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Self-management for Men With Uncomplicated Lower Urinary Tract Symptoms

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ClinicalTrials.gov Identifier: NCT00270309
Recruitment Status : Completed
First Posted : December 26, 2005
Last Update Posted : May 6, 2015
Sponsor:
Collaborator:
University College, London
Information provided by:
The Royal College of Surgeons of England

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.


Condition or disease Intervention/treatment Phase
Uncomplicated Lower Urinary Tract Symptoms Behavioral: Self-management Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Self-management for Men With Uncomplicated Lower Urinary Tract Symptoms. A Randomised Controlled Trial Against Standard Therapy
Study Start Date : January 2004
Actual Primary Completion Date : April 2004
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  1. quality of life / bother assessment (BPH Impact Index)
  2. Short Form-36
  3. Illness Perception Questionnaire - IPQ
  4. health-seeking behaviour (unscheduled clinic, A&E or GP visits)
  5. infection
  6. 3 day frequency / volume chart


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00270309     History of Changes
Other Study ID Numbers: 64582
First Posted: December 26, 2005    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: December 2005

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

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms