Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT02193451
Eligibility Criteria:
"UPSTREAM - Phase I":
Inclusion Criteria:
* Men seeking further treatment for their bothersome lower urinary tract symptoms (LUTS) which may include surgery
Exclusion Criteria:
* 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:
1. Patients who are not already randomised (enrolled) to the UPSTREAM trial (Phase I)
2. UPSTREAM (Phase I) participants who:
2.1. 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 have withdrawn trial participation, or at least withdrawn permission to be contacted in the future for long term follow up, at the time of their 18-month timepoint 2.3.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:
1. Patients who are not already randomised (enrolled) to the UPSTREAM trial (Phase I)
2. UPSTREAM (Phase I) participants who have withdrawn permission for the study to continue to access sections of their medical notes and NHS records, ONS and NHS Central registers information, at the time of their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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02193451
Study Brief:
Protocol Section:
NCT02193451