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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain, Discomfort

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients Age 18 and above Scheduled and consented for urodynamic study Able to sign an informed consent and agree to be included to a study. Exclusion Criteria: indwelling catheter use of pain killers in 24 hours prior to urodynamic study persistent abdominal, perineal or pelvic pain or discomfort prior to a study prior or suspected urethral stricture urinary tract infection positive asymptomatic urine culture prior to urodynamic study scheduled for a transurethral cystoscopic examination at the same day

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female Speedicath nelathon<br>Evaluation of pain or discomfort in female patients at/during/after Speedicath nelathon-tip catheter insertion | |
| Female nelathon<br>Evaluation of pain or discomfort in female patients at/during/after standard nelathon-tip catheter insertion | |
| Male Speedicath tiemann<br>Evaluation of pain or discomfort in male patients at/during/after Speedicath tiemann-tip catheter insertion | |
| Male tiemann<br>Evaluation of pain or discomfort in male patients at/during/after standard tiemann-tip catheter insertion | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, discomfort, hydrophylic catheter, urodynamic study