Contractility: Cuff Versus Urodynamics Testing In Males With Voiding Lower Urinary Tract Symptoms
NCT03603015 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2018-09-17
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.
Conditions
- Lower Urinary Tract Symptoms
Interventions
- DIAGNOSTIC_TEST
-
Penile cuff test
Comparison of invasive vs non-invasive urodynamics
Sponsors & Collaborators
-
Newcastle-upon-Tyne Hospitals NHS Trust
lead OTHER
Principal Investigators
-
Helen C Morton, MBBS · Newcastle upon Tyne Hospitals NHS Foundation Trust
-
Chris K Harding, MBBChir, MD · Newcastle upon Tyne Hospitals NHS Foundation Trust
-
Alison Bray, PhD · Newcastle upon Tyne Hospitals NHS Foundation Trust
-
James Blake, PhD · Newcastle upon Tyne Hospitals NHS Foundation Trust
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-28
- Primary Completion
- 2019-03-31
- Completion
- 2019-03-31
Countries
- United Kingdom
Study Locations
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