Prophylactic Antibiotics for Urinary Incontinence

Overseen By Shirley Dong, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Ohio State University

Must not be taking: Daily antibiotics

Disqualifiers: Recurrent UTIs, Immunosuppression, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

138 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking daily antibiotics, you cannot participate. Also, if you've had recent antibiotic treatment within a week of the procedure, you may not be eligible.

Is there evidence that the drug Bactrim is effective for preventing urinary tract infections after gynecological surgery?

Yes, a study showed that patients who received Bactrim had fewer urinary tract infections and other complications after gynecological surgery compared to those who did not receive the drug. ^{1 2 3 4 5}

Is it safe to use prophylactic antibiotics like Bactrim and Macrobid for urinary incontinence?

Studies show that antibiotics like Bactrim and Macrobid are generally safe for preventing infections, but they can cause side effects like skin rashes and stomach issues. In one study, 6% of patients experienced skin problems, and some had stomach disturbances, but these side effects were not common enough to be statistically significant. ^{3 4 6 7 8}

How does the drug Bactrim differ from other treatments for urinary incontinence?

Bactrim, a combination of trimethoprim and sulfamethoxazole, is used as a prophylactic antibiotic to prevent infections, which is different from other treatments for urinary incontinence that may not focus on infection prevention. This approach is unique because it targets the prevention of urinary tract infections, which can be a complication associated with urinary incontinence, especially after surgery. ^{3 4 5 7 9}

Research Team

Susanne Taege, MD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for individuals planning to undergo Bulkamid treatment for stress urinary incontinence or mixed urinary incontinence at The Ohio State University. Participants must not have recurrent UTIs, be on daily antibiotics, pregnant, have significant pelvic organ prolapse or immunosuppression, and should not have taken recent antibiotics.

Inclusion Criteria

I have been diagnosed with stress urinary incontinence.

I am seeing a specialist for urinary incontinence and plan to have a Bulkamid treatment.

Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan)

Exclusion Criteria

I cannot take oral antibiotics due to allergies or kidney problems.

Patients with immunosuppression due to underlying medical conditions

I am having other pelvic or urologic surgeries along with my main procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants receive either a placebo pill or oral antibiotic in the pre-operative holding area prior to their procedure

Single day

1 visit (in-person)

Immediate Post-operative

Participants are monitored for post-operative urinary tract infections (UTI) and other immediate effects

6 weeks

1 visit (in-person) at 6 weeks

Follow-up

Participants complete surveys to assess improvement in stress urinary incontinence and patient satisfaction

1 year

1 visit (in-person) at 1 year, online survey link provided

Treatment Details

Interventions

• Bactrim
• Macrobid

Trial Overview The study aims to determine if prophylactic oral antibiotics reduce the risk of UTI after Bulkamid urethral bulking. It compares the effectiveness of a placebo with Bactrim or Macrobid and looks at UTI rates with different catheterization methods post-surgery.

Participant Groups

Group I: Bactrim or Macrobid (single dose) Active Control 1 Intervention

Bactrim (800/160mg) or Macrobid (100 mg) depending on participants' allergies

Group II: Placebo Placebo Group 1 Intervention

Identical appearing placebo for a single dose

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Findings from Research

In a study involving 449 patients undergoing pelvic organ prolapse and urinary incontinence surgery, antibiotic prophylaxis with nitrofurantoin significantly reduced the rate of positive urine cultures and symptomatic urinary tract infections (UTIs) compared to a placebo.

Specifically, the use of nitrofurantoin led to a decrease in positive urine cultures (46% vs 61%) and symptomatic UTIs at the time of catheter removal (7.2% vs 19.8%), demonstrating its efficacy in preventing infections immediately following surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled comparison of the effect of nitrofurantoin monohydrate macrocrystals on the development of urinary tract infections after surgery for pelvic organ prolapse and/or stress urinary incontinence with suprapubic catheterization. Rogers, RG., Kammerer-Doak, D., Olsen, A., et al.[2022]

In a study of 518 patients undergoing transurethral surgery, a single 500 mg dose of ciprofloxacin was found to be effective in reducing post-operative bacteriuria, with only 3.3% of patients experiencing this complication compared to higher rates in the cefotaxime (4.8%) and placebo (7.0%) groups.

Ciprofloxacin demonstrated a favorable safety profile, with only 3% of patients reporting drug-related adverse events, suggesting it is a suitable prophylactic option for preventing infections after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose oral ciprofloxacin compared with cefotaxime and placebo for prophylaxis during transurethral surgery. Klimberg, IW., Malek, GH., Cox, CE., et al.[2013]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Benefits and Harms of Treatment of Asymptomatic Bacteriuria: A Systematic Review and Meta-analysis by the European Association of Urology Urological Infection Guidelines Panel. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effect of consecutive antibacterial therapy on bacteriuria in hospitalized geriatric patients. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Comparative study on the question of systemic chemoprophylaxis following gynecological surgery]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled comparison of the effect of nitrofurantoin monohydrate macrocrystals on the development of urinary tract infections after surgery for pelvic organ prolapse and/or stress urinary incontinence with suprapubic catheterization. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Non-Antibiotic Prophylaxis for Recurrent UTIs in Neurogenic Lower Urinary Tract Dysfunction (NAPRUN): Study Protocol for a Prospective, Longitudinal Multi-Arm Observational Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse reactions of nitrofurantoin, trimethoprim and sulfamethoxazole in children. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

A comparative trial of low dose cefaclor and macrocrystalline nitrofurantoin in the prevention of recurrent urinary tract infection. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Single-dose oral ciprofloxacin compared with cefotaxime and placebo for prophylaxis during transurethral surgery. [2013]

9. Canada pubmed.ncbi.nlm.nih.gov

Prophylaxis of recurring urinary tract infection in females: a comparison of nitrofurantoin with trimethoprim-sulfamethoxazole. [2018]