Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03508921
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
The Allergan Foundation
Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction
Information provided by (Responsible Party):
Rachel Sosland, Vanderbilt University Medical Center

Brief Summary:
Injection of OnabotulinumtoxinA (BTX-A) into the bladder is a widely used treatment option for patients with overactive bladder who have failed medical therapy. Urinary tract infection is the most common side effect of this procedure and therefore antibiotics are given around the time of injection in order to prevent these events. While antibiotics are commonly given at the time of injection, the duration of these antibiotic regimens are variable. The investigators propose a study to investigate different antibiotic protocols and their affect on the rate of urinary tract infection after injection.

Condition or disease Intervention/treatment Phase
Overactive Bladder Urinary Tract Infections Procedure: Periprocedural Antibiotics Drug: Extended Antibiotics Procedure: Injection of OnabotulinumtoxinA (BTX-A) Phase 4

Detailed Description:

Intravesical injection of OnabotulinumtoxinA (BTX-A) is a widely practiced third line therapy for non-neurogenic overactive bladder (OAB). However, a paucity of data exists regarding urinary tract infections (UTI), the most common adverse event following injection. The investigators propose a randomized, controlled cross-over trial to investigate the utility of commonly practiced antibiotic protocols and simultaneously derive information regarding risk factors for post-procedural UTIs and their affect on treatment efficacy.

The investigators plan to initiate a prospective, randomized non-inferiority cross-over trial, in which a participant receives peri-procedural antibiotics exclusively at the time of one injection, and then at a subsequent injection, completes a three-day course of antibiotics post-operatively in addition to the peri-procedural dose. Enrollment is planned to achieve a total of 68 participants. Participants will be evaluated at 3 weeks and 3 months following injection to identify adverse events and treatment success. Inter-injection time will be measured and used a surrogate for efficacy over multiple injections.

These results, in addition to filling a void in current literature regarding the increasingly utilized treatment with BTX-A, have the potential to modify clinical practice regarding antibiotic use and decrease rates of adverse events. The means to stratify patients based on their specific risk of UTI may be used to facilitate antibiotic stewardship and improve patient outcomes.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection: a Non-Inferiority Trial
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Periprocedural Antibiotics Only
Patients receive a one-time dose of antibiotics at the time of injection, prior to injection.
Procedure: Periprocedural Antibiotics
One the day of injection, after eligibility is determined and consent obtained, research staff will refer to the randomization list to determine to which arm the patient is randomized. Patients randomized to the "Procedural Antibiotics Only" arm will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally at the time of the first injection.

Procedure: Injection of OnabotulinumtoxinA (BTX-A)
Patients will receive injection of OnabotulinumtoxinA (BTX-A) per standard clinic practice protocol. All patients will undergo injection per a standardized protocol of 1ml injection per site at a concentration of 10 units/ml.

Experimental: Extended Antibiotics
Patients receive a peri-procedural dose of antibiotics and an extended (3-day) course of antibiotics to be taken post-procedurally.
Procedure: Periprocedural Antibiotics
One the day of injection, after eligibility is determined and consent obtained, research staff will refer to the randomization list to determine to which arm the patient is randomized. Patients randomized to the "Procedural Antibiotics Only" arm will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally at the time of the first injection.

Drug: Extended Antibiotics

Patients randomized to the "Extended Antibiotics" arm will receive one dose of trimethoprim/sulfamethoxazole peri-procedurally and additionally be prescribed trimethoprim/sulfamethoxazole twice daily for three days. Patients who are allergic will receive amoxicillin/clavulanic acid (875/125mg) twice daily for three days. If allergic to both of the above antibiotics, patients will receive 100mg nitrofurantoin BID for three days.

For their second injection, they will receive peri-procedural antibiotics only.

Other Name: trimethoprim/sulfamethoxazole

Procedure: Injection of OnabotulinumtoxinA (BTX-A)
Patients will receive injection of OnabotulinumtoxinA (BTX-A) per standard clinic practice protocol. All patients will undergo injection per a standardized protocol of 1ml injection per site at a concentration of 10 units/ml.




Primary Outcome Measures :
  1. Post procedural- urinary tract infection [ Time Frame: 3 weeks post-injection ]
    Development of urinary tract infection as measured by a urine culture with >10^5 bacterial colonies in the setting of symptoms. This outcome will be assessed at the 3 week post-injection visit by a voided urine culture.


Secondary Outcome Measures :
  1. Urinary retention [ Time Frame: 3 weeks post-injection ]
    Development of urinary retention post-procedurally as measured by post void residual volume using a bladder scanner in clinic.

  2. Recurrent urinary tract infection [ Time Frame: up to 12 months post-injection ]
    Development of multiple urinary tract infections after injections, measured by a urine culture and defined as a urine culture with >10^5 bacterial colonies in the setting of urinary symptoms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • ≥ 18 years of age
  • Medication refractory OAB, identified per AUA guidelines

Exclusion criteria:

  • Post void residual urine >150ml on two occasions
  • Untreated, symptomatic UTI
  • Comorbid neurological conditions, including spinal cord injury, systemic neurologic illnesses (i.e. multiple sclerosis, Parkinson's disease) or central nervous system disease (i.e. brain tumor, stroke)
  • Prior pelvic irradiation
  • Current or prior bladder malignancy
  • Hematuria lacking a clinically appropriate evaluation
  • Chronic indwelling or intermittent catheterization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508921


Contacts
Layout table for location contacts
Contact: Rachel Urologic Surgery Resident, MD (615) 322-8990 rachel.sosland@vanderbilt.edu

Locations
Layout table for location information
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
The Allergan Foundation
Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction
Investigators
Layout table for investigator information
Study Director: Melissa Kaufman, MD, PhD Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Rachel Sosland, Vanderbilt University Medical Center:

Layout table for additonal information
Responsible Party: Rachel Sosland, Urology Resident, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03508921     History of Changes
Other Study ID Numbers: 00011112222
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Rachel Sosland, Vanderbilt University Medical Center:
Onabotulinumtoxin

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Urinary Bladder, Overactive
Urinary Tract Infections
Urinary Bladder Diseases
Lower Urinary Tract Symptoms
Anti-Infective Agents, Urinary
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Trimethoprim
Sulfamethoxazole
Botulinum Toxins, Type A
abobotulinumtoxinA
Anti-Infective Agents
Antitubercular Agents
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Neuromuscular Agents
Peripheral Nervous System Agents