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

Pain Clinical Trial

— HYDRUDS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03330483
• Other study ID #: 0246-16-MMC
• Status: Terminated
• Start date: November 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Discomfort
• Pain

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in pulse rate	Pulse rate/minute	0, 2, 15, 30 minutes