Parkinson’s Disease Urinary Bladder, Overactive
Conditions
Interventions
This is a randomized, controlled, double-blind clinical trial with three parallel arms, including a total of 45 participants, with 15 participants allocated to each group. Participants will be randomi
Sponsors
Universidade Federal de Ciências da Saúde de Porto Alegre
Universidade Federal de Ciências da Saúde de Porto Alegre
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Medical diagnosis of Parkinson’s disease. both genders. age greater than or equal to 18 years. use of antiparkinsonian medication at stable doses for at least four weeks prior to study inclusion. not undergoing any other treatment for overactive bladder during the study period, including pelvic floor physical therapy. presenting at least two symptoms of overactive bladder according to the definition by Haylen et al. characterized by urinary urgency with or without urinary incontinence, urinary frequency greater than seven voids per day and nocturia greater than one void per night. presenting a minimum score of 22.5 points on the Montreal Cognitive Assessment, translated and adapted version. agreement to participate in the study and signing of the informed consent form
Exclusion criteria
Exclusion criteria: History of bladder outlet obstruction. history of pelvic radiotherapy. active bladder carcinoma. history of peripheral nerve injury. active lower urinary tract infection. uncontrolled diabetes mellitus. pregnancy or immediate postpartum period less than six months. urinary incontinence exclusively due to stress. presence of a cardiac pacemaker or implantable defibrillator. presence of metallic implants. botulinum toxin application to the bladder and or pelvic muscles within the past year. history of seizures. current use of anticoagulant medications. current use of anticholinergic medications. other central or peripheral neurological disorders that may interfere with neuromuscular transmission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate changes in overactive bladder symptoms after the treatment protocol. This outcome will be assessed using the Overactive Bladder Score version 8 and a 24-hour voiding diary applied before and after the intervention. Changes in the total Overactive Bladder Score version 8 score, as well as daily urinary frequency, number of urgency episodes, urgency urinary incontinence episodes and nocturia episodes recorded in the voiding diary will be observed | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the severity of urinary incontinence and its impact on quality of life after the treatment protocol. This outcome will be assessed using the International Consultation on Incontinence Questionnaire Short Form applied before and after the intervention. Changes in the total questionnaire score and in the domains related to symptom severity and quality of life impact will be observed;To evaluate quality of life related to urinary symptoms after the treatment protocol. This outcome will be assessed using the King’s Health Questionnaire applied before and after the intervention. Changes in domain scores and in the overall quality of life score will be observed;To evaluate participants’ perceived improvement after the treatment protocol. This outcome will be assessed using patient-reported outcomes applied before and after the intervention. Changes in global perceived improvement scores reported by participants will be observed;To evaluate urinary flow after the treatment protocol. This outcome will be assessed using uroflowmetry performed before and after the intervention. Maximum urinary flow, mean urinary flow, voided volume and voiding time values will be observed;To evaluate pelvic floor thermal parameters after the treatment protocol. This outcome will be assessed using pelvic floor thermographic analysis performed before and after the intervention. Changes in mean temperature, maximum temperature and thermal asymmetry of the assessed region will be observed | — |
Countries
BR
Contacts
Public ContactBruna Nascimento Zanfir da Silva
Universidade Federal de Ciências da Saúde de Porto Alegre
Outcome results
None listed