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

San Donato Group (GSD)

Status: Unknown

Conditions: Muscle Strain; Multiple Sclerosis; Overactive Bladder Syndrome

Treatments: Other: Usual physical therapy; Other: Usual physical therapy+ strengthening of lower limbs muscles

Study type: Interventional

Funder types: Other

Identifiers

NCT03322748

OVERACT V1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Experimental group

Experimental group

Description:

Usual physical therapy+ strengthening of lower limbs muscles

Treatment:

Other: Usual physical therapy+ strengthening of lower limbs muscles

Control group

Other group

Description:

Usual physical therapy

Treatment:

Other: Usual physical therapy