Efficacy of Lower Limb Exercises on Overactive Bladder Symptoms in Patients With Multiple Sclerosis
- Conditions
- Multiple SclerosisOveractive Bladder SyndromeMuscle Strain
- Interventions
- Other: Usual physical therapy+ strengthening of lower limbs musclesOther: Usual physical therapy
- Registration Number
- NCT03322748
- Lead Sponsor
- IRCCS San Raffaele
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Usual physical therapy+ strengthening of lower limbs muscles Usual physical therapy+ strengthening of lower limbs muscles Control group Usual physical therapy Usual physical therapy
- Primary Outcome Measures
Name Time Method Change of Urinary frequency at 6th and 22nd day mean of voluntary urination episodes daytime during 4 days of bladder diary
Change of Urge score at 6th and 22nd day 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 urineChange of total score of OAB-q ( Overact Bladder questionnaire) long form at 3rd and 18th day 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)
- Secondary Outcome Measures
Name Time Method Change of Urine volume at 6th and 22nd day Minimum , maximum and mean of urine volume voiding during 4 days of bladder diary
Change of episodes of urinary incontinence at 6th and 22nd day Mean of involuntary leakage of urine during 4 days of bladder diary
Change of episodes of nocturia at 6th and 22nd day Mean of voluntary urination episodes nightime during 4 days of bladder diary
Change of Postvoid Residual Volume at 3rd and 18th day Mean of 3 measurement of Urine residual after voluntary voiding
Change of Pad-test 24 Hours at 6th and 22nd day Mean of numbers and weight of pads
Change of value at Uroflussimetry at 3rd and 18th day Mean of maximum urinary flow rate (Qmax) value at uroflussimetry
PGI (Patient global impression of improvement) at 18th day Questionnaire on subjective impression of improvement of overactive bladder symptoms
Change of value at "H REFLEX" test at 6th and 22nd day 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
Change of EDSS (Expanded Disability Status Scale) at 2nd and 22nd day Mean of value at EDSS that quantifying disability in multiple sclerosis
Change of Barthel Index Score at 2nd and 22nd day Mean of total score measuring performance in activities of daily living
Change of MAS (Modified Ashworth Scale ) at 2nd and 22nd day Mean of score (0-4) measuring spasticity of plantarflexors and Hamstring muscles
Trial Locations
- Locations (1)
Prof. Giancarlo Comi
🇮🇹Milan, MI, Italy