UPSTREAM: Urodynamics Before Surgery for Male Lower Urinary Tract Symptoms
UPSTREAM was a pragmatic, multicenter, open-label noninferiority randomized trial of routine noninvasive tests plus invasive urodynamics versus routine tests alone in 820 men at 26 English NHS hospitals who sought further treatment, possibly including surgery, for bothersome lower urinary tract symptoms (LUTS), with 18-month International Prostate Symptom Score (IPSS) as the primary endpoint and a 1-point noninferiority margin. Mean IPSS was 12.6 with urodynamics and 13.1 with routine care (adjusted difference −0.33, 95% CI −1.47 to 0.80), and surgery occurred in 153/408 men (38%) versus 138/384 (36%).[1]
- Design and population
- Pragmatic multicenter open-label noninferiority randomized trial. 820 men (median age 68) at 26 English NHS hospitals who had received conservative or medical therapy and sought further treatment, possibly including surgery, for bothersome LUTS; catheter dependence, relevant neurologic disease, prostate or bladder cancer treatment, prior prostate surgery and unfitness for surgery were excluded.
- Arms
- Routine noninvasive tests plus invasive urodynamics versus routine noninvasive tests alone
- Report and follow-up
- 2020 · 18 months after randomisation
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| Mean IPSS at 18 months (0–35); adjusted difference, urodynamics minus routine care | 12.6 (SD 7.9; n = 340) vs 13.1 (SD 7.9; n = 329) | difference -0.33; 95% -1.47–0.8 | Met |
| Urological surgery within 18 months | 153/408 (38%) vs 138/384 (36%) | OR 1.05; 95% 0.77–1.43; P 0.7 | Not met |
| Median time from randomisation to surgery | 216 days vs 177 days | — | Descriptive |
Harms: Adverse events (all events): 234 events vs 194 events; Deaths within 18 months: An independent reviewer judged none related to diagnostic testing or treatment.
ISRCTN56164274 · Report DOI
Design
Urology departments recruited men from October 2014 to December 2016. Of 8,671 men assessed, 5,910 were not eligible, 662 declined and 1,279 were not included for an unidentified reason; 820 were randomized.[1] Eligibility was deliberately broad: men aged 18 or older who had already had conservative or medical therapy and sought further treatment for bothersome LUTS, including men already on a surgical waiting list who were willing to have urodynamics first. Men were excluded for catheter dependence, relevant neurologic disease (stroke, multiple sclerosis, Parkinson disease, spina bifida), current treatment for prostate or bladder cancer, prior prostate surgery, unfitness for surgery or unwillingness to comply with trial procedures.[1][2] At baseline the mean age was 67.5 years in the urodynamics arm and 67.8 in the routine care arm, the mean IPSS was 18.5 versus 19.4, the median Qmax was 10.2 versus 11.0 mL/s and the median postvoid residual was 100 mL in both arms; 67% and 68% had comorbidities and 91% and 93% were white.[1][2]
The control pathway followed NICE guidance on male LUTS: flow rate, bladder diary and symptom questionnaires, with discretionary tests such as PSA, cystoscopy or prostate volume measurement left to each center. The intervention pathway added multichannel urodynamics, in which catheters record bladder and abdominal pressure during filling and voiding and detrusor pressure is derived to judge voiding function and obstruction. The surgeon then made the treatment recommendation with the result in hand and the man decided whether to accept it; no operation was specified, and standard practice at each center governed the type of surgery and any medical treatment.[1][2]
The IPSS is scored 0 to 35 and was collected at baseline and at 6, 12 and 18 months. Noninferiority was to be declared if the upper limit of the two-sided 95% CI for the difference was below 1 point.[1] The 1-point margin was chosen as more conservative than the accepted 3-point minimal clinically important difference, because a 1-point change could reflect a clinically meaningful shift in a single item such as nocturia. The sample size of 310 men per arm assumed an SD of 5, a one-sided alpha of 5% and 80% power, and was inflated to 388 per arm for 20% attrition.[2] The key secondary outcome was the proportion of men having surgery within 18 months, tested for superiority on the hypothesis that urodynamics would reduce it; the denominator was men with a completed 18-month case report form or notes review.[1][2] Randomization was simple rather than stratified by center as planned, and every analysis was adjusted for center and baseline IPSS.[1][2] Men and hospital staff were not blinded; the co-applicants were blinded to arm throughout recruitment and analysis.[1]
Results
The 18-month IPSS was available for 340 of 427 men (80%) in the urodynamics arm and 329 of 393 (84%) in the routine care arm, and 328 and 313 men entered the adjusted primary analysis.[1] Mean IPSS fell from 18.5 to 12.6 with urodynamics and from 19.4 to 13.1 with routine care, and the adjusted difference of −0.33 (95% CI −1.47 to 0.80) lay inside the 1-point margin, so urodynamics was noninferior for symptoms.[1] The observed SD of 7.89 was larger than the planned 5 but the interval remained narrow.[1][2] The IPSS quality-of-life score was 2.7 in both arms (adjusted difference −0.07, 95% CI −0.32 to 0.18).[1][2] Prespecified interaction tests, including age and urinary function, showed no evident effect modifiers, though the authors call them underpowered.[1]
The noninferiority conclusion held in most sensitivity analyses but not all. The per-protocol difference was −0.10 (95% CI −1.25 to 1.05), with an upper limit slightly above the margin that the report attributes to the smaller sample; the complier average causal effect was −0.39 (95% CI −1.70 to 0.92).[1][2] Adjusting for time from surgery to the questionnaire gave 0.19 (95% CI −0.84 to 1.21), an interval that crosses the margin and that the report called inconclusive, and a post hoc restriction to questionnaires returned 16 to 20 months after randomization was also inconclusive.[2] Multiple imputation gave −0.11 (95% CI −1.22 to 0.99), just inside the margin.[2]
Urodynamics did not reduce surgery. Surgery occurred in 153/408 men (38%) versus 138/384 (36%) (adjusted odds ratio 1.05, 95% CI 0.77 to 1.43), well below the 60% to 73% assumed in the sample size calculation.[1][2] The surgeon recommended surgery in 196/397 men (49%) versus 182/378 (48%) and 41% of each arm were listed.[1][2] Among men for whom surgery was recommended, 143/190 (75%) versus 132/180 (73%) had it, and among men for whom it was not recommended, 10/195 (5%) versus 6/195 (3%) did.[2] The median time from randomization to surgery was 216 days versus 177 days, and in both arms at least 75% of men having surgery had TURP.[1][2] Mean Qmax about 4 months after surgery was 17.2 mL/s with urodynamics (59 men) versus 18.2 mL/s with routine care (59 men).[1]
Among men who had surgery for LUTS, the mean IPSS fell from 19.64 to 9.39 in the urodynamics arm (137 men) and from 22.00 to 8.79 in the routine care arm (116 men).[2] An exploratory post hoc interaction indicated a smaller IPSS benefit of surgery in the urodynamics arm (difference 2.93, 95% CI 0.86 to 5.01; p = 0.006 in the HTA report, where it fell to 1.14, 95% CI −0.94 to 3.22, p = 0.283, when analyzed as treated and was suggested to be a chance finding), and the journal report gives p < 0.001 for the interaction and raises delayed surgery in the urodynamics arm as one explanation.[1][2] Qmax at 18 months was 15.26 versus 15.68 mL/s (difference 0.14, 95% CI −1.33 to 1.62).[2] Nocturia more than once per night was reported by 176/299 men (59%) versus 189/282 (67%) (odds ratio 0.66, 95% CI 0.44 to 0.99), one of many secondary comparisons that the report considers possibly due to chance.[2] Reduced or absent ejaculation was reported by 244/286 (85%) versus 219/264 (83%) (odds ratio 1.37, 95% CI 0.82 to 2.28), and the ICIQ-MLUTS incontinence score was 3.9 versus 4.0 (difference −0.27, 95% CI −0.67 to 0.13).[1][2]
From an NHS secondary-care perspective, the urodynamics pathway cost an adjusted £216 more over 18 months (95% CI −£40 to £471), with a QALY difference of 0.006 (95% CI −0.023 to 0.035).[2] Interviews in the trial's qualitative component found that patients and clinicians valued urodynamics for its perceived insight into the cause of symptoms and the best treatment.[2]
Exploratory analyses
A post hoc analysis by pathway received examined what predicted the surgical decision and the outcome. Among men who had urodynamics, surgery was recommended in 106/150 (71%) with a bladder outlet obstruction index (BOOI) of 40 or more versus 4/34 (12%) of those judged unobstructed. In men who received routine care, the best model predicting a surgery recommendation (Qmax, age, ICIQ voiding subscale, IPSS quality of life; n=311) had an area under the curve of 0.78; in men who had urodynamics, the best model (Qmax, postvoid residual, ICIQ total score, age; n=220) had 0.69, rising to 0.78 when BOOI was added. Mean IPSS change was −11.60 with surgery and −2.59 without.[3]
Baseline values associated with an IPSS fall of 3 or more points after surgery were IPSS above 16, age below 74 years, Qmax below 9.8 mL/s, an ICIQ voiding subscale above 8, and, in men who had urodynamics, BOOI above 47.6 or bladder contractility index above 123.0. The relationship between urodynamic indices and IPSS change appeared stronger at Qmax above 15 mL/s (16 men) and weaker when detrusor overactivity was present; the authors treat these as hypotheses from small subgroups.[3]
Long-term follow-up
Five-year follow-up used a postal questionnaire (October 2019 to December 2021) and linked NHS England records. Among 570 contactable men, 415 returned at least partly completed questionnaires (211 urodynamics and 204 routine care), representing 211/427 (49.4%) and 204/393 (51.9%) of all randomized men, respectively; routine NHS data were obtained for 801/820 (97.7%).[4][5] Mean IPSS was 13.68 versus 13.62 (adjusted difference 0.41, 95% CI −1.10 to 1.93).[4] The 1-point margin was retained and the upper limit exceeds it, so noninferiority could not be confirmed; the point estimate favored urodynamics at 18 months and routine care at 5 years, by small differences.[4][5] The HTA report calls the study underpowered to confirm noninferiority; among men with 5-year data the 18-month difference was −0.84 (95% CI −2.26 to 0.57), and every 5-year sensitivity analysis had an upper limit above 1 point.[5]
Surgery for LUTS, identified from NHS England records, occurred in 180/415 men (43%) versus 167/386 (43%) (odds ratio 0.96, 95% CI 0.71 to 1.28), against 36% to 38% at 18 months, and the 347 men include 282 of the 291 identified at 18 months.[4][5] Median time to first operation was 242 days overall (260 days with urodynamics, 232 with routine care). The most frequent code was endoscopic prostate resection not elsewhere classified (185 procedures), and 41 procedures were introductions of a therapeutic substance into the bladder that the study counted as LUTS surgery.[4][5] Surgery rates at 5 years also stayed below the 60% to 73% assumed at design, which the authors read as a shift away from surgery for male LUTS.[4]
Among secondary outcomes, voiding and incontinence scores and the quality-of-life item did not differ. Nocturia more than once per night was reported by 114/197 men (58%) versus 114/172 (66%) (odds ratio 0.68, 95% CI 0.43 to 1.09), and painful ejaculation by 23/177 (13%) versus 34/154 (22%) (odds ratio 0.49, 95% CI 0.25 to 0.95), which the HTA report suggests may be a chance finding.[4][5] By 5 years 28 men in the urodynamics arm and 26 in the routine care arm had died.[4][5] Among men who had surgery, the mean IPSS fell from 19.01 to 11.75 with urodynamics (99 men) and from 21.40 to 11.22 with routine care (93 men); the exploratory interaction between surgery and arm was 2.26 (95% CI −0.58 to 5.09; p = 0.118).[5] In one of five prespecified subgroup analyses the arm effect on 5-year IPSS differed by maximum flow rate (interaction −4.72, 95% CI −7.86 to −1.58; p = 0.002): the mean IPSS was 14.23 with urodynamics versus 12.47 with routine care at 12 mL/s or less, and 13.03 versus 15.50 above 12 mL/s.[5] No subgroup interaction appeared for surgery rate.[5]
The HTA report found the urodynamics pathway cost £176.63 more over 5 years (95% CI −£464.06 to £817.32), with an incremental QALY difference of −0.039 (95% CI −0.152 to 0.073) and an incremental net monetary benefit of −£962.62 (95% CI −£3,323.54 to £1,398.30) at £20,000 per QALY; the probability of urodynamics being cost-effective at that threshold was 21%. The extra cost fell mostly in the first 2 years, and the unit cost of a urodynamic test was £268 (2020 to 2021 NHS reference costs).[5]
Surgery and treatment delivery
Urodynamics was done in 353/427 men (83%) allocated to it and in 28/393 (7%) allocated to routine care.[1] Among men with known status, 353/421 (84%) in the urodynamics arm received the allocated pathway, against 360/388 (93%) in the routine care arm (p < 0.001).[2] Of 68 men in the urodynamics arm who did not have the test, 14 declined, 14 reported resolved symptoms, 10 cancelled or did not attend, 3 had surgery arranged first and 10 had an unsuccessful attempt; 28 routine care men had urodynamics, 22 by clinician decision to inform the surgical decision.[2]
The operations were not specified. Among men with an 18-month IPSS who had LUTS surgery, 102 of 137 in the urodynamics arm had transurethral resection of the prostate (TURP), 19 laser surgery, 5 bladder neck incision and 10 UroLift; the routine care arm had 99 TURP, 5 laser, 4 bladder neck incision and 7 UroLift among 116.[2] At least 10% of traces from each center were reviewed against International Continence Society standards, and most practice was broadly compliant, with some non-compliant incidents addressed by the trial team.[2] The quality-control review found errors of standardization, testing, interpretation and equipment maintenance, mostly with low risk to decisions, and an erroneous diagnosis of bladder outlet obstruction in 5.5% of tests.[1] Of the 353 men who had urodynamics, 297 reported overall satisfaction (median 10 of 10); 294/303 (97%) would take the test again, and 77/302 (26%) found it worse than expected.[2]
Adverse events
Adverse events numbered 234 in the urodynamics arm and 194 in the routine care arm; 32% and 30% of men had at least one, and 43% to 44% of events in each arm were judged related to testing or treatment.[1][2] The excess in the urodynamics arm came largely from events attributed to the test, for example urinary tract infection, and the journal report found no evidence that either arm was superior for adverse events per participant.[1] Serious events attributed to urodynamics numbered 3 versus 1, expected non-serious events due to urodynamics 10 versus 1, and unexpected non-serious events 3 versus 0. Serious events attributed to surgery numbered 21 versus 23. Surgery-related Clavien–Dindo grade IIIa events numbered 1 versus 1 and grade IIIb events 2 versus 7, with 4 versus 5 graded III without subdivision and none graded IV or V.[2]
Episodes of acute urinary retention numbered 13 in the urodynamics arm and 29 in the routine care arm; the report describes more retention with routine care but performed no formal test.[2] Nine of 427 men (2.1%) in the urodynamics arm and 2 of 393 (0.5%) in the routine care arm died within 18 months (p = 0.047); an independent reviewer found none related to diagnostic testing or treatment.[1][2] By 5 years the counts had evened out at 28 versus 26 deaths.[4]
Limitations
Men and treating clinicians were unblinded, and the recommendation for surgery was made by clinicians who knew the arm. Surgery occurred in 36% to 38% of men, below the 60% to 73% assumed; the report attributes the low rates partly to a general decline in interventional therapy and suggests that site set-up and trial participation may have improved routine care in both arms.[2] Allocation was unbalanced (427 versus 393), stratification by center did not occur as planned, and adherence differed between pathways, with 28 routine care men crossing over to urodynamics.[2]
Several sensitivity analyses were inconclusive for noninferiority, 39 men in the urodynamics arm and 28 in the routine care arm withdrew, more deaths occurred in the urodynamics arm (9 versus 2), and more than 90% of the cohort was white.[2] No operation was specified, so the trial tests the testing pathway rather than any procedure. At 5 years about half of each arm returned questionnaires, which left the symptom comparison underpowered to confirm noninferiority; baseline comorbidities were recorded in 278/394 men (71%) not included in the questionnaire analysis versus 263/409 (64%) included, and more than 90% of respondents were white.[4][5] Urodynamics was incompletely coded in routine NHS records, which identified only 265 of 376 Phase I tests (70%).[5]
In conversation
- Parallel to VALUE (2012). Same question in women before stress-incontinence surgery; office evaluation alone was noninferior to adding urodynamics.
VALUE asked the same question for women before stress-incontinence surgery, with 12-month patient-reported success and an 11-percentage-point margin; UPSTREAM used a 1-point IPSS margin and added surgery rate as the key secondary outcome. UPSTREAM enrolled the full spectrum of LUTS, with nocturia more than once per night in 75% to 80% of men,[2] and the thresholds for selective testing come from its exploratory analyses rather than from randomized subgroups.[3]
Guidelines and approvals
- AUA (Management of LUTS Attributed to BPH, 2026), statement 4. Clinicians may perform invasive or non-invasive pressure-flow testing or urodynamic studies in patients with LUTS/BPH to define bladder function when diagnostic uncertainty exists . The supporting text cites UPSTREAM in stating that urodynamics has not been shown to decrease intervention rates compared with routine care and has little utility in the initial evaluation of men with uncomplicated LUTS/BPH.[6]
- EAU (Non-Neurogenic Male LUTS, March 2026), section 4.12.1. The summary of evidence states that pressure-flow studies are not tests for routine use before prostate surgery in all patients (level of evidence 3), and the guideline recommends urodynamics only in individual patients for specific indications before invasive treatment or when further evaluation of LUTS pathophysiology is warranted . Specific indications, each , are previous unsuccessful invasive treatment, inability to void more than 150 mL, bothersome predominantly voiding LUTS with Qmax above 10 mL/s, and bothersome predominantly voiding LUTS at age above 80 or below 50 years. The text describes UPSTREAM and its exploratory findings.[7]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2020-06-30 | 18-month primary report · primary | — | Mean IPSS at 18 months (0–35); adjusted difference, urodynamics minus routine care: 12.6 (SD 7.9; n = 340) vs 13.1 (SD 7.9; n = 329); difference -0.33; 95% -1.47–0.8 Met Mean IPSS at 18 months, per-protocol; adjusted difference: 12.6 (SD 7.8; n = 306) vs 12.8 (SD 7.5; n = 305); difference -0.1; 95% -1.25–1.05 Complier average causal effect on 18-month IPSS (instrumental-variable regression using allocation); adjusted difference: 330 versus 339 men in the as-treated groups; the authors describe the result as generally similar to the intention-to-treat analysis.; difference -0.39; 95% -1.7–0.92 IPSS quality-of-life item at 18 months (0–6); adjusted difference, urodynamics minus routine care: 2.7 (SD 1.69; n = 343) vs 2.7 (SD 1.64; n = 332); difference -0.07; 95% -0.32–0.18; P 0.6 Tests of interaction between arm and prespecified subgroups (including age and urinary function) on 18-month IPSS: No evident interactions; the authors call the tests underpowered.; — Urological surgery within 18 months: 153/408 (38%) vs 138/384 (36%); OR 1.05; 95% 0.77–1.43; P 0.7 Not met Surgery recommended by the surgeon after assessment: 196/397 (49%) vs 182/378 (48%); OR 1.02; 95% 0.76–1.38; P 0.9 Median time from randomisation to surgery: 216 days vs 177 days; — Descriptive Mean maximum flow rate at 18 months (mL/s); adjusted difference: 15.3 (SD 8.3; n = 268) vs 15.7 (SD 9.1; n = 270); difference 0.14; 95% -1.33–1.62; P 0.8 Mean maximum flow rate about 4 months after surgery (mL/s) in men who had surgery; adjusted difference: 17.2 (SD 9.3; n = 59) vs 18.2 (SD 9.8; n = 59); difference -0.17; 95% -4.24–3.89; P 0.9 ICIQ-MLUTS voiding scale at 18 months; adjusted difference: 6.4 (SD 4.40; n = 296) vs 6.2 (SD 4.23; n = 278); difference 0.09; 95% -0.59–0.77; P 0.8 ICIQ-MLUTS incontinence scale at 18 months; adjusted difference: 3.9 (SD 3.07; n = 295) vs 4.0 (SD 2.81; n = 282); difference -0.27; 95% -0.67–0.13; P 0.19 Nocturia more than once per night at 18 months (ICIQ-MLUTS): 176/299 (59%) vs 189/282 (67%); OR 0.66; 95% 0.44–0.99; P 0.042 Reduced or absent ejaculation at 18 months (ICIQ-MLUTSsex): 244/286 (85%) vs 219/264 (83%); OR 1.37; 95% 0.82–2.28; P 0.2 Post hoc interaction between arm and surgery on change in IPSS: The authors report surgery as potentially more beneficial in the routine care arm and offer delayed surgery in the urodynamics arm as one explanation. The HTA report gives p = 0.006 for the interaction between surgery and arm.; P <0.001 | Drake MJ, Lewis AL, Young GJ, et al. "Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals." *Eur Urol.* 2020;78(5):701-710. doi:10.1016/j.eururo.2020.06.004 DOI |
| 2020-09-01 | Full HTA report · secondary | — | IPSS quality-of-life score at 18 months (0–6); adjusted difference, urodynamics minus routine care: 2.72 vs 2.74; difference -0.07; 95% -0.32–0.18 Mean IPSS at 18 months, per-protocol; adjusted difference: 12.56 vs 12.78; difference -0.1; 95% -1.25–1.05 Mean IPSS at 18 months adjusted for days from surgery to questionnaire; adjusted difference: 336 versus 323 men; the interval crosses the 1-point margin and the report calls the result inconclusive for noninferiority, noting that the 1000-day value imputed for men without surgery was arbitrary.; difference 0.19; 95% -0.84–1.21 Mean IPSS at 18 months after multiple imputation; adjusted difference: 12.80 vs 13.19; difference -0.11; 95% -1.22–0.99 Surgery recommended at the decision-making appointment: 196/397 (49%) vs 182/378 (48%); OR 1.02; 95% 0.76–1.38; P 0.872 Listed for surgery after the decision-making appointment: 156/376 (41%) vs 147/358 (41%); — Surgery within 18 months in men for whom surgery was or was not recommended: 143/190 (75%) recommended; 10/195 (5%) not recommended vs 132/180 (73%) recommended; 6/195 (3%) not recommended; — Descriptive Median time from randomisation to surgery: 216 days vs 177 days; — Descriptive Mean IPSS at baseline and 18 months among men who had LUTS surgery: 19.64 to 9.39 (n = 137) vs 22.00 to 8.79 (n = 116); difference 2.93; 95% 0.86–5.01; P 0.006 Mean maximum flow rate at 18 months (mL/s); adjusted difference: 15.26 vs 15.68; difference 0.14; 95% -1.33–1.62; P 0.850 Nocturia more than once per night at 18 months (ICIQ-MLUTS): 176/299 (59%) vs 189/282 (67%); OR 0.66; 95% 0.44–0.99; P 0.042 Reduced or absent ejaculation at 18 months (ICIQ-MLUTSsex): 244/286 (85%) vs 219/264 (83%); OR 1.37; 95% 0.82–2.28; P 0.229 Adjusted incremental NHS secondary-care cost over 18 months, urodynamics minus routine care (GBP): —; difference 216; 95% -40–471 Adjusted incremental QALYs over 18 months, urodynamics minus routine care: —; difference 0.006; 95% -0.023–0.035 | Lewis AL, Young GJ, Selman LE, et al. "Urodynamics tests for the diagnosis and management of bladder outlet obstruction in men: the UPSTREAM non-inferiority RCT." *Health Technol Assess.* 2020;24(42):1-122. doi:10.3310/hta24420 DOI |
| 2021-12-16 | Exploratory predictors of surgery and outcome · post-hoc | — | Surgery recommended after a BOOI of 40 or more versus below 40 (men who had urodynamics): 106/150 (71%) with BOOI ≥40 vs 4/34 (12%) unobstructed; — Area under the ROC curve of the best routine-care model, and of the urodynamics model without and with BOOI: 0.69, rising to 0.78 with BOOI added vs 0.78; — Mean change in IPSS at 18 months: −11.60 with surgery vs −2.59 without surgery; — Baseline values associated with an IPSS fall of 3 or more points after surgery: IPSS above 16, age below 74 years, Qmax below 9.8 mL/s, ICIQ voiding subscale above 8, and, in men who had urodynamics, BOOI above 47.6 or BCI above 123.0.; — | Young GJ, Metcalfe C, Lane JA, et al. "Prostate Surgery for Men with Lower Urinary Tract Symptoms: Do We Need Urodynamics to Find the Right Candidates? Exploratory Findings from the UPSTREAM Trial." *Eur Urol Focus.* 2022;8(5):1331-1339. doi:10.1016/j.euf.2021.11.010 DOI |
| 2025-03-12 | 5-year follow-up · updated | — | IPSS at 5 years; adjusted difference, urodynamics minus routine care: 13.68 (SD 8.09; n = 208) vs 13.62 (SD 8.10; n = 202); difference 0.41; 95% -1.1–1.93 Not met Surgery for LUTS within 5 years from NHS England routine data; adjusted odds ratio: 180/415 (43%) vs 167/386 (43%); OR 0.96; 95% 0.71–1.28; P 0.763 Not met IPSS quality-of-life score at 5 years (0-6); adjusted difference: 2.67 (SD 1.55) vs 2.69 (SD 1.52); difference -0.01; 95% -0.31–0.28 Median time from randomisation to first LUTS procedure in routine data: 260 days vs 232 days; — Descriptive ICIQ-MLUTS voiding scale at 5 years (0-20); adjusted difference: 7.06 (SD 4.36; n = 197) vs 6.99 (SD 4.33; n = 176); difference 0.17; 95% -0.68–1.02; P 0.696 ICIQ-MLUTS incontinence scale at 5 years (0-24); adjusted difference: 4.44 (SD 3.57; n = 195) vs 4.24 (SD 3.01; n = 173); difference 0.24; 95% -0.39–0.87; P 0.452 Nocturia more than once per night at 5 years (ICIQ-MLUTS): 114/197 (58%) vs 114/172 (66%); OR 0.68; 95% 0.43–1.09; P 0.106 Reduced or absent ejaculation at 5 years (ICIQ-MLUTSsex): 174/193 (90%) vs 155/170 (91%); OR 1.05; 95% 0.49–2.25; P 0.892 Painful ejaculation at 5 years (ICIQ-MLUTSsex): 23/177 (13%) vs 34/154 (22%); OR 0.49; 95% 0.25–0.95; P 0.034 | Clout M, Lewis AL, Cochrane M, et al. "Five-year Follow-up of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods-A Noninferiority Randomised Controlled Trial of Urodynamics." *Eur Urol Focus.* 2025;11(4):618-624. doi:10.1016/j.euf.2025.02.004 DOI |
| 2025 | 5-year HTA report and costs · secondary | — | IPSS at 5 years; adjusted difference, urodynamics minus routine care: 13.68 (SD 8.09; n = 208) vs 13.62 (SD 8.10; n = 202); difference 0.41; 95% -1.1–1.93 Not met 18-month IPSS in the men who also had a 5-year IPSS; adjusted difference: 11.72 (SD 7.43) vs 12.63 (SD 7.41); difference -0.84; 95% -2.26–0.57 5-year IPSS, per-protocol by urodynamics status recorded in Phase I; adjusted difference: 13.55 (SD 8.16) vs 13.69 (SD 7.93); difference 0.36; 95% -1.19–1.91 Surgery for LUTS within 5 years from routine data; adjusted odds ratio: 180/415 (43%) vs 167/386 (43%); OR 0.96; 95% 0.71–1.28; P 0.763 Not met Men having first LUTS surgery in each 6-month period after randomisation: 55 (31%) at 0-6 months, 67 (37%) at 6-12, 24 (13%) at 12-18 vs 69 (41%) at 0-6 months, 49 (29%) at 6-12, 17 (10%) at 12-18; — Descriptive Mean IPSS at baseline and 5 years in men who had LUTS surgery (routine data): 19.01 to 11.75 (n = 99) vs 21.40 to 11.22 (n = 93); — Interaction between surgery and arm on 5-year IPSS; adjusted difference in surgery effect, urodynamics minus routine care: Surgery lowered the IPSS in both arms (-3.25 with urodynamics, 95% CI -5.35 to -1.14; -6.30 with routine care, 95% CI -8.57 to -4.03). The report calls the analysis hypothesis-generating.; difference 2.26; 95% -0.58–5.09; P 0.118 Interaction between arm and maximum flow rate (12 mL/s or less versus above 12 mL/s) on 5-year IPSS: Mean 5-year IPSS with urodynamics versus routine care was 14.23 versus 12.47 at 12 mL/s or less (129 versus 126 men) and 13.03 versus 15.50 above 12 mL/s (72 versus 72). One of five prespecified subgroup variables (age, flow rate, voided volume, nocturia, storage LUTS); age showed a weak interaction (p = 0.068), voided volume, nocturia and storage LUTS showed none, and no subgroup interaction appeared for surgery rate (Table 15).; difference -4.72; 95% -7.86–-1.58; P 0.002 Incremental mean cost, urodynamics minus routine care (GBP): Adjusted mean cost 4,464.41 versus 4,287.78 GBP. Increments by year: +135.86 (year 1), +167.77 (year 2), +9.21, +1.55 and -137.76 (year 5). Unit cost of a urodynamic test was 268 GBP (2020-21 NHS reference costs). Discounted at 3.5%; NHS secondary care perspective.; difference 176.63; 95% -464.06–817.32 Incremental mean QALYs, urodynamics minus routine care: Adjusted mean QALYs 3.490 versus 3.529; EQ-5D-5L mapped to the UK three-level value set, zero imputed after death.; difference -0.039; 95% -0.152–0.073 Incremental net monetary benefit at 20,000 GBP per QALY, urodynamics minus routine care (GBP): The probability that urodynamics was cost-effective at 20,000 GBP per QALY was 21%. With a 1.5% discount rate the net monetary benefit was -983.33 (95% CI -3,446.02 to 1,479.35); with outpatient costs cut by 62% it was -1,127.15 (95% CI -3,414.44 to 1,160.14).; difference -962.62; 95% -3323.54–1398.3 | Clout M, Lewis AL, Cochrane M, et al. "Urodynamics tests for the diagnosis and management of male bladder outlet obstruction: long-term follow-up of the UPSTREAM non-inferiority RCT." *Health Technol Assess.* 2025;29(26). doi:10.3310/slpt4675 DOI |
References
1. Drake MJ, Lewis AL, Young GJ, et al. "Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals." Eur Urol. 2020;78(5):701-710. doi:10.1016/j.eururo.2020.06.004
2. Lewis AL, Young GJ, Selman LE, et al. "Urodynamics tests for the diagnosis and management of bladder outlet obstruction in men: the UPSTREAM non-inferiority RCT." Health Technol Assess. 2020;24(42):1-122. doi:10.3310/hta24420
3. Young GJ, Metcalfe C, Lane JA, et al. "Prostate Surgery for Men with Lower Urinary Tract Symptoms: Do We Need Urodynamics to Find the Right Candidates? Exploratory Findings from the UPSTREAM Trial." Eur Urol Focus. 2022;8(5):1331-1339. doi:10.1016/j.euf.2021.11.010
4. Clout M, Lewis AL, Cochrane M, et al. "Five-year Follow-up of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods-A Noninferiority Randomised Controlled Trial of Urodynamics." Eur Urol Focus. 2025;11(4):618-624. doi:10.1016/j.euf.2025.02.004
5. Clout M, Lewis AL, Cochrane M, et al. "Urodynamics tests for the diagnosis and management of male bladder outlet obstruction: long-term follow-up of the UPSTREAM non-inferiority RCT." Health Technol Assess. 2025;29(26). doi:10.3310/slpt4675
6. Goueli R, Badlani GH, Welliver C, et al. "Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA guideline (2026)." American Urological Association; approved April 2026.
7. European Association of Urology. EAU Guidelines on Management of Non-neurogenic Male Lower Urinary Tract Symptoms (LUTS). March 2026 update, section 4.12.1.