The efficacy on dysuria and safety of combination therapy with terazosin and bethanechol in Benign Prostatic Hyperplasia patients with Underactive Bladder

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005772

Enrollment

123

Registered

2021-01-13

Start date

2024-02-08

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Experiment group 1: terazosin 5mg QD + bethanechol 25mg BID for 12 weeks Experiment group 2: terazosin 2.5mg QD + bethanechol 25mg BID for 12 weeks Control group: terazosin 2.5mg QD for 12 week

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) Patients over 19 years diagnosed with benign prostatic hyperplasia (2) Those with an IPSS total score of 8 or more and a maximum urine velocity of 15mL/s or less (3) Those with BVE(Bladder Void Efficiency)<90 *BVE=(Voided Volume/(Voided Volume+Post Voided Residual)*100) (4) Those who voluntarily decide to participate in this study and consent in writing to the subject's consent.

Exclusion criteria

Exclusion criteria: (1) Patients with urinary tract stones, urethral stenosis or urinary tract infection (2) Prostate cancer patients or patients who have undergone prostate surgery (3) Patients who have undergone surgery due to bladder muscle obstruction or prostatic hyperplasia (4) Patients diagnosed with cardiovascular disease, liver disease, orthostatic hypotension, hypertension or renal dysfunction (5) Patients taking anticholinergic drugs, beta3-antagonists, and 5-alpha reductase inhibitors. (6) Patients with malignant tumors in the urinary tract epithelium (7) Those with hypersensitivity to alpha-blocker agents or cholinergic agents (8) Those with a histoory of urinary tract related surgery (9) Patients with mechanical obstruction of the gastrointestinal tract or urinary tract (10) Convulsive gastrointestinal disease, gastric ulcer, acute gastrointestinal inflammatory disease (11) peritonitis patients (12) Vagus hypertonia patients (13) Asthma patients (14) Patients with hyperthyroidism (15) Patients with coronary artery obstruction (16) Patients with bradycardia, atrioventricular conduction disorder, and vasomotor instability (17) Patients with epilepsy and Parkinsonism (18) Patients who did not heal after undergoing gastric duct anastomosis (19) Others who are inadequate to participate in this research when judged by the research director or the research manager

Design outcomes

Primary

Measure	Time frame
Internation Prostate Symptom Score(IPSS) total change	—

Secondary

Measure	Time frame
Maximum urine velocity(Qmax) change;Post-Void Residual urine(PVR) change;Internation Prostate Symptom Score-QoL(IPSS-QoL) change	—

Countries

Korea, Republic of

Contacts

Public ContactJae Won Park

National Health Insurance Service Ilsan Hospital

epria@nhimc.or.kr+82-44-900-3385

Outcome results