The main objective of this study is to assess the additive effect of EMG-feedback in the treatment of LUTS in men.
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is the improvement in symptoms as measured by
uroflowmetry.
Secondary outcome
The secondary endpoint of this study is the improvement in International
Prostate Symptom Score (IPSS), Male Pelvic Floor Symptomscore, the micturition
diary and the EMG of the pelvic floor.
Background summary
Male patients are referred to the urologist when they report Lower Urinary
Tract Symptoms (LUTS). In daily practice most patients with LUTS will be
treated with an *-blocker. This treatment has been used for many years and
proven to be effective. During the last 5 years the role of the pelvic floor
muscles (PFM) in LUTS has been suggested to be of important value. When the
pelvic floor muscles are overactive, they will contract when they should relax.
When this is done during voiding the patient will experience LUTS, like slow
stream, hesitation, nocturia and post void dribble. So far there are no
publications on the effect of Pelvic Floor Muscle Therapy (PFMT) in this group
of patients. In pilot studies the effect seems to be fairly good. Pelvic floor
muscle therapy has different modalities. One of them is the EMG-feedback, which
is often used in treating male patients with pelvic floor muscle dysfunction.
The additive effect however has never been proven.
Study objective
The main objective of this study is to assess the additive effect of
EMG-feedback in the treatment of LUTS in men.
Study design
A prospective randomised controlled intervention study. Patients are randomly
assigned to two groups: pelvic floor physiotherapy alone or in combination with
EMG-feedback.
Intervention
Both groups receive physiotherapy of the pelvic floor muscles, in one of the
two groups EMG-feedback is added in the other it is not.
Study burden and risks
Patients in both groups have to perform a uroflowmetrie 2 times. A uroflowmetry
means voiding on a normal toilet, in private. Inside the toilet is a measuring
device. An EMG of the pelvic floor muscles is performed 2 times. The EMG is
done with an anal probe. Patients also have to fill out the IPSS, a micturition
diary and the MPFS 2 times. Except for the MPFS these are all regular
diagnostic procedures. All patients receive a form of active treatment.
Postbus 30001
9700 RB Groningen
Nederland
Postbus 30001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Slow urinary stream, hesitation, nocturia
Exclusion criteria
Urinary tract infection, neurogenic bladder, catheter
Design
Recruitment
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 | NL22053.042.08 |