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

NCT05814614 | Recruiting DMC

• 1 other identifier: NL8301905822
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms; Parkinson Disease

Keywords

Parkinson disease; Lower urinary tract symptoms; Electrical simulation; Pelvic floor muscle exercises; Bladder training; Biofeedback

Outcome Measures

Primary Outcomes (1)

• Change in International Prostate Symptom Score (IPSS)

  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 Outcomes (8)

• 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

• 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

• Change in 24 hour bladder diary, bladder volume

  Change from baseline at 12 weeks

• Change in 24 hour bladder diary, frequency of micturition

  Change from baseline at 12 weeks

• Change in 24 hour bladder diary, urgency

  Change from baseline at 12 weeks

Study Arms (3)

electrical stimulation small phase duration

ACTIVE COMPARATOR

phase duration 200 microseconds, frequency 20 Hertz, 20 minutes

Other: pelvic physical therapy

electrical stimulation broad pulse duration

ACTIVE COMPARATOR

phase duration 1000 microseconds, frequency 8 Hertz, 20 minutes

Other: pelvic physical therapy

electrical stimulation inactive 100Hz

SHAM COMPARATOR

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

Other: pelvic physical therapy

Interventions

pelvic physical therapy OTHER

Pelvic floor muscle exercises, biofeedback, bladder training

electrical stimulation broad pulse duration; electrical stimulation inactive 100Hz; electrical stimulation small phase duration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Royal Dutch Society for Physical Therapy: collaborator
• The Dutch Brain Foundation: collaborator

Study Sites (1)

Leiden Univesity Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Related Publications (3)

• 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.

  PMID: 32054791 BACKGROUND

• 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.

  PMID: 25810035 BACKGROUND

• 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.

  PMID: 15895303 BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Parkinson Disease

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Rob Pelger, Prof.

  Head department urology Leiden University Medical Center

  STUDY CHAIR

Central Study Contacts

Dorien Bennink, MSc

CONTACT

+31715299763; d.bennink@lumc.nl

Heidi Moossdorff, Dr

CONTACT

+31715299763; h.moossdorff@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, clinical epidemiologist MSc, of the department of urology,

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

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: April 18, 2023
• Study Start: September 25, 2023
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2026
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after publication of the results.
• Access Criteria: Data can only be used for scientific research, not for educational purposes. Request will be reviewed by the research team.

Locations

NL (1)