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

Status unknownNot a drug-phase studyMS (type not specified)NCT03322748

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Usual physical therapy+ strengthening of lower limbs muscles
  • Usual physical therapy

What it measured

Main measures

  • Change of Urinary frequency

    at 6th and 22nd day

    Bladder, bowel and sexual function
  • Change of Urge score

    at 6th and 22nd day

  • Change of total score of OAB-q ( Overact Bladder questionnaire) long form

    at 3rd and 18th day

    Bladder, bowel and sexual functionQuality of life (reported by participants)

Other measures (11)

  • Change of Urine volume

    at 6th and 22nd day

    Bladder, bowel and sexual function
  • Change of episodes of urinary incontinence

    at 6th and 22nd day

    Bladder, bowel and sexual function
  • Change of episodes of nocturia

    at 6th and 22nd day

    Bladder, bowel and sexual function
  • Change of Postvoid Residual Volume

    at 3rd and 18th day

    Bladder, bowel and sexual function
  • Change of Pad-test 24 Hours

    at 6th and 22nd day

  • PGI (Patient global impression of improvement)

    at 18th day

    Bladder, bowel and sexual function
  • Change of value at Uroflussimetry

    at 3rd and 18th day

    Bladder, bowel and sexual function
  • Change of value at "H REFLEX" test

    at 6th and 22nd day

  • Change of EDSS (Expanded Disability Status Scale)

    at 2nd and 22nd day

    Disability progression
  • Change of Barthel Index Score

    at 2nd and 22nd day

Who could take part

MS (type not specified) · 18 to 80

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Feb 2018

    2. Main results due

      Feb 2020

    3. Finished

      Feb 2020

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