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

IRCCS San Raffaele30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Overactive Bladder Syndrome Multiple Sclerosis Muscle Strain

Interventions

Usual physical therapy+ strengthening of lower limbs musclesOTHER

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 therapyOTHER

Usual physical therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Prof. Giancarlo Comi

Milan, MI, Italy

Outcomes

Primary Outcomes

Change of Urinary frequency

mean of voluntary urination episodes daytime during 4 days of bladder diary

Time frame: 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

Time frame: 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)

Time frame: at 3rd and 18th day

Secondary Outcomes

Change of Urine volume

Minimum , maximum and mean of urine volume voiding during 4 days of bladder diary

Time frame: at 6th and 22nd day

Change of episodes of urinary incontinence

Mean of involuntary leakage of urine during 4 days of bladder diary

Time frame: at 6th and 22nd day

Change of episodes of nocturia

Mean of voluntary urination episodes nightime during 4 days of bladder diary

Time frame: at 6th and 22nd day

Central Contacts

Giancarlo Comi, MD

CONTACT

0226432990 giancarlo.comi@hsr.it

Valentina Grazioli, PT

CONTACT

0226432928 grazioli.valentina@hsr.it

Data from ClinicalTrials.gov

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