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Trial record 2 of 274 for:    Recruiting, Not yet recruiting, Available Studies | "Lower Urinary Tract Symptoms"

Contractility: Cuff Versus Urodynamics Testing In Males With Voiding Lower Urinary Tract Symptoms (CONCUR)

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ClinicalTrials.gov Identifier: NCT03603015
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Brief Summary:

A number of men will experience bothersome urinary symptoms, which become more common as they age. A number of conditions can cause these symptoms, and general practitioners may refer men to their local hospital for further assessment and treatment. Symptoms can include poor flow of urine, the need to pass urine more frequently, or the sensation that the bladder is not completely emptying. This can be due to an enlargement of the prostate gland. These symptoms can also be caused when the bladder muscle is not able to contract (squeeze) as well as it previously has to empty the bladder. This is known as underactive bladder (UAB).

It is important to distinguish between the two conditions as a cause for these symptoms, to prevent side effects from unnecessary medications or operations. Currently, men would need to undergo a bladder pressure test (urodynamics). This involves inserting a catheter via the penis into the bladder, through which the bladder is filled with fluid and pressure is measured. A separate second small tube is inserted into the rectum to measure the pressure in the abdomen. The pressure changes are observed as the bladder is filled, and then urine is passed around the catheter.

A second technique for measuring bladder pressure is the use of a small inflatable cuff which is placed around the penis (penile cuff test). The bladder pressure can then be determined by inflating the cuff and interrupting the flow of urine. The bladder can be filled naturally before the test, which means a bladder catheter tube is not required. This study is designed to find out ways that the penile cuff test can be made more accurate. It will compare the cuff results to those obtained from a bladder pressure test, and will take x-ray pictures of the urinary tract during the test.


Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Diagnostic Test: Penile cuff test Not Applicable

Detailed Description:

The investigators intend to refine the procedural steps of the cuff test to improve the measurement and reduce variability with pves.isv, therefore giving a more reproducible test. By improving the penile cuff test, the investigators can then go on to assess how our non-invasive measurements correlate with urodynamically derived indices of contractility, and use data from this pilot to help construct methodology of future cuff research. The current hypotheses are that; 1) accuracy of the cuff interruption pressure (pcuff.int) can be improved by modification of penile cuff test factors, 2) the number of valid inflations obtained per patient will increase with the modifications, and 3) that this non-invasive measure of contractility will correlate with pre-existing invasive indices.

The research protocol also gives the opportunity to explore correlation between commonly used symptom scores, and accuracy in the assessment of ultrasound residual urine volume measurement.

The primary objectives are therefore:

  • To modify procedural steps of the penile cuff test that may reduce the previously observed variability and perform a pilot study to assess a reduction in variance
  • To identify behaviour of the urethra during penile cuff inflation, by performing x-ray screening during the penile cuff test, and assess whether this is another source of inaccuracy
  • To test the basic assumption of the penile cuff test that the bladder neck remains open during flow interruption

Secondary objectives of the study include the following:

  • To compare non-invasive measurements from the penile cuff test against invasive indices of contractility
  • To compare 2 different symptom scores for men with voiding lower urinary tract symptoms (LUTS)
  • To assess accuracy and inter-observer variability of ultrasound residual measurement against a known volume.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single pilot group all receiving the same tests
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contractility: Cuff Versus Urodynamics Testing In Males With Voiding Lower Urinary Tract Symptoms
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Pilot group: urodynamics and cuff test
Single-arm study with all participants undergoing cystometrogram, then cystometrogram with simultaneous penile cuff test, then penile cuff test alone
Diagnostic Test: Penile cuff test
Comparison of invasive vs non-invasive urodynamics
Other Name: Cystometrogram




Primary Outcome Measures :
  1. Difference between invasive and non-invasive measurements [ Time Frame: During the procedure ]
    Comparison of the pressure required to interrupt urine flow (pcuff.int) and simultaneously measured isovolumetric bladder pressure (pves.isv).


Secondary Outcome Measures :
  1. Change in variance [ Time Frame: During the procedure ]
    Comparison of results from this pilot study with analysis of past cohort to see if variances within the two populations are different (F test)

  2. Assessment of bladder contractility - BCI [ Time Frame: During the procedure ]
    Invasive assessment of contractility using the bladder contractility index (BCI). (it will also be analysed for correlation with pcuff.int)

  3. Assessment of bladder contractility - Watt's Factor [ Time Frame: During the procedure ]
    Invasive assessment of contractility using Watt's Factor (it will also be analysed for correlation with pcuff.int)

  4. Quality of Life Assessment - ICIQ-MLUTS [ Time Frame: During the procedure ]
    International Consultation on Incontinence Modular Questionnaire for male LUTS (ICIQ-MLUTS) will be completed by the participant. This is a modular symptom and quality of life questionnaire, in which the participant scores the frequency of a symptom from 0-4, and completes a 0-10 bother score (10 =worst) for each symptom. There are 20 questions in total. ( and analysed for correlation with outcome 6)

  5. Quality of Life Assessment - IPSS [ Time Frame: During the procedure ]
    International prostate symptoms score (IPSS) will be completed by the participant. Total score range 0-35 - generated from the sum of 7 questions related to urinary symptoms - all scored from 0-5 on degree of frequency. It will also be analysed for correlation with outcome 5)

  6. Accuracy of ultrasound residual urine volume [ Time Frame: During the procedure ]
    catheterized post void residual volume will be used as a gold standard to compare ultrasound residual measurements from two clinicians



Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Male aged 18 years old or over
  • Referred for video urodynamics within our department
  • Predominant voiding LUTS as assessed by IPSS at screening. [The total IPSS score is out of 35, with up to 15 points for storage symptoms and 20 for voiding symptoms. If voiding symptoms as a percentage of total score is higher than storage symptoms they will be included in the study].
  • Capacity to understand study procedures and give informed consent
  • At least 2 voided volumes on frequency volume chart (FVC) of 250 mL

Exclusion Criteria:

  • Female patients
  • Long term catheterisation
  • Predominant storage LUTS on IPSS at screening
  • Fewer than 2 voids on FVC > 250 mL
  • Known pre-existing neurological cause for symptoms
  • Active urinary tract infection (UTI)

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): NCT03603015


Contacts
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Contact: Helen C Morton, MBBS 0191 2139602 Helen.Morton@nuth.nhs.uk
Contact: Alison Bray, PhD 0191 2823823 ABray3@nhs.net

Locations
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United Kingdom
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust Recruiting
Newcastle, Tyne And Wear, United Kingdom, NE7 7DN
Contact: Helen C Morton, MBBS         
Contact: Nicola Brown    (+44) 0191 2137322    Nicola.Brown@nuth.nhs.uk   
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
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Principal Investigator: Helen C Morton, MBBS Newcastle upon Tyne Hospitals NHS Foundation Trust
Study Director: Chris K Harding, MBBChir, MD Newcastle upon Tyne Hospitals NHS Foundation Trust
Study Director: Alison Bray, PhD Newcastle upon Tyne Hospitals NHS Foundation Trust
Study Director: James Blake, PhD Newcastle upon Tyne Hospitals NHS Foundation Trust
  Study Documents (Full-Text)

Documents provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Informed Consent Form  [PDF] April 24, 2018


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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03603015     History of Changes
Other Study ID Numbers: 8598
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
bladder
urinary tract
symptoms
contractility
urodynamics
penile cuff test
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms