Stress Urinary Incontinence
Conditions
Keywords
Bulkamid, Urinary tract infections, Bactrim, Macrobid, Urethral bulking
Brief summary
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).
Detailed description
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.
Interventions
DRUGBactrim or Macrobid
Participants will be assigned to Bactrim or Macrobid depending on participants' allergies
DRUGPlacebo
Participants will be assigned to identical appearing placebo
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Neither participants, providers, investigators or outcome assessors will know to which of these groups participants are assigned. In case of an emergency, however, the study doctor can get this information.
Intervention model description
a double-blinded randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at The Ohio State University with plans to undergo urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant). * Negative testing for UTI in pre-operative work-up (including either negative urine culture or urine dip negative for infection). * Office evaluation with evidence of SUI either with urodynamic studies (UDS) or positive cough stress test (CST). * Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan)
Exclusion criteria
* Contraindications to both oral antibiotics including antibiotic allergies or significant renal disease * Patient undergoing additional pelvic organ prolapse procedures or other urologic procedures concomitantly * Recurrent UTIs, defined as 3 or more UTIs within the past 12 months or 2 UTIs within the past 6 months * Patients currently taking daily antibiotic prophylaxis for any reason * Non-English speaking patients * Pregnant patients * Pelvic organ prolapse stage greater than 2 * Patients with immunosuppression due to underlying medical conditions * Recent antibiotic treatment within one week of the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of post operative urinary tract infections (UTI) | 6 weeks after the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Use and Side Effects | 6 weeks and 1 year after the procedure, up to 1 year | 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. |
| Effects on higher patient satisfaction | 6 weeks and 1 year after the procedure, up to 1 year | 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. |
Countries
United States
Contacts
Primary ContactSusanne Taege, MD
Backup ContactShirley Dong, MD
Outcome results
None listed