Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.
What data supports the idea that Prophylactic Antibiotics for Preventing Urinary Tract Infections is an effective drug?The available research shows that prophylactic antibiotics can help prevent urinary tract infections during certain urological procedures. For example, one study mentions that using antibiotics before transurethral surgery can be beneficial, even if the urine is sterile before the operation. Another study highlights that antibiotics can reduce the risk of infections after surgeries like bladder tumor removal. However, there is some debate about their effectiveness in all cases, and concerns about overuse leading to antibiotic resistance.236810
Is the drug Prophylactic antibiotics a promising treatment for preventing urinary tract infections?Yes, prophylactic antibiotics are promising for preventing urinary tract infections, especially in surgeries. They help reduce the risk of infections by using a single dose or short-term treatment, which is effective and convenient.13489
What safety data exists for prophylactic antibiotics in preventing urinary tract infections?The safety data for prophylactic antibiotics in preventing urinary tract infections primarily comes from studies in urology. These studies highlight the use of antibiotics to prevent infections during urological procedures, with a focus on minimizing side effects and microbial resistance. While there is evidence supporting the efficacy of antibiotic prophylaxis, especially in procedures like transurethral resection of the prostate, there are concerns about unnecessary exposure to antibiotics and the associated risks. Proper timing and selection of antibiotics are crucial, and guidelines emphasize the importance of sterile conditions and controlling risk factors. However, inconsistencies in study designs and definitions of complications mean that more well-designed studies are needed to establish clear standards.157811
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications.
Eligibility Criteria
This trial is for adults over 18 who are scheduled for a urethral bulking procedure to treat urinary incontinence. It's not suitable for those with frequent UTIs, known urinary retention issues, allergies to many antibiotics, inability to take oral antibiotics, other surgeries at the same time as bulking, or if pregnant/breastfeeding.Inclusion Criteria
I am 18 years old or older.
I am scheduled for a procedure to help control my urine flow.
Exclusion Criteria
I have had multiple urinary tract infections.
I have a history of not being able to empty my bladder completely.
I cannot tolerate oral antibiotics.
I am having other surgeries along with urethral bulking.
Treatment Details
The study is testing whether giving patients antibiotics before their urethral bulking procedure can prevent infections afterwards. Some participants will receive no antibiotics (control group), while others will get prophylactic antibiotics (test group).
2Treatment groups
Experimental Treatment
Group I: No antibiotic groupExperimental Treatment1 Intervention
Those randomized to this group will not receive an antibiotic prior to the urethral bulking procedure.
Group II: Antibiotic GroupExperimental Treatment1 Intervention
Those randomized to this group will receive a one-time dose of an oral antibiotic prior to the urethral bulking procedure. The antibiotic will be based on the participants' allergies, medical history, and current medication list.
Prophylactic antibiotics is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Prophylactic Antibiotics for:
- Prevention of urinary tract infections in urethral bulking procedures
🇨🇦 Approved in Canada as Prophylactic Antibiotics for:
- Prevention of urinary tract infections in urethral bulking procedures
🇪🇺 Approved in European Union as Prophylactic Antibiotics for:
- Prevention of surgical site infections and urinary tract infections in various surgical procedures, including urethral bulking
Find a clinic near you
Research locations nearbySelect from list below to view details:
Atlantic HealthMorristown, NJ
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Who is running the clinical trial?
Atlantic Health SystemLead Sponsor
References
[Prophylactic antibiotic therapy in urology]. [2006]Prophylactic antibiotic therapy is used increasingly frequently in urology to prevent post-operative septic complications. The use of this method is based on experimental and clinical data which define the optimal time of administration of the antibiotic and the criteria for selection of the most effective drug. Transurethral resection of the prostate is the urological operation most frequently associated with antibiotic prophylaxis. It has been the subject of a large number of randomised studies which have confirmed the efficacy and usefulness of antibiotic prophylaxis. The other urological operations are reviewed and a critical study of the basis for antibiotic prophylaxis for each one is presented.
Antibiotic prophylaxis in surgical procedures. A critical analysis of the literature. [2019]The use of prophylactic antibiotics in surgery is widespread and often inappropriate. The lack of well-designed clinical studies partially explains the present confusion regarding the subject. We reviewed the literature in English on antibiotic prophylaxis through June 1982. Antibiotic prophylaxis reduces the incidence of wound infection after colorectal surgery, vaginal hysterectomy, and laryngeal and oropharyngeal resection for carcinoma, and in high-risk patients undergoing gastroduodenal or biliary surgery. In clean operations such as cardiac surgery, vascular procedures, and orthopedic surgery with placement of prostheses, the high morbidity associated with an infection justifies the use of antibiotics even though the risk of infection is small. There are conflicting data on the usefulness of prophylaxis in abdominal hysterectomy, cesarean section, noncardiac thoracic procedures, and urologic surgery. The effectiveness of prophylaxis in neurosurgery cannot be evaluated at the present time.
[Prevention using quinolones in transurethral surgery]. [2006]Much controversy exists as to the benefit of antimicrobial prophylaxis in transurethral surgery. Any urinary tract infection should be treated before proceeding with a transurethral operation. There is growing evidence that antimicrobial prophylaxis is also beneficial in the case of preoperatively sterile urine. A single dose or short-term prophylaxis appears to be sufficient. As newer fluoroquinolones reach very high tissue concentrations, possess a suitable antimicrobial spectrum to cover most uropathogens and may also be administered orally, these new drugs represent an attractive choice for prophylaxis in transurethral surgery.
Quinolone prophylaxis in transurethral surgery. [2018]In transurethral surgery, there is much controversy about the benefit of antimicrobial prophylaxis. Any urinary tract infection should be treated before proceeding with a transurethral operation. There is growing evidence that antimicrobial prophylaxis is also beneficial in cases with preoperatively sterile urine. A single dose or short-term prophylaxis appears to be sufficient. As newer fluoroquinolones reach very high tissue concentrations, have a suitable antimicrobial spectrum to cover most uropathogens and can be administered orally, these new drugs represent an attractive choice for prophylaxis in transurethral surgery.
Perioperative antibiotic prophylaxis in urology. [2019]This report reviews recent studies on infectious complications and antibiotic prophylaxis in common urological instrumentation. As a result of variations in the definitions of infectious complications and inconsistencies in study design and risk factor analysis there is presently limited clear-cut evidence for giving definite standards regarding antibiotic prophylaxis for most urological interventions. The consequences are that patients may be exposed to unnecessary hazards and the healthcare system to additional costs. Nonetheless, most authors agree that patients should have sterile urine at urological instrumentation and that any other detected risk factor should be controlled. When antibiotic prophylaxis is considered, it should be timed properly before the intervention, which varies with the type of intervention and the choice of antibiotic, and should last for a limited period of time. In most common urological manipulations, correctly administered oral prophylaxis has been shown to be as effective as intravenous prophylaxis. A series of guidelines aimed at keeping the rates of healthcare-associated infections and the level of bacterial resistance as low as possible should, in combination with the rational use of antibiotics, be one of several marks of quality of a urological centre. To achieve this goal, new well-designed studies considering different regimens, risk factor analysis and economical analysis should be encouraged.
[Antimicrobial prophylaxis in urological surgery]. [2008]The present review is dedicated to the problem of perioperative antimicrobial prophylaxis in urological surgery. There are considered modern guidelines for perioperative antimicrobial prophylaxis in urology. There are discussed; aims, timing, and duration of perioperative antimicrobial prophylaxis, risk factors of postoperative infections in urological surgery, pharmacological properties of major antimicrobial drugs, selection and route of administration of antibacterial agents. There are presented the recommendations of perioperative antimicrobial prophylaxis for the varies types of urological surgery, as well as, are given in detail the recommendations about clinical uses of antibiotics for the different types of urological interventions. There are concluded, that perioperative antimicrobial prophylaxis reduces risk of postoperative infections in urological surgery, but sometimes this prophylaxis is not effective and the problem of perioperative antimicrobial prophylaxis in urology is debatable at present. It is necessary continues search of optimal methods of of perioperative antimicrobial prophylaxis in urology. These review are designed for urologists and clinical pharmacologists.
Antibiotic prophylaxis in urologic procedures: a systematic review. [2022]Antibiotic prophylaxis is used to minimize infectious complications resulting from interventions. Side-effects and development of microbial resistance patterns are risks of the use of antibiotics. Therefore, the use should be well considered and based on high levels of evidence. In this review, all available evidence on the use of antibiotic prophylaxis in urology is gathered, assessed, and presented in order to make choices in the use of antibiotic prophylaxis on the best evidence currently available.
[Antibiotic prophylaxis in urology]. [2021]The aim of perioperative antibiotic prophylaxis is the prevention of surgical site infections and urinary tract infections during urological procedures. The indication for antibiotic prophylaxis comprises several risk factors such as the degree of contamination of the operative site, duration of surgery, implantation of devices and comorbidities of the individual patient. In general this involves a single antibiotic administration before the operative procedure. The antibiotic prophylaxis is part of the total antibiotic consumption and thus a factor contributing to emergence of antibiotic resistance. It is not a substitute for hygiene measures or operative precision.
Profilassi antibiotica nelle procedure urologiche. [2019]Antibiotic prophylaxis in urological procedures Thousands of patients receive every day an antibiotic prophylaxis before diagnostic or therapeutic urological procedures. Aim of antibiotic prophylaxis is to reduce the risk of infective complications, unfortunately good quality evidences for the best choice of prophylaxis strategy are often lacking. Nowadays antimicrobial resistance is a major health problem caused primarily by overuse of antibiotics. It is the responsibility of all physicians to practice antibiotic stewardship avoiding the unnecessary use of this precious drugs. Given the previous consideration prophylaxis should be chosen on the base of the best evidences, if evidences are lacking prophylaxis should be tailored on the base of each patient individual features and risk factor for infection complications. This narrative review of antibiotic prophylaxis in urological procedure resumes the principle to follow for the correct management of antibiotic prophylaxis in urological procedure.
Antibiotic prophylaxis in transurethral resection of bladder tumours: study protocol for a systematic review and meta-analysis. [2022]The necessity of antibiotic prophylaxis for postoperative urinary tract infections (UTIs) after transurethral resection of bladder tumours is controversial. This potentially leads to the overuse of antibiotic prophylaxis and rising antimicrobial resistance rates. The objective of this systematic review and meta-analysis is to compare the impact of different antimicrobial prophylaxis schemes versus placebo on the prevention of postoperative UTI and asymptomatic bacteriuria.
The use of antibiotic prophylaxis in patients undergoing urologic procedures in an academic hospital Surabaya: A retrospective study. [2023]Prophylactic antibiotics in urological procedures are essential to prevent postoperative infections. A different approach in selecting antibiotic prophylaxis according to the type of procedure is needed.