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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Usual physical therapy+ strengthening of lower limbs muscles |
|
| Control group | Other | Usual physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual physical therapy+ strengthening of lower limbs muscles | Other | Experimental group will perform usual physical therapy plus 3 series of isometric contractions of ankle plantarflexor and Hamstring muscles bilaterally, each lasting 5 seconds. |
| 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:
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giancarlo Comi, MD | Contact | 0226432990 | +39 | giancarlo.comi@hsr.it |
| Valentina Grazioli, PT | Contact | 0226432928 | +39 | grazioli.valentina@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Giancarlo Comi, MD | IRCCS San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Giancarlo Comi | Milan | MI | 20132 | Italy |
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| Usual physical therapy | Other | Usual physical therapy |
|
| 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 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014947 | Wounds and Injuries |
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