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Self-Management for Men With Uncomplicated Lower Urinary Tract Symptoms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by The Royal College of Surgeons of England.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University College, London
Information provided by:
The Royal College of Surgeons of England
ClinicalTrials.gov Identifier:
NCT00270309
First received: December 22, 2005
Last updated: July 9, 2009
Last verified: December 2005
History of Changes
  Purpose

Objective To test the hypothesis that a nurse-led self-management programme is effective for men with uncomplicated lower urinary tract symptoms. This will be achieved by comparing symptom seveirty and the amount of drug therapy used to manage these symptoms in men who attend a self-management programme, compared to those who do not.

Study design This study will use the format of a randomised controlled trial. 200 new patients with uncomplicated LUTS will be randomised to either attend or not attend (standard therapy) a self-management programme. The programme provides education, reassurance, prostate cancer risk, advice on lifestyle modifications (e.g. fluids - type and amount), concurrent medication re-scheduling and behavioural changes (double-voiding, strategies for dribbling, and bladder re-training). These strategies are learnt through group discussion, problem solving and goal setting.

All men start the study with a period of watchful waiting (monitoring symptoms only) and are followed up for a total of 1 year. At each assessment (baseline, 3, 6, and 12 months) symptom severity and the use of drug therapy to control symptoms will be compared between the two groups. The only difference between them is that one group has attended a self-management programme and the other has not.

Potential application of results Self-management focuses on patient involvement in health care by involving them in the day-to-day control of their symptoms. If effective, self-management may provide a long-term method of managing LUTS without using drug therapy, thereby offering considerable health gain and financial savings.

The NHS Modernisation Agency wishes to develop the role of the nurse specialist to manage some patients independently of doctors. Nurse-led LUTS assessment clinics are now well established, perhaps nurses managing these patients with self-management interventions may become part of standard therapy.


Condition Intervention Phase
Uncomplicated Lower Urinary Tract Symptoms
 Behavioral: Self-management
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Self-Management for Men With Uncomplicated Lower Urinary Tract Symptoms. A Randomised Controlled Trial Against Standard Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Royal College of Surgeons of England:

Primary Outcome Measures:
  • treatment failure (use of drug therapy for symptom control, surgical intervention, symptom deterioration of 3 points or more measured with the I-PSS, acute urinary retention, or death)

Secondary Outcome Measures:
  • quality of life / bother assessment (BPH Impact Index)
  • Short Form-36
  • Illness Perception Questionnaire - IPQ
  • health-seeking behaviour (unscheduled clinic, A&E or GP visits)
  • infection
  • 3 day frequency / volume chart

Estimated Enrollment: 168
Study Start Date: January 2004
Estimated Study Completion Date: May 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • new patients with uncomplicated LUTS (I-PSS score 0-35)
  • aged 40 years and over
  • referred for the first time by their family doctor (general practitioner) to one of a participating urological outpatient departments

Exclusion Criteria:

  • lower urinary tract symptoms due to any urological malignancy
  • previous prostatic surgery within the last 10 years or pelvic radiotherapy
  • complications of urinary obstruction (acute or chronic urinary retention - post micturition volumes over 300ml, bladder stones, renal failure, recurrent urinary tract infection or haematuria)
  • uncontrolled diabetes, dementia and end stage cardiac or respiratory failure
  • inability to speak or understand the English language
  • severe symptoms where drug therapy or surgical management is indicated or requested by the patient
  • medical therapy for lower urinary tract symptoms in the previous 3 months, including alpha-blockers, 5-alpha reductase inhibitors (finasteride) or anti-cholinergics.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270309

Sponsors and Collaborators
The Royal College of Surgeons of England
University College, London
Investigators
Principal Investigator: Christian Brown Clinical Effectiveness Unit, The Royal College of Surgeons of England
Study Chair: Mark Emberton Clinical Effectiveness Unit, The Royal College of Surgeons of England
Study Director: Jan HP Van der Meulen, PhD Clinical Effectiveness Unit, The Royal College of Surgeons of England
  More Information

Additional Information:
Centre for Behavioural and Social Sciences in Medicine, University College London, UK  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00270309     History of Changes
Other Study ID Numbers: 64582
Study First Received: December 22, 2005
Last Updated: July 9, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by The Royal College of Surgeons of England:
lower urinary tract symptoms, self-management

ClinicalTrials.gov processed this record on May 16, 2013