Overactive Bladder SyndromeNCT03322748
Efficacy of Lower Limb Exercises on Overactive Bladder Symptoms in Patients With Multiple Sclerosis
A study testing Usual physical therapy+ strengthening of lower limbs muscles and Usual physical therapy in people with Overactive Bladder Syndrome and Multiple Sclerosis, run by IRCCS San Raffaele at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overactive Bladder Syndrome, Multiple Sclerosis, Muscle Strain
- What is being tested?
- Usual physical therapy+ strengthening of lower limbs muscles and Usual physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2018to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- FIM ( Functional Independence Measure) memory items <=4
- impairment in registering bladder diary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Isometric Contraction Exercises of Lower Limbs Muscles, in Modulating Neurological Control of Bladder Function in Patients With Multiple Sclerosis
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.
Read the 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.
- Being tested
- Usual physical therapy+ strengthening of lower limbs muscles, Usual physical therapy
- Medical subject headings
- Multiple Sclerosis, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Usual physical therapyOther
Usual physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Usual physical therapy+ strengthening of lower limbs muscles Receives: Other: Usual physical therapy+ strengthening of lower limbs muscles |
| Control group | Other | Usual physical therapy Receives: Other: Usual physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Urinary frequency
mean of voluntary urination episodes daytime during 4 days of bladder diary
Measured: 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
Measured: 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)
Measured: at 3rd and 18th day
Secondary outcomes (11)
Change of Urine volume
Minimum , maximum and mean of urine volume voiding during 4 days of bladder diary
Measured: at 6th and 22nd day
Change of episodes of urinary incontinence
Mean of involuntary leakage of urine during 4 days of bladder diary
Measured: at 6th and 22nd day
Change of episodes of nocturia
Mean of voluntary urination episodes nightime during 4 days of bladder diary
Measured: at 6th and 22nd day
Change of Postvoid Residual Volume
Mean of 3 measurement of Urine residual after voluntary voiding
Measured: at 3rd and 18th day
Change of Pad-test 24 Hours
Mean of numbers and weight of pads
Measured: at 6th and 22nd day
PGI (Patient global impression of improvement)
Questionnaire on subjective impression of improvement of overactive bladder symptoms
Measured: at 18th day
Change of value at Uroflussimetry
Mean of maximum urinary flow rate (Qmax) value at uroflussimetry
Measured: at 3rd and 18th day
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
Measured: at 6th and 22nd day
Change of EDSS (Expanded Disability Status Scale)
Mean of value at EDSS that quantifying disability in multiple sclerosis
Measured: at 2nd and 22nd day
Change of Barthel Index Score
Mean of total score measuring performance in activities of daily living
Measured: at 2nd and 22nd day
Change of MAS (Modified Ashworth Scale )
Mean of score (0-4) measuring spasticity of plantarflexors and Hamstring muscles
Measured: at 2nd and 22nd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study startFeb 2018 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giancarlo Comi, IRCCS San Raffaele
- Investigators
- Giancarlo Comi, MD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322748
- Sponsor's protocol ID
- OVERACT V1
- Status last verified
- Jan 2018
- First submitted
- 13 Oct 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Isometric Contraction Exercises of Lower Limbs Muscles, in Modulating Neurological Control of Bladder Function in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03322748
- Acronym / sponsor ID
- OVERACT V1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Usual physical therapy+ strengthening of lower limbs musclesUsual physical therapy+ strengthening of lower limbs muscles |
| Control group | Other | Other: Usual physical therapyUsual physical therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (2 listed)
- FIM ( Functional Independence Measure) memory items <=4
- impairment in registering bladder diary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual physical therapy+ strengthening of lower limbs musclesExperimental group will perform usual physical therapy plus 3 series of isometric contractions of ankle plantarflexor and Hamstring muscles bilaterally, each lasting 5 seconds. | Other | Experimental group |
| Usual physical therapyUsual physical therapy | Other | Control group |
Primary outcome
Change of Urinary frequency
Time frame: at 6th and 22nd day
mean of voluntary urination episodes daytime during 4 days of bladder diary
Change of Urge score
Time frame: 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 urine
Change of total score of OAB-q ( Overact Bladder questionnaire) long form
Time frame: 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)
11 secondary outcomes
Change of Urine volume
Time frame: at 6th and 22nd day
Change of episodes of urinary incontinence
Time frame: at 6th and 22nd day
Change of episodes of nocturia
Time frame: at 6th and 22nd day
Change of Postvoid Residual Volume
Time frame: at 3rd and 18th day
Change of Pad-test 24 Hours
Time frame: at 6th and 22nd day
PGI (Patient global impression of improvement)
Time frame: at 18th day
Change of value at Uroflussimetry
Time frame: at 3rd and 18th day
Change of value at "H REFLEX" test
Time frame: at 6th and 22nd day
Change of EDSS (Expanded Disability Status Scale)
Time frame: at 2nd and 22nd day
Change of Barthel Index Score
Time frame: at 2nd and 22nd day
Change of MAS (Modified Ashworth Scale )
Time frame: at 2nd and 22nd day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giancarlo Comi, MD principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual physical therapy+ strengthening of lower limbs muscles and Usual physical therapy in people with Overactive Bladder Syndrome and Multiple Sclerosis, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giancarlo Comi, MD (0226432990 ext. +39, giancarlo.comi@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Urinary frequency (time frame: at 6th and 22nd day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.