NCT03330483

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Pain
• Discomfort

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2017-11-06
• Last updated: 2019-03-11

Locations

1 site across 1 country: Israel