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

March 27, 2024 updated by: Dorien Bennink, Leiden University Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Zuid Holland
      • Leiden, Zuid Holland, Netherlands, 2333 ZA
        • Recruiting
        • Leiden Univesity Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: electrical stimulation small phase duration
phase duration 200 microseconds, frequency 20 Hertz, 20 minutes
Other: pelvic physical therapy
Pelvic floor muscle exercises, biofeedback, bladder training
Active Comparator: electrical stimulation broad pulse duration
phase duration 1000 microseconds, frequency 8 Hertz, 20 minutes
Other: pelvic physical therapy
Pelvic floor muscle exercises, biofeedback, bladder training
Sham Comparator: electrical stimulation inactive 100Hz
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Prostate Symptom Score (IPSS)
Time Frame: 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.
Change from baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short form (ICIQ-UI SF)
Time Frame: 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 from baseline at 12 weeks; at 24 weeks; at one year
Change International Consultation on Incontinence Questionnaire-Lower Urinary Tract quality of life (ICIQ-LUTSqol)
Time Frame: 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 from baseline at 12 weeks; at 24 weeks; at one year
Change in 24 hour bladder diary, bladder volume
Time Frame: Change from baseline at 12 weeks
24 hour bladder diary: change in mean of bladder volume. Normal bladder volume ranges between: 250-500ml.
Change from baseline at 12 weeks
Change in 24 hour bladder diary, frequency of micturition
Time Frame: 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 from baseline at 12 weeks
Change in International Prostate Symptom Score (IPSS)
Time Frame: 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.
Change from baseline at 24 weeks and at one year.
Change in 24 hour bladder diary, urgency
Time Frame: 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.

  1. Mild urgency I could postpone voiding as long as necessary, without fear of wetting myself.
  2. Moderate urgency I could postpone voiding for a short while, without fear of wetting myself.
  3. Severe urgency I could not postpone voiding, but had to rush to the toilet in order not to wet myself.
  4. Urge incontinence I leaked before arriving to the toilet.

A higher score on the PPIUS implicates more severe urgency complaints.
Change from baseline at 12 weeks
Change in 24 hour bladder diary, urinary incontinence
Time Frame: Change from baseline at 12 weeks
24 hour bladder diary change in urinary incontinence episodes. Number of urinary incontinence episodes in 24 hours.
Change from baseline at 12 weeks
Change in International Consultation on Incontinence Questionnaire-Overactive Bladder Short form (ICIQ-OAB)
Time Frame: Change from baseline at 12 weeks; at 24 weeks; at one year
The validated ICIQ-OAB evaluating overactive bladder and related impact on quality of life (QoL) and outcome of treatment in men and women, measure the impact of urinary frequency, urgency, urge incontinence and nocturia symptoms. It consist of 6 questions. The scores range from 0-16, overall score with greater values indicating increased symptom severity.
Change from baseline at 12 weeks; at 24 weeks; at one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

The Dutch Brain Foundation
Royal Dutch Society for Physical Therapy

Investigators

  • Study Chair: Rob Pelger, Prof., Head department urology Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL8301905822

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication. Data will be made (publicly) accessible following funder's guidelines, LUMC data management guidelines and following policies for availability of data, material and methods from publishers when submitting our manuscripts.

IPD Sharing Time Frame

12 months after publication of the results.

IPD Sharing Access Criteria

Data can only be used for scientific research, not for educational purposes. Request will be reviewed by the research team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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