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

NCT03330483 | Terminated

• 1 other identifier: 0246-16-MMC
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Discomfort

Keywords

pain; discomfort; hydrophylic catheter; urodynamic study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in pulse rate

  0, 2, 15, 30 minutes

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 44410, Israel

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: November 6, 2017
• Study Start: November 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 11, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)