Lower Urinary Tract Symptoms Clinical Trial
— CONCUROfficial title:
Contractility: Cuff Versus Urodynamics Testing In Males With Voiding Lower Urinary Tract Symptoms
NCT number | NCT03603015 |
Other study ID # | 8598 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 28, 2018 |
Est. completion date | March 2019 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | March 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle | Tyne And Wear |
Lead Sponsor | Collaborator |
---|---|
Newcastle-upon-Tyne Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between invasive and non-invasive measurements | Comparison of the pressure required to interrupt urine flow (pcuff.int) and simultaneously measured isovolumetric bladder pressure (pves.isv). | During the procedure | |
Secondary | Change in variance | Comparison of results from this pilot study with analysis of past cohort to see if variances within the two populations are different (F test) | During the procedure | |
Secondary | Assessment of bladder contractility - BCI | Invasive assessment of contractility using the bladder contractility index (BCI). (it will also be analysed for correlation with pcuff.int) | During the procedure | |
Secondary | Assessment of bladder contractility - Watt's Factor | Invasive assessment of contractility using Watt's Factor (it will also be analysed for correlation with pcuff.int) | During the procedure | |
Secondary | Quality of Life Assessment - ICIQ-MLUTS | 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) | During the procedure | |
Secondary | Quality of Life Assessment - IPSS | 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) | During the procedure | |
Secondary | Accuracy of ultrasound residual urine volume | catheterized post void residual volume will be used as a gold standard to compare ultrasound residual measurements from two clinicians | During the procedure |
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