Memokath Prostatic Stent Study

Not Applicable

Completed

• Conditions: Renal surgery; Surgery

• Registration Number: ISRCTN33583715
• Lead Sponsor: Royal Devon and Exeter Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-11
• Study Completion: 2012-09-15
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified