NCT03322748

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

October 13, 2017

Last Update Submit

January 9, 2018

Conditions

Overactive Bladder SyndromeMultiple SclerosisMuscle Strain

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (11)

  • Change of Urine volume

    at 6th and 22nd day

  • Change of episodes of urinary incontinence

    at 6th and 22nd day

  • Change of episodes of nocturia

    at 6th and 22nd day

  • Change of Postvoid Residual Volume

    at 3rd and 18th day

  • Change of Pad-test 24 Hours

    at 6th and 22nd day

  • +6 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Usual physical therapy+ strengthening of lower limbs muscles

Other: Usual physical therapy+ strengthening of lower limbs muscles

Control group

OTHER

Usual physical therapy

Other: Usual physical therapy

Interventions

Usual physical therapy+ strengthening of lower limbs musclesOTHER

Experimental group will perform usual physical therapy plus 3 series of isometric contractions of ankle plantarflexor and Hamstring muscles bilaterally, each lasting 5 seconds.

Experimental group
Usual physical therapyOTHER

Usual physical therapy

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • FIM ( Functional Independence Measure) memory items \<=4
  • impairment in registering bladder diary
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Giancarlo Comi

Milan, MI, 20132, Italy

Location

MeSH Terms

Conditions

Multiple SclerosisSprains and Strains

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesWounds and Injuries

Study Officials

  • Giancarlo Comi, MD

    IRCCS San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giancarlo Comi, MD

CONTACT

0226432990giancarlo.comi@hsr.it

Valentina Grazioli, PT

CONTACT

0226432928grazioli.valentina@hsr.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Neurology and Institute of Experimental Neurology

Study Record Dates

First Submitted

October 13, 2017

First Posted

October 26, 2017

Study Start

February 1, 2018

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

January 10, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)