Urinary Track Infection Prevention After Urogynecological Surgery

NCT03818321 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 18-115
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief 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 reconstructive surgery.

Conditions

Urinary Tract Infections; Urinary Retention Postoperative; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Incidence of Urinary Track Infection (UTI)

  Incidence of UTIs will be diagnosed at one week post-op visit.

  From surgery to one week post-op visit, approximately 1 week post surgery

Study Arms (2)

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.

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.

Drug: Placebo tablet

Interventions

Methenamine Hippurate 1 g tablet DRUG

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).

Methenamine Hippurate with Cranberry

Placebo tablet DRUG

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.

Placebo with Cranberry

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• 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.

  PMID: 35272334 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections; Pelvic Organ Prolapse

Interventions

methenamine hippurate; Tablets

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Rachel Pauls
• Organization: TriHealth

Rachel_Pauls@trihealth.com

513-463-4300

Study Officials

• Rachel Pauls, MD

  TriHealth - Cincinnati Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is randomized double-blinded placebo-controlled trial, and both patients and investigators are blinded. However, a research nurse will not be blinded to the group allocation, and the research nurse will order each patient's medication to the inpatient pharmacy based on the study randomization scheme.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 28, 2019
• Study Start: June 17, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-10

Locations

US (1)