Relapsing-Remitting Multiple SclerosisNCT03000647
Guided Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis
A study testing Pelvic floor exercises guided by a physiotherapist and Non guided pelvic floor exercises in people with Relapsing-Remitting Multiple Sclerosis and Urinary Incontinence, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
The aim of the study is to evaluate the effectiveness of guided versus non guided pelvic floor exercises for urinary incontinence in patients with Relapsing-Remitting Multiple Sclerosis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis, Urinary Incontinence
- What is being tested?
- Pelvic floor exercises guided by a physiotherapist and Non guided pelvic floor exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Oct 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Relapsing-Remitting Multiple Sclerosis
- Diagnosed with Urinary Incontinence
- Minimental Sate Examination (MMSE) scale: More than 24
- Expanded Disability Status Scale (EDSS) scale: Bladder function 0-4; EDSS 0-6,5
- Willing to participate in the study
- Having Signed an informed consent
Who cannot join
- Diagnosed with another neurological disease
- Diagnosed with kidney diseases
- Having a Relapse of the disease in the last 6 months
- In Women: Pregnancy os postpartum < 6 months
- Having gone through surgery for urinary incontinence or prolapses or prostate diseases
- Having gone through other treatment for pelvic floor
Show all 10Show fewer
- MMSE scale: Under 24
- EDSS scale: Bladder function 5-6 or not knowing; EDSS 7-10
- ICIQ-SF scale: Severity 19-21
- Not willing to participate or sign the informed consent form or not able to understand the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effectiveness of Guided by a Physiotherapist Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence (UI) in Patients With Relapsing-Remitting (RR) Multiple Sclerosis
The aim of the study is to evaluate the effectiveness of guided versus non guided pelvic floor exercises for urinary incontinence in patients with Relapsing-Remitting Multiple Sclerosis
Read the detailed description
Subjects of the study should conduct a specific training in pelvic floor exercises. They were randomly assigned into 2 groups: Group A only received written instructions for exercises to be performed at home; Group B received written instructions and, in addition, exercises were performed in a 30 minutes weekly session with a physiotherapist guiding them
- Being tested
- Pelvic floor exercises guided by a physiotherapist, Non guided pelvic floor exercises
- Keywords
- Pelvic floor muscle exercise, Supervision, Physiotherapy
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor exercises guided by a physiotherapistProcedure or surgery
Subjects perform two types of contractions of the pelvic floor in two different positions 3 times a day and once a week they check it with a physiotherapist (this day only they do it twice at home)
Non guided pelvic floor exercisesProcedure or surgery
Subjects perform two types of contractions of the pelvic floor in two different positions 3 times a day. They do not attend to meetings with a physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Guided Pelvic floor exercises | Active comparator | Pelvic floor exercises guided by a physiotherapist Receives: Procedure: Pelvic floor exercises guided by a physiotherapist |
| Non-guided pelvic floor exercises | Active comparator | Pelvic floor exercises not guided Receives: Procedure: Non guided pelvic floor exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in the number of urinary leakages from baseline
Difference in the mean number of leakages (Registered for 3 days with a bladder diary)
Measured: 12 weeks
Secondary outcomes (5)
Decrease of urinary incontinence severity from baseline
Comparison of the results: Questions 1, 2 and 3 of the International Consultation on Incontinence Questionnaire (ICIQ-SF) between the group 1 and 2
Measured: 4,8 and 12 weeks
Change in quality of life from baseline
Comparison of the results (Question 3 of the questionnaire ICIQ-SF and second part (13 questions) of the Overactive Bladder questionnaire (OABQ-SF) between the group 1 and 2
Measured: 4,8 and 12 weeks
Decrease in the number of urinary leakages from baseline
Comparison of the results (Registered for 3 days with a bladder diary) between the group 1 and 2
Measured: 4 and 8 weeks
Lower urinary tract symptoms from baseline
Comparison of de results (First part (6 questions) of the questionnaire OABQ-SF) between the group 1 and 2
Measured: 4,8 and 12 weeks
Adherence
Comparison of the results (Registered with exercise diary)between the group 1 and 2
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Sponsor
- Investigators
- Denise Cuevas, BSc, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000647
- Sponsor's protocol ID
- EC 65-15 HGV
- Status last verified
- Mar 2018
- First submitted
- 14 Dec 2016
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Quarto G, Autorino R, Gallo A, De Sio M, D'Armiento M, Perdona S, Damiano R. Quality of life in women with multiple sclerosis and overactive bladder syndrome. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Feb;18(2):189-94. doi: 10.1007/s00192-006-0131-9. Epub 2006 May 13.
PubMed 16699915Gilpin SA, Gilpin CJ, Dixon JS, Gosling JA, Kirby RS. The effect of age on the autonomic innervation of the urinary bladder. Br J Urol. 1986 Aug;58(4):378-81. doi: 10.1111/j.1464-410x.1986.tb09089.x.
PubMed 3756405Lucio AC, Campos RM, Perissinotto MC, Miyaoka R, Damasceno BP, D'ancona CA. Pelvic floor muscle training in the treatment of lower urinary tract dysfunction in women with multiple sclerosis. Neurourol Urodyn. 2010 Nov;29(8):1410-3. doi: 10.1002/nau.20941.
PubMed 20976816De Ridder D, Vermeulen C, Ketelaer P, Van Poppel H, Baert L. Pelvic floor rehabilitation in multiple sclerosis. Acta Neurol Belg. 1999 Mar;99(1):61-4.
PubMed 10218095Litwiller SE, Frohman EM, Zimmern PE. Multiple sclerosis and the urologist. J Urol. 1999 Mar;161(3):743-57.
PubMed 10022678Perez DC, Chao CW, Jimenez LL, Fernandez IM, de la Llave Rincon AI. Pelvic floor muscle training adapted for urinary incontinence in multiple sclerosis: a randomized clinical trial. Int Urogynecol J. 2020 Feb;31(2):267-275. doi: 10.1007/s00192-019-03993-y. Epub 2019 Jun 10.
PubMed 31183535
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Guided by a Physiotherapist Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence (UI) in Patients With Relapsing-Remitting (RR) Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03000647
- Acronym / sponsor ID
- EC 65-15 HGV
- Keywords
- Pelvic floor muscle exercise, Supervision, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Dec 2016 (estimated)
- 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 aim of the study is to evaluate the effectiveness of guided versus non guided pelvic floor exercises for urinary incontinence in patients with Relapsing-Remitting Multiple Sclerosis
Detailed description
Subjects of the study should conduct a specific training in pelvic floor exercises. They were randomly assigned into 2 groups: Group A only received written instructions for exercises to be performed at home; Group B received written instructions and, in addition, exercises were performed in a 30 minutes weekly session with a physiotherapist guiding them
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Pelvic floor exercises | Active comparator | Procedure: Pelvic floor exercises guided by a physiotherapistPelvic floor exercises guided by a physiotherapist |
| Non-guided pelvic floor exercises | Active comparator | Procedure: Non guided pelvic floor exercisesPelvic floor exercises not guided |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with Relapsing-Remitting Multiple Sclerosis
- Diagnosed with Urinary Incontinence
- Minimental Sate Examination (MMSE) scale: More than 24
- Expanded Disability Status Scale (EDSS) scale: Bladder function 0-4; EDSS 0-6,5
- Willing to participate in the study
Key exclusion criteria (10 listed)
- Diagnosed with another neurological disease
- Diagnosed with kidney diseases
- Having a Relapse of the disease in the last 6 months
- In Women: Pregnancy os postpartum < 6 months
- Having gone through surgery for urinary incontinence or prolapses or prostate diseases
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 floor exercises guided by a physiotherapistSubjects perform two types of contractions of the pelvic floor in two different positions 3 times a day and once a week they check it with a physiotherapist (this day only they do it twice at home) | Procedure or surgery | Guided Pelvic floor exercises |
| Non guided pelvic floor exercisesSubjects perform two types of contractions of the pelvic floor in two different positions 3 times a day. They do not attend to meetings with a physiotherapist | Procedure or surgery | Non-guided pelvic floor exercises |
Primary outcome
Decrease in the number of urinary leakages from baseline
Time frame: 12 weeks
Difference in the mean number of leakages (Registered for 3 days with a bladder diary)
5 secondary outcomes
Decrease of urinary incontinence severity from baseline
Time frame: 4,8 and 12 weeks
Change in quality of life from baseline
Time frame: 4,8 and 12 weeks
Decrease in the number of urinary leakages from baseline
Time frame: 4 and 8 weeks
Lower urinary tract symptoms from baseline
Time frame: 4,8 and 12 weeks
Adherence
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Background: PubMed 16699915Quarto G, Autorino R, Gallo A, De Sio M, D'Armiento M, Perdona S, Damiano R. Quality of life in women with multiple sclerosis and overactive bladder syndrome. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Feb;18(2):189-94. doi: 10.1007/s00192-006-0131-9. Epub 2006 May 13.
- Background: PubMed 3756405Gilpin SA, Gilpin CJ, Dixon JS, Gosling JA, Kirby RS. The effect of age on the autonomic innervation of the urinary bladder. Br J Urol. 1986 Aug;58(4):378-81. doi: 10.1111/j.1464-410x.1986.tb09089.x.
- Background: PubMed 20976816Lucio AC, Campos RM, Perissinotto MC, Miyaoka R, Damasceno BP, D'ancona CA. Pelvic floor muscle training in the treatment of lower urinary tract dysfunction in women with multiple sclerosis. Neurourol Urodyn. 2010 Nov;29(8):1410-3. doi: 10.1002/nau.20941.
- Background: PubMed 10218095De Ridder D, Vermeulen C, Ketelaer P, Van Poppel H, Baert L. Pelvic floor rehabilitation in multiple sclerosis. Acta Neurol Belg. 1999 Mar;99(1):61-4.
- Background: PubMed 10022678Litwiller SE, Frohman EM, Zimmern PE. Multiple sclerosis and the urologist. J Urol. 1999 Mar;161(3):743-57.
- Derived from this study: PubMed 31183535Perez DC, Chao CW, Jimenez LL, Fernandez IM, de la Llave Rincon AI. Pelvic floor muscle training adapted for urinary incontinence in multiple sclerosis: a randomized clinical trial. Int Urogynecol J. 2020 Feb;31(2):267-275. doi: 10.1007/s00192-019-03993-y. Epub 2019 Jun 10.
- Individual participant dataSharing planned: No
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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.
Denise Cuevas, BSc principal investigator
Universidad Rey Juan Carlos
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 floor exercises guided by a physiotherapist and Non guided pelvic floor exercises in people with Relapsing-Remitting Multiple Sclerosis and Urinary Incontinence, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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: finished, as of the sponsor's last update on 11 Jul 2019. 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 Spain. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in the number of urinary leakages from baseline (time frame: 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 NCT03000647, which also lists 6 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 11 Jul 2019.