Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
Intervention: Tolterodine ER 4mg; Placebo; Pre-randomization Dutasteride
Intervention description: 1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4 mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily; 1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily; All participants were on Dutasteride 0.5mg orally once daily prior to randomization.
Intervention MeSH terms: Tolterodine Tartrate; Dutasteride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Benign prostatic hyperplasia (BPH); dutasteride; tolterodine ER

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).
    

Eligibility 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.