The main objective of this study is to assess the effectiveness of pelvic floor muscle therapy in comparison with α-blockers, in men with LUTS. The second objective is the validation of the questionnaire (MPFS) in this group of patients
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
uroflowmetrie
Secondary outcome
The secundary endpoint of this study is the improvement in International
Prostate Symptom Score (IPSS), micturition diary and 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 α-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 this study we investigate the effectiveness of PFMT compared to
pharmalogical treatment with α-blockers, being the gold standard.
The results are evaluated using uroflowmetrie, a micturition diary, the
International Prostate Symptom Score (IPSS) and an EMG of the pelvic floor.
The Male Pelvic Floor Symptomscore (MPFS) is a questionnaire that will be
validated in this study.
Study objective
The main objective of this study is to assess the effectiveness of pelvic floor
muscle therapy in comparison with α-blockers, in men with LUTS.
The second objective is the validation of the questionnaire (MPFS) in this
group of patients
Study design
A multicenter, prospective, randomised controlled intervention study, using
medication and physiotherapy.
Intervention
One group receives an α-blocker once daily for 4 months. The other group
receives physiotherapy of the pelvic floor muscles, for 4 months
Study burden and risks
Patients in both groups have to perform a uroflowmetrie 2 times. A
uroflowmetrie 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 | NL15270.042.06 |