Renal surgery Surgery
Conditions
Interventions
This pilot trial will recruit 60 men with retention of urine, and these will be randomised in a 1:1 ratio to either continue with the long term catheter that they already have fitted or to have a pros
Sponsors
Royal Devon and Exeter Foundation Trust (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men aged 50 years and older 2. Acute or chronic urinary retention initially treated with a urethral catheter 3. Considered to be medically unfit for, or to present a significant risk for TURP, such that the admitting urologist would consider a long term catheter to be the standard management. 4. Considered by the admitting urologist and trial team to be medically suitable to be managed with a long term prostatic stent
Exclusion criteria
Exclusion criteria: 1. Inability or unwillingness to sign informed consent form / any written questionnaire and participate in investigation due to physical or mental limitations 2. Meatal or urethral strictures that cannot be opened to 26 Fr 3. Urethral diverticuli 4. Any known condition requiring transurethral manipulations within 6 months after stent placement 5. Bladder stones, bladder or urethral carcinoma 6. Prior TURP or other surgical intervention for BPH within the last year 7. Presence of another urological prosthesis 8. Unresolved major symptomatic medical problem which would interfere with the investigation, including any and all disorders contraindicating insertion and/or removal procedure 9. Life expectancy < 1 year 10. Concurrent participation in another clinical trial during the period of this investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health Related Quality of Life measured using: 1. SF-36 at baseline, 3 months and 6 months 2. ICIQ-MLUTS at baseline, 3 months and 6 months 3. ICIQ-LUTSqol at baseline, 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed