Does the Act of Urination During Urethral Catheterisation in Males Reduce Pain?

NCT ID: NCT02196987

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 96 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

Brief Summary

Currently, there are no specific guidelines or best practice suggestions for best male catheterization as fat as insertion technique. There is however, information as to reducing infection, and as to recommended lubricant.

From our experience, the investigators have noticed that when requesting the patient to attempt urination while inserting a urethral catheter, the level of pain and discomfort is reduced. In this study, the investigators will evaluate the pain level during male urethral catheterization in each technique.

Our hypothesis is that the level of pain will be much less if the in the study group where the act of urination will be requested from the patient.

Detailed Description

This is a randomized prospective study that will compare the pain levels of urethral catheterization in men randomized to requesting to urinate while inserting a urethral catheter to normal catheter insertion.

Males aged 18 years and older who will be referred for multichannel Urodynamic study in order to evaluate lower urinary tract symptoms will be included.

Patients will be randomized to 2 groups: (1) Patients who will be requested to urinate while catheterising the urethra to its full length; (2), Patients who will be requested to lie while catheterising the urethra, without further instructions from the medical professional. In both groups, prior to catheterisation, 10 ml of lidocaine gel will be inserted into the urethra. The randomization technique will be employed by a computerized random number generator.

A 12F Tieman urethral catheter will be introduced in order to measure post-void residual volumes. Subsequently, multichannel Urodynamic testing (Duet Encompass System - Mediwatch Group Plc) will be performed using a dual lumen 6F urethral and 9F rectal catheters. Filling will be carried out using room temperature saline at a filling rate of 50 ml/min.

Patients will be requested to fill out a 0 (no pain) to 10 (worst imaginable pain) visual analog pain scale (VAS) in different time points: before the procedure (baseline), immediately after gel instillation, immediately after the introduction of the Tieman catheter, 15 minutes after the catheter will be taken out.

Time frame of the study: 30 minutes before the test and 1 hour after the test. Since the study evaluates pain during the procedure the time frame of the study and assessment is very short. longer follow-up is not needed.

Conditions

Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Urination, urethral catheterisation

Act of urination during urethral catheterisation in males

Urination during urethral catheterisation

Intervention Type: OTHER

Requesting the patient to urinate while inserting urethral catheter

Lie, catheterisation, urethra

Urethral catheterisation without medical professional guidance

Urethral catheterisation, without further guidance

Intervention Type: OTHER

Lying, inserting urethral catheter, without further guidance from health care professional

Interventions

Urination during urethral catheterisation

Requesting the patient to urinate while inserting urethral catheter

Intervention Type: OTHER

Urethral catheterisation, without further guidance

Lying, inserting urethral catheter, without further guidance from health care professional

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• men aged 18 years and older who will be referred for multichannel Urodynamic study in order to evaluate lower urinary tract symptoms.

Exclusion Criteria

• use of any analgesics within the previous 24 hours, known urethral stricture, active urinary tract infection, indwelling urethral catheter, pre-existing urethral pain (e.g. patients with chronic pelvic pain syndromes and interstitial cystitis), inability to cooperate with pain assessment due to mental disorders.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assaf Harofeh MC

Dr. Kobi Stav

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kobi Stav, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf Harofe Medical Center

Locations

Assaf Harofe Medical Center

Beer Yaakov, Zeriffin, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Kobi Stav, MD

Role: CONTACT

stavkobi@gmail.com

972-8-9778461

Facility Contacts

Kobi Stav, MD

Role: primary

stavkobi@gmail.com

972-8-9778461

Other Identifiers

109/14

Identifier Type: -

Identifier Source: org_study_id