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

NCT02196987 | Unknown

• 1 other identifier: 109/14
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; Catheter; Urethra; Urination

Outcome Measures

Primary Outcomes (1)

• Change from baseline in visual analog pain scales

  A 0 to 10 visual analog pain scale (VAS)

  Before catheterisation, during catheterisation, 15 minutes after catheterisation

Study Arms (2)

Urination, urethral catheterisation

Act of urination during urethral catheterisation in males

Other: Urination during urethral catheterisation

Lie, catheterisation, urethra

Urethral catheterisation without medical professional guidance

Other: Urethral catheterisation, without further guidance

Interventions

Urination during urethral catheterisation OTHER

Requesting the patient to urinate while inserting urethral catheter

Urination, urethral catheterisation

Urethral catheterisation, without further guidance OTHER

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

Lie, catheterisation, urethra

Eligibility Criteria

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

Study Population

Men who will be referred to Urodynamic study

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofe Medical Center

Beer Yaakov, Zeriffin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Urinary Catheterization

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Kobi Stav, MD

  Assaf Harofe Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kobi Stav, MD

CONTACT

972-8-9778461; stavkobi@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Kobi Stav

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

IL (1)