Lower Urinary Tract SymptomsLIPPENCT05814614
Bladder Complaints in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation
A study testing pelvic physical therapy in people with Lower Urinary Tract Symptoms and Parkinson Disease, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Urinary Tract Symptoms, Parkinson Disease
- What is being tested?
- pelvic physical therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Sep 2023to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Botox, PTNS or pelvic physical therapy in the last year
- Sacral neuromodulator
- Pacemaker and Implantable cardioverter defibrillator (ICD)
- Deep Brain stimulation (DBS)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden Univesity Medical Center
Leiden, South Holland, 2333 ZA
Dorien Bennink, MSc, +31715299763, d.bennink@lumc.nl
Heidi Moossdorff, Dr, +31715299763, h.moossdorff@lumc.nl
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Lower Urinary Tract Symptoms, Parkinson Disease
- Being tested
- pelvic physical therapy
- Keywords
- Parkinson disease, Lower urinary tract symptoms, Electrical simulation, Pelvic floor muscle exercises, Bladder training, Biofeedback
- Medical subject headings
- Lower Urinary Tract Symptoms, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic physical therapyOther
Pelvic floor muscle exercises, biofeedback, bladder training
| Study group | Role | What they receive |
|---|---|---|
| electrical stimulation small phase duration | Active comparator | phase duration 200 microseconds, frequency 20 Hertz, 20 minutes Receives: Other: pelvic physical therapy |
| electrical stimulation broad pulse duration | Active comparator | phase duration 1000 microseconds, frequency 8 Hertz, 20 minutes Receives: 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 Receives: Other: pelvic physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 12 weeks
Secondary outcomes (8)
Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short form (ICIQ-UI SF)
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.
Measured: 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)
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.
Measured: Change from baseline at 12 weeks; at 24 weeks; at one year
Change in 24 hour bladder diary, bladder volume
24 hour bladder diary: change in mean of bladder volume. Normal bladder volume ranges between: 250-500ml.
Measured: Change from baseline at 12 weeks
Change in 24 hour bladder diary, frequency of micturition
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.
Measured: Change from baseline at 12 weeks
Change in 24 hour bladder diary, urgency
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.
Measured: Change from baseline at 12 weeks
Change in 24 hour bladder diary, urinary incontinence
24 hour bladder diary change in urinary incontinence episodes. Number of urinary incontinence episodes in 24 hours.
Measured: Change from baseline at 12 weeks
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.
Measured: Change from baseline at 24 weeks and at one year.
Change in International Consultation on Incontinence Questionnaire-Overactive Bladder Short form (ICIQ-OAB)
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.
Measured: Change from baseline at 12 weeks; at 24 weeks; at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start25 Sep 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to three parallel arms for the duration of the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Dutch Society for Physical Therapy, The Dutch Brain Foundation
- Responsible party
- Principal investigator, Dorien Bennink, Leiden University Medical Center
- Investigators
- Rob Pelger, Prof., Study chair, Head department urology Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814614
- Sponsor's protocol ID
- NL8301905822
- Acronym
- LIPPE
- Status last verified
- Mar 2024
- First submitted
- 14 Dec 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32054791Sakakibara 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.
PubMed 25810035Balash 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.
PubMed 15895303
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Urinary Tract Symptoms in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation, a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05814614
- Acronym / sponsor ID
- LIPPE / NL8301905822
- Conditions
- Lower Urinary Tract Symptoms, Parkinson Disease
- Keywords
- Parkinson disease, Lower urinary tract symptoms, Electrical simulation, Pelvic floor muscle exercises, Bladder training, Biofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Royal Dutch Society for Physical Therapy, The Dutch Brain Foundation
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are assigned to three parallel arms for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| electrical stimulation small phase duration | Active comparator | Other: pelvic physical therapyphase duration 200 microseconds, frequency 20 Hertz, 20 minutes |
| electrical stimulation broad pulse duration | Active comparator | Other: pelvic physical therapyphase duration 1000 microseconds, frequency 8 Hertz, 20 minutes |
| electrical stimulation inactive 100Hz | Sham comparator | Other: pelvic physical therapyphase duration 200 microseconds, frequency 100 Hertz, 2 seconds active 20 seconds no output, 20 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvic physical therapyPelvic floor muscle exercises, biofeedback, bladder training | Other | electrical stimulation broad pulse duration, electrical stimulation inactive 100Hz, electrical stimulation small phase duration |
Primary outcome
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.
8 secondary outcomes
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
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
Change in 24 hour bladder diary, bladder volume
Time frame: Change from baseline at 12 weeks
Change in 24 hour bladder diary, frequency of micturition
Time frame: Change from baseline at 12 weeks
Change in 24 hour bladder diary, urgency
Time frame: Change from baseline at 12 weeks
Change in 24 hour bladder diary, urinary incontinence
Time frame: 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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 32054791McDonald 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.
- Background: PubMed 25810035Sakakibara 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.
- Background: PubMed 15895303Balash 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Pelger, Prof. study chair
Head department urology Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic physical therapy in people with Lower Urinary Tract Symptoms and Parkinson Disease, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorien Bennink, MSc (+31715299763, d.bennink@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: Change from baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05814614, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.