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Self-management for Men With Uncomplicated Lower Urinary Tract Symptoms

NCT00270309 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2015-05-06

No results posted yet for this study

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

Interventions

BEHAVIORAL

Self-management

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • The Royal College of Surgeons of England

    lead OTHER

Principal Investigators

  • Christian Brown · Clinical Effectiveness Unit, The Royal College of Surgeons of England

  • Mark Emberton · Clinical Effectiveness Unit, The Royal College of Surgeons of England

  • Jan HP Van der Meulen, PhD · Clinical Effectiveness Unit, The Royal College of Surgeons of England

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2004-04-30
Completion
2006-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00270309 on ClinicalTrials.gov