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Trial record 2 of 117 for:    upstream study

Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02193451
Recruitment Status : Active, not recruiting
First Posted : July 17, 2014
Last Update Posted : January 10, 2020
Sponsor:
Collaborators:
University of Bristol
University of Aberdeen
Newcastle University
Royal Devon and Exeter NHS Foundation Trust
University of Sheffield
Information provided by (Responsible Party):
North Bristol NHS Trust

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.


Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Voiding Dysfunction Benign Prostate Obstruction Detrusor Underactivity Procedure: Urodynamics Procedure: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for Diagnosis and Management of Bladder Outlet Obstruction in Men
Actual Study Start Date : April 2014
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Urodynamics
Invasive urodynamic cystometry including pressure flow studies, along with usual diagnostics in male LUTS
Procedure: Urodynamics
Diagnostic test for urinary storage and voiding function
Other Names:
  • Cystometry
  • Pressure flow study

Procedure: Usual care
Other Names:
  • Flow rate
  • Symptom scores
  • Bladder diary

Active Comparator: Usual care
Usual diagnostics in male LUTS; flow rate test, symptom score and bladder diary
Procedure: Usual care
Other Names:
  • Flow rate
  • Symptom scores
  • Bladder diary




Primary Outcome Measures :
  1. International Prostate Symptom Score [ Time Frame: 18 months ]
    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)


Secondary Outcome Measures :
  1. Surgery rate [ Time Frame: 18 months ]
    The relative proportion of men in each group having surgery up to 18 months after randomisation

  2. Cost-effectiveness analyses [ Time Frame: 18 months ]
    Cost effectiveness from the perspectives of the Health Service, Personal Social Services and patients

  3. Adverse events [ Time Frame: 18 months ]
    Adverse events of testing and treatment (e.g. infection, urinary retention).

  4. International Consultation on Incontinence Questionnaires [ Time Frame: 18 months ]
    Measures from the International Consultation on Incontinence Questionnaires (ICIQ) regarding LUTS severity/ bother, sexual function, quality of life and satisfaction with urodynamic testing. The following will be measured at 6, 12 and 18 months; IPSS (including quality of life) ICIQ Male LUTS (ICIQ-MLUTS) ICIQ sexual function in Male LUTS (ICIQ-MLUTS-sex)

  5. Maximum urinary flow rate [ Time Frame: 18 months ]
    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. EQ-5D-5L [ Time Frame: 18 months ]
    EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). In the descriptive system, respondents rate their health 'TODAY' according to 5 dimensions (Mobility; Self-Care; Usual Activities; Pain/Discomfort; and Anxiety/Depression), with 5 levels of severity (No Problems; Slight; Moderate; Severe; and Extreme Problems). This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). The VAS can be used as a quantitative measure of health outcome reflecting the patient's own judgement. Full details of the scoring system can be found via the EQ-5D website/user guide.

  7. International Prostate Symptom Score (IPSS) [ Time Frame: 5 years post randomisation ("UPSTREAM - Phase II") ]
    "UPSTREAM - Phase II": difference in lower urinary tract symptom (LUTS)

  8. Surgery rate [ Time Frame: 5 years post randomisation ("UPSTREAM - Phase II") ]
    "UPSTREAM - Phase II": The relative proportion of men in each group having surgery up to 5 years after randomisation

  9. Measures from the International Consultation on Incontinence Questionnaires (ICIQ) regarding male lower urinary tract symptoms (LUTS) severity/ bother [ Time Frame: 5 years post randomisation ("UPSTREAM - Phase II") ]
    "UPSTREAM - Phase II": ICIQ Male LUTS (ICIQ-MLUTS); questionnaire evaluating MLUTS and impact on quality of life. 13 items, Scoring: 0-20 voiding symptoms subscale 0-24 incontinence symptoms subscale. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient. See https://iciq.net for further information.

  10. Measures from the International Consultation on Incontinence Questionnaires Measures from the International Consultation on Incontinence Questionnaires (ICIQ) regarding regarding sexual function [ Time Frame: 5 years post randomisation ("UPSTREAM - Phase II") ]
    "UPSTREAM - Phase II":ICIQ sexual function in Male LUTS (ICIQ-MLUTS-sex). Patient-complete questionnaire for evaluation of male sexual function associated with their MLUTS and impact of quality of life. 4 items, scoring: 0-12 overall score with greater values indicating increasing problems with sexual matters. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient. See https://iciq.net for further information.

  11. Quality of Life (QoL) [ Time Frame: 5 years post randomisation ("UPSTREAM - Phase II") ]
    "UPSTREAM - Phase II": International Prostate Symptom Score (IPSS) including QoL question. The IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

  12. EQ-5D-5L [ Time Frame: 5 years post randomisation ("UPSTREAM - Phase II") ]
    "UPSTREAM - Phase II": EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). In the descriptive system, respondents rate their health 'TODAY' according to 5 dimensions (Mobility; Self-Care; Usual Activities; Pain/Discomfort; and Anxiety/Depression), with 5 levels of severity (No Problems; Slight; Moderate; Severe; and Extreme Problems). This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). The VAS can be used as a quantitative measure of health outcome reflecting the patient's own judgement. Full details of the scoring system can be found via the EQ-5D website/user guide.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193451


Locations
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United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom, BS10 5NB
Sponsors and Collaborators
North Bristol NHS Trust
University of Bristol
University of Aberdeen
Newcastle University
Royal Devon and Exeter NHS Foundation Trust
University of Sheffield
Investigators
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Principal Investigator: Marcus Drake, DM, MA, FRCS(Urol) University of Bristol
Study Director: Athene Lane, PhD University of Bristol

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: North Bristol NHS Trust
ClinicalTrials.gov Identifier: NCT02193451    
Other Study ID Numbers: UPSTREAM 3250
12/140/01 ( Other Grant/Funding Number: NIHR HTA )
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by North Bristol NHS Trust:
Lower urinary tract symptoms
Male LUTS
Voiding dysfunction
Benign prostate obstruction
Detrusor underactivity
Additional relevant MeSH terms:
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Hypokinesia
Urinary Bladder, Underactive
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases