Multiple Sclerosis, Muscle Strain, Overactive Bladder Syndrome
Conditions
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.
Interventions
OTHERUsual physical therapy+ strengthening of lower limbs muscles
Experimental group will perform usual physical therapy plus 3 series of isometric contractions of ankle plantarflexor and Hamstring muscles bilaterally, each lasting 5 seconds.
Usual physical therapy
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Urinary frequency | at 6th and 22nd day | mean of voluntary urination episodes daytime during 4 days of bladder diary |
| Change of Urge score | at 6th and 22nd day | 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 | at 3rd and 18th day | 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
| Measure | Time frame | Description |
|---|---|---|
| Change of episodes of nocturia | at 6th and 22nd day | Mean of voluntary urination episodes nightime during 4 days of bladder diary |
| Change of Postvoid Residual Volume | at 3rd and 18th day | Mean of 3 measurement of Urine residual after voluntary voiding |
| Change of Pad-test 24 Hours | at 6th and 22nd day | Mean of numbers and weight of pads |
| Change of value at Uroflussimetry | at 3rd and 18th day | Mean of maximum urinary flow rate (Qmax) value at uroflussimetry |
| PGI (Patient global impression of improvement) | at 18th day | Questionnaire on subjective impression of improvement of overactive bladder symptoms |
| Change of EDSS (Expanded Disability Status Scale) | at 2nd and 22nd day | Mean of value at EDSS that quantifying disability in multiple sclerosis |
| Change of Barthel Index Score | at 2nd and 22nd day | Mean of total score measuring performance in activities of daily living |
| Change of MAS (Modified Ashworth Scale ) | at 2nd and 22nd day | Mean of score (0-4) measuring spasticity of plantarflexors and Hamstring muscles |
| Change of value at H REFLEX test | at 6th and 22nd day | 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 Urine volume | at 6th and 22nd day | Minimum , maximum and mean of urine volume voiding during 4 days of bladder diary |
| Change of episodes of urinary incontinence | at 6th and 22nd day | Mean of involuntary leakage of urine during 4 days of bladder diary |
Countries
Italy
Contacts
Primary ContactGiancarlo Comi, MD
Backup ContactValentina Grazioli, PT
Outcome results
None listed