Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1

NCT01661621 | Completed Phase 4 Results

• 1 other identifier: TCGHUROL002
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective randomized, open label, controlled, double arm, post-marketing study to compare the treatment efficacy of first-line antimuscarinics and α-blockers monotherapy for men with moderate to severe lower urinary tract symptoms (LUTS) (International Prostate Symptom Score (IPSS-T) ≥8) and IPSS voiding-to-storage subscore ratio (IPSS-V/S) ≤1.

Conditions

Bladder Outlet Obstruction

Keywords

Lower urinary tract symptoms (LUTS); International Prostate Symptom Score (IPSS); Antimuscarinics; α-blockers

Outcome Measures

Primary Outcomes (1)

• The Global Response Assessment (GRA) After the Treatment Day

  Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month. The global response assessment on a 6-point scale ranging from 1 "No problems at all" to 6 "Many severe problems". Changes of the global response assessment (GRA) improved or reduction by 1 points. Change = Baseline minus Month 1 value Safety: Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness

  1 month after initial treatment

Secondary Outcomes (7)

• The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day

  Baseline and 1 month

• The Maximum Flow Rate (Qmax) After the Treatment Day

  Baseline and 1 month

• The Voided Volume After the Treatment Day

  Baseline and 1 month

• The Postvoid Residual Volume (PVR) After the Treatment Day

  Baseline and 1 month

• The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day

  Baseline and 1 month

Study Arms (2)

Group 1

EXPERIMENTAL

Antimuscarinics (Detrusitol 4 mg QD)

Drug: Detrusitol 4 mg QD

Group 2

EXPERIMENTAL

α-blockers (Doxazosin 4 mg QD)

Drug: Doxazosin 4 mg QD

Interventions

Detrusitol 4 mg QD DRUG

Group 1

Group 1

Doxazosin 4 mg QD DRUG

Group 2

Group 2

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged ≥40 years with lower urinary tract symptoms (IPSS ≥8)
• Patient or his/her legally acceptable representative has signed the written informed consent form

You may not qualify if:

• Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
• Patients with urinary retention, urodynamically proven detrusor underactivity or PVR ≥250 mL
• Patients with known active urinary tract infection, urinary stone or malignancy
• Patients with history of urethral injury or transurethral surgery for prostate or bladder
• Patients have laboratory abnormalities at screening including:
• Aspartate aminotransferase (AST) \>3 x upper limit of normal range
• Alanine aminotransferase (ALT) \>3 x upper limit of normal range
• Patients have abnormal serum creatinine level \>2 x upper limit of normal range
• Patients with any other serious disease or condition considered by the investigator not suitable for entry into the trial
• Patients participated investigational drug trial within 1 month before entering this study
• Patients with major psychiatric illness or drug abuse
• Patients taken medication such as alpha-blocker, antimuscarinic or 5 alpha-reductase (5AR) inhibitor within 6 months

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, 970, Taiwan

Location

Related Publications (16)

• Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.

  PMID: 11857671 BACKGROUND

• Chapple CR, Roehrborn CG. A shifted paradigm for the further understanding, evaluation, and treatment of lower urinary tract symptoms in men: focus on the bladder. Eur Urol. 2006 Apr;49(4):651-8. doi: 10.1016/j.eururo.2006.02.018. Epub 2006 Feb 17.

  PMID: 16530611 BACKGROUND

• Athanasopoulos A, Gyftopoulos K, Giannitsas K, Fisfis J, Perimenis P, Barbalias G. Combination treatment with an alpha-blocker plus an anticholinergic for bladder outlet obstruction: a prospective, randomized, controlled study. J Urol. 2003 Jun;169(6):2253-6. doi: 10.1097/01.ju.0000067541.73285.eb.

  PMID: 12771763 BACKGROUND

• Lee JY, Kim HW, Lee SJ, Koh JS, Suh HJ, Chancellor MB. Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU Int. 2004 Oct;94(6):817-20. doi: 10.1111/j.1464-410X.2004.05039.x.

  PMID: 15476515 BACKGROUND

• Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. doi: 10.1001/jama.296.19.2319.

  PMID: 17105794 BACKGROUND

• Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. J Urol. 2009 Dec;182(6):2825-30. doi: 10.1016/j.juro.2009.08.023. Epub 2009 Oct 17.

  PMID: 19837435 BACKGROUND

• Chung DE, Te AE, Staskin DR, Kaplan SA. Efficacy and safety of tolterodine extended release and dutasteride in male overactive bladder patients with prostates >30 grams. Urology. 2010 May;75(5):1144-8. doi: 10.1016/j.urology.2009.12.010. Epub 2010 Mar 5.

  PMID: 20206978 BACKGROUND

• Chung SD, Chang HC, Chiu B, Liao CH, Kuo HC. The efficacy of additive tolterodine extended release for 1-year in older men with storage symptoms and clinical benign proastatic hyperplasia. Neurourol Urodyn. 2011 Apr;30(4):568-71. doi: 10.1002/nau.20923. Epub 2011 Feb 22.

  PMID: 21344494 BACKGROUND

• Blake-James BT, Rashidian A, Ikeda Y, Emberton M. The role of anticholinergics in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a systematic review and meta-analysis. BJU Int. 2007 Jan;99(1):85-96. doi: 10.1111/j.1464-410X.2006.06574.x. Epub 2006 Oct 9.

  PMID: 17026588 BACKGROUND

• Martin-Merino E, Garcia-Rodriguez LA, Masso-Gonzalez EL, Roehrborn CG. Do oral antimuscarinic drugs carry an increased risk of acute urinary retention? J Urol. 2009 Oct;182(4):1442-8. doi: 10.1016/j.juro.2009.06.051. Epub 2009 Aug 15.

  PMID: 19683302 BACKGROUND

• McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.

  PMID: 21420124 BACKGROUND

• Djavan B, Margreiter M, Dianat SS. An algorithm for medical management in male lower urinary tract symptoms. Curr Opin Urol. 2011 Jan;21(1):5-12. doi: 10.1097/MOU.0b013e32834100ef.

  PMID: 21045704 BACKGROUND

• Kaplan SA, Roehrborn CG, Abrams P, Chapple CR, Bavendam T, Guan Z. Antimuscarinics for treatment of storage lower urinary tract symptoms in men: a systematic review. Int J Clin Pract. 2011 Apr;65(4):487-507. doi: 10.1111/j.1742-1241.2010.02611.x. Epub 2011 Jan 7.

  PMID: 21210910 BACKGROUND

• Athanasopoulos A, Chapple C, Fowler C, Gratzke C, Kaplan S, Stief C, Tubaro A. The role of antimuscarinics in the management of men with symptoms of overactive bladder associated with concomitant bladder outlet obstruction: an update. Eur Urol. 2011 Jul;60(1):94-105. doi: 10.1016/j.eururo.2011.03.054. Epub 2011 Apr 9.

  PMID: 21497434 BACKGROUND

• Chapple C. Antimuscarinics in men with lower urinary tract symptoms suggestive of bladder outlet obstruction due to benign prostatic hyperplasia. Curr Opin Urol. 2010 Jan;20(1):43-8. doi: 10.1097/MOU.0b013e3283330862.

  PMID: 19875964 BACKGROUND

• Liao CH, Chung SD, Kuo HC. Diagnostic value of International Prostate Symptom Score voiding-to-storage subscore ratio in male lower urinary tract symptoms. Int J Clin Pract. 2011 May;65(5):552-8. doi: 10.1111/j.1742-1241.2011.02638.x.

  PMID: 21489080 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neck Obstruction; Lower Urinary Tract Symptoms

Interventions

Tolterodine Tartrate; Doxazosin

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols; Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Hann-Chorng Kuo
• Organization: Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University

hck@tzuchi.com.tw

886-3-8561825

Study Officials

• Hann-Chorng Kuo, M.D.

  Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Urology

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 9, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 25, 2014
• Results First Posted: June 25, 2014

Record last verified: 2014-06

Locations

TW (1)