Neurogenic Urinary Bladder, SpasticUROSTIMNCT04225143
Bilateral vs. Unilateral Stimulation in Neurological Bladder Disroders
A study testing urostim bilateral and urostim unilateral in people with Neurogenic Urinary Bladder, Spastic, run by University Hospital, Caen at 1 site in France.
Trial summary
This study evaluates the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Urinary Bladder, Spastic
- What is being tested?
- urostim bilateral and urostim unilateral
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2019to 31 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who received research information
- Individuals affiliated to a social security scheme
- Individuals over 18 years of age
- Individuals with non-serious neurological bladder hyperactivity
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Caen Normandie
Caen, 14000
Joffrey Drigny, MD MSC, +33231064533, drigny-j@chu-caen.fr
Alexis Ruet, MD MSC, +33231064721, ruet-a@chu-caen.fr
About this study
Official title: Efficacité Clinique comparée de la Stimulation transcutanée du Nerf Tibial postérieur unilatérale vs bilatérale Pour Traiter Une hyperactivité vésicale Neurologique Non sévère : Essai Clinique randomisé
This study evaluates the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.
Read the detailed description
Urinary disorders are common in neurological diseases. The prognosis of neurological bladders is twofold. On the one hand, symptoms such as incontinence or retention affect quality of life and comfort. On the other hand, complications such as urinary tract infections or renal failure threaten health and even involve patients' vital prognosis. Several therapies are used to treat these urinary disorders including transcutaneous or percutaneous posterior tibial nerve stimulation (SNTP). SNTP is used in treating symptoms of bladder overactivity. This treatment is most often used unilaterally, but can be used bilaterally.
The aim of this study is to evaluate the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.
50 patients will be included, in two arms by randomization, one arm of 25 patients will be treated by unilateral stimuylation and the other arm of 25 patients will be trated by bilateral stimulation.
They will be evaluate at 3, 6 and 12 months by auto questionnaire and the effectivess of each therapy will be compared.
- Conditions
- Neurogenic Urinary Bladder, Spastic
- Being tested
- urostim bilateral, urostim unilateral
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urostim bilateralProcedure or surgery
Treatment by bilateral neurostimulation of the tibial nerve
urostim unilateralProcedure or surgery
Treatment by unilateral neurostimulation of the tibial nerve
| Study group | Role | What they receive |
|---|---|---|
| bilateral | Experimental | 25 patients with an overactive bladder Receives: Procedure: urostim bilateral |
| unilateral | Active comparator | 25 patients with an overactive bladder Receives: Procedure: urostim unilateral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary symptom profile score (USP score)
auto quastionnaire between 0 and 39 points The higher the score the higher the urinary symptoms
Measured: 3 months
Secondary outcomes (2)
mictional calendar
records the number of mictions per day and the number of urinary leaks per day over 48 hours
Measured: 3 months
Patient global impression of improvement (PGI-I)
Questionnaire of quality of life improvement :The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better) to 7 (Very much worse)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start27 Nov 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Urinary Bladder, SpasticStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225143
- Sponsor's protocol ID
- UROSTIM
- Acronym
- UROSTIM
- Status last verified
- Nov 2019
- First submitted
- 12 Dec 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacité Clinique comparée de la Stimulation transcutanée du Nerf Tibial postérieur unilatérale vs bilatérale Pour Traiter Une hyperactivité vésicale Neurologique Non sévère : Essai Clinique randomisé
- ClinicalTrials.gov ID
- NCT04225143
- Acronym / sponsor ID
- UROSTIM / UROSTIM
- Conditions
- Neurogenic Urinary Bladder, Spastic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 13 Jan 2020 (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.
This study evaluates the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.
Detailed description
Urinary disorders are common in neurological diseases. The prognosis of neurological bladders is twofold. On the one hand, symptoms such as incontinence or retention affect quality of life and comfort. On the other hand, complications such as urinary tract infections or renal failure threaten health and even involve patients' vital prognosis. Several therapies are used to treat these urinary disorders including transcutaneous or percutaneous posterior tibial nerve stimulation (SNTP). SNTP is used in treating symptoms of bladder overactivity. This treatment is most often used unilaterally, but can be used bilaterally.
The aim of this study is to evaluate the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.
50 patients will be included, in two arms by randomization, one arm of 25 patients will be treated by unilateral stimuylation and the other arm of 25 patients will be trated by bilateral stimulation.
They will be evaluate at 3, 6 and 12 months by auto questionnaire and the effectivess of each therapy will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bilateral | Experimental | Procedure: urostim bilateral25 patients with an overactive bladder |
| unilateral | Active comparator | Procedure: urostim unilateral25 patients with an overactive bladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who received research information
- Individuals affiliated to a social security scheme
- Individuals over 18 years of age
- Individuals with non-serious neurological bladder hyperactivity
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| urostim bilateralTreatment by bilateral neurostimulation of the tibial nerve | Procedure or surgery | bilateral |
| urostim unilateralTreatment by unilateral neurostimulation of the tibial nerve | Procedure or surgery | unilateral |
Primary outcome
Urinary symptom profile score (USP score)
Time frame: 3 months
auto quastionnaire between 0 and 39 points The higher the score the higher the urinary symptoms
2 secondary outcomes
mictional calendar
Time frame: 3 months
Patient global impression of improvement (PGI-I)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urostim bilateral and urostim unilateral in people with Neurogenic Urinary Bladder, Spastic, run by University Hospital, Caen at 1 site in France.
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 4 inclusion and 1 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 13 Jan 2020. 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 France. 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 Hélène LARDREAU (02 31 06 47 21, lardreau-h@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary symptom profile score (USP score) (time frame: 3 months). 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 13 Jan 2020.