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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a single dose of oral antibiotics, such as Bactrim or Macrobid, can prevent urinary tract infections (UTIs) after the Bulkamid procedure for treating stress urinary incontinence (leaking urine when laughing, coughing, or exercising). Researchers aim to determine if temporary catheter use affects UTI rates and treatment success. Specialists have evaluated potential participants, who plan to undergo this procedure for stress urinary incontinence and have no recent history of frequent UTIs. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research seeks to understand its benefits for more patients.

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.

What is the safety track record for Bactrim and Macrobid?

A previous study showed that Bactrim, a combination of sulfamethoxazole and trimethoprim, effectively treats urinary tract infections (UTIs). Most people tolerate it well, though some may experience side effects like nausea or a rash. Serious side effects are rare.

Research indicates that Macrobid, which contains nitrofurantoin, also treats UTIs. It is generally safe but can cause mild side effects such as an upset stomach or headache. There is a slightly higher chance of minor side effects compared to other antibiotics.

Both Bactrim and Macrobid have been used to treat infections for a long time, making them well-studied and generally considered safe. Always consult a healthcare provider if there are concerns about side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Bactrim and Macrobid as prophylactic antibiotics for urinary incontinence because these medications could offer a quick, preventative approach to managing urinary tract infections (UTIs) often associated with this condition. Unlike many standard treatments that are reactive and focus on treating existing UTIs, Bactrim and Macrobid are being explored for their potential to prevent infections before they start, which could significantly improve patient comfort and quality of life. Additionally, the single-dose administration of these antibiotics may offer a more convenient option compared to longer, more complex treatment regimens. This proactive strategy could revolutionize how we manage urinary incontinence-related complications.

What evidence suggests that Bactrim or Macrobid could be effective in reducing UTIs after Bulkamid transurethral bulking?

In this trial, participants will receive either Bactrim, Macrobid, or a placebo, depending on their allergies. Research has shown that both Bactrim and Macrobid can reduce urinary tract infections (UTIs). Specifically, studies have found that Bactrim can lower the risk of UTIs by 85% compared to a placebo. One study demonstrated that antibiotics like Bactrim could reduce UTI episodes by almost half. For Macrobid, evidence indicates it can decrease UTI rates by 14-15% in some cases. Both medications are often recommended for preventing UTIs and have proven effective in various studies. ^{5 6 7 8 9}

Who Is on the Research Team?

Susanne Taege, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. academic.oup.com academic.oup.com/ofid/article/9/7/ofac327/6628136

Antibiotics for Preventing Recurrent Urinary Tract Infection Study quality was low. In the 11 placebo-controlled trials, the risk for developing UTI was 85% lower with prophylaxis in comparison with placebo (risk ratio [ ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10271986/

Recurrent Urinary Tract Infection in Adult Patients, Risk ... Antibiotics regimens used included Nitrofurantoin, trimethoprim and Bactrim resulted in close to 50% reduction in the rate of UTI episodes. The benefit ...

3. aafp.org aafp.org/pubs/afp/issues/2011/0215/p409.html

Diagnosis and Treatment of Urinary Tract Infections in ... The recommended initial antibiotic for most children with UTI is trimethoprim/sulfamethoxazole (Bactrim, Septra).

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/324723/

Long-term treatment with sulphamethoxazole/trimethoprim ... 12 out of 17 patients fulfilled a 12-month treatment with sulphamethoxazole/trimethoprim (Bactrim) with continuous sterile urine compared to 1 out of 13 ...

5. rochesterpatientsafety.com rochesterpatientsafety.com/Images_Content/Site1/Files/Pages/Guidelines-treatment-UTI.pdf

UTI Treatment Guidelines Data suggests that oral beta-lactams are inferior to Bactrim or fluoroquinolones for pyelonephritis. • Initial dose of IV ceftriaxone and longer.

6. mayoclinic.org mayoclinic.org/drugs-supplements/sulfamethoxazole-and-trimethoprim-oral-route/description/drg-20071899

Sulfamethoxazole and trimethoprim (oral route) Sulfamethoxazole and trimethoprim combination is best taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/017377s084lbl.pdf

BACTRIM™ sulfamethoxazole and trimethoprim DS (double ... To date, there are limited data on the safety of repeated use of BACTRIM in pediatric patients under two years of age. BACTRIM is not indicated for prophylactic ...

8. drugs.com drugs.com/bactrim.html

Bactrim & Bactrim DS: Uses, Dosage, Side Effects Bactrim (sulfamethoxazole and trimethoprim) is an antibiotic used to treat ear infections, urinary tract and other infections.

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557479/

Recurrent Urinary Tract Infections - StatPearls - NCBI Bookshelf The oral vaccine, MV140, has shown good efficacy in preventing recurrent UTIs in several studies with safety data and minimal adverse effects. A preliminary ...