Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03522961
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-28
First Post:
2018-04-17
Brief Title:
Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery a Double-blinded Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We aim to compare the effectiveness of cranberry capsules versus nitrofurantoin prophylaxis in preventing urinary tract infections UTIs after urogynecologic surgery by conducting a double-blinded randomized clinical trial involving women with pelvic organ prolapse andor urinary incontinence scheduled to have surgery with the Urogynecologists who comprise the Brigham and Womens Urogynecology Group
Detailed Description:
We plan to conduct a double-blinded randomized clinical trial involving women who undergo surgery for pelvic organ prolapse andor urinary incontinence
Participants who need transurethral catheterization postoperatively will be randomized to cranberry capsules or nitrofurantoin prophylaxis Randomization will be performed the day of discharge Both participants and surgeons will be blinded to treatment allocation All participants will receive routine perioperative intravenous antibiotic prophylaxis
Participants who fail their voiding trial after surgery and require transurethral catheterization upon discharge from the hospital will be randomized to either one cranberry capsule TheraCran one Theralogix LLC Rockville Maryland or one 100 mg capsule of nitrofurantoin by mouth daily beginning postoperative day 1 Participants randomized to the cranberry capsule group will continue to take one cranberry capsule daily for 28 days Participants randomized to the nitrofurantoin group will continue to take 100 mg of nitrofurantoin each day transurethral catheterization is needed for up to 28 days All participants will be scheduled for a repeat voiding trial within 48 hours to 1 week after discharge
All participants will complete a daily catheterization and medication diary to record the type of catheterization used indwelling or intermittent and to confirm they are taking the study medication for the duration of the study period They will also be asked to record any urinary symptoms they experience and will be encouraged to contact the office immediately if they experience urinary symptoms consistent with a UTI
Participants who need transurethral catheterization postoperatively will be randomized to cranberry capsules or nitrofurantoin prophylaxis Randomization will be performed the day of discharge Both participants and surgeons will be blinded to treatment allocation All participants will receive routine perioperative intravenous antibiotic prophylaxis
Participants who fail their voiding trial after surgery and require transurethral catheterization upon discharge from the hospital will be randomized to either one cranberry capsule TheraCran one Theralogix LLC Rockville Maryland or one 100 mg capsule of nitrofurantoin by mouth daily beginning postoperative day 1 Participants randomized to the cranberry capsule group will continue to take one cranberry capsule daily for 28 days Participants randomized to the nitrofurantoin group will continue to take 100 mg of nitrofurantoin each day transurethral catheterization is needed for up to 28 days All participants will be scheduled for a repeat voiding trial within 48 hours to 1 week after discharge
All participants will complete a daily catheterization and medication diary to record the type of catheterization used indwelling or intermittent and to confirm they are taking the study medication for the duration of the study period They will also be asked to record any urinary symptoms they experience and will be encouraged to contact the office immediately if they experience urinary symptoms consistent with a UTI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 016086 | OTHER_GRANT | Brigham and Womens Hospital OBGYN Department | None |