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Tamculosin for urinary retention in hip fracture patients

Efficacy and safety of tamsulosin in prevention of post-operative urinary retention in hip fracture: a randomized double-blind placebo-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042897
Enrollment
118
Registered
2022-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue Health Condition 2: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: Tamsulosin: Tamsulosin 0.4mg OD from the time of admission to two days postoperatively Control Intervention1: Placebo: Starch capsule OD from the time of admission to two days postopera

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients undergoing hip fracture surgery (ORIF or arthroplasty) 2. >=18 years of age. 3. Patients willing to participate

Exclusion criteria

Exclusion criteria: 1. History of neurogenic bladder or urological problems requiring routine intermittent catheterization 2. Patients unable to take an oral medication 3. Patient who would require an indwelling catheter for other reasons, or patients who needed catheterisation during admission to the emergency for voiding difficulty 4. Patients with systolic blood pressure 5. Pregnant women 6. Associate trauma of spine or pelvis 7. Patients taking medications for lower urinary tract symptoms or who had previously undergone prostatectomy 8. Patients with severe liver or kidney disease 9. Patients taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir/ritonavir, lopinavir/ritonavir, or conivaptan), use of a 5-alpha reductase inhibitor medication, the use of sildenafil, tadalafil, or vardenafil, history of an allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, Terazosin, or phenoxybenzamine), 10. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection 11. Congestive heart failure, unstable angina pectoris, cardiac arrhythmia, 12. Psychiatric illness

Design outcomes

Primary

MeasureTime frame
1. Number of patients developing postoperative urinary retention (POUR)Timepoint: 6 hours of surgery

Secondary

MeasureTime frame
1. No. of patients needing urinary catheter placement (unable to void, bladder scan with 500 mL residual urine or patient discomfort) 2. No. of intermittent catheterization 3. Total days of hospital stay 4. Analgesic use 5. No. of patient developing UTI or surgical site infection 6. No. of patient developing other complications such as VTE, pneumonia, hypotension or cardiac event Timepoint: within hospital admission period

Countries

India

Contacts

Public ContactSujit Kumar Tripathy

AIIMS Bhubaneswar

sujitortho@aiimsbhubaneswar.edu.in9438884155

Outcome results

None listed

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