Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods

NCT02193451 | Unknown DMC

• 2 other identifiers: UPSTREAM 325012/140/01
• Study Type: interventional
• Target: 820
• Locations: 1 country
• Sites: 1

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 restriction of flow. As a result, some men develop difficulty passing urine (voiding) as they age. For these men, prostate surgery can be helpful by removing the part of the prostate causing the narrowing, so that flow improves. However, for some men, almost identical symptoms of difficulty passing urine are due to underactive bladder. In other words, the bladder contraction is too weak, and is not effective at expelling the urine. This is a smaller group, but important, as these men may have no improvement after prostate surgery, while being exposed to risk of complications of surgery. Medical assessment of men with voiding problems typically involves discussing the symptoms, doing a physical examination of the prostate and measuring the urine flow rate. In many NHS hospitals, these are the only tests done before deciding whether to proceed to prostate surgery. In effect, voiding symptoms are presumed to be a result of prostate enlargement for these men, since it is the more common problem compared with bladder underactivity. However, this approach cannot identify which men actually have bladder underactivity as the cause of their voiding symptoms. So, in some hospitals an extra test is used, called urodynamics. Urodynamics is done to measure how much pressure the bladder generates when passing urine, because a high pressure shows the problem is obstruction, and a low pressure shows it is bladder weakness. Urodynamics involves gently putting a small tube into the bladder via the penis to measure the bladder pressure, and to fill the bladder with a sterile fluid (saline). Another small tube is gently placed into the rectum, via the anus, to measure abdominal pressures. Measuring abdominal pressure is necessary because any change in abdominal pressure can affect bladder pressure, and if the test did not allow for this it could give a misleading result. Urodynamics is safe, but some men find it uncomfortable or undignified, and a few develop urine infection afterwards. No studies have been conducted so far to tell us which of these two approaches to assessing men with voiding urinary problems is better overall. UPSTREAM consists of two phases: "UPSTREAM - Phase I" was a pragmatic, two-arm, multicentre, randomised controlled trial (RCT) to determine the clinical and cost-effectiveness of invasive urodynamics (UDS) for the diagnosis and management of bladder outlet obstruction in men. Men from 26 urology departments of NHS Hospitals in England who had bothersome lower urinary tract symptoms (LUTS) and were seeking further treatment, which may have included surgery, were randomised to one of two study arms; 'Routine Care' (as per the NICE diagnostic pathway), or routine care plus UDS ('Urodynamics'), which is currently optional. The design was utilised to establish noninferiority in symptom severity (International Prostate Symptom Score \[IPSS\]) 18-months post-randomisation. The primary outcome was IPSS at 18-months post-randomisation, and a key secondary outcome was the influence of UDS on rates of bladder outlet surgery. The RCT started 01 April 2014 and ended 30 September 2018. In 2018, we were awarded an extension to conduct a further (long term) follow up of UPSTREAM participants, five years post-randomisation; "UPSTREAM - Phase II". We aim to identify: the symptom outcomes of treatment; definitive surgery rates in the two study arms; and the long-term impact of LUTS and its therapy. The focus will continue to be on effectiveness and patient outcomes as per the original commissioning brief. "UPSTREAM - Phase II" started 01 July 2019 and has a planned end date of 30 June 2022.

Conditions

Lower Urinary Tract Symptoms; Voiding Dysfunction; Benign Prostate Obstruction; Detrusor Underactivity

Keywords

Lower urinary tract symptoms; Male LUTS; Voiding dysfunction; Benign prostate obstruction; Detrusor underactivity

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptom Score

  Primary clinical outcome: difference in lower urinary tract symptom (LUTS) between the two arms at 18 months, measured with the International Prostate Symptom Score (IPSS)

  18 months

Secondary Outcomes (12)

• Surgery rate

  18 months

• Cost-effectiveness analyses

  18 months

• Adverse events

  18 months

• International Consultation on Incontinence Questionnaires

  18 months

• Maximum urinary flow rate

  18 months

Study Arms (2)

Urodynamics

EXPERIMENTAL

Invasive urodynamic cystometry including pressure flow studies, along with usual diagnostics in male LUTS

Procedure: Urodynamics; Procedure: Usual care

Usual care

ACTIVE COMPARATOR

Usual diagnostics in male LUTS; flow rate test, symptom score and bladder diary

Procedure: Usual care

Interventions

Urodynamics PROCEDURE

Diagnostic test for urinary storage and voiding function

Also known as: Cystometry, Pressure flow study

Urodynamics

Usual care PROCEDURE

Also known as: Flow rate, Symptom scores, Bladder diary

Urodynamics; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men seeking further treatment for their bothersome lower urinary tract symptoms (LUTS) which may include surgery

You may not qualify if:

• 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":
• 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).
• PROMS (questionnaire) study component:
• Patients who are not already randomised (enrolled) to the UPSTREAM trial (Phase I)
• UPSTREAM (Phase I) participants who:
• 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)

Sponsors & Collaborators

• North Bristol NHS Trust: lead
• University of Bristol: collaborator
• University of Aberdeen: collaborator
• Newcastle University: collaborator
• Royal Devon and Exeter NHS Foundation Trust: collaborator
• University of Sheffield: collaborator

Study Sites (1)

North Bristol NHS Trust

Bristol, BS10 5NB, United Kingdom

Location

Related Publications (6)

• Young GJ, Lewis AL, Lane JA, Winton HL, Drake MJ, Blair PS. Statistical analysis plan for the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). Trials. 2017 Oct 3;18(1):455. doi: 10.1186/s13063-017-2206-y.

  PMID: 28974250 BACKGROUND

• Bailey K, Abrams P, Blair PS, Chapple C, Glazener C, Horwood J, Lane JA, McGrath J, Noble S, Pickard R, Taylor G, Young GJ, Drake MJ, Lewis AL. Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for diagnosis and management of bladder outlet obstruction in men: study protocol for a randomised controlled trial. Trials. 2015 Dec 10;16:567. doi: 10.1186/s13063-015-1087-1.

  PMID: 26651344 BACKGROUND

• Drake MJ, Lewis AL, Lane JA. Urodynamic Testing for Men with Voiding Symptoms Considering Interventional Therapy: The Merits of a Properly Constructed Randomised Trial. Eur Urol. 2016 May;69(5):759-60. doi: 10.1016/j.eururo.2016.01.035. Epub 2016 Feb 1.

  PMID: 26847139 BACKGROUND

• Selman LE, Ochieng CA, Lewis AL, Drake MJ, Horwood J. Recommendations for conducting invasive urodynamics for men with lower urinary tract symptoms: Qualitative interview findings from a large randomized controlled trial (UPSTREAM). Neurourol Urodyn. 2019 Jan;38(1):320-329. doi: 10.1002/nau.23855. Epub 2018 Oct 12.

  PMID: 30311686 RESULT

• Lewis AL, Young GJ, Abrams P, Blair PS, Chapple C, Glazener CMA, Horwood J, McGrath JS, Noble S, Taylor GT, Ito H, Belal M, Davies MC, Dickinson AJ, Foley CL, Foley S, Fulford S, Gammal MM, Garthwaite M, Harris MRE, Ilie PC, Jones R, Sabbagh S, Mason RG, McLarty E, Mishra V, Mom J, Morley R, Natale S, Nitkunan T, Page T, Payne D, Rashid TG, Saeb-Parsy K, Sandhu SS, Simoes A, Singh G, Sullivan M, Tempest HV, Viswanath S, Walker RMH, Lane JA, Drake MJ. Clinical and Patient-reported Outcome Measures in Men Referred for Consideration of Surgery to Treat Lower Urinary Tract Symptoms: Baseline Results and Diagnostic Findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). Eur Urol Focus. 2019 May;5(3):340-350. doi: 10.1016/j.euf.2019.04.006. Epub 2019 Apr 30.

  PMID: 31047905 RESULT

• Wei DY, Drake MJ. Undiagnosed neurological disease as a potential cause of male lower urinary tract symptoms. Curr Opin Urol. 2016 Jan;26(1):11-6. doi: 10.1097/MOU.0000000000000243.

  PMID: 26555692 DERIVED

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder, Underactive

Interventions

Urodynamics

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Marcus Drake, DM, MA, FRCS(Urol)

  University of Bristol

  PRINCIPAL INVESTIGATOR

• Athene Lane, PhD

  University of Bristol

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 17, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: June 30, 2022
• Last Updated: January 10, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)