Methenamine for Urinary Tract Infection

Overseen By Rena Ow, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Atlantic Health System

Disqualifiers: Renal impairment, Pregnancy, Breastfeeding, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Stress urinary incontinence (SUI) affects at least 40% of women in the United States. Synthetic polypropylene mid-urethral slings (MUS) are the gold standard treatment for SUI. Post-operative urinary tract infections (UTI) are one of the most common complications after MUS placement. Some studies have demonstrated that MUS placement can increase the risk of UTI up to 21-34%. Post-operative UTI can lead to significant healthcare and patient burden. This additional burden further contributes to an estimated annual cost of $1.6 billion for UTI management in the United States. With increased antibiotic usage, there is simultaneous increase in bacterial resistance leading to treatment refractory UTI. The investigators prescribe post-operative antibiotics prophylactically for 3 days after MUS placement with or without concurrent pelvic reconstructive surgery based on prior literature recommending post-operative prophylaxis. There is a greater emphasis on limiting antibiotic use given the trend of development of bacterial resistance. There are studies supporting alternatives such as methenamine for recurrent UTI prophylaxis treatment, but there are limited studies evaluating methenamine for UTI prophylaxis after MUS.

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 methenamine hippurate safe for humans?

Methenamine hippurate has been used in studies for preventing urinary tract infections, and no significant side effects were observed, although some people mentioned the taste. It appears to be generally safe for long-term use in humans, including children and the elderly. ^{1 2 3 4 5}

How does the drug methenamine hippurate differ from other treatments for urinary tract infections?

Methenamine hippurate is unique because it acts as a urinary antiseptic, preventing recurrent urinary tract infections (UTIs) rather than treating active infections. Unlike antibiotics, it doesn't lead to bacterial resistance, making it a useful option for long-term prevention of UTIs. ^{1 2 4 5 6}

Eligibility Criteria

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 18 years old or older.

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

Trial Timeline

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

Treatment Details

Interventions

• Methenamine Hippurate (Anti-infective)

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

References

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

Methenamine Prophylaxis for Recurrent Urinary Tract Infections in a Tertiary Referral Center. [2023]

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

Methenamine hippurate to prevent recurrent urinary tract infections in older women: protocol for a randomised, placebo-controlled trial (ImpresU). [2023]

3. Sweden pubmed.ncbi.nlm.nih.gov

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

4. England 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Treatment with methenamine hippurate in the patient with a catheter. [2017]

6. Sweden pubmed.ncbi.nlm.nih.gov

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