Objective: To study the effectiveness of pelvic physical therapy and ES in patients with PD suffering from LUTS. Which are the most effective parameters for ES. Intervention: Intervention: 8 treatment sessions of 30 minutes pelvic physical therapy…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of pelvic physical therapy with ES will be estimated by evaluating
LUTS symptoms at 12 weeks (T1), based on the IPSS score (men and women) at T1
in the 3 study arms.
Secondary outcome
Demographic: age, sex, obstetric history, constipation, level of completed
education, year of diagnosis PD, bloodpressureand diabetes
Secondary outcome IPSS: measure at T2 (short term effect) -T3 (long term
effect)
Secondary outcomes at T0, 12 weeks (T1), 24 weeks (T2), and one year (T3)
- International Consultation on Incontinence Questionnaire-Urinary Incontinence
Short form (ICIQ-UI SF),
- International Consultation on Incontinence Questionnaire-Lower Urinary Tract
Symptoms quality of Life (ICIQ-LUTSqol), evaluating QoL in LUTS,
particular reference to social effects.
- International Consultation on Incontinence Questionnaire-Overactive
Bladder, evaluating quality of Life of urgency incontinence
Other secondary outcomes (T0) and 12 weeks (T1)
- 24 hour bladder diary T0-T1
- Global Perceived Effect (GPE), to quantify the patient*s perceived
improvement or deterioration over time. (T1)
- Changes in EMG signals after pelvic physical therapy intervention of PFM
during rest, maximum voluntary contractions (MVC) and
endurance contractions (EC). T0-T1
Background summary
In the Netherlands, 63.500 people suffer from Parkinson's Disease(PD). PD is
predominantly a movement disorder. In addition, PD is associated with non-motor
and autonomic symptoms. Over 75% of PD patients, experience lower urinary tract
symptoms (LUTS), one of the most common autonomic symptoms. LUTS consists of
urgency, frequency and nocturia with or without urinary incontinence(UI). More
than 60% of PD patients experience nocturia. LUTS have a negative impact on
Quality of Life(QoL), increases the risk of falls, are a barrier to exercise
and reduce social activities. Therefore, this potentially increases healthcare
related costs.
Treatment options for LUTS in the general population are conservative therapy
and medication, botox in the bladder muscle and neuromodulation ( kind of
pacemaker, providing electrical stimulation on the nerve to reduce urge).
In people with Parkinson's disease, medications do not work as well and produce
more side effects such as dry mouth and difficulty defecating.
Conservative therapy consists of e.g. behavioral advice, bladder training
provided by a pelvic physical therapist(PPT), and, electrical stimulation(ES).
Two small studies show that pelvic physical therapy has a positive effect.
Knowledge of the effectiveness of conservative treatment options for LUTS in PD
is limited. Although ES is used effectively in patients with LUTS, it has not
yet been studied in PD patients. ES has hardly any side effects, but there is
uncertainty about optimal ES parameters.
Pelvic physical therapy with electrical stimulation can be promising treatment
option for LUTS in Parkinson's disease
Study objective
Objective: To study the effectiveness of pelvic physical therapy and ES in
patients with PD suffering from LUTS. Which are the most effective parameters
for ES.
Intervention:
Intervention: 8 treatment sessions of 30 minutes pelvic physical therapy over a
12 week period. The intervention consists of bladder- and behavioural advice,
pelvic floor muscle exercises (PFME), urge suppression techniques, biofeedback
and ES with an intra anal or intra vaginal probe. The group is divided into 3
groups. Group 1: ES with phase duration 200µs/20hz, group 2: ES with 1000µs/8hz
and, group 3: (control group) receiving ES 200µs/100Hz,(2 sec active
stimulation 20 sec no stimulation) sham ES.
Study design
Randomized control trial , single blind
Intervention
Pelvic physical therapy
All patients: bladder training , toilet behavioral, biofeedback assisted pelvic
floor muscle exercises
Randomization in three groups:
group 1 : electrical stimulation, pulse duration 1000 microsec /8 Hz for 20
min
group 2: electrical simulation, pulse duration 200 microsec e/20 Hz for 20 min
group 3: electrical stimulation, (2 sec active stimulation 20 sec no
stimulation) pulse duration 200 microsec /100Hz sham for 20 min
All groups 8 treatment sessions
Study burden and risks
-Very low risks
-Burden :
Online questionnaires : total 59 questionnaires at T0-T1-T2-T3 ( four times,
about 15 minutes)
bladder diary, before and after pelvic physical therapy, T0-T1
2 visits to a research pelvic physical therapist , 30-45 min each visit
8 treatment sessions , pelvic physical therapy, 30 min per treatment session,
one a week, (8 treatment sessions in 10 weeks)
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Parkinson*s disease
- >= 18 years of age
- Self-reported LUTS
- Patients taking (stable) for at least three months medications such as
alpha-blocker medicines could be
included at the discretion of the PI.
- Stable Parkinson*s medication for at least three months
- Able and willing to independently read and fill in online questionnaires in
the Dutch language, sufficient
understanding of Dutch language
- Able to independently visit a pelvic physical therapy practice
Exclusion criteria
- Patients with other neurological diseases
- Surgery in the pelvic region in the last year
- Cancer or cancer treatment in the pelvic region
- Pregnancy
- Current urinary tract infection
- Pure stress-urinary incontinence without urgency, frequency, nocturia
- Botox, PTNS or pelvic physical therapy in the last year
- Sacral neuromodulator
- Pacemaker and Implantable cardioverter defibrillator (ICD)
- Deep Brain stimulation (DBS)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL83019.058.22 |