A Phase 2 interventional study of Ciprofloxacin and Tamsulosin Hydrochloride in Chronic Prostatitis With Chronic Pelvic Pain Syndrome, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-18.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 2, Interventional, and Treatment
Although the cause of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) 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 CP/CPPS 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 CP/CPPS. Patients had long-standing, refractory CP/CPPS and received trial treatments for only 6 weeks. Patients with new diagnoses who are given longer courses of the trial treatments might respond differently.
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder and accounts for approximately 2 million visits to physicians annually in the United States. The substantial impact of CP/CPPS 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 CP/CPPS is used. Chronic prostatitis/chronic 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 CP/CPPS 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 CP/CPPS 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 CP/CPPS. This randomized clinical trial was designed to evaluate whether ciprofloxacin or tamsulosin reduces symptoms of long-standing CP/CPPS 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 CP/CPPS, who are commonly seen in our referral-based urologic practices.
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 196 is above the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 538 studies on the registry; 55 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Men assigned to placebo
Drug: Tamsulosin Hydrochloride Placebo · Drug: Ciprofloxacin placebo
Men assigned to Ciprofloxacin alone
Drug: Ciprofloxacin · Drug: Tamsulosin Hydrochloride Placebo
Men assigned to Tamsulosin alone
Drug: Tamsulosin Hydrochloride · Drug: Ciprofloxacin placebo
Men assigned to a combination of ciprofloxacin and tamsulosin
Drug: Ciprofloxacin · Drug: Tamsulosin Hydrochloride
Ciprofloxacin, 500 mg twice daily
Also known as: CF
Tamsulosin Hydrochloride, 0.4 mg once daily
Also known as: TH
Tamsulosin Hydrochloride Placebo (Placebo-TH) one tablet once daily
Also known as: Placebo-TH
Ciprofloxacin placebo (Placebo-CF) one tablet twice daily
Also known as: Placebo-CF
Change in the NIH-CPSI total score
Change in the overall NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) total score (range of 0-43 points) from baseline to 6 weeks; a higher score indicates a worse outcome
Time frame: Baseline and 6 weeks
Change in the 7-point patient-reported global response assessment (GRA)
GRA assesses the change in overall symptoms from baseline to 6 weeks using a 7-point scale which ranges from:(0) markedly worse to (6) markedly improved.
Time frame: 6 weeks
Change in the physical summary scores on the Medical Outcomes Study 12-Item Short-Form Health Survey (MOS SF-12)
Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP).
Time frame: Baseline and 6 weeks
Change in the mental summary scores on the Medical Outcomes Study 12-Item Short-Form Health Survey (MOS SF-12)
Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).
Time frame: Baseline and 6 weeks
Change in the pain scores of the NIH-CPSI
Change in the pain scores of the NIH-CPSI (range of 0-21 points) from baseline to 6 weeks; a higher score indicates a worse outcome
Time frame: Baseline and 6 weeks
Change in the voiding scores of the NIH-CPSI
Change in the voiding scores of the NIH-CPSI (range of 0-10 points) from baseline to 6 weeks; a higher score indicates a worse outcome
Time frame: Baseline and 6 weeks
Change in the quality of life scores of the NIH-CPSI
Change in the quality of life scores of the NIH-CPSI (range of 0-12 points) from baseline to 6 weeks; a higher score indicates a worse outcome
Time frame: Baseline and 6 weeks
No study locations are listed for this record.
Plan to share: Yes — Data are available at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository: https://repository.niddk.nih.gov/home/
Data sharing details ↗ · repository.niddk.nih.gov
Ran from Sep 1997 to primary completion in Aug 2003, 71 months.
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ciprofloxacin · Tamsulosin
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) →