Study of FLOMAX® Versus Placebo in Female Patients With Lower Urinary Tract Symptoms (LUTS) With a Significant Component of Voiding Symptoms

NCT02244281 | Completed Phase 2

• 1 other identifier: 527.25
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To study the symptomatic improvement in LUTS afforded by FLOMAX® capsules, 0.4 mg daily compared to placebo, in female patients with lower urinary tract symptoms (LUTS) with a significant component of voiding symptoms
2. 2.To study the improvement afforded by FLOMAX® capsules versus placebo, in this patient population, in quality of life
3. 3.To assess the safety and tolerability of FLOMAX® capsules, 0.4 mg compared to placebo, in women suffering from LUTS with a significant component of voiding symptoms

Conditions

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• Assessment of efficacy on a American Urological Association (AUA) Symptom Score Index

  Up to day 56 after first study drug administration

Secondary Outcomes (6)

• Assessment of Quality of Life on a incontinence impact questionary and urogenital distress inventory

  Up to day 56 after first study drug administration

• Assessment of urinary frequency and nocturia on a seventy-two hour voiding diary

  Up to day 28 after first study drug administration

• Assessment of urinary obstruction

  Up to day 56 after first study drug administration

• Assessment of Post-Void Residual volume

  Up to day 56 after first study drug administration

• Assessment of lower urinary tract symptoms of obstruction

  Up to day 56 after first study drug administration

Study Arms (2)

FLOMAX®

EXPERIMENTAL

Drug: tamsulosin hydrochloride

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

tamsulosin hydrochloride DRUG

Also known as: FLOMAX®

FLOMAX®

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Adult women, 18 years of age or older, currently diagnosed with LUTS with a significant component of voiding symptoms
• The Patient must be diagnosed with one of the following: hesitancy, intermittency, difficulty in bladder emptying, or straining to void
• Patients must have had an AUA Symptom Score of 13 or higher
• Obstruction component of AUA Symptom Score (Items 1, 3, 5, and 6) had to be 5 points or higher
• Patients that are currently taking alpha-blockers or anticholinergics must discontinue the drugs at least 2 weeks prior to Visit 1
• Patients should show compliance of greater than or equal to 80% with placebo usage
• Patients should be surgically sterile, or 2 years postmenopausal, or practicing a medically acceptable method of birth control
• Patients must have a negative urine Beta Human Chorionic Gonadotropin (beta-HCG)
• Patients must be able to provide written informed consent prior to participation in the study in accordance with regulatory requirements
• Patients must be judged by the investigator to be reliable and should comply with all tests and examinations stipulated in the protocol
• All patients should be able to understand and read English

You may not qualify if:

• Patients who presented with an active urinary tract infection or who had presented with two or more culture positive urinary tract infections within 6 months of the study
• Patients with significant prolapse beyond the hymenal ring, per the investigator's judgment
• Patients who had taken anticholinergic medications for the treatment of other urologic conditions and had not discontinued their use 2 weeks prior to study entry
• Patients who had a history or active condition of renal or urethral calculi, urethral colic, mechanical outlet obstruction (i.e., bladder neck contracture or stricture, bladder tumor, or bladder calculi) 3 months prior to study entry
• Patients with a history of bladder, vaginal or urethral surgery in the last 6 months
• Patients who have a history of microscopic hematuria and not had a recent work-up including cystoscopy and upper urinary tract study (within 6 months of screening) or a diagnosis of a condition that may exclude the patient in the opinion of the investigator
• Abnormal urinalysis as defined by the following mid-stream, clean-catch specimen results:
• A bacterial colony count of greater than 100,000/ml.
• More than 10 leukocytes per high power field with more than two granular casts per high power field.
• More than 10 red blood cells (non-menstrual tainted urine sample) per high power field.
• Proteinuria \>+1 (equivalent to \>30 mg/dL)
• Patients presenting with any of the following: history of a neurogenic bladder due to any neurologic condition that might involve the lower urinary tract, active urinary stone disease, previous pelvic radiotherapy, perirectal inflammatory disorder or inflammatory bowel disease
• Patients that had a history of sexually transmitted diseases of the genitourinary system such as syphilis, herpes, gonorrhea, chlamydia, mycoplasma, trichomonas (within 3 months of the study) or any other diagnosis that in the opinion of the investigator may have excluded the patient
• Patients that are pregnant or breast-feeding
• The Patient has significant pelvic pain that demands treatment with narcotics

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: May 1, 2001
• Primary Completion: November 1, 2003
• Last Updated: September 19, 2014

Record last verified: 2014-09