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Will the short duration of Tablet Bicalutamide prevent catheter dependence in patients with urinary retention due to benign prostatic hypertrophy?

Short term course of Androgen receptor blocker (Bicalutamide) - Does it improve the results of trial void without catheter in refractory urinary retention due to Benign prostatic hypertrophy - A single arm clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049027
Enrollment
43
Registered
2023-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: N399- Disorder of urinary system, unspecified

Interventions

Intervention1: Tablet Bicalutamide 50mg BID for 2 months and OD for 1month.: Trial void will be assessed at follow-ups at 1,3,6 and 12months. Patients who void successfully, improvement in IPSS scores

Sponsors

SRI BALAJI VIDYAPEETH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ALL PATIENTS WITH BENIGN PROSTATIC HYPERTROPHY WITH REFRACTORY RETENTION, WHO FAIL TRIAL VOID WITHOUT CATHETER ON DUAL DRUG THERAPY

Exclusion criteria

Exclusion criteria: PATIENTS WITH BENIGN PROSTATIC HYPERTROPHY ON CATHETER OPTING FOR SURGERY. PATIENTS WITH OTHER UROLOGICAL DISEASES SUCH AS BLADDER CALCULI DUE TO BENIGN PROSTATIC HYPERTROPHY, CHRONIC URINARY RETENTION, RECURRENT URINARY TRACT INFECTION, AND PROSTATIC ADENOCARCINOMA.

Design outcomes

Primary

MeasureTime frame
TO EVALUATE THE RESULTS OF TRIAL VOID WITHOUT CATHETER WITH THREE MONTHS OF BICALUTAMIDE, IN PATIENTS WITH REFRACTORY URINARY RETENTION DUE TO BENIGN PROSTATIC HYPERTROPHY. INTERNATIONAL PROSTATE SYMPTOM SCORE UROFLOWMETRY POSTVOID RESIDUE AFTER SUCCESSFUL VOID ULTRASOUND ABDOMEN WITH PELVISTimepoint: 1 MONTH, 3 MONTH, 6 MONTH AND 12 MONTH—

Secondary

MeasureTime frame
IPSS SCORE IMPROVEMENT SERUM TESTOSTERONE SERUM PSATimepoint: 1 MONTH, 3 MONTH, 6 MONTH AND 12 MONTH—

Countries

India

Contacts

Public ContactSUHAS U

MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE, PUDUCHERRY

kalyanramkone@gmail.com

Outcome results

None listed

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