Primary objective:Subjective improvement of urinary incontinence (PGI-I)Secondary objectives:Objective (using stress test, padtest, bladder diaries, Sandvik score) and subjective cure of incontinence (questionnaires)Complicaties en de novo…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective:
Subjective improvement of urinary incontinence (PGI-I)
Secondary outcome
Secondary objectives:
Objective (using stress test, padtest, bladder diaries, Sandvik score) and
subjective cure of incontinence (questionnaires)
Complicaties en de novo urogenital symptoms
Effect on defaecation (questionnaires)
Effect on dyspareunia (questionnaires)
Discomfort of treatment (VAS Scores)
Cost/ effectiveness analysis
Background summary
Conservative treatment of urinary incontience is our first choice.
Studies have shown that physiotherapy can be uncomfortable due to insertion of
various vaginal devices.
A large number patients receive further treatment after completing
physiotherapy or bladder training due to insufficient effect.
Electromagnetic stimulation is an existing treatment, but not widely used and
has shown variable results in previous studies. The QRS PelviCenter is a new
version of the pre-existing electromagnetic chair. Advantages include no
physical contact and optimal effect may be seen sooner, namely after 6 weeks
versus 3-6 months with physiotherapy/ bladder training.
Study objective
Primary objective:
Subjective improvement of urinary incontinence (PGI-I)
Secondary objectives:
Objective (using stress test, padtest, bladder diaries, Sandvik score) and
subjective cure of incontinence (questionnaires)
Complicaties en de novo urogenital symptoms
Effect on defaecation (questionnaires)
Effect on dyspareunia (questionnaires)
Discomfort of treatment (VAS Scores)
Cost/ effectiveness analysis
Study design
Monocentre prospective study consisting of 2 trials, namely one for patients
with urge urinary incontinence who will be randomised between bladder training
or electromagnetic chair and secondly one for patients with stress urinary
incontinence who will then be randomised between physiotherapy or
electromagnetic chair.
Intervention
Physiotherapy / bladdertraining versus electromagnetic stimulation
Study burden and risks
De belasting welke het onderzoek met zich meebrengt voor de patient bestaat uit
het invullen van vragenlijsten en het uitvoeren van padtests. Indien patiente
loot voor electromagnetische stimulatie 18 behandelsessies op de polikliniek in
het ziekenhuis. Indien patiente loot voor fysiotherapie of blaastraining
(standaard behandeling): geen extra ziekenhuis bezoeken.
The burden of the study for the patiente will be completing questionnaires and
padtests. When the patient randomises for electromagnetic stimulation 18
treatment sessions at outpatient clinic. If the patient randomises for
physiotherapy or bladdertrainign (standard treatment): no extra hospital
visits.
Dr. van Heesweg 2
Zwolle 8025 AB
NL
Dr. van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
urinary incontience
Exclusion criteria
Metal or electronic inplants
Pregnancy
Cardiac arrhythmia
Neurological disease
History of anti-incontinece surgery
Pelvic malignancy
History of pelvic radiotherapy
Physiotherapy for incontinence in the last 6 months
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 | NL46289.075.13 |