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Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)

Information source: Siami, Paul F., M.D.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Benign Prostatic Hyperplasia (BPH)

Intervention: Tolterodine ER 4mg (Drug); Placebo (Drug); Pre-randomization Dutasteride (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Siami, Paul F., M.D.

Official(s) and/or principal investigator(s):
Paul F Siami, MD, Principal Investigator, Affiliation: Deaconess Clinic Research Institute


This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride given for 18 months, including a 1-year double-blind randomized co-administration with either tolterodine ER or placebo in men suffering from lower urinary tract symptoms (LUTS) including urgency and frequency, with or without urgency urinary incontinence (i. e., overactive bladder (OAB) symptoms).

Clinical Details

Official title: A Randomized, Double-blind, Placebo-controlled, Study of Safety and Efficacy of Dutasteride in Combination With Tolterodine ER or Placebo in Men With Lower Urinary Tract Symptoms (LUTS) Including Urgency and Frequency

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Post-void Residual (PVR) Volume

Maximum Urine Flow Rate (Qmax).

Urine Voided Volume (Voiding)

Acute Urinary Retention (AUR)

Secondary outcome:

Overactive Bladder Questionnaire (OABq)

Patient Perception of Bladder Condition (PPBC)

International Prostate Symptoms Score (IPSS), Total

International Prostate Symptoms Score, Voiding Subscore

International Prostate Symptoms Score (IPSS), Storage Subscore

Detailed description: Men who are treated with an alpha blocker (AB) or 5-alpha reductase inhibitor (5-ARI) for benign prostatic enlargement (BPE) and lower urinary tract symptoms (LUTS) often have symptoms including urinary frequency and urgency. ABs and 5-ARIs may improve the obstructive voiding symptoms but not necessarily the storage symptoms. This study will evaluate the safety and efficacy of dutasteride 0. 5 mg once daily for 6 months in an open label fashion. Those patients who continue to report storage urinary symptoms, will be randomized to receive dutasteride 0. 5 mg once daily for an additional one year together with double-blind tolterodine ER 4 mg or matched tolterodine ER placebo once daily.


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.


Inclusion Criteria: This subject population will consist of males ≥ 50 years of age who have lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) for a minimum of 3 months Inclusion criteria at screening: 1. Subjects who understand and speak English and are able to comply with the protocol, complete the diaries, and other study tools 2. Subject has provided written informed consent and HIPAA authorization 3. Ambulatory male subjects ≥ 50 years of age 4. Able to use the toilet without difficulty 5. History of LUTS due to BPE, as diagnosed by history as well as digital rectal exam (DRE), for ≥ 3 months suitable for medical therapy with 5-ARI in combination with antimuscarinic drugs 6. Prostate volume (PV) ≥ 30 cc as measured by transrectal ultrasound (TRUS) 7. International prostate symptoms score (IPSS) ≥12 8. Post Void Residual Volume < 150 mL at baseline 9. Uroflowmetry-Qmax > 5 mL/sec and ≤ 15 mL/sec 10. Prostate specific antigen (PSA) ≥ 1. 5 ng/ml and in normal age-adjusted range. For those subjects with an elevated age-adjusted PSA, it is the responsibility of the investigator to take standard of care measures to assure reasonable absence of prostate cancer 11. Have an average of ≥ 8 micturitions per 24 hrs 12. Have an average of 2 episodes of urgency per 24 hrs (defined as those with the Urinary Sensation Scale rating of 3 or more) Exclusion Criteria: 1. Concurrent use of 5-ARI therapy within the past 3 months 2. Concurrent use of alpha blockers within the past 2 weeks 3. Concurrent use of antimuscarinics within the past 4 weeks 4. Concurrent use of Phosphodiesterase type 5 (PDE-5) inhibitors on a daily basis 5. Evidence of chronic inflammation such as interstitial cystitis and bladder stones. 6. Evidence of untreated urethral stricture disease 7. Uncontrolled narrow angle glaucoma 8. Increased post-void residual volume (PVR) defined as PVR > 150 mL 9. Uroflowmetry-Qmax ≤ 5 mL/sec 10. Acute urinary tract infection (UTI). These subjects may be treated and re-screened 11. Acute urinary retention (AUR) requiring catheter within the last 3 months 12. Previous or planned transurethral resection of the prostate (TURP) 13. Minimally invasive surgery (MIS) such as transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other minimally invasive procedures within 12 months. Those patients who in the opinion of the investigator did not respond adequately to MIS and fulfill the inclusion criteria are eligible to participate 14. A known diagnosis of prostate cancer. 15. A known diagnosis of bladder cancer within 5 years of screening. Those patients with history of non-muscle invasive bladder cancer who have not had a recurrence in the past 5 years are eligible to screen for this study and must maintain continued adequate bladder cancer screening at the discretion of the Investigator 16. Renal or hepatic impairment defined as 2. 5 x upper limit of normal. Some isolated abnormalities would be left at the discretion of the investigator with always keeping in mind to not pose a hazard to the patient. 17. PSA > 10 ng/mL (if the PSA is greater than 4 ng/mL and less than or equal to 10 ng/mL, subjects may be included at the discretion of the Investigator if the PSA has been stable and the patient has had a prostate biopsy showing no evidence of prostate cancer) 18. Known or suspected hypersensitivity to dutasteride or tolterodine ER . 19. Participation in a clinical trial involving an investigational drug, within 30 days prior to enrollment. 20. History of diagnosed gastrointestinal obstruction disease. 21. Myocardial infarction within the past 8 weeks. 22. Known or suspected drug and/or alcohol abuse. 23. Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study.

Locations and Contacts

Deaconess Clinic Gateway Health Center, Newburgh, Indiana 47630, United States
Additional Information

Starting date: July 2009
Last updated: April 15, 2015

Page last updated: August 23, 2015

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