Methenamine for Urinary Tract Infection

Overseen By Rena Ow, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Atlantic Health System

Disqualifiers: Renal impairment, Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 days

190 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find a better way to prevent urinary tract infections (UTIs) after surgery for stress urinary incontinence (SUI) in women. It compares methenamine (specifically Methenamine Hippurate, a medication believed to help prevent UTIs) with standard antibiotics. Women planning to undergo a sling procedure to support their bladder might be suitable candidates. The study seeks to reduce antibiotic use and address the issue of bacterial resistance. As an unphased trial, participants contribute to important research that may lead to improved UTI prevention strategies without relying on antibiotics.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that methenamine is generally safe for preventing urinary tract infections (UTIs). Studies suggest it is well-tolerated and effective for UTI prevention without antibiotics. It has a good safety record, typically not causing serious side effects. In older adults, methenamine has been used successfully to prevent UTIs. Its unique mechanism makes it suitable for long-term use. Overall, methenamine appears to be a safe and effective option for preventing UTIs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for urinary tract infections, which often involves antibiotics, Methenamine Hippurate offers a unique approach. This treatment works by acidifying urine, which helps prevent bacteria from growing, rather than directly killing them like antibiotics do. Researchers are excited about Methenamine because it might reduce the need for antibiotics, potentially lowering the risk of antibiotic resistance and minimizing side effects. Additionally, Methenamine could be a safer long-term prophylactic option for those who frequently suffer from UTIs.

What evidence suggests that methenamine might be an effective treatment for post-operative UTI prophylaxis after MUS?

Research has shown that methenamine hippurate, which participants in this trial may receive, can help prevent urinary tract infections (UTIs). One study found it to be as effective as antibiotics in preventing UTIs from recurring. Methenamine works by making urine more acidic, stopping bacterial growth. This treatment can reduce the number of UTIs by about 25% in some cases. It is also considered a safe option that avoids antibiotics, which is important for preventing antibiotic resistance. Another group in this trial will receive antibiotic prophylaxis, chosen per physician preference, to compare its effectiveness against methenamine. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for women who have undergone a mid-urethral sling procedure to treat stress urinary incontinence. Participants should not currently have a urinary tract infection or other infections, and must not be allergic to the study medications.

Inclusion Criteria

I am female.

I am scheduled for a mid-urethral sling procedure.

Exclusion Criteria

I have a condition that weakens my immune system.

I have been diagnosed with interstitial cystitis.

Medication intolerance or allergy to study medications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either methenamine or antibiotic prophylaxis for 3 days post-operatively

3 days

Follow-up

Participants are monitored for incidence of urinary tract infection and adverse effects

6 weeks

Regular follow-up visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Methenamine Hippurate

Trial Overview The trial is testing if Methenamine Hippurate (1g twice daily) can prevent urinary tract infections after surgery as effectively as standard antibiotic prophylaxis. It's a randomized controlled study comparing these two methods of prevention.

How Is the Trial Designed?

Group I: Methenamine prophylaxis Experimental Treatment 1 Intervention

Methenamine will be prescribed for urinary tract infection prophylaxis

Group II: Antibiotic prophylaxis Active Control 1 Intervention

Antibiotic prophylaxis chosen per physician preference

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials

58

Recruited

9,400+

Published Research Related to This Trial

In a study of 24 patients treated with methenamine hippurate for an average of 16 months, the number of urinary tract infection reinfections was reduced by about two-thirds in patients who achieved abacteriuria, indicating its efficacy as a prophylactic treatment.

Methenamine hippurate was found to have limited effectiveness in treating established urinary tract infections, suggesting that it should be used primarily for prevention after achieving abacteriuria, as no significant side effects or complications, such as urinary calculus or renal function deterioration, were observed during the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term treatment with methenamine hippurate in recurrent urinary tract infection. Nilsson, S.[2019]

Methenamine hippurate (MH) demonstrated high success rates in preventing recurrent uncomplicated urinary tract infections (UTIs) in women, with an 83% success rate in premenopausal women and 77% in postmenopausal women over a 6-month period.

The study involved 162 women and found that success rates were not significantly affected by factors like age or diabetes, but patients using intermittent catheterization had lower success rates, indicating a need for further research to optimize treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methenamine Prophylaxis for Recurrent Urinary Tract Infections in a Tertiary Referral Center. Wade, C., Lacy, ME., Harris, L., et al.[2023]

In a study involving 22 elderly female subjects with indwelling catheters, treatment with methenamine hippurate (1 g twice daily for four months) significantly reduced the incidence of catheter blockage compared to a control period.

Additionally, while bacteriuria (bacteria in urine) persisted, the treatment also led to a decrease in symptomatic urinary tract infections during the four-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment with methenamine hippurate in the patient with a catheter. Norrman, K., Wibell, L.[2017]

This study is a randomized, controlled trial involving 400 women aged 70 and older, aimed at assessing the efficacy of methenamine hippurate in reducing recurrent urinary tract infections (UTIs) over a 6-month treatment period.

The primary outcome is the number of antibiotic treatments for UTIs during the treatment phase, with safety outcomes also being monitored, which will help determine the long-term safety and effectiveness of methenamine hippurate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methenamine hippurate to prevent recurrent urinary tract infections in older women: protocol for a randomised, placebo-controlled trial (ImpresU). Heltveit-Olsen, SR., Sundvall, PD., Gunnarsson, R., et al.[2023]

In a trial involving 240 women with recurrent urinary tract infections, methenamine hippurate was found to be non-inferior to daily low-dose antibiotics in preventing symptomatic infections, with an incidence of 1.38 episodes per person year compared to 0.89 for antibiotics.

Both treatment groups reported similar rates of mild adverse reactions (24% for antibiotics and 28% for methenamine hippurate), suggesting that methenamine hippurate could be a safe alternative for antibiotic prophylaxis in managing recurrent urinary tract infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial. Harding, C., Mossop, H., Homer, T., et al.[2022]

In a study of 20 girls aged 5-12 with recurrent urinary tract infections, treatment with methenamine hippurate (Hiprex) for 12 months significantly reduced the average number of infections from 3.1 to 0.7 per year (p < 0.001).

After stopping the treatment, the infection rate increased to 1.4 per year, indicating that methenamine hippurate is effective for long-term prevention of urinary tract infections, with minimal side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term prophylaxis with methenamine hippurate in girls with recurrent urinary tract infections. Petersen, S.[2019]

Citations

1. bmcurol.biomedcentral.com bmcurol.biomedcentral.com/articles/10.1186/s12894-025-01708-8

Effectiveness of methenamine hippurate in preventing urinary ... Methenamine hippurate versus ciprofloxacin to prevent postoperative urinary tract infection: results of a randomized controlled trial.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39955521/

Effectiveness of methenamine hippurate in preventing ... Our meta-analysis provides evidence supporting methenamine hippurate as an effective, non-inferior and safe prophylactic option for preventing recurrent UTIs ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1198743X25003441

Methenamine hippurate as prophylaxis for recurrent ... Methenamine hippurate reduces the frequency of rUTIs in older women with a point estimate of a 25% reduction, suggesting advantages over low-dose antibiotic ...

4. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/10.1002/phar.2895

Methenamine for urinary tract infection prophylaxis: A ... This systematic review suggests methenamine generally appears to be an effective and well-tolerated antibiotic-sparing option for UTI prophylaxis.

5. tandfonline.com tandfonline.com/doi/full/10.1080/17512433.2024.2445621

Full article: Methenamine Hippurate in UTI management The primary clinical outcome was incidence of symptomatic antibiotic-treated UTI during the 12-month treatment period. Cost-effectiveness was assessed by ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6759703/

Evaluation of methenamine for urinary tract infection ... The available data, however, suggest that methenamine may be a safe and effective drug for the prevention of UTI in older adults with adequate ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/methenamine-oral-route/description/drg-20064676

Methenamine (oral route) - Side effects & dosage Methenamine belongs to the family of medicines called anti-infectives. It is used to help prevent and treat infections of the urinary tract.