Do Hydrophilic Catheters Decrease Pain and Discomfort of a Patient During Urodynamic Study (HYDRUDS)

Do Hydrophilic Catheters Decrease Pain and Discomfort of a Patient During Urodynamic Study: Single-blinded Randomized Study

This study attempts to verify whether different types of catheters could impact on patients' feelings at the first-time catheter insertion at urodynamic study.

Each patient will undergo an insertion of only one type of a catheter and will rate his/her pain and discomfort feelings.

Study Overview

• Status: Terminated
• Conditions: Pain; Discomfort

Detailed Description

Urodynamic study usually starts with non-invasive uroflowmetry following by insertion of a urethral catheter (nelathon or tiemann tip) for measuring of post-void residual of urine. Insertion of a urethral catheter is usually accompanied by a discomfort and sometimes even a pain. In order to minimize these unpleasant feelings urodynamic technician uses gel with anesthetic agents.

Single-use sterile catheters without any equipment and no coating can be used with lubricants and nowadays are the standard equipment at urodynamic study. Non-coated standard catheters are widely considered in the literature to cause an increase in urethral irritation, poor patient satisfaction, increased bacteriuria, and long-term urethral complications. Single-use sterile catheters with hydrophilic coatings, ready-to-use solution, with gel on the surface of the catheter or gel in the wrapping. Hydrophilic-coated catheters are characterized by having a layer of polymer coating, which absorbs and binds water to the catheter up to 10 times its own weight. This results in a thick, smooth and slippery surface reducing friction between the catheter surface and the urethral mucosa during insertion. The coating layer remains intact upon introduction into the urethra and ensures lubrication of the urethra in its entire length. Coloplast Speedicath hydrophylic catheters are designed for single use and are pre-coated to allow ease of insertion and removal, thereby reducing the risk of urethral mucosal irritation that can be more prevalent in an non-coated product.

Up today, there are no studies to verify whether a patient has different feelings with different type of catheters during the first-time urethral cauterization at urodynamic study.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 44410
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are referred to Urodynamic Suite at Meir Medical Center and comply with inclusion criteria

Description

Inclusion Criteria:

1. Male and female patients
2. Age 18 and above
3. Scheduled and consented for urodynamic study
4. Able to sign an informed consent and agree to be included to a study.

Exclusion Criteria:

1. indwelling catheter
2. use of pain killers in 24 hours prior to urodynamic study
3. persistent abdominal, perineal or pelvic pain or discomfort prior to a study
4. prior or suspected urethral stricture
5. urinary tract infection
6. positive asymptomatic urine culture prior to urodynamic study
7. scheduled for a transurethral cystoscopic examination at the same day

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Female Speedicath nelathon; Evaluation of pain or discomfort in female patients at/during/after Speedicath nelathon-tip catheter insertion
Female nelathon; Evaluation of pain or discomfort in female patients at/during/after standard nelathon-tip catheter insertion
Male Speedicath tiemann; Evaluation of pain or discomfort in male patients at/during/after Speedicath tiemann-tip catheter insertion
Male tiemann; Evaluation of pain or discomfort in male patients at/during/after standard tiemann-tip catheter insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain and discomfort level from a baseline	Change in Visual Analogue Scale (VAS) questionnaire score from a baseline. VAS questionnaire score assesses pain and discomfort of a patient from 0 to 10 where 0 is no pain and discomfort and 10 is a maximal pain and discomfort.	0, 2, 15, 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pulse rate	Pulse rate/minute	0, 2, 15, 30 minutes

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: pain; discomfort; urodynamic study; hydrophylic catheter
• Other Study ID Numbers: 0246-16-MMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No