An interventional study of Methenamine Hippurate 1g BD and Antibiotic prophylaxis in Urinary Tract Infection (Diagnosis), sponsored by Atlantic Health System. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Atlantic Health System · Not applicable, Interventional, and Prevention
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.
Synthetic polypropylene mid-urethral slings (MUS) are the gold standard for treatment of stress urinary incontinence (SUI). The most common post-operative complications are urinary tract infection (UTI), bladder injury, bleeding, and mesh erosion. Amongst these complications, post-operative urinary tract infections are the most common complication with incidences up to 21-34%. With high incidences in post-operative UTI, previous studies have shown evidence for the use of prophylactic antibiotics after MUS placement. Previous studies have demonstrated prophylactic antibiotics after MUS placement decreased the incidence of post-operative UTI in the treated groups. While the use of post-operative prophylactic antibiotics may decrease the risk of post-operative UTI, it is essential to consider the broader implication of such antibiotic use.
Along with increased antibiotic use, there is an increase in multidrug resistant uropathogens. This has led to an increased emphasis on antibiotic stewardship to optimize patient care by minimizing the risk of developing antibiotic resistant organisms, preserving effectiveness of currently used antibiotics, and promoting appropriate prescribing practices. There are no studies evaluating post-operative UTI prophylaxis after MUS with methenamine.
Methenamine is a urinary antiseptic that acts when methenamine is converted to ammonia and formaldehyde, which denatures bacterial proteins and nucleic acids. There is no evidence of bacterial resistance to methenamine. Methenamine has been shown to be non-inferior to antibiotic prophylaxis in the setting of recurrent UTI. Methenamine has most commonly been used as long-term UTI prophylaxis treatment, but there are studies demonstrating benefit from short-term methenamine use for prophylaxis.
The investigator's aim is to evaluate whether methenamine is non-inferior to antibiotic prophylaxis after MUS procedure in preventing post-operative UTI.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's planned enrollment of 190 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Atlantic Health System is the lead sponsor of 64 studies on the registry; 12 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Methenamine will be prescribed for urinary tract infection prophylaxis
Drug: Methenamine Hippurate 1g BD
Antibiotic prophylaxis chosen per physician preference
Other: Antibiotic prophylaxis
Antibiotic prophylaxis
Antibiotic prophylaxis
Incidence of urinary tract infection
Urinary tract infection (Positive urine culture) within 6 weeks post-operatively after completing 3 days of antibiotics or methenamine
Time frame: Within 6 weeks after the procedure
Number of participants with adverse effects
Adverse effects or side effects of treatment
Time frame: within 6 weeks after the procedure
Occurrence of additional treatment of UTI
Further treatment antibiotics given to participants
Time frame: Within 6 weeks after the procedure
Plan to share: No
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Started Jan 2025 (actual). Primary completion is estimated for Jul 2027, 30 months after the start.
Of 136 non-industry interventional studies with no phase under Urinary Tract Infections, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 39. This study's planned 30 months is above that.
Counting every sponsor, half of 153 studies reached it within 22 months; a quarter within 8 and three quarters within 37.
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Studies of the drug tested here: Methenamine hippurate
Atlantic Health System