The primary aim of this study is to assess the utility of prophylactic oral antibiotics at time of Bulkamid transurethral bulking to reduce the incidence of urinary tract infection (UTI) in the immediate postoperative period. The secondary aims of the study include assessing UTI rates and success rates if patients require temporary indwelling catheter versus intermittent self-catheterization (ISC).
Specific Aim 1: To determine if receiving prophylactic oral antibiotics at time of urethral bulking reduces the risk of post-operative urinary tract infection (UTI). Patients will be randomized and blinded into two arms: oral antibiotic versus placebo. Patients will receive either the placebo pill or oral antibiotic in the pre-operative holding area prior to their procedure. Oral antibiotics will include trimethoprim/sulfamethoxazole (Bactrim, first line) or nitrofurantoin (Macrobid, second line), determined by patient allergies. Specific Aim 2: To assess if factors such as patient discharge with ISC/indwelling foley or number of Bulkamid injection sites is correlated to improvement in Stress urinary incontinence (SUI) at 6 weeks postoperatively and at one year postoperatively. Patients will complete a brief survey preoperative, at 6 weeks postoperatively after their procedure, and at 1 year postoperatively after their procedure. The survey will consist of prior validated urogynecologic surveys including the Pelvic Floor Disability Index/Urinary Distress Inventory (PFDI/UDI- 6) and the MESA questionnaires as well as an extended VAS scale to evaluate global improvement. Specific Aim 3: To discern if any patient characteristics are associated with higher patient satisfaction following the procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
Participants will be assigned to Bactrim or Macrobid depending on participants' allergies
Participants will be assigned to identical appearing placebo
The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery
Columbus, Ohio, United States
RECRUITINGRisk of post operative urinary tract infections (UTI)
Intervention (pre-operative oral antibiotics) and placebo groups will be compared for the risk of post-operative UTIs following urethral bulking procedures performed in the operating room. Patients who have symptoms, concerning for UTI during the immediate 6 week postoperative period will be asked to give a urine sample for culture. UTIs which are culture proven and symptomatic will be treated per individual provider preference. Positive urine cultures will be defined as cultures with greater than 50,000 CFU for voided specimens and greater than 5,000 CFU for catheter specimens. If a patient's urine culture is positive for mixed flora and cannot be speciated further by our microbiology laboratory, they will be asked to present for a straight catheter specimen in the office for definitive diagnosis; this is an established protocol which is already standard in our practice. All positive cultures during this time period will be recorded.
Time frame: 6 weeks after the procedure
Drug Use and Side Effects
Assessing if factors such as patient discharge with Intermittent self-catheterization (ISC)/indwelling foley or number of Bulkamid injection sites is correlated to improvement in SUI at 6 weeks and 1 year postoperatively.
Time frame: 6 weeks and 1 year after the procedure, up to 1 year
Effects on higher patient satisfaction
If any patient characteristics are associated with higher patient satisfaction following the procedure. Following the procedure, patients will be asked to complete a survey compromising of the Pelvic Floor Disability Index/Urinary Distress Inventory - Short Form (PFDI/UDI-6), the MESA questionnaire and an extended Visual Analogue Scale (VAS; scale of 0 or extremely unsatisfied to 100 or extremely satisfied). Patients will be given a paper copy of the survey at their 6 week post-operative appointment as well as an online link to complete the survey. This same survey will then be administered again approximately 1 year after the patient's procedure.
Time frame: 6 weeks and 1 year after the procedure, up to 1 year
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