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

Efficacy of Isometric Contraction Exercises of Lower Limbs Muscles, in Modulating Neurological Control of Bladder Function 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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis; Overactive Bladder Syndrome; Muscle Strain
• Intervention / Treatment: Other: Usual physical therapy+ strengthening of lower limbs muscles; Other: Usual physical therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giancarlo Comi, MD; Phone Number: +39 0226432990; Email: giancarlo.comi@hsr.it
• Study Contact Backup: Name: Valentina Grazioli, PT; Phone Number: +39 0226432928; Email: grazioli.valentina@hsr.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20132
      • Prof. Giancarlo Comi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Usual physical therapy+ strengthening of lower limbs muscles	Other: Usual 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.
Other: Control group; Usual physical therapy	Other: Usual physical therapy; Usual physical therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Giancarlo Comi, MD, IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Multiple Sclerosis; Sclerosis; Urinary Bladder, Overactive
• Other Study ID Numbers: OVERACT V1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No