Bladder Complaints in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation (LIPPE)

Leiden University Medical Center (LUMC)

Status: Enrolling

Conditions: Lower Urinary Tract Symptoms; Parkinson Disease

Treatments: Other: pelvic physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05814614

NL8301905822

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

electrical stimulation small phase duration

Active Comparator group

Description:

phase duration 200 microseconds, frequency 20 Hertz, 20 minutes

Treatment:

Other: pelvic physical therapy

electrical stimulation broad pulse duration

Active Comparator group

Description:

phase duration 1000 microseconds, frequency 8 Hertz, 20 minutes

Treatment:

Other: pelvic physical therapy

electrical stimulation inactive 100Hz

Sham Comparator group

Description:

phase duration 200 microseconds, frequency 100 Hertz, 2 seconds active 20 seconds no output, 20 minutes

Treatment:

Other: pelvic physical therapy