Lower urinary tract symptoms
Conditions
Interventions
A care pathway based on urodynamic tests with invasive multichannel cystometry ('invasive urodynamics' active intervention arm) and a care pathway based on non-invasive tests, i.e. without multichanne
Sponsors
Southmead Hospital (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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: Inclusion criteria: 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: Inclusion criteria: Men randomised (enrolled) to the UPSTREAM trial (Phase I).
Exclusion criteria
Exclusion criteria: 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 have withdrawn trial participation, or at least withdrawn permission to be contacted in the future for long term follow up, at the time of their 18-month timepoint 2.3.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 UPSTREAM (Phase I) participants who have withdrawn permission for the study to continue to access sections of their medical notes and NHS records, ONS and NHS Central registers information, at the time of their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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in lower urinary tract symptom (LUTS) between the two arms at 18 months, measured with the International Prostate Symptom Score (IPSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/02/2019: 1. Surgery rate (the relative proportion of men in each group having surgery up to 18 months after randomisation). 2. Cost-effectiveness analyses from the perspectives of the NHS, Personal Social Services and patients. Subsequent need for surgery will be recorded. 3. Adverse events of testing and treatment (e.g. infection, urinary retention). 4. Measures from the International Consultation on Incontinence Questionnaires (ICIQ) (Abrams et al., 2006) will be used alongside the IPSS, giving sensitive and comprehensive assessment of LUTS severity/ bother, sexual function, quality of life and satisfaction with urodynamic testing. The following will be measured at 6, 12 and 18 months: 4.1. IPSS 4.2. ICIQ Male LUTS (ICIQ-MLUTS) 4.3. ICIQ sexual function in Male LUTS (ICIQ-MLUTS-sex) 4.4. ICIQ urodynamics satisfaction (ICIQ-UDS-S) will be administered at a single time point after urodynamic testing for relevant patients. 5. Maximum urinary flow rate (Qmax) at 18 months. In men undergoing surgery in both arms, an additional Qmax measure at 4 months after operation will be used as a quality measure for surgery. 6. The EQ-5D-5L will be used to provide the quality of life weights used to calculate Quality Adjusted Life Years (QALYs). 7. Qualitative interviewing will explore user acceptability and influences on decisions made by the participating men and the surgeons. UPSTREAM – Phase II (added 11/12/2019): 1. LUTS measured with the IPSS PROM at 5 years post-randomisation (objective A) 2. Alongside the IPSS (including the QoL measure), measures from selected International Consultation on Incontinence Questionnaires (ICIQs) will be used, collectively giving sensitive and comprehensive assessment of QoL, LUTS severity/bother, sexual function, and general health (objective D). The following measures will be used: 2.1. IPSS – including QoL 2.2. ICIQ Male LUTS (ICIQ-MLUTS) 2.3. ICIQ sexual function in Male LUTS (ICIQ-MLUTS-sex | — |
Countries
England, United Kingdom
Outcome results
None listed