Back to resultsEfficacy of Lower Limb Exercises on Overactive Bladder Symptoms in Patients With Multiple Sclerosis
Primary Purpose
Overactive Bladder Syndrome, Multiple Sclerosis, Muscle Strain
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Usual physical therapy+ strengthening of lower limbs muscles
Usual physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome
Eligibility Criteria
Inclusion Criteria:
- Multiple Sclerosis Patients
- Urge score >=2
- urinary daytime frequency >=8
- stable overactive bladder symptoms for 6 months
- MRC ( Medical Research Council) scale of ankle plantarflexors and hamstrings >=2
- signed informed consensus
Exclusion Criteria:
- FIM ( Functional Independence Measure) memory items <=4
- impairment in registering bladder diary
- inclusion in other experimental study
- specific straightening during the suty period
- PVR >= 200 ml ina single evaluation or PVR (post void residual) >=150 in 4 evaluation (twice a day for 2 consecutive days)
- Urinary infections
- concomitant urological disease
- intrathecal baclofen pump
- SANS (Stoller Afferent Nerve Stimulation)
- modification of therapy for overactive bladder symptoms within three months before entering the study
Sites / Locations
- Prof. Giancarlo Comi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental group
Control group
Arm Description
Usual physical therapy+ strengthening of lower limbs muscles
Usual physical therapy
Outcomes
Primary Outcome Measures
Change of Urinary frequency
mean of voluntary urination episodes daytime during 4 days of bladder diary
Change of Urge score
mean of score evaluating the perception of urge that patient experiences every urination. The subscale scores are:
0, if patient doesn't need to urinate, but urinates before going out from home or concerned about the unavailability of toilet;
1, if patient doesn't experience urgent urination;
2, presence of urgency but disappeared before getting to the toilet;
3, presence of urgency and reached the toilet without leakage of urine
4, presence of urgency and did not reach the toilet with leakage of urine
Change of total score of OAB-q ( Overact Bladder questionnaire) long form
questionnaire evaluates the impact of overactive bladder symptoms on activities of daily living 8 ITEMS SYMPTOM BOTHER (each item has a subscale score from 1 to 6) + 25 ITEMS HEALTH-RELATED QUALITY OF LIFE (each item has a subscale score from 1 to 6)
Secondary Outcome Measures
Change of Urine volume
Minimum , maximum and mean of urine volume voiding during 4 days of bladder diary
Change of episodes of urinary incontinence
Mean of involuntary leakage of urine during 4 days of bladder diary
Change of episodes of nocturia
Mean of voluntary urination episodes nightime during 4 days of bladder diary
Change of Postvoid Residual Volume
Mean of 3 measurement of Urine residual after voluntary voiding
Change of Pad-test 24 Hours
Mean of numbers and weight of pads
PGI (Patient global impression of improvement)
Questionnaire on subjective impression of improvement of overactive bladder symptoms
Change of value at Uroflussimetry
Mean of maximum urinary flow rate (Qmax) value at uroflussimetry
Change of value at "H REFLEX" test
Evaluation of H wave mean amplitude and of Ratio of maximum H reflex to maximum M response after a train of stimuli given at 1 and 0.1 Hz
Change of EDSS (Expanded Disability Status Scale)
Mean of value at EDSS that quantifying disability in multiple sclerosis
Change of Barthel Index Score
Mean of total score measuring performance in activities of daily living
Change of MAS (Modified Ashworth Scale )
Mean of score (0-4) measuring spasticity of plantarflexors and Hamstring muscles
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03322748
Brief Title
Efficacy of Lower Limb Exercises on Overactive Bladder Symptoms in Patients With Multiple Sclerosis
Official Title
Efficacy of Isometric Contraction Exercises of Lower Limbs Muscles, in Modulating Neurological Control of Bladder Function in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2018 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
February 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study (OVERACT_V1) is to verify if the isometric contraction of ankle plantarflexor and Hamstring muscles, induces a significant reduction of overactive bladder symptoms in patients with Multiple sclerosis.
Detailed Description
The aim of the study (OVERACT_V1) is to verify if the isometric contraction of ankle plantarflexor and Hamstring muscles, induces a significant reduction of overactive bladder symptoms in patients with Multiple sclerosis. It's known that the electric stimulation of the Posterior Tibial nerve induces an improvement of overactive bladder symptoms through a modulation of spinal circuitry, which occurs with unknown mechanisms. The investigators' hypothesis is that the voluntary muscular activation may induce a modulation of the sacral root as long as the electric stimulation. 30 patients will be recruited within 2 years, since October 2017 through October 2019. This is a monocentric, randomized controlled , in single blind, not pharmacological study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome, Multiple Sclerosis, Muscle Strain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Usual physical therapy+ strengthening of lower limbs muscles
Arm Title
Control group
Arm Type
Other
Arm Description
Usual physical therapy
Intervention Type
Other
Intervention Name(s)
Usual physical therapy+ strengthening of lower limbs muscles
Intervention Description
Experimental group will perform usual physical therapy plus 3 series of isometric contractions of ankle plantarflexor and Hamstring muscles bilaterally, each lasting 5 seconds.
Intervention Type
Other
Intervention Name(s)
Usual physical therapy
Intervention Description
Usual physical therapy
Primary Outcome Measure Information:
Title
Change of Urinary frequency
Description
mean of voluntary urination episodes daytime during 4 days of bladder diary
Time Frame
at 6th and 22nd day
Title
Change of Urge score
Description
mean of score evaluating the perception of urge that patient experiences every urination. The subscale scores are:
0, if patient doesn't need to urinate, but urinates before going out from home or concerned about the unavailability of toilet;
1, if patient doesn't experience urgent urination;
2, presence of urgency but disappeared before getting to the toilet;
3, presence of urgency and reached the toilet without leakage of urine
4, presence of urgency and did not reach the toilet with leakage of urine
Time Frame
at 6th and 22nd day
Title
Change of total score of OAB-q ( Overact Bladder questionnaire) long form
Description
questionnaire evaluates the impact of overactive bladder symptoms on activities of daily living 8 ITEMS SYMPTOM BOTHER (each item has a subscale score from 1 to 6) + 25 ITEMS HEALTH-RELATED QUALITY OF LIFE (each item has a subscale score from 1 to 6)
Time Frame
at 3rd and 18th day
Secondary Outcome Measure Information:
Title
Change of Urine volume
Description
Minimum , maximum and mean of urine volume voiding during 4 days of bladder diary
Time Frame
at 6th and 22nd day
Title
Change of episodes of urinary incontinence
Description
Mean of involuntary leakage of urine during 4 days of bladder diary
Time Frame
at 6th and 22nd day
Title
Change of episodes of nocturia
Description
Mean of voluntary urination episodes nightime during 4 days of bladder diary
Time Frame
at 6th and 22nd day
Title
Change of Postvoid Residual Volume
Description
Mean of 3 measurement of Urine residual after voluntary voiding
Time Frame
at 3rd and 18th day
Title
Change of Pad-test 24 Hours
Description
Mean of numbers and weight of pads
Time Frame
at 6th and 22nd day
Title
PGI (Patient global impression of improvement)
Description
Questionnaire on subjective impression of improvement of overactive bladder symptoms
Time Frame
at 18th day
Title
Change of value at Uroflussimetry
Description
Mean of maximum urinary flow rate (Qmax) value at uroflussimetry
Time Frame
at 3rd and 18th day
Title
Change of value at "H REFLEX" test
Description
Evaluation of H wave mean amplitude and of Ratio of maximum H reflex to maximum M response after a train of stimuli given at 1 and 0.1 Hz
Time Frame
at 6th and 22nd day
Title
Change of EDSS (Expanded Disability Status Scale)
Description
Mean of value at EDSS that quantifying disability in multiple sclerosis
Time Frame
at 2nd and 22nd day
Title
Change of Barthel Index Score
Description
Mean of total score measuring performance in activities of daily living
Time Frame
at 2nd and 22nd day
Title
Change of MAS (Modified Ashworth Scale )
Description
Mean of score (0-4) measuring spasticity of plantarflexors and Hamstring muscles
Time Frame
at 2nd and 22nd day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Multiple Sclerosis Patients
Urge score >=2
urinary daytime frequency >=8
stable overactive bladder symptoms for 6 months
MRC ( Medical Research Council) scale of ankle plantarflexors and hamstrings >=2
signed informed consensus
Exclusion Criteria:
FIM ( Functional Independence Measure) memory items <=4
impairment in registering bladder diary
inclusion in other experimental study
specific straightening during the suty period
PVR >= 200 ml ina single evaluation or PVR (post void residual) >=150 in 4 evaluation (twice a day for 2 consecutive days)
Urinary infections
concomitant urological disease
intrathecal baclofen pump
SANS (Stoller Afferent Nerve Stimulation)
modification of therapy for overactive bladder symptoms within three months before entering the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giancarlo Comi, MD
Phone
0226432990
Ext
+39
Email
giancarlo.comi@hsr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Grazioli, PT
Phone
0226432928
Ext
+39
Email
grazioli.valentina@hsr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giancarlo Comi, MD
Organizational Affiliation
IRCCS San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. Giancarlo Comi
City
Milan
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Lower Limb Exercises on Overactive Bladder Symptoms in Patients With Multiple Sclerosis
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