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Multicenter clinical study for early use of M-blockers to prevent irreversible damage of detrusor muscle in patients with benign prostatic hyperplasia

Multicenter clinical study for early use of M-blockers to prevent irreversible damage of detrusor muscle in patients with benign prostatic hyperplasia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025399
Enrollment
Unknown
Registered
2019-08-26
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

Benign prostatic hyperplasia

Interventions

Group 1:a1-blockers
Group 2:a1-blockers and M-blockers

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male BPH patients aged 45-80 years old; 2. IPSS score is greater than or equal to 8; 3. Willingness to receive medication; 4. Qmax is less than or equal to 15; 5. Voided volume during free flow is greater than or equal to 120ml; 6. Urinary B-ultrasound found that the prostate volume is greater than 20ml.

Exclusion criteria

Exclusion criteria: 1.Patients with serum PSA>10 ng/ml, suspected and diagnosed with prostate cancer; 2.Severe obstruction of bladder outlet (residual urine greater than 200ml or Qmax less than 5mL/s); 3.Baseline urodynamics showed severe damage to the bladder detrusor function; 4.The prostate volume is greater than 80ml; 5.Patients treated with 5a reductase inhibitors, alpha blockers, and M receptor antagonists within 3 months; 6.Liver and kidney dysfunction, allergic to research drugs, or patients with drug contraindications; 7.History of orthostatic hypotension or syncope, history of acute urinary retention, history of urinary tract infection or recurrent urinary tract infection (greater than or equal to 3 times/year); 8.History of previous prostate and bladder neck surgery; 9.Neurogenic (multiple sclerosis, spinal cord injury, Parkinson's disease) bladder dysfunction, diabetic neuropathy; 10.Bladder outlet obstruction caused by other causes besides BPH.

Design outcomes

Primary

MeasureTime frame
B-ultrasonography of urinary system;

Secondary

MeasureTime frame
OABSS;IPSS;Urodynamic test;Voiding diary;

Countries

China

Contacts

Public ContactKunjie WANG

Department of Urology, Institute of Urology (Laboratory of Reconstructive Urology), West China Hospital, Sichuan University

wangkj@scu.edu.cn+86 18980601848

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026