Efficacy of Lower Limb Exercises on Overactive Bladder Symptoms in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Isometric Contraction Exercises of Lower Limbs Muscles, in Modulating Neurological Control of Bladder Function in Patients With Multiple Sclerosis

Conditions
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Overactive Bladder Syndrome, Multiple Sclerosis, Muscle Strain

Intervention / Treatment
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* Other: Usual physical therapy+ strengthening of lower limbs muscles
* Other: Usual physical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Usual physical therapy+ strengthening of lower limbs muscles | Other: Usual physical therapy+ strengthening of lower limbs muscles<br>* Experimental group will perform usual physical therapy plus 3 series of isometric contractions of ankle plantarflexor and Hamstring muscles bilaterally, each lasting 5 seconds.<br>|
| Other: Control group<br>Usual physical therapy | Other: Usual physical therapy<br>* Usual physical therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Urinary frequency | mean of voluntary urination episodes daytime during 4 days of bladder diary | at 6th and 22nd day | 
| 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 | at 6th and 22nd day | 
| 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) | at 3rd and 18th day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Urine volume | Minimum , maximum and mean of urine volume voiding during 4 days of bladder diary | at 6th and 22nd day | 
| Change of episodes of urinary incontinence | Mean of involuntary leakage of urine during 4 days of bladder diary | at 6th and 22nd day | 
| Change of episodes of nocturia | Mean of voluntary urination episodes nightime during 4 days of bladder diary | at 6th and 22nd day | 
| Change of Postvoid Residual Volume | Mean of 3 measurement of Urine residual after voluntary voiding | at 3rd and 18th day | 
| Change of Pad-test 24 Hours | Mean of numbers and weight of pads | at 6th and 22nd day | 
| PGI (Patient global impression of improvement) | Questionnaire on subjective impression of improvement of overactive bladder symptoms | at 18th day | 
| Change of value at Uroflussimetry | Mean of maximum urinary flow rate (Qmax) value at uroflussimetry | at 3rd and 18th day | 
| 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 | at 6th and 22nd day | 
| Change of EDSS (Expanded Disability Status Scale) | Mean of value at EDSS that quantifying disability in multiple sclerosis | at 2nd and 22nd day | 
| Change of Barthel Index Score | Mean of total score measuring performance in activities of daily living | at 2nd and 22nd day | 
| Change of MAS (Modified Ashworth Scale ) | Mean of score (0-4) measuring spasticity of plantarflexors and Hamstring muscles | at 2nd and 22nd day |