Clinical trial NCT03322748: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder Syndrome
Multiple Sclerosis
Muscle Strain
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of Urinary frequency
timeFrame: at 6th and 22nd day
measure: Change of Urge score
timeFrame: at 6th and 22nd day
measure: Change of total score of OAB-q ( Overact Bladder questionnaire) long form
timeFrame: at 3rd and 18th day
Secondary outcomes:
measure: Change of Urine volume
timeFrame: at 6th and 22nd day
measure: Change of episodes of urinary incontinence
timeFrame: at 6th and 22nd day
measure: Change of episodes of nocturia
timeFrame: at 6th and 22nd day
measure: Change of Postvoid Residual Volume
timeFrame: at 3rd and 18th day
measure: Change of Pad-test 24 Hours
timeFrame: at 6th and 22nd day
measure: PGI (Patient global impression of improvement)
timeFrame: at 18th day
measure: Change of value at Uroflussimetry
timeFrame: at 3rd and 18th day
measure: Change of value at "H REFLEX" test
timeFrame: at 6th and 22nd day
measure: Change of EDSS (Expanded Disability Status Scale)
timeFrame: at 2nd and 22nd day
measure: Change of Barthel Index Score
timeFrame: at 2nd and 22nd day
measure: Change of MAS (Modified Ashworth Scale )
timeFrame: at 2nd and 22nd day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Prof. Giancarlo Comi
state: MI
Study officials:
affiliation: IRCCS San Raffaele
name: Giancarlo Comi, MD
role: PRINCIPAL_INVESTIGATOR
References: