overactive bladder
Conditions
Interventions
Pelvic physical therapy
All patients: bladder training , toilet behavioral, biofeedback assisted pelvic
floor muscle exercises
Randomization in three groups:
group 1 : electrical stimulation, pul
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed