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

NCT00939120 | Completed Phase 4 Results DMC

• 1 other identifier: 110983
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Benign prostatic hyperplasia (BPH); dutasteride; tolterodine ER

Outcome Measures

Primary Outcomes (4)

• Post-void Residual (PVR) Volume

  To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.

  12 months

• Maximum Urine Flow Rate (Qmax).

  To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry.

  12 months

• Urine Voided Volume (Voiding)

  To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry.

  12 months

• Acute Urinary Retention (AUR)

  To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization.

  12 months

Secondary Outcomes (5)

• Overactive Bladder Questionnaire (OABq)

  12 months

• Patient Perception of Bladder Condition (PPBC)

  12 months

• International Prostate Symptoms Score (IPSS), Total

  12 months

• International Prostate Symptoms Score, Voiding Subscore

  12 months

• International Prostate Symptoms Score (IPSS), Storage Subscore

  12 months

Study Arms (2)

Tolterodine ER 4mg

EXPERIMENTAL

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

Drug: Tolterodine ER 4mg; Drug: Pre-randomization Dutasteride

placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Pre-randomization Dutasteride

Interventions

Tolterodine ER 4mg DRUG

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

Also known as: Detrol LA

Tolterodine ER 4mg

Placebo DRUG

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

placebo

Pre-randomization Dutasteride DRUG

All participants were on Dutasteride 0.5mg orally once daily prior to randomization.

Tolterodine ER 4mg; placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subjects who understand and speak English and are able to comply with the protocol, complete the diaries, and other study tools
• Subject has provided written informed consent and HIPAA authorization
• Ambulatory male subjects ≥ 50 years of age
• Able to use the toilet without difficulty
• 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
• Prostate volume (PV) ≥ 30 cc as measured by transrectal ultrasound (TRUS)
• International prostate symptoms score (IPSS) ≥12
• Post Void Residual Volume \< 150 mL at baseline
• Uroflowmetry-Qmax \> 5 mL/sec and ≤ 15 mL/sec
• 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
• Have an average of ≥ 8 micturitions per 24 hrs
• Have an average of 2 episodes of urgency per 24 hrs (defined as those with the Urinary Sensation Scale rating of 3 or more)

You may not qualify if:

• Concurrent use of 5-ARI therapy within the past 3 months
• Concurrent use of alpha blockers within the past 2 weeks
• Concurrent use of antimuscarinics within the past 4 weeks
• Concurrent use of Phosphodiesterase type 5 (PDE-5) inhibitors on a daily basis
• Evidence of chronic inflammation such as interstitial cystitis and bladder stones.
• Evidence of untreated urethral stricture disease
• Uncontrolled narrow angle glaucoma
• Increased post-void residual volume (PVR) defined as PVR \> 150 mL
• Uroflowmetry-Qmax ≤ 5 mL/sec
• Acute urinary tract infection (UTI). These subjects may be treated and re-screened
• Acute urinary retention (AUR) requiring catheter within the last 3 months
• Previous or planned transurethral resection of the prostate (TURP)
• A known diagnosis of prostate cancer.
• 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
• 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.

Sponsors & Collaborators

• Siami, Paul F., M.D.: lead
• GlaxoSmithKline: collaborator
• Pfizer: collaborator

Study Sites (1)

Deaconess Clinic Gateway Health Center

Newburgh, Indiana, 47630, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Results Point of Contact

• Title: Dr. Paul Siami
• Organization: Research institute at Deaconess Clinic

paul.siami@deaconess.com

812-426-9548

Study Officials

• Paul F Siami, MD

  Deaconess Clinic Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Deaconess Clinic Research Institute

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: July 14, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 1, 2015
• Results First Posted: May 1, 2015

Record last verified: 2015-04

Locations

US (1)