Postoperative Urinary Tract Infection, Pelvic Organ Prolapse, Stress Urinary Incontinence
Conditions
Keywords
gentamicin sulfate, pelvic organ prolapse surgery, midurethral sling, bladder instillation
Brief summary
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).
Interventions
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.
OTHERCatheter 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.
Sponsors
University of California, San Diego
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women undergoing pelvic organ prolapse surgery and/or stress urinary incontinence surgery with surgical plan for at least 1 cystoscopy and will leave the operating room with a standard-of-care transurethral catheter. * Negative urine culture within 4 weeks or completion of UTI treatment ≥48 hours prior to surgery
Exclusion criteria
* History of allergic reaction or anaphylaxis to gentamicin sulfate or to sodium metabisulfite (one of the preservatives in the gentamicin sulfate product) * Abnormal intraoperative urinary tract finding (e.g. bladder mass, stone, or fistula) * Intraoperative urinary tract injury * Suppressive recurrent UTI treatment * Chronic indwelling catheter/self-catheterization * Unable to provide informed consent * Severe renal impairment - glomerular filtration rate of less than 30 mL / minute * Current pregnancy * Currently incarcerated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Urinary Tract Infection | Within 6 weeks after surgery | Number of participants in each arm treated with antibiotics for urinary tract infection symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Within 6 weeks after surgery | Hospital readmissions |
| Number of Participants With Isolated Uropathogen on Post-operative Urine Culture | Within 6 weeks after surgery | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 183 |
| 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. | 180 |
| Total | 363 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet eligibility criteria | 1 | 4 |
| Overall Study | Physician Decision | 1 | 1 |
Baseline characteristics
| Characteristic | Gentamicin Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 12 | 58.7 years STANDARD_DEVIATION 12.8 | 58.6 years STANDARD_DEVIATION 12.4 |
| American Society of Anesthesiologists (ASA) Physical Status Classification | 2 units on a scale | 2 units on a scale | 2 units on a scale |
| Body mass index | 28.5 kg/m^2 STANDARD_DEVIATION 5.6 | 28.2 kg/m^2 STANDARD_DEVIATION 5.1 | 28.2 kg/m^2 STANDARD_DEVIATION 5.1 |
| Current menopausal hormone therapy use | 10 Participants | 9 Participants | 19 Participants |
| Current smoker | 9 Participants | 12 Participants | 21 Participants |
| Current vaginal estrogen use | 79 Participants | 76 Participants | 155 Participants |
| Diabetes mellitus | 24 Participants | 25 Participants | 49 Participants |
| Number of culture positive UTIs in 12 months prior to surgery 0 UTIs | 155 participants | 156 participants | 311 participants |
| Number of culture positive UTIs in 12 months prior to surgery 1 UTI | 20 participants | 20 participants | 40 participants |
| Number of culture positive UTIs in 12 months prior to surgery 2 UTIs | 6 participants | 3 participants | 9 participants |
| Number of culture positive UTIs in 12 months prior to surgery 3 UTIs | 2 participants | 1 participants | 3 participants |
| Parity | 2 births | 2 births | 2 births |
| Positive urine culture within 4 weeks before surgery | 6 Participants | 4 Participants | 10 Participants |
| Postmenopausal No | 47 Participants | 48 Participants | 95 Participants |
| Postmenopausal Unknown | 14 Participants | 16 Participants | 30 Participants |
| Postmenopausal Yes | 122 Participants | 116 Participants | 238 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Black | 5 Participants | 6 Participants | 11 Participants |
| Race/Ethnicity, Customized Hispanic | 70 Participants | 61 Participants | 131 Participants |
| Race/Ethnicity, Customized Not specified | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 8 Participants | 12 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 97 Participants | 99 Participants | 196 Participants |
| Region of Enrollment United States | 183 participants | 180 participants | 363 participants |
| Sex: Female, Male Female | 183 Participants | 180 Participants | 363 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Study site Kaiser Permanente San Diego | 61 Participants | 57 Participants | 118 Participants |
| Study site University of California San Diego | 122 Participants | 123 Participants | 245 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 183 | 0 / 180 |
| other Total, other adverse events | 0 / 183 | 0 / 180 |
| serious Total, serious adverse events | 5 / 183 | 6 / 180 |
Outcome results
Primary
Post-operative Urinary Tract Infection
Number of participants in each arm treated with antibiotics for urinary tract infection symptoms
Time frame: Within 6 weeks after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gentamicin Arm | Post-operative Urinary Tract Infection | 19 Participants |
| Control Arm | Post-operative Urinary Tract Infection | 20 Participants |
Secondary
Adverse Events
Hospital readmissions
Time frame: Within 6 weeks after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gentamicin Arm | Adverse Events | 5 Participants |
| Control Arm | Adverse Events | 6 Participants |
Secondary
Number of Participants With Isolated Uropathogen on Post-operative Urine Culture
Time frame: Within 6 weeks after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gentamicin Arm | Number of Participants With Isolated Uropathogen on Post-operative Urine Culture | 12 Participants |
| Control Arm | Number of Participants With Isolated Uropathogen on Post-operative Urine Culture | 15 Participants |