Primary Objective: To answer the following question: Does the extended approach (defined as uroflowmetry and bladder scan after the first consultation, followed by a check-up in month 3 of the male patient over 50 years of age first presenting with…
ID
Source
Brief title
Condition
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of referrals to urologist in connection with LUTS-BPH symptoms in 12
months
Secondary outcome
Number of patients on medication (i.e., alpha-blockers or 5-alpha-reductase
inhibitors) in 12 months
IPSS-measurement after 12 months
Background summary
The diagnostics and treatment of older men suffering from LUTS/BPH symptoms
(Lower Urine Tract Symptoms / Benign Prostate Hyperplasia) comes under
first-line health care in accordance with the NHG standard *Problematic
urination in older males*. LUTS (Lower Urine Tract Symptoms) is an umbrella
term for complaints of the lower urinary tract. A distinction is made between
obstructive and irritative complaints. These LUTS symptoms may have a number of
different causes. In the case of older men, benign prostate hypertrophy is one
of the major causes.
Epidemiological research conducted in Rotterdam and Boxmeer shows that 30% of
men older than 50 have moderate to severe urinary complaints with an IPSS
(International Prostate Symptom Score) higher than seven. The annual GP-surgery
incidence rate is 4-9 in every 1,000 men annually in the age category 45-64,
rising to 10-18 in every 1,000 men older than 75. Annual prevalence in the age
categories referred to above is 8-19 and 36-165 in every 1,000 men respectively.
Although the symptoms can seriously affect the quality of life, they are often
accepted: *It*s just part of getting older*. The Boxmeer study showed that only
17% of men with moderate symptoms and 42% of men with serious symptoms
consulted their GPs regarding their symptoms (2).
First-line treatment is conducted as described in the NHG standard *Problematic
urination in older males". If the GP is unable to provide an acceptable
solution for the patient, the patient will be referred to the urologist. In the
second line of care, more extensive variants of the first-line tests are
carried out: blood test, uroflowmetry, a bladder scan and possibly an
ultrasound of the prostate. The diagnostics for LUTS-BPH complaints are
performed in accordance with the guidelines of the Netherlands Association for
Urology, the LUTS-BPH guideline.
As things are now, the GP has no direct access to the uroflowmetry and the
bladder scan.
It would be desirable for the GP to be able to conduct these tests
independently or, as is the case with lung function tests for example, to be
able to request these tests from the medical specialist directly, including an
assessment and recommendation from the medical specialist. We know of no
literature, however, that describes the value of a uroflowmetry and a bladder
scan for first-line health care.
Study objective
Primary Objective:
To answer the following question: Does the extended approach (defined as
uroflowmetry and bladder scan after the first consultation, followed by a
check-up in month 3 of the male patient over 50 years of age first presenting
with LUTS-BPH symptoms in the GP*s surgery) show a different referral rate ,
compared with current treatment in accordance with the NHG standard
*Problematic urination in older males*?
Secondary Objectives:
In the new approach, the use of medication decreases significantly.
Study design
This is an open randomised interventional study.
Intervention
The usual-care group receives treatment according to the NHG standard
*Problematic urination in older males*. The members of the study group will
have a bladder scan and uroflowmetry assessment immediately after the first
consultation, on the basis of which the subsequent policy will be determined.
Check-up by the GP is to be scheduled in month 3. After 12 months, the
participants will receive an IPSS form and a patient satisfaction survey.
Study burden and risks
After the consultation, participating patients from the study group will be
invited for a uroflowmetry assessment and a bladder scan. These procedures will
be performed by a duly trained assistant. The results will be assessed by a
trained GP, and the recommendation sent to the referring GP. The study involves
a time investment of 20-30 minutes on the part of the patient. There are no
risks associated with this study. Over time, this study may help improve the
first-line treatment of patients with LUTS-BPH symptoms.
G. Grooteplein 21
6500 HB Nijmegen
NL
G. Grooteplein 21
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
All males over 50 registered with one of the GPs associated with the Huisartsenzorg IJsselstein Partnership first presenting with LUTS-BPH symptoms in the GP*s surgery
Exclusion criteria
Man under treatmant of an urologist
Man using medication; @-blocker or 5-@-reductaseremmer
Man with hematurie, urine-tract infection or abnormal rectal investigation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL29822.091.10 |