FLOMAX® Versus Placebo, in Male Patients With Acute Urinary Retention Related to Benign Prostatic Hyperplasia (BPH)

NCT02244294 | Completed Phase 2

• 1 other identifier: 527.26
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

Brief Summary

To establish whether the administration of FLOMAX® improves the outcome of a trial without catheter (TWOC) after an episode of acute urinary retention and to determine whether spontaneous voiding is maintained over the course of six months of active treatment

Conditions

Prostate Hyperplasia

Outcome Measures

Primary Outcomes (2)

• Successful spontaneous voiding after urethral catheter removal

  For Phase I of the trial

  Up to 96 hours after start of treatment

• Maintenance of successful spontaneous voiding

  For Phase II of the trial

  Up to 6 months after start of treatment

Secondary Outcomes (5)

• Change in voided urine volume

  Up to 6 months after start of treatment

• Determination of post-void residual urine volume

  Up to 6 months after start of treatment

• Time to recurrence of AUR

  Up to 6 months after start of treatment

• Clinically significant changes from baseline in vital signs

  Pre-dose, up to 6 months after start of treatment

• Number of patients with adverse events

  Up to 6 months

Study Arms (2)

FLOMAX®

EXPERIMENTAL

Drug: FLOMAX® capsules

Placebo

PLACEBO COMPARATOR

Drug: Placebo capsules

Interventions

FLOMAX® capsules DRUG

Also known as: Tamsulosin hydrochloride

FLOMAX®

Placebo capsules DRUG

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase I
• Adult men, 45 years of age or older, diagnosed with acute urinary retention due to BPH
• Patients who have never taken alpha-blockers or discontinued taking alpha-blockers 72 hours or more prior to entrance into this study
• Patients that have been treated with an indwelling urethral catheter as treatment for acute urinary retention (AUR) due to BPH
• Patients must be judged by the investigator to be reliable and willing to comply with all tests and examinations stipulated in the protocol
• All patients must be willing to give meaningful, written, informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must also have sufficient understanding to communicate effectively with the investigator
• Phase II - Patients who voided spontaneously, at least 100 mL and a post-void residual volume of ≤ 300 mL, at Visit 2

You may not qualify if:

• Phase I
• Patients diagnosed with a symptomatic/active urinary tract infection (UTI) or an abnormal urine culture at baseline or 2 or more UTIs within the last six months. An abnormal urine culture was defined as:
• A bacterial colony count of greater than or equal to 100,000 CFU/mL or
• A bacterial colony count of greater than or equal to 100 CFU/mL of a known urinary pathogen in a symptomatic patient
• Patients that have a distended bladder volume greater than 1.5 liters (1500 ml) of retention as measured by initial catheter urine volume
• Patients with history of sexually transmitted disease within last two years
• Patients with active genital herpes disease whose urinary function was impacted due to the disease
• Patients who have a history of mechanical outlet obstruction excluding BPH (i.e., bladder neck contracture or stricture, bladder tumor, or bladder calculi)
• Patients with urethral stricture disease
• Patients with a history of bladder, prostate, or urethral surgery in the last three months
• Patients presenting with AUR who were not been seen within 5 days of urethral catheter placement
• Patients presenting with any of the following: active urinary stone disease, previous pelvic radiotherapy, perirectal inflammatory disorders or inflammatory bowel disease
• Participation in another drug study within 30 days of Visit 1
• Clinically relevant conditions which may interfere with the patient's ability to participate in the study including, but not limited to, the following: neurologic, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, hematologic or respiratory disease and clinically relevant laboratory abnormalities not mentioned above (e.g., hematuria) based upon the clinical judgment of the investigator
• Patients receiving cimetidine, ranitidine or warfarin within two weeks of study start date and who would potentially use such medications during the course of the trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 19, 2014
• Study Start: March 1, 2001
• Primary Completion: June 1, 2005
• Last Updated: September 19, 2014

Record last verified: 2014-09