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Urinary Track Infection Prevention After Urogynecological Surgery

Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
Statusİşə qəbul
Sponsorlar
TriHealth Inc.

Açar sözlər

Mücərrəd

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.

Təsvir

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.

Tarixlər

Son Doğrulandı: 06/30/2020
İlk təqdim: 01/22/2019
Təxmini qeydiyyat təqdim edildi: 01/22/2019
İlk Göndərmə: 01/27/2019
Son Yeniləmə Göndərildi: 07/20/2020
Son Yeniləmə Göndərildi: 07/22/2020
Həqiqi Təhsilin Başlama Tarixi: 06/16/2019
Təxmini İlkin Tamamlanma Tarixi: 12/31/2020
Təxmini İşin Tamamlanma Tarixi: 04/30/2021

Vəziyyət və ya xəstəlik

Urinary Tract Infections
Urinary Retention Postoperative
Pelvic Organ Prolapse

Müdaxilə / müalicə

Drug: Methenamine Hippurate with Cranberry

Drug: Placebo with Cranberry

Faza

Faza 2

Qol Qrupları

QolMüdaxilə / müalicə
Experimental: 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.
Drug: Methenamine Hippurate with Cranberry
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 Comparator: 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.
Drug: Placebo with Cranberry
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.

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar 18 Years Üçün 18 Years
Təhsilə Uyğun CinslərFemale
Sağlam Könüllüləri qəbul edirBəli
Kriteriyalar

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Nəticə

İlkin nəticə tədbirləri

1. Incidence of urinary track infection (UTI) [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.

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Elm tərəfindən dəstəklənən ən tam dərman bitkiləri bazası

  • 55 dildə işləyir
  • Elm tərəfindən dəstəklənən bitki mənşəli müalicələr
  • Təsvirə görə otların tanınması
  • İnteraktiv GPS xəritəsi - yerdəki otları etiketləyin (tezliklə)
  • Axtarışınızla əlaqəli elmi nəşrləri oxuyun
  • Təsirlərinə görə dərman bitkilərini axtarın
  • Maraqlarınızı təşkil edin və xəbər araşdırmaları, klinik sınaqlar və patentlər barədə məlumatlı olun

Bir simptom və ya bir xəstəlik yazın və kömək edə biləcək otlar haqqında oxuyun, bir ot yazın və istifadə olunan xəstəliklərə və simptomlara baxın.
* Bütün məlumatlar dərc olunmuş elmi araşdırmalara əsaslanır

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