Urinary Tract InfectionsPhase 2NCT03818321
Urinary Track Infection Prevention After Urogynecological Surgery
A Phase 2 study testing Methenamine Hippurate 1 g tablet in people with Urinary Tract Infections and Urinary Retention Postoperative, run by TriHealth Inc. at 1 site in United States.
Trial summary
This study is randomized double-blinded placebo-controlled trial to access oral Methenamine Hippurate (MH) in combination with cranberry capsules is superior to cranberry capsules alone in prevention of UTI in patients with transient post-operative urinary retention requiring a Foley catheter after pelvic… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Urinary Tract Infections, Urinary Retention Postoperative, Pelvic Organ Prolapse
- What is being tested?
- Methenamine Hippurate 1 g tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 1 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo major pelvic organ prolapse surgery that are diagnosed with POUR via failed retrograde void trial and require an indwelling Foley catheter upon hospital discharge.
Who cannot join
- Unwillingness to participate in the study
- Inability to understand English
- Pregnant women
- Patient personal history of nephrolithiasis, urogenital anomaly, neurogenic bladder, chronic renal insufficiency (GFR <60 ml/min/1.73 m² or serum creatinine level >1.03 for >3months), sarcoidosis, and severe hepatic insufficiency
- Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis
- Active urinary tract infection
Show all 10Show fewer
- Patient history of taking Warfarin (Coumadin)
- Intraoperative bladder injury or cystotomy
- Physical or mental impairment that would affect the subject's ability to take medications daily or fill out questionnaires
- Reported allergy to any of the ingredients in the cranberry, MH, or placebo pill
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
About this study
Official title: Methenamine Hippurate With Cranberry Capsules Versus Cranberry Capsules Alone for UTI Prevention in a Short-term Indwelling Foley Catheter Population After Urogynecological Surgery: A Double-Blinded Randomized Controlled Trial
This study is randomized double-blinded placebo-controlled trial to access oral Methenamine Hippurate (MH) in combination with cranberry capsules is superior to cranberry capsules alone in prevention of UTI in patients with transient post-operative urinary retention requiring a Foley catheter after pelvic reconstructive surgery.
Read the detailed description
Urinary tract infections (UTIs) are one of the most common bacterial infections in women. It is estimated that 1.6 billion dollars are spent on UTI treatment each year. Antibiotics have been the mainstay of treatment of UTIs, however frequent use has increased the prevalence of antibiotic resistant organisms. Therefore, focus has shifted to non-antibiotic therapy for UTI prophylaxis.
Methenamine Hippurate (MH) has been studied for decades due to its potential role in prevention of UTI. While not technically an antibiotic, MH works via its bacteriostatic action in the bladder. Benefits of MH are the lack of development of resistance, and the selective nature of this drug to the urinary system only. However, MH is best used in conjunction with an acidifying agent to increase its bioavailability (such as cranberry capsules or other acidic products). The usage of MH has been studied in various populations, has been seen to be effective in short-term catheterization. Usage of cranberry as prophylaxis for UTI is controversial; however, results have been favorable in the post-operative gynecological population.
Post-operative urinary retention (POUR) occurs frequently in patients who undergo incontinence and pelvic prolapse surgery. Although the definition of POUR can vary between clinicians, it is reported as 2.5-24% to as high as 43% after tension-free transvaginal mesh sling placement. This population is at also at high risk for UTI due to advanced age and menopausal status. Moreover, using a catheter longer than 2 days incurs a 2-fold increased risk of development of UTI with an estimated 5% increase in bacteriuria each day of catheterization.
In hopes to decrease the overuse of antibiotics and decrease the likelihood of antibiotic resistance, we propose that the use of MH and cranberry can reflect a potential benefit in this population of short-term indwelling Foley catheter use and help reduce the incidence of post-operative UTI after pelvic surgery.
The patients will then be randomized to either receive cranberry capsules and placebo OR cranberry capsules and Methenamine Hippurate.
- Being tested
- Methenamine Hippurate 1 g tablet, Placebo tablet
- Medical subject headings
- Urinary Tract Infections, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methenamine Hippurate 1 g tabletDrug
Methenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD\&C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert).
Placebo tabletDrug
Placebo is a tablet that will be provided to you that looks like the study drug but does not contain any medication. These pills are comprised of gelatin and minimal amounts of lactose powder. The pills are designed to have no effect on the patient.
| Study group | Role | What they receive |
|---|---|---|
| Methenamine Hippurate with Cranberry | Experimental | Subjects will be instructed to take Methenamine Hippurate 1 g tablet ( 1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days. Receives: Drug: Methenamine Hippurate 1 g tablet |
| Placebo with Cranberry | Placebo comparator | Subjects will be instructed to take Placebo tablet (1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days.
Cranberry capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016. Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Urinary Track Infection (UTI)
Incidence of UTIs will be diagnosed at one week post-op visit.
Measured: From surgery to one week post-op visit, approximately 1 week post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start17 Jun 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Pauls, MD, Principal investigator, TriHealth - Cincinnati Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818321
- Sponsor's protocol ID
- 18-115
- Status last verified
- Oct 2022
- First submitted
- 23 Jan 2019
- Last updated
- 14 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Tam TY, Aldrich ER, Crisp CC, Yook E, Yeung J, Pauls RN. Methenamine Hippurate With Cranberry Capsules Versus Cranberry Alone for Urinary Tract Infection Prevention in a Short-Term Indwelling Foley Catheter Population After Urogynecologic Surgery: A Double-Blinded Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2022 Mar 1;28(3):e55-e61. doi: 10.1097/SPV.0000000000001147.
PubMed 35272334
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methenamine Hippurate With Cranberry Capsules Versus Cranberry Capsules Alone for UTI Prevention in a Short-term Indwelling Foley Catheter Population After Urogynecological Surgery: A Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03818321
- Acronym / sponsor ID
- 18-115
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 14 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is randomized double-blinded placebo-controlled trial to access oral Methenamine Hippurate (MH) in combination with cranberry capsules is superior to cranberry capsules alone in prevention of UTI in patients with transient post-operative urinary retention requiring a Foley catheter after pelvic reconstructive surgery.
Detailed description
Urinary tract infections (UTIs) are one of the most common bacterial infections in women. It is estimated that 1.6 billion dollars are spent on UTI treatment each year. Antibiotics have been the mainstay of treatment of UTIs, however frequent use has increased the prevalence of antibiotic resistant organisms. Therefore, focus has shifted to non-antibiotic therapy for UTI prophylaxis.
Methenamine Hippurate (MH) has been studied for decades due to its potential role in prevention of UTI. While not technically an antibiotic, MH works via its bacteriostatic action in the bladder. Benefits of MH are the lack of development of resistance, and the selective nature of this drug to the urinary system only. However, MH is best used in conjunction with an acidifying agent to increase its bioavailability (such as cranberry capsules or other acidic products). The usage of MH has been studied in various populations, has been seen to be effective in short-term catheterization. Usage of cranberry as prophylaxis for UTI is controversial; however, results have been favorable in the post-operative gynecological population.
Post-operative urinary retention (POUR) occurs frequently in patients who undergo incontinence and pelvic prolapse surgery. Although the definition of POUR can vary between clinicians, it is reported as 2.5-24% to as high as 43% after tension-free transvaginal mesh sling placement. This population is at also at high risk for UTI due to advanced age and menopausal status. Moreover, using a catheter longer than 2 days incurs a 2-fold increased risk of development of UTI with an estimated 5% increase in bacteriuria each day of catheterization.
In hopes to decrease the overuse of antibiotics and decrease the likelihood of antibiotic resistance, we propose that the use of MH and cranberry can reflect a potential benefit in this population of short-term indwelling Foley catheter use and help reduce the incidence of post-operative UTI after pelvic surgery.
The patients will then be randomized to either receive cranberry capsules and placebo OR cranberry capsules and Methenamine Hippurate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methenamine Hippurate with Cranberry | Experimental | Drug: Methenamine Hippurate 1 g tabletSubjects will be instructed to take Methenamine Hippurate 1 g tablet ( 1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days. |
| Placebo with Cranberry | Placebo comparator | Drug: Placebo tabletSubjects will be instructed to take Placebo tablet (1 tablet twice daily) with Cranberry supplementation (1 tablet twice daily) by mouth starting at time of discharge for 6-8 days. Cranberry capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who undergo major pelvic organ prolapse surgery that are diagnosed with POUR via failed retrograde void trial and require an indwelling Foley catheter upon hospital discharge.
Key exclusion criteria (10 listed)
- Unwillingness to participate in the study
- Inability to understand English
- Pregnant women
- Patient personal history of nephrolithiasis, urogenital anomaly, neurogenic bladder, chronic renal insufficiency (GFR <60 ml/min/1.73 m² or serum creatinine level >1.03 for >3months), sarcoidosis, and severe hepatic insufficiency
- Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis
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 1 g tabletMethenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD\&C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert). | Drug | Methenamine Hippurate with Cranberry |
| Placebo tabletPlacebo is a tablet that will be provided to you that looks like the study drug but does not contain any medication. These pills are comprised of gelatin and minimal amounts of lactose powder. The pills are designed to have no effect on the patient. | Drug | Placebo with Cranberry |
Primary outcome
Incidence of Urinary Track Infection (UTI)
Time frame: From surgery to one week post-op visit, approximately 1 week post surgery
Incidence of UTIs will be diagnosed at one week post-op visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35272334Tam TY, Aldrich ER, Crisp CC, Yook E, Yeung J, Pauls RN. Methenamine Hippurate With Cranberry Capsules Versus Cranberry Alone for Urinary Tract Infection Prevention in a Short-Term Indwelling Foley Catheter Population After Urogynecologic Surgery: A Double-Blinded Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2022 Mar 1;28(3):e55-e61. doi: 10.1097/SPV.0000000000001147.
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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. This study is not recruiting at the moment.
Rachel Pauls, MD principal investigator
TriHealth - Cincinnati Urogynecology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methenamine Hippurate 1 g tablet in people with Urinary Tract Infections and Urinary Retention Postoperative, run by TriHealth Inc. 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 14 Nov 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Urinary Track Infection (UTI) (time frame: From surgery to one week post-op visit, approximately 1 week post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03818321, which also lists 1 linked publication.
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 14 Nov 2022.