Effect of pelvic floor exercises and electrical stimulation on bladder issues in Parkinson's disease
Lower Urinary Tract Symptoms in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation, a Randomized Control Trial
This study is testing whether pelvic floor exercises combined with different types of electrical stimulation can help people with Parkinson's disease who have bladder problems feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, Zuid Holland) |
| Trial ID | NCT05814614 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of pelvic physical therapy combined with different types of electrical stimulation for bladder complaints in individuals with Parkinson's disease. Participants will be randomized into three groups: two receiving different forms of electrical stimulation and one sham group. Each participant will undergo eight sessions of pelvic physical therapy, which includes bladder training, pelvic floor muscle exercises, and biofeedback. The study seeks to determine the most effective treatment approach for alleviating lower urinary tract symptoms associated with Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of Parkinson's disease who report lower urinary tract symptoms.
Not a fit: Patients with other neurological diseases, recent pelvic surgery, or specific urinary conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve bladder function and quality of life for patients with Parkinson's disease experiencing urinary symptoms.
How similar studies have performed: While electrical stimulation has shown effectiveness in treating lower urinary tract symptoms in other populations, its application in Parkinson's disease is relatively novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Leiden, Zuid Holland
- Leiden Univesity Medical Center — Leiden, Zuid Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Dorien Bennink, MSc
- Email: d.bennink@lumc.nl
- Phone: +31715299763
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.