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
Summary
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) VolumeMaximum 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.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
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