Status:
UNKNOWN
Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods
Lead Sponsor:
North Bristol NHS Trust
Collaborating Sponsors:
University of Bristol
University of Aberdeen
Conditions:
Lower Urinary Tract Symptoms
Voiding Dysfunction
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Background and study aims: The prostate gland sits around the exit of the bladder in men. As men get older, the prostate grows, and this can narrow the exit from the bladder, so that there is restrict...
Detailed Description
The aim of the UPSTREAM trial ("UPSTREAM - Phase I") was to determine whether a care pathway including invasive urodynamics is no worse for men in terms of symptom outcome than one in which it is not ...
Eligibility Criteria
Inclusion
- "UPSTREAM - Phase I":
- Men seeking further treatment for their bothersome lower urinary tract symptoms (LUTS) which may include surgery
Exclusion
- unable to pass urine without a catheter (urinary retention)
- relevant neurological disease, such as a stroke
- undergoing treatment for prostate or bladder cancer
- previously had prostate surgery
- not medically fit for surgery, or are unable to complete outcome assessments
- do not consent to be assigned at random to one of the pathways
- "UPSTREAM - Phase II":
- Inclusion criteria:
- PROMS (questionnaire) study component:
- Men randomised (enrolled) to the UPSTREAM trial (Phase I) who were willing to be contacted for long term follow up, as indicated on their original (Phase I) consent form.
- NHS Digital data extraction study component:
- Men randomised (enrolled) to the UPSTREAM trial (Phase I).
- Exclusion criteria:
- PROMS (questionnaire) study component:
- Patients who are not already randomised (enrolled) to the UPSTREAM trial (Phase I)
- UPSTREAM (Phase I) participants who:
- 1. are not willing to be contacted about long term follow up 2.2. have withdrawn trial participation, or at least withdrawn permission to be contacted in the future for long term follow up, at the time of their 18-month timepoint 2.3. do not consent and/or are not willing or able to comply with essential study procedures of this further follow up (UPSTREAM - Phase II)
- NHS Digital data extraction study component:
- Patients who are not already randomised (enrolled) to the UPSTREAM trial (Phase I)
- UPSTREAM (Phase I) participants who have withdrawn permission for the study to continue to access sections of their medical notes and NHS records, ONS and NHS Central registers information, at the time of their 18-month timepoint
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT02193451
Start Date
April 1 2014
End Date
June 30 2022
Last Update
January 10 2020
Active Locations (1)
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1
North Bristol NHS Trust
Bristol, United Kingdom, BS10 5NB