Urinary Tract Infection (Diagnosis)NCT06810687
Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis?
A study testing Methenamine Hippurate 1g BD and Antibiotic prophylaxis in people with Urinary Tract Infection (Diagnosis), run by Atlantic Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection (Diagnosis)
- What is being tested?
- Methenamine Hippurate 1g BD and Antibiotic prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2025to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Age ≥ 18
- Patients undergoing mid-urethral sling procedure
Who cannot join
- Medication intolerance or allergy to study medications
- Renal impairment with GFR <30
- Breast feeding
- Pregnancy
- Recurrent urinary tract infections
- Active urinary tract infection
- Immunosuppressive disease
- Interstitial cystitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atlantic Health
Morristown, New Jersey, 07928
Rena Ow, MD, 9739717267, rena.ow@atlantichealth.org
Shaun Adair, MD
About this study
Official title: Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis? A Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Urinary Tract Infection (Diagnosis)
- Being tested
- Methenamine Hippurate 1g BD, Antibiotic prophylaxis
- Keywords
- urinary tract infection, midurethral sling, prophylaxis, methenamine
- Medical subject headings
- Urinary Tract Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methenamine Hippurate 1g BDDrug
Antibiotic prophylaxis
Antibiotic prophylaxisOther
Antibiotic prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Methenamine prophylaxis | Experimental | Methenamine will be prescribed for urinary tract infection prophylaxis Receives: Drug: Methenamine Hippurate 1g BD |
| Antibiotic prophylaxis | Active comparator | Antibiotic prophylaxis chosen per physician preference Receives: Other: Antibiotic prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of urinary tract infection
Urinary tract infection (Positive urine culture) within 6 weeks post-operatively after completing 3 days of antibiotics or methenamine
Measured: Within 6 weeks after the procedure
Secondary outcomes (2)
Number of participants with adverse effects
Adverse effects or side effects of treatment
Measured: within 6 weeks after the procedure
Occurrence of additional treatment of UTI
Further treatment antibiotics given to participants
Measured: Within 6 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start30 Jan 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaun Adair, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810687
- Sponsor's protocol ID
- 2248168-1
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06810687
- Acronym / sponsor ID
- 2248168-1
- Conditions
- Urinary Tract Infection (Diagnosis)
- Keywords
- urinary tract infection, midurethral sling, prophylaxis, methenamine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Methenamine prophylaxis | Experimental | Drug: Methenamine Hippurate 1g BDMethenamine will be prescribed for urinary tract infection prophylaxis |
| Antibiotic prophylaxis | Active comparator | Other: Antibiotic prophylaxisAntibiotic prophylaxis chosen per physician preference |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Age ≥ 18
- Patients undergoing mid-urethral sling procedure
Key exclusion criteria (8 listed)
- Medication intolerance or allergy to study medications
- Renal impairment with GFR <30
- Breast feeding
- Pregnancy
- Recurrent urinary tract infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methenamine Hippurate 1g BDAntibiotic prophylaxis | Drug | Methenamine prophylaxis |
| Antibiotic prophylaxisAntibiotic prophylaxis | Other | Antibiotic prophylaxis |
Primary outcome
Incidence of urinary tract infection
Time frame: Within 6 weeks after the procedure
Urinary tract infection (Positive urine culture) within 6 weeks post-operatively after completing 3 days of antibiotics or methenamine
2 secondary outcomes
Number of participants with adverse effects
Time frame: within 6 weeks after the procedure
Occurrence of additional treatment of UTI
Time frame: Within 6 weeks after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methenamine Hippurate 1g BD and Antibiotic prophylaxis in people with Urinary Tract Infection (Diagnosis), run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rena Ow, MD (9739717267, rena.ow@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of urinary tract infection (time frame: Within 6 weeks after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.