The study on the efficacy and safety of combination of low dose propiverine hydrocholoride and alpha-antagonist in men with BPH with overactive bladder

Not Applicable

Recruiting

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0000077
• Lead Sponsor: Inha University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 236

Inclusion Criteria

1. signed Informed consent form
2. Male aged more than 45
3. IPSS more than 12
4. Enlarged prostate on DRE
5. Symptoms of urinary urgency with voiding 3/day
6. Symptoms of urinary frequency (8 micturitions per 24 hours)
7. Symptoms of LUTS more than 3 months
8. understanding and agreed the purpose of trial

Exclusion Criteria

1. Total daily urine volume of > 3000 ml
2. Initial RU more than 150ml
3. Significant hepatic or renal disease
(twice the upper limit of the reference ranges for serum concentrations of AST [SGOT], ALT [SGPT], alkaline phosphatase or creatinine)
4. Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
5. Symptomatic acute urinary tract infection (UTI) during the run-in period
6. Recurrent UTIs defined as having been treated for symptomatic UTIs > 4 times in the last year
7. Diagnosed or suspected interstitial cystitis
8. Clinically significant hematuria or hematuria secondary to malignant disease.
9. PSA more than 10ng/dl (can include PSA between 4 and 10 if biopsy is negative)
10. Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs other than randomized trial drug
11. Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study
12. An indwelling catheter or practicing intermittent self-catheterization
13. Use of any investigational drug within 2 months preceding the start of the study
14. Patients with chronic constipation or history of severe constipation
15. Patients who have bladder cancer or prostate cancer
16. History of bladder and prostate surgery
17. suspicious prostatitis
18. suspicious neurogenic bladder
19. Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
urgency episodes with voiding

Secondary Outcome Measures

Name	Time	Method
urgency episodes without voiding ;number of total voiding;number of total urgency;number of nocturia;voided volume of one time;IPSS score;OABSS score;OABqSF score;Global Impression of improvement score;uroflowmetry and PVR ;Incidence of acute urinary retention requiring catheterization;Voiding difficulties requiring study medication to be discontinued;Incidence and severity of adverse events;Incidence and reason of withdrawals