Post-operative Urine Culture | Posted | Count of Participants | Participants | Within 6 weeks after surgery |
|
|
|
| 0 |
| 183 |
| 5 |
| 183 |
| 0 |
| 183 |
| EG001 | Control Arm | If the patient is randomized to no instillation, at the end of the surgery but prior to awakening from anesthesia, the surgeon will clamp the catheter and label the catheter with the clamping time. The purpose of clamping the catheter for subjects receiving usual care will be to ensure patients are masked to study arm assignment if they wake up and notice their catheter. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care. Catheter clamping only: Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm. | 0 | 180 | 6 | 180 | 0 | 180 |
| Reoperation for hematoma | Surgical and medical procedures | Systematic Assessment |
|
| Pelvic abscess | Infections and infestations | Systematic Assessment |
|
| Ischemic stroke | Nervous system disorders | Systematic Assessment |
|
| Diabetic Ketoacidosis | Endocrine disorders | Systematic Assessment |
|
| Uncontrolled postoperative pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Acute cholecystitis | Gastrointestinal disorders | Systematic Assessment |
|
| Admitted for planned breast surgery | Surgical and medical procedures | Systematic Assessment |
|
| Reoperation for sling division | Renal and urinary disorders | Systematic Assessment |
|
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
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| D014555 | Urination Disorders |
| 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 |