We aim to explore the role of PFM activity in male LUTS
ID
Source
Brief title
Condition
- Muscle disorders
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pelvic floor muscle activity (overactivity, underactivity), based on physicial
examination and electromyographic (EMG) measurements, severity and type of
LUTS, as assessed with questionnaires.
Secondary outcome
-
Background summary
Medical treatment for male lower urinary tract symptoms (LUTS) only has a
moderate effect. This is caused by the multifactorial origine of male LUTS and
the unidirectional mechanisme of medication. In female patients, pelvic floor
muscle (PFM) activity appears to have a considerable impact on voiding and
continence. It is unknown what the role of these muscles are in men. The
availability of a small rectal probe to measure pelvic floor muscle activity
enables us with the opportunity to study the possible role of PFM in male LUTS.
Study objective
We aim to explore the role of PFM activity in male LUTS
Study design
Observational study with a 12 week follow-up period.
Study burden and risks
Participants will undergo the structured examination like all other male
patients referred to the outpatient urology clinic. This includes the
completion of questionnaires, a voiding diary, urolflowmetry, postvoid residual
measurement, and a physical examination including digital rectal examination.
For this study, additional measurements are performed using the Multiple Array
Probe Leiden (MAPLe). Participants will put this small probe into their rectum,
while lying on their side. The MAPLe measures muscle activity (electomyography)
of the different pelvic floor muscles. This measurement may be uncomfortable,
but is not painful and takes a few minutes. Men will watch an instruction video
and place the probe themselves. Correctness of the placement will be checked by
a researcher, before measurements take place.
Patients are treated according to the guidelines. Outcomes of this study will
not influence treatment decisions. Symptoms will be evaluated after 6-12 weeks,
for which participants will fill out additional questionnaires. At the
follow-up appointment (scheduled as regular care), MAPLe measurement will be
repeated.
Dokter van Heesweg 2
Zwolle 8025AB
NL
Dokter van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
- male
- 18 years and older
- moderate to severe lower urinary tract symptoms (symptom score 8 or more on International Prostate Symptom Score)
Exclusion criteria
- history of urological malignancy (prostate- or bladdercancer)
- history of urological surgery (to bladder or prostate)
- absence of informed consent
- inability to understand the Dutch language
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 | NL64332.075.17 |