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

Multiple Sclerosis Clinical Trial

Official title:

Efficacy of Isometric Contraction Exercises of Lower Limbs Muscles, in Modulating Neurological Control of Bladder Function in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03322748
• Other study ID #: OVERACT V1
• Status: Not yet recruiting
• Phase: N/A
• First received: October 13, 2017
• Last updated: January 9, 2018
• Start date: February 2018
• Est. completion date: February 2020

Study information

• Verified date: January 2018
• Source: IRCCS San Raffaele
• Contact: Giancarlo Comi, MD
• Phone: 0226432990
• Email: giancarlo.comi[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Strain
• Overactive Bladder Syndrome
• Sclerosis
• Urinary Bladder, Overactive

Intervention

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.
• Usual physical therapy
Usual physical therapy

Locations

Country	Name	City	State
Italy	Prof. Giancarlo Comi	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Urinary frequency	mean of voluntary urination episodes daytime during 4 days of bladder diary	at 6th and 22nd day
Primary	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
Primary	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	Change of Urine volume	Minimum , maximum and mean of urine volume voiding during 4 days of bladder diary	at 6th and 22nd day
Secondary	Change of episodes of urinary incontinence	Mean of involuntary leakage of urine during 4 days of bladder diary	at 6th and 22nd day
Secondary	Change of episodes of nocturia	Mean of voluntary urination episodes nightime during 4 days of bladder diary	at 6th and 22nd day
Secondary	Change of Postvoid Residual Volume	Mean of 3 measurement of Urine residual after voluntary voiding	at 3rd and 18th day
Secondary	Change of Pad-test 24 Hours	Mean of numbers and weight of pads	at 6th and 22nd day
Secondary	PGI (Patient global impression of improvement)	Questionnaire on subjective impression of improvement of overactive bladder symptoms	at 18th day
Secondary	Change of value at Uroflussimetry	Mean of maximum urinary flow rate (Qmax) value at uroflussimetry	at 3rd and 18th day
Secondary	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
Secondary	Change of EDSS (Expanded Disability Status Scale)	Mean of value at EDSS that quantifying disability in multiple sclerosis	at 2nd and 22nd day
Secondary	Change of Barthel Index Score	Mean of total score measuring performance in activities of daily living	at 2nd and 22nd day
Secondary	Change of MAS (Modified Ashworth Scale )	Mean of score (0-4) measuring spasticity of plantarflexors and Hamstring muscles	at 2nd and 22nd day