Trial Information

Self-Management for Men With Uncomplicated Lower Urinary Tract Symptoms. A Randomised Controlled Trial Against Standard Therapy

1. OBJECTIVES

To assess the effectiveness of self-management interventions in men with uncomplicated
LUTS.

2. STUDY DESIGN

2.1 This is a randomised controlled trial comparing self-management with standard
therapy. These interventions are proposed to optimise watchful waiting, providing an
alternative to drugs and surgery for symptom control.

Participants

2.2. Participating urological units include the Middlesex Hospital NHS Trust and the
Whittington Hospital NHS Trust.

2.3. 200 new patients with uncomplicated LUTS (I-PSS score 0-35) will be randomised to
either attend a self-management programme or not attend a self-management programme
(standard therapy - control group). There will be approximately 100 men in each group.
Standard therapy, as described previously, involves watchful waiting, drugs or surgery,
the therapeutic choice depending on weighting severity and bother, with risks and
benefits.

2.4. All new patients over the age of 40 years with a diagnosis of lower urinary tract
symptoms secondary to benign prostatic hyperplasia or age related bladder dysfunction
are eligible for inclusion.

2.5. The following exclusion criteria applies:

- age under 40 yrs

- lower urinary tract symptoms due to any urological malignancy or whilst
investigating any urological malignancy e.g. prostate cancer

- 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

- any man who is or has been in the previous 3 months on medical therapy for lower
urinary tract symptoms, including alpha-blockers, 5-alpha reductase inhibitors
(finasteride) or anti-cholinergics. The use of alpha-blockers for the control of
hypertension is permitted, since these men have symptoms and still are eligible
for medical treatment (finasteride, anti-cholinergics) and surgery.

2.6. Each patient will be fully informed regarding the study process and possible uses
of subsequent data collected. An information sheet on headed paper will be available
and a consent form signed by both researcher and patient. The patients who participate
in this study will not participate in any other study conducted by our group in the
future.

2.7. All GP's will be informed by letter of their patient's participation and progress
in this study. A copy of this standard letter will be left in the patients' notes on
recruitment.

2.8. Once recruited men will be randomised into 2 groups. Computer generated
randomisation will be carried out by a third party. Randomisation takes place at week
zero of each mans 12 months overall participation in the study. Patients will be
recruited by the study coordinator. On recruitment an enrolment form is completed, and
a copy left in the patient notes along with their consent form.

2.9. Group 1 will receive self-management and Group 2 will receive standard therapy.

2.10. All men start the study with a period of watchful waiting until their first
assessment at 2 months. During this time men assigned to self-management will attend
their 3 sessions, the control group will not.

2.11. Men in Groups 1 & 2 will be followed up as per protocol at 2, 6, and 12 months
after randomisation i.e. short, medium, and long term.

Intervention

2.12. Men randomised into Group 1 (self-management) will in addition to standard follow
up, be invited to attend 3 small group (4-6 men) sessions and receive a single
telephone call (as their self-management programme).

2.13. The four key areas within the self-management programme are:

- Education

- Reassurance

- Lifestyle modifications

- Behavioural changes

2.14. The sessions will be facilitated by local nurse practitioners).

2.15. The sessions are standardised and run from a Facilitators Manual developed and
piloted at The Royal College of Surgeons and The Centre for Behavioural and Social
Sciences in Medicine, UCL.

2.16. Each session lasts approximately 2 hours and is a mixture of group learning
through brainstorming and discussion, teaching, and goal setting. All sessions are
supported with a self-management booklet given in session 1.

2.17. Session 1 (first week):

- Introduction and programme review

- Introduction to the concept of self-management

- Education/reassurance - prostate and bladder health, prostate cancer, future
symptoms

- Managing fluid intake

- Caffeine abstinence

- Alcohol advice

2.18. Session 2 (second week):

- Adjusting medications which affect LUTS e.g. diuretics (if relevant)

- Constipation advice

- Strategies for dribbling

- Double-voiding

- Bladder re-training

2.19. Third week telephone call - trouble shooting problems and answering queries

2.20. Session 3 (six weeks):

- Booster session

- Designed for men to share reasons why some things work and others do not

- Used to discuss reasons why for example they have found it difficult to abstain
from caffeine or other goals set

2.21. Each man in Group 1 will be able to contact the Clinical Nurse Specialist at
other times aside from the sessions in the case of confusion or query, by telephone,
e-mail or letter.

Intervention components

2.22. Education - Men with LUTS should understand:

- LUTS are real symptoms worthy of medical care

- Not all LUTS require treatment with drugs and/or surgery (give details of expected
future symptomology)

- That patients have an important role to play in the management of their symptoms

- Each patient has the ability to follow a self-management programme which can have
a beneficial effect on their symptoms - self-efficacy

- The range of treatments available for men with LUTS including why some treatments
are used and not others i.e. the appropriateness of treatment

2.23. Reassurance - Men with LUTS should understand:

- The symptom severity of many men with LUTS does not change over time (85% stable
at 1 year and 65% at 5 years [17,18])

- Some men may see spontaneous symptom improvement

- The annual risk of acute urinary retention is 2% [19]

- LUTS are often affected by a man's current state of mind, high levels of arousal
or worry can have a detrimental effect

- Their symptoms are not due to detectable prostate cancer

- That their risk of prostate cancer is that of an age related man with no symptoms
i.e. that of the general male population of the same age [20]

2.24. Lifestyle modifications include fluid, caffeine and alcohol advice.

Fluid advice • Introduce the concept of a healthy fluid balance

- Explain the significance of concentrated urine and the potential detrimental
(irritative) effects

- There are good fluid habits all men can use regularly with minimal effort

- There are specific changes that some men may have to make based on their
previously completed charts e.g. excessive intake of water at night

- Excessive or inadequate fluid intake should always be avoided

- A total daily intake of 1500-2000 mls is advised (minor adjustments made for
climate and activity)

- Fluid should be spaced evenly throughout the day rather than in large single
amounts

- Fluid restriction for symptom control at times of greatest inconvenience e.g. long
car journeys or when out in public places, is appropriate, but the overall daily
intake should not be restricted significantly (for control of irritative symptoms)

- If nocturia is bothersome, fluid restriction 2 hours before retiring to bed can be
effective

Caffeine Advice

• Explain that caffeine has a detrimental effect on symptoms in men with LUTS
especially irritative symptoms

- Explain that caffeine can be found in tea, coffee, chocolate, energy drinks and
over the counter flu remedies

- Explain that by completely avoiding caffeine, symptom improvement may be found

- If caffeine use is excessive then it should not be stopped overnight but over 2-3
days to avoid headaches and stomach cramps etc

- Caffeine avoidance can be achieved by substituting for drinks that are
de-caffeinated or non-caffeinated e.g. de-caffeinated coffee or a soft drink

- Nocturia can be exacerbated by evening caffeine use, to prevent this caffeine
should be avoided for 5 hours prior to retiring

Alcohol advice

• Explain that alcohol has a detrimental effect on symptoms in men with LUTS especially
irritative symptoms

• Explain that by completely avoiding alcohol, symptom improvement may be found, but
that we understand this may not be possible and avoiding alcohol or restriction of
alcohol at times of greatest inconvenience may be more appropriate

- Explain there are quality of life issues with alcohol abstinence and this
information is a guide only

- In men with nocturia evening alcohol use should be avoided

- Explain when we consume alcohol we often consume large quantities of extra fluid
and symptom reduction may be achieved by substituting large volume alcoholic
drinks for small volume alcoholic drinks e.g. a pint to a short

Timing of concurrent medication • Adjust the time medication (with an effect on urinary
symptoms) is taken to improve LUTS at times of most inconvenience e.g. meetings, long
car journeys and when out in public places

• Substitute an anti-hypertensive diuretic (with the aid of the patient's GP) to a
suitable alternative with less urinary effects in a man with LUTS

Behavioural changes • Men with obvious 'bad habits' will be advised e.g. the going
'just in case' type of man

• Men with LUTS will be advised to double void

• Men with post micturition dribble should be advised on urethral milking

• Men with LUTS who have 'irritative' symptoms will be offered a formal bladder
re-training programme.

• Advice will be given to men with LUTS regarding avoiding constipation

2.25. Men randomised to the self-management arm of the study will also be offered a
booster or refresher session at six-months, or just after their six month assessment.

Outcomes

2.26. The primary outcome is treatment failure. In this study treatment failure is
defined as:

• The use of drug therapy for symptom control (as determined by a consultation between
clinician and patient)

- Surgical intervention (as determined by a consultation between clinician and
patient)

- Symptom deterioration of 3 points[22] or more measured with the I-PSS

- Acute urinary retention

- Death

2.27. Secondary outcomes include a 3 day frequency / volume chart, infection, and
health-seeking behaviour (unscheduled clinic, A&E or GP visits). Secondary outcomes
also include Quality of life / bother assessment using the BPH Impact Index,[24]
(appendix 5.), Short Form-36 - SF-36 (appendix 7.) and the Illness Perception
Questionnaire - IPQ (appendix 8.).

The clinicians will be blinded to which group the patients have been assigned to, and
the patients will be asked not to divulge which group they are in. It is not possible
to blind the patients to the group to which group they are assigned to. Any instances
of unblinding will be declared.

Follow up assessment

2.28. Men within the study group will see only the consultant or the specialist
registrar (i.e. continuity throughout the study) doctors will be briefed to the study
design but blinded as to which group each man has been assigned to.

2.29. If a man has deteriorated significantly then drug therapy (alpha-blockers,
finasteride or anti-cholinergics) will be offered; standard urological practice. As
these men will only see one of 2 different doctors, moving from conservative to drug
therapy will be consistent.

2.30. The outcome of the consultation between clinician and patient will be recorded by
the clinician on a standard form (appendix 9.) and given to the patient, a copy will be
left in the notes.

2.31. At this visit the patient will be given the following to complete: I-PSS, BPH
Impact Index, SF-36, Illness perception questionnaire and a 3-day frequency / volume
chart, and will be asked to send to the data manager along with the outcome form
completed by the consultant in a pre-paid envelope.

2.32. The data manager is blinded to which group the patient is in and will be
responsible for collecting, loading, and chasing missing data. The data manager will
telephone each patient within 48 hours of their out-patient follow up to complete the
assessment and encourage completion of the study documents.

2.33. A follow up rate of more than 80% will be achieved.

3. STATISTICAL ANALYSIS

3.1. The two groups will be directly compared with respect to all outcome measurements over
each man's 12 month study period.

3.2. Analysis will be on an intention to treat basis, i.e. - men will always be analysed in
the group to which they were assigned.

3.3. Statistical analysis will be performed with STATA Version 7. An unpaired t-test will be
used to analyse continuous variables e.g. I-PSS, and chi-squared or exact tests will be used
for categorical data. Logarithmic transformation will be used to normalise continuous
variables.

3.4. Sample size - A minimum of 84 men are required in each group to have a 90% chance of
detecting a 3 point difference in mean I-PSS score (SD=6) at the 5% level of significance
using the unpaired t-test. We have chosen a 3-point reduction in I-PSS as it corresponds to
a detectable clinical difference in symptoms by patients.

4. DATA COLLECTION

4.1. Each man is part of the study programme for 12 months. After this time each man is
discharged from the study programme. If they still require the services of the urology
out-patients for further appointments, investigations or treatment, this will be arranged.

4.2. If self-management is seen to be effective then it will be offered to men in Group 2
who received only standard treatment.

4.3. The information is anonymised with each patient being given a unique identification
number.

4.4. Data will be stored securely on The Royal College of Surgeons network in accordance
with the Data Protection Act 1988. Access to this data will be limited to the data manager
and the study coordinator