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

NCT03603015 | Unknown

• 1 other identifier: 8598
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

bladder; urinary tract; symptoms; contractility; urodynamics; penile cuff test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in variance

  During the procedure

• Assessment of bladder contractility - BCI

  During the procedure

• Assessment of bladder contractility - Watt's Factor

  During the procedure

• Quality of Life Assessment - ICIQ-MLUTS

  During the procedure

• Quality of Life Assessment - IPSS

  During the procedure

Study Arms (1)

Pilot group: urodynamics and cuff test

OTHER

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

Interventions

Penile cuff test DIAGNOSTIC_TEST

Comparison of invasive vs non-invasive urodynamics

Also known as: Cystometrogram

Pilot group: urodynamics and cuff test

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead

Study Sites (1)

Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, Tyne and Wear, NE7 7DN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Helen C Morton, MBBS

  Newcastle upon Tyne Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Helen C Morton, MBBS

CONTACT

0191 2139602; Helen.Morton@nuth.nhs.uk

Alison Bray, PhD

CONTACT

0191 2823823; ABray3@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single pilot group all receiving the same tests

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 27, 2018
• Study Start: August 28, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)