Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04552431
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2020-09-11
Brief Title:
Chronic Prostatitis Collaborative Research Network Clinical Trial- Ciprofloxacin and Tamsulosin
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Ciprofloxacin or Tamsulosin in Men With Chronic ProstatitisChronic Pelvic Pain Syndrome a Randomized Double-blind Trial
Status:
COMPLETED
Status Verified Date:
2020-09
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:
CPCRN RCT1
Brief Summary:
Although the cause of chronic prostatitischronic pelvic pain syndrome CPCPPS is unknown physicians sometimes try to treat it with antibiotics or alpha-receptor blockers
In this multicenter double-blind factorial trial 196 men with moderately severe CPCPPS were randomly assigned to 6 weeks of treatment with ciprofloxacin tamsulosin both drugs or placebo Neither ciprofloxacin nor tamsulosin substantively reduced symptoms
Ciprofloxacin and tamsulosin were not effective treatments for CPCPPS Patients had long-standing refractory CPCPPS and received trial treatments for only 6 weeks Patients with new diagnoses who are given longer courses of the trial treatments might respond differently
In this multicenter double-blind factorial trial 196 men with moderately severe CPCPPS were randomly assigned to 6 weeks of treatment with ciprofloxacin tamsulosin both drugs or placebo Neither ciprofloxacin nor tamsulosin substantively reduced symptoms
Ciprofloxacin and tamsulosin were not effective treatments for CPCPPS Patients had long-standing refractory CPCPPS and received trial treatments for only 6 weeks Patients with new diagnoses who are given longer courses of the trial treatments might respond differently
Detailed Description:
Chronic prostatitischronic pelvic pain syndrome CPCPPS is a common disorder and accounts for approximately 2 million visits to physicians annually in the United States The substantial impact of CPCPPS includes bothersome lower urinary tract symptoms sexual dysfunction reduced quality of life and increased health care expenditures The syndrome is diagnosed only on the basis of symptoms principally pain or discomfort in the pelvic region No objective measures can help define the disease Although bacteria can infect the prostate most men with prostatitis have a negative midstream urine culture indicating that bacteria may not be the cause of their symptoms Such men are classified as having National Institutes of Health NIH category III prostatitis the most common of the clinically defined prostatitis syndromes It is by no means clear that the disease is characterized by inflammation of the prostate or that the prostate is responsible for symptoms in a substantial proportion of patients Because of this uncertainty the term CPCPPS is used Chronic prostatitischronic pelvic pain syndrome is commonly seen by primary care practitioners internists and urologists In the Olmsted County Study of Urinary Symptoms and Health Status Among Men a population-based study in Olmstead County Minnesota the overall prevalence rate of a physician-assigned diagnosis of prostatitis was 9 Population-based surveys of symptoms have estimated that the prevalence of the syndrome ranges from 9 to 12 among men It is difficult to estimate the proportion of patients with symptoms lasting longer than 3 months whose disorder remains refractory to empirical therapy These patients are commonly seen by urologists but whether they represent a minor subpopulation of the overall symptomatic group or make up the majority of patients is unknown The investigators chose to study these patients because they present with a troubling long-standing problem and are usually treated with agents of unclear benefit Even if a relatively large number of men whose symptoms last 3 months or more are cured by standard empirical therapy and the clinical scenario the investigators describe is uncommon men with refractory symptoms still present a substantial problem to internists and urologists who have little information to guide therapy Because the cause of CPCPPS is unknown affected men receive many empirical therapies The 2 most common treatments prescribed by physicians are antimicrobial agents and alpha-adrenergic receptor antagonists although there is little objective evidence to support their use Quinolones such as ciprofloxacin are commonly used to treat CPCPPS because of their excellent penetration into the prostate and broad spectrum of coverage for uropathogens and other organisms traditionally believed to be associated with the syndrome Tamsulosin an alpha-blocker is an effective treatment for lower urinary tract symptoms in men with benign prostatic hyperplasia and it has been hypothesized that tamsulosin may improve these symptoms in men with CPCPPS This randomized clinical trial was designed to evaluate whether ciprofloxacin or tamsulosin reduces symptoms of long-standing CPCPPS of at least moderate severity typical of the 488 men in our Chronic Prostatitis Cohort Study The primary purpose of the trial was to test the most common prescription treatments given to men with CPCPPS who are commonly seen in our referral-based urologic practices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| U01DK065209 | NIH | None | httpsreporternihgovquickSearchU01DK065209 |