Self-management for Men With Uncomplicated Lower Urinary Tract Symptoms

NCT00270309 | Completed Phase 3

• 1 other identifier: 64582
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Uncomplicated Lower Urinary Tract Symptoms

Keywords

lower urinary tract symptoms, self-management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Interventions

Self-management BEHAVIORAL

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Royal College of Surgeons of England: lead
• University College, London: collaborator

Related Publications (4)

• Brown CT, van der Meulen J, Mundy AR, O'Flynn E, Emberton M. Defining the components of a self-management programme for men with uncomplicated lower urinary tract symptoms: a consensus approach. Eur Urol. 2004 Aug;46(2):254-62; discussion 263. doi: 10.1016/j.eururo.2004.02.008.

  PMID: 15245822 BACKGROUND

• Brown CT, Van Der Meulen J, Mundy AR, Emberton M. Lifestyle and behavioural interventions for men on watchful waiting with uncomplicated lower urinary tract symptoms: a national multidisciplinary survey. BJU Int. 2003 Jul;92(1):53-7. doi: 10.1046/j.1464-410x.2003.04268.x.

  PMID: 12823383 BACKGROUND

• Newman S, Steed L, Mulligan K. Self-management interventions for chronic illness. Lancet. 2004 Oct 23-29;364(9444):1523-37. doi: 10.1016/S0140-6736(04)17277-2.

  PMID: 15500899 BACKGROUND

• Brown CT, Yap T, Cromwell DA, Rixon L, Steed L, Mulligan K, Mundy A, Newman SP, van der Meulen J, Emberton M. Self management for men with lower urinary tract symptoms: randomised controlled trial. BMJ. 2007 Jan 6;334(7583):25. doi: 10.1136/bmj.39010.551319.AE. Epub 2006 Nov 21.

  PMID: 17118949 DERIVED

Related Links

• Project list of the Clinical Effectiveness Unit, The Royal College of Surgeons of England
• Centre for Behavioural and Social Sciences in Medicine, University College London, UK

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Self-Management

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Christian Brown

  Clinical Effectiveness Unit, The Royal College of Surgeons of England

  PRINCIPAL INVESTIGATOR

• Mark Emberton

  Clinical Effectiveness Unit, The Royal College of Surgeons of England

  STUDY CHAIR

• Jan HP Van der Meulen, PhD

  Clinical Effectiveness Unit, The Royal College of Surgeons of England

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: January 1, 2004
• Primary Completion: April 1, 2004
• Study Completion: October 1, 2006
• Last Updated: May 6, 2015

Record last verified: 2005-12