rodynamics for prostate surgery trial: randomised evaluation of assessment methods
- Conditions
- ower urinary tract symptomsUrodynamicsUrological and Genital Diseases
- Registration Number
- ISRCTN56164274
- Lead Sponsor
- Southmead Hospital (UK)
- Brief Summary
2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26651344 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30311686 qualitative interview results 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/26847139 article (added 29/11/2019) 2015 Other publications in https://doi.org/10.1177%2F2051415815591407 article (added 29/11/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31047905 baseline results and diagnostic findings (added 29/11/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32902375/ results (added 10/09/2020) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32469267/ establishing severity threshold scores for lower urinary tract symptoms patient reported outcomes measures (added 23/05/2022) 2022 Other publications in https://doi.org/10.1016/j.euf.2021.12.009 evaluation and ICIQ-BD completion rates (added 23/05/2022) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34922898/ exploratory findings (added 23/05/2022) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33053240/ qualitative study of men's experiences and recommendations for patient-centred practice (added 23/05/2022) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32187720/ quality control of uroflowmetry and urodynamic data (added 23/05/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 820
UPSTREAM – Phase I:
Current inclusion criteria as of 05/02/2019:
1. Men seeking further treatment for their bothersome lower urinary tract symptoms (LUTS) which may include surgery
2. Willing to be randomised
Previous inclusion criteria:
1. Men considering undergoing surgery as a treatment option for their bothersome LUTS
2. Willing to be randomised
UPSTREAM – Phase II (added 03/12/2019):
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).
UPSTREAM – Phase I:
Patients who:
1. are unable to pass urine without a catheter (urinary retention)
2. have a relevant neurological disease
3. undergoing active treatment, or on active surveillance, for prostate or bladder cancer
4. have previously had prostate surgery
5. are not medically fit for surgery, or unable to complete outcome assessments
6. do not consent to be randomised
UPSTREAM – Phase II (added 03/12/2019):
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in lower urinary tract symptom (LUTS) between the two arms at 18 months, measured with the International Prostate Symptom Score (IPSS)
- Secondary Outcome Measures
Name Time Method