Trial Outcomes & Findings for Urinary Track Infection Prevention After Urogynecological Surgery (NCT NCT03818321)
NCT ID: NCT03818321
Last Updated: 2022-11-14
Results Overview
Incidence of UTIs will be diagnosed at one week post-op visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
185 participants
Primary outcome timeframe
From surgery to one week post-op visit, approximately 1 week post surgery
Results posted on
2022-11-14
Participant Flow
Participant milestones
| Measure |
Methenamine Hippurate With Cranberry
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.
Methenamine Hippurate 1 g tablet: 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 With Cranberry
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.
Placebo tablet: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
91
|
|
Overall Study
COMPLETED
|
93
|
89
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Methenamine Hippurate With Cranberry
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.
Methenamine Hippurate 1 g tablet: 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 With Cranberry
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.
Placebo tablet: 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Urinary Track Infection Prevention After Urogynecological Surgery
Baseline characteristics by cohort
| Measure |
Methenamine Hippurate With Cranberry
n=93 Participants
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.
Methenamine Hippurate 1 g tablet: 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 With Cranberry
n=89 Participants
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.
Placebo tablet: 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.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.27 years
STANDARD_DEVIATION 12.86 • n=5 Participants
|
60.61 years
STANDARD_DEVIATION 12.44 • n=7 Participants
|
60.95 years
STANDARD_DEVIATION 12.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
85 participants
n=5 Participants
|
85 participants
n=7 Participants
|
170 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=5 Participants
|
89 participants
n=7 Participants
|
182 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From surgery to one week post-op visit, approximately 1 week post surgeryIncidence of UTIs will be diagnosed at one week post-op visit.
Outcome measures
| Measure |
Methenamine Hippurate With Cranberry
n=93 Participants
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.
Methenamine Hippurate 1 g tablet: 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 With Cranberry
n=89 Participants
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.
Placebo tablet: 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.
|
|---|---|---|
|
Incidence of Urinary Track Infection (UTI)
|
62 Participants
|
71 Participants
|
Adverse Events
Methenamine Hippurate With Cranberry
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo With Cranberry
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place