The Effect of Catheter Valve Vs. Standard Catheter Removal in Outpatients

NCT02717975 | Unknown Phase 2

• 1 other identifier: 191435
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

It is estimated that over 10% of men above the age of 60 will experience an episode of urinary retention over a period of 5 years and will need urethral catheter. Some of these patients are discharged from the hospital with urethral catheter, for them to attend a Trial Without Catheter (TWOC) clinic at a later date for catheter removal. Traditionally after catheter is removed in the clinic the nurse has to wait for up to 5 hours before the patient get the urge to pass urine and empty the bladder. The main objective of this study is to see the effect of catheter valve on the length of clinic stay (timing of discharge)for the patients (men age 60-85) after catheter is removed. In this study after randomization, patients in Group A (catheter valve group) will be given a catheter valve before they are sent home with the catheter.They will be asked to close the valve 3-4 hours (time required for adequate filling of bladder, which means minimum of 250 mls in bladder with natural filling) before their appointment. It is very likely that by the time these patients are seen in the TWOC clinic their bladder is already full and they will void soon after removal of catheter.The patients in Group B (control) will go home with free drainage catheter and urine bag (standard catheter removal). These patients on arrival, in the TWOC clinic will have an empty bladder when their catheter is removed, they will then drink plenty of fluids in the clinic and wait for their bladder to be full before they void spontaneously. This study will last for one year after approval by ethical committee. The time saved in this process would lessen patient anxiety, lead to more patients being reviewed in clinic and therefore reduced waiting times in TWOC clinics and will save money.

Conditions

Urinary Retention

Keywords

Urinary retention; trial removal of catheter; valve

Outcome Measures

Primary Outcomes (1)

• Time to spontaneous void after catheter removal

  The primary outcome measure of this study is to see if usage of catheter valve results in early spontaneous voiding after catheter removal and thus significantly reduces the time spent by these patients in the clinic.

  On the day of catheter removal

Secondary Outcomes (3)

• Complications associated with valve

  On the day of catheter removal

• Reduction in clinic waiting time (hours)

  On the day of catheter removal

• Reduction in the cost of running the clinic

  On the day of catheter removal

Study Arms (2)

Without valve

ACTIVE COMPARATOR

Trial removal of catheter without catheter valve in patients with urinary retention. These are those patients who have catheter on free drainage, attend the clinic for catheter removal and bladder to be filled naturally ( which may take upto 4-5 hours). After removal of catheter they will be asked to drink plenty of fluids while waiting for the bladder to fill up. This is the traditional method of catheter removal.

Procedure: Trial removal of catheter in patients with urinary retention

With valve

EXPERIMENTAL

Trial removal of catheter in patients with urinary retention with closed catheter valve. These patients will be asked to close the valve 3-4 hours before attending the clinic prior to catheter removal. Here the intervention is catheter valve that allows bladder to be comfortably full by the time patient arrives in the clinic. By this intervention the investigators hypothesise that the investigators can save the clinic time as the patient will not need to wait for natural bladder filling which generally takes 4-5 hours. Intervention: Urinary catheter valve

Procedure: Use of catheter valve before 'trial removal of catheter'

Interventions

Use of catheter valve before 'trial removal of catheter' PROCEDURE

The investigators are comparing two groups of patients (Group A) Trial removal of urinary catheter in patients with urinary retention after applying catheter valve and closing it 3-4 hours before catheter removal.

With valve

Trial removal of catheter in patients with urinary retention PROCEDURE

The investigators are comparing two groups of patients (Group B) Trial removal of urinary catheter in patients with urinary retention without using catheter valve - 'Traditional method'

Without valve

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 60-85 catheterised for urinary retention and booked for outpatient removal of catheter
• Mobile patients

You may not qualify if:

• Who cannot consent
• Residual urine of more then 1 litre
• Abnormal renal functions
• Poor manual dexterity
• Learning difficulties/dementia.

Sponsors & Collaborators

• Medway NHS Foundation Trust: lead

Study Sites (1)

Medway NHS Foundation Trust

Gillingham, Kent, ME7 5NY, United Kingdom

RECRUITING

Related Publications (6)

• Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Natural history of prostatism: risk factors for acute urinary retention. J Urol. 1997 Aug;158(2):481-7. doi: 10.1016/s0022-5347(01)64508-7.

  PMID: 9224329 BACKGROUND

• Lyth DR, Braslis K, Iacovou JW. The infusion trial of micturition. Br J Urol. 1997 Jan;79(1):94-5. doi: 10.1046/j.1464-410x.1997.30520.x.

  PMID: 9043505 BACKGROUND

• Boccola MA, Sharma A, Taylor C, Wong LM, Travis D, Chan S. The infusion method trial of void vs standard catheter removal in the outpatient setting: a prospective randomized trial. BJU Int. 2011 Apr;107 Suppl 3:43-6. doi: 10.1111/j.1464-410X.2011.10044.x.

  PMID: 21492377 BACKGROUND

• Du J, Marshall D, Leyland J, Shaw L, Broome KE, Mason DF. Prospective, multicentre, randomized controlled trial of bladder filling prior to trial of void on the timing of discharge. ANZ J Surg. 2013 Apr;83(4):239-42. doi: 10.1111/j.1445-2197.2012.06253.x. Epub 2012 Sep 18.

  PMID: 22984818 BACKGROUND

• Wilson C, Sandhu SS, Kaisary AV. A prospective randomized study comparing a catheter-valve with a standard drainage system. Br J Urol. 1997 Dec;80(6):915-7. doi: 10.1046/j.1464-410x.1997.00473.x.

  PMID: 9439409 BACKGROUND

• German K, Rowley P, Stone D, Kumar U, Blackford HN. A randomized cross-over study comparing the use of a catheter valve and a leg-bag in urethrally catheterized male patients. Br J Urol. 1997 Jan;79(1):96-8. doi: 10.1046/j.1464-410x.1997.30321.x.

  PMID: 9043506 BACKGROUND

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Shikohe Masood, MD

  Medway NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shikohe Masood, MD

CONTACT

00441634830000; shikohemasood@nhs.net

Robert Hughes, MA

CONTACT

00441634830000; robert.hughes@medway.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Urological Surgeon

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: March 24, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 28, 2016

Record last verified: 2016-03

Locations

GB (1)