A prospective randomised double blind and placebo controlled trial of tamsulosin for post operative urinary retention in men undergoing hip and knee arthroplasty and spinal surgery

ISRCTN ISRCTN19582534
DOI https://doi.org/10.1186/ISRCTN19582534
Protocol serial number N0084096576
Sponsor Department of Health (UK)
Funders The North and South Bank Research and Development Consortium (NHS R&D Support Funding), British Orthopaedic Society
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
09/03/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Amr Mohsen
Scientific

Orthopaedic Department
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA prospective randomised double blind and placebo controlled trial of tamsulosin for post operative urinary retention in men undergoing hip and knee arthroplasty and spinal surgery
Study objectivesCan perioperative use of tamsulosin reduce the incidence of postoperative urinary retention at statistically and clinically significant levels?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPost operative urinary retention
InterventionRandomised controlled trial comparing (a) Tamsulosin and (b) placebo.
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Tamulosin
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date14/07/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target sample size at registration512
Key inclusion criteria512 patients in total
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment30/12/1999
Date of final enrolment14/07/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

09/03/2018: No publications found, verifying study status with principal investigator.
03/02/2016: No publications found, verifying study status with principal investigator.