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

Sponsor

Leiden University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05814614

Collaborator

Royal Dutch Society for Physical Therapy (Other), The Dutch Brain Foundation (Other)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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(s) it aims to answer is:

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

second question is: 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.

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms Parkinson Disease	Other: pelvic physical therapy	N/A

Detailed Description

Parkinson's disease (PD) is the second most common degenerative neurological disease in 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. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are assigned to three parallel arms for the duration of the study.Participants are assigned to three parallel arms for the duration of the study.

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Lower Urinary Tract Symptoms in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation, a Randomized Control Trial

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention 1 phase duration 200 microseconds, frequency 20 Hertz, 20 minutes	Other: pelvic physical therapy Pelvic floor muscle exercises, biofeedback, bladder training
Active Comparator: Intervention 2 phase duration 1000 microseconds, frequency 8 Hertz, 20 minutes	Other: pelvic physical therapy Pelvic floor muscle exercises, biofeedback, bladder training
Sham Comparator: Intervention 3 phase duration 200 microseconds, frequency 100 Hertz, 2 seconds active 20 seconds no output, 20 minutes	Other: pelvic physical therapy Pelvic floor muscle exercises, biofeedback, bladder training

Arm

Intervention/Treatment

Active Comparator: Intervention 1

phase duration 200 microseconds, frequency 20 Hertz, 20 minutes

Other: pelvic physical therapy

Pelvic floor muscle exercises, biofeedback, bladder training

Active Comparator: Intervention 2

phase duration 1000 microseconds, frequency 8 Hertz, 20 minutes

Other: pelvic physical therapy

Pelvic floor muscle exercises, biofeedback, bladder training

Sham Comparator: Intervention 3

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

Other: pelvic physical therapy

Pelvic floor muscle exercises, biofeedback, bladder training

Outcome Measures

Primary Outcome Measures

Change in International Prostate Symptom Score (IPSS) [Change from baseline at 12 weeks]
Questionnaire of bladder function and urination, of last month, validated for men and women, 6-point-scale; contains 8 items, 3 about storage of urine, 4 about urination and 1 of quality of life. Total score of 0-35, with a minimal important difference(MID) of 3, validated in the Netherlands (MID 5.2) A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. The IPSS is the most prevalent patient-administered questionnaire used in urology.

Secondary Outcome Measures

Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short form (ICIQ-UI SF) [Change from baseline at 12 weeks; at 24 weeks; at one year]
The validated ICIQ-UI SF measures frequency, severity and, impact on QoL in men and women. The ICIQ-UI SF consists of 4 questions on: frequency or urinary incontinence, amount of leakage, overall impact of urinary incontinence, self-diagnostic item. The score ranges between 0-21. A higher score represents worse QoL.
Change International Consultation on Incontinence Questionnaire-Lower Urinary Tract quality of life (ICIQ-LUTSqol) [Change from baseline at 12 weeks; at 24 weeks; at one year]
The validated ICIQ-LUTSqol measures QoL with particular reference to social effects.The ICIQ-LUTSqol consists of 20 questions. Total score ranges between 19-76 with greater values indicating increased impact on QoL. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient.
Change in 24 hour bladder diary, bladder volume [Change from baseline at 12 weeks]
24 hour bladder diary: change in mean of bladder volume. Normal bladder volume ranges between: 250-500ml.
Change in 24 hour bladder diary, frequency of micturition [Change from baseline at 12 weeks]
24 hour bladder diary, change in frequency of micturition. Number of micturition's in 24 hours. Normal frequency with fluid intake of 1.5-2 liters is 6-8 times in 24 hour.
Change in 24 hour Bladder diary, urgency [Change from baseline at 12 weeks]
24 hour bladder diary change in urgency scale: patient perception of intensity of urgency scale(PPIUS). 0 No urgency I felt no need to empty my bladder, but did so for other reasons. Mild urgency I could postpone voiding as long as necessary, without fear of wetting myself. Moderate urgency I could postpone voiding for a short while, without fear of wetting myself. Severe urgency I could not postpone voiding, but had to rush to the toilet in order not to wet myself. Urge incontinence I leaked before arriving to the toilet. A higher score on the PPIUS implicates more severe urgency complaints.
Change in 24 hour Bladder diary, urinary incontinence [Change from baseline at 12 weeks]
24 hour bladder diary change in urinary incontinence episodes. Number of urinary incontinence episodes in 24 hours.
Change in International Prostate Symptom Score (IPSS) [Change from baseline at 24 weeks and at one year.]
Questionnaire of bladder function and urination, of last month, validated for men and women, 6-point-scale; contains 8 items, 3 about storage of urine, 4 about urination and 1 of quality of life. Total score of 0-35, with a minimal important difference(MID) of 3, validated in the Netherlands (MID 5.2). A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. The IPSS is the most prevalent patient-administered questionnaire used in urology.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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