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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03603015 on ClinicalTrials.gov