Clinical trial NCT05814614: Bladder Complaints in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation
Official title: Lower Urinary Tract Symptoms in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation, a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Parkinson Disease
Keywords: Parkinson disease
Lower urinary tract symptoms
Electrical simulation
Pelvic floor muscle exercises
Bladder training
Biofeedback
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Royal Dutch Society for Physical Therapy
name: The Dutch Brain Foundation
First posted: 2023-04-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to three parallel arms for the duration of the study.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effect of pelvic physical therapy with different types of electrical stimulation(ES) for bladder complaints in people with Parkinson's disease.

The main question it aims to answer is:

What is the effect of pelvic physical therapy with ES for bladder complaints in people with Parkinson's disease.

Secondary question:

What is the most effective type of ES on bladder complaints in people with Parkinson's disease.

Participants will be randomized into three groups. Two different kinds of ES and a sham group. Participants will receive eight session of pelvic physical therapy. Pelvic physical therapy consists of e.g. bladder training, pelvic floor muscle exercises and biofeedback.

Detailed description: Parkinson's disease (PD) is the second most common degenerative neurological disease in the elderly. 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 may lead to early admission into care. Therefore, this potentially increases healthcare related costs. First treatment options for LUTS in the general population are conservative therapy and medication. Conservative therapy consists of e.g., behavioral advice, bladder training, pelvic floor muscle exercises provided by a pelvic physical therapist(PPT) and, electrical stimulation(ES). 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.

Objective: to study the effectiveness of pelvic physical therapy and ES in patients with PD suffering from LUTS.

Study design: Randomized Controlled Trial (RCT).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Questionnaires are online, allowing participants to complete the questionnaires at home at a convenient time.

Participants may have direct benefits of participating in this study. Participants included in the study will have two additional visits to a research PPT that will last one hour each, at baseline and after treatment. During this visit, a digital pelvic floor muscle (PFM) assessment and an EMG measurement of the PFM will be performed. EMG measurement will be done with a small anal- or vaginal probe. No risks are associated with the use of this probe.

Participants will be referred to local PPT's close to the subjects home address for the treatment sessions.

Intervention: eight treatment sessions of 30 minutes pelvic physical therapy over a 10-week period. The intervention consists of bladder- and behavioral 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 three groups. Group 1: ES with small pulse duration, group 2: ES with broad pulse duration, group 3: (control group) receiving sham ES.

No adverse events are expected since pelvic physical therapy and ES in LUTS is usual care in the general population in the Netherlands. Expected burden for the participants is very low.

Eligibility criteria: Inclusion Criteria:

* Parkinson's disease
* ≥ 18 years of age
* Self-reported LUTS
* Stable Parkinson's medication for at least three months
* Able and willing to independently read and fill in 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)

Primary outcomes:
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short form (ICIQ-UI SF)
timeFrame: Change from baseline at 12 weeks; at 24 weeks; at one year
measure: Change International Consultation on Incontinence Questionnaire-Lower Urinary Tract quality of life (ICIQ-LUTSqol)
timeFrame: Change from baseline at 12 weeks; at 24 weeks; at one year
measure: Change in 24 hour bladder diary, bladder volume
timeFrame: Change from baseline at 12 weeks
measure: Change in 24 hour bladder diary, frequency of micturition
timeFrame: Change from baseline at 12 weeks
measure: Change in 24 hour bladder diary, urgency
timeFrame: Change from baseline at 12 weeks
measure: Change in 24 hour bladder diary, urinary incontinence
timeFrame: Change from baseline at 12 weeks
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: Change from baseline at 24 weeks and at one year.
measure: Change in International Consultation on Incontinence Questionnaire-Overactive Bladder Short form (ICIQ-OAB)
timeFrame: Change from baseline at 12 weeks; at 24 weeks; at one year
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden Univesity Medical Center
state: Zuid Holland
Study officials:
affiliation: Head department urology Leiden University Medical Center
name: Rob Pelger, Prof.
role: STUDY_CHAIR
References:
citation: McDonald C, Rees J, Winge K, Newton JL, Burn DJ. Bladder training for urinary tract symptoms in Parkinson disease: A randomized controlled trial. Neurology. 2020 Mar 31;94(13):e1427-e1433. doi: 10.1212/WNL.0000000000008931. Epub 2020 Feb 13.
citation: Sakakibara R, Panicker J, Finazzi-Agro E, Iacovelli V, Bruschini H; Parkinson's Disease Subcomittee, The Neurourology Promotion Committee in The International Continence Society. A guideline for the management of bladder dysfunction in Parkinson's disease and other gait disorders. Neurourol Urodyn. 2016 Jun;35(5):551-63. doi: 10.1002/nau.22764. Epub 2015 Mar 25.
citation: Balash Y, Peretz C, Leibovich G, Herman T, Hausdorff JM, Giladi N. Falls in outpatients with Parkinson's disease: frequency, impact and identifying factors. J Neurol. 2005 Nov;252(11):1310-5. doi: 10.1007/s00415-005-0855-3. Epub 2005 May 18.