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Bladder HyperactivityNEUROBILNCT01960270

Secondary Bilateral Sacral Nerve Stimulation in Overactive Bladder Patients

A study testing Device: INTERSTIM II in people with Bladder Hyperactivity, run by University Hospital, Rouen at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Unilateral sacral neuromodulation (SNM) has emerged as a valuable treatment for patient with low urinary tract dysfunction when failure or bad tolerance to anticholinergic treatment for overactive bladder. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Bladder Hyperactivity
What is being tested?
Device: INTERSTIM II
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
12 sitesFrance
Study dates
12 Nov 2013to 2 May 2018
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

  • Patients implanted with Sacral Neuro Modulation for idiopathic OAB with initial efficacy of at least 3 months following by a failure despite optimization of the stimulation (minimum 3)
  • OAB evaluated by voiding diary: number of frequency ≥ 8/24 h or urgencies ≥ 3 during 3 days, with or without urge incontinence.
  • Age between 18 and 80 years.

Who cannot join

  • Psychiatric or neurologic disabilities on neurologic evaluation.
  • Bladder lithiasis or tumor (cystoscopy or ultrasonography).
  • Treatment by drugs that could interfere with the OAB syndromes.
  • Pelvic floor exercises should have been interrupted 1 month before.
  • No planned surgery on bladder or urinary neurologic tract.
  • Diuresis > 3 liters per 24 hours.
  • Negative test at the end of screening period.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • UH Caen

    Caen

  • UH Grenoble

    Grenoble

  • GHICL Lille Saint Philibert

    Lille

  • Lille University Hospital

    Lille

  • Hospices civiles de Lyon

    Lyon

  • AP-HM

    Marseille

  • UH Nantes

    Nantes

  • UH Nîmes

    Nîmes

  • AP-HP Pitié Salpetrière

    Paris

  • AP-HP Tenon

    Paris

  • UH Rouen

    Rouen, 76031

  • UH Toulouse

    Toulouse

Other trials in France

About this study

Official title: Secondary Bilateral or Controlateral Sacral Nerve Stimulation in Overactive Bladder Patients With Unilateral Stimulation Failure - Multicenter Study

Unilateral sacral neuromodulation (SNM) has emerged as a valuable treatment for patient with low urinary tract dysfunction when failure or bad tolerance to anticholinergic treatment for overactive bladder. However, in the medium or long term, some patients failed to benefit from unilateral stimulation (unilateral neuromodulation). A contralateral stimulation could be tested then implanted to restore the efficacy. An other option is to perform a bilateral stimulation of the sacral nerves that could lead to a summation effects better than unilateral stimulation. Therefore, if a unilateral sacral nerve stimulation fails, a contralateral or a bilateral test should be considered.

Read the detailed description

Sacral neuromodulation (SNM) is a treatment in non neurogenic (idiopathic) patients with overactivity of the bladder (OAB) symptoms, refractory to conservative treatment. After selection of patients with positive stimulation test (PNE test), the success rate of stimulation implant is approximatively 70% (40 to 80%). Unilateral versus bilateral initial implantation was retrospectively compared by Pham et al. with respectively 58 and 77% success rate. Wound infection and complication rate were similar. However the limitation of bilateral stimulation is an increased cost for the health care system, augmented duration of the procedure, possible morbidity. Therefore initial implantation in the first step of the treatment is unilateral in current practice. However, after a period of time, a secondary failure may happen, either a complete failure with return to initial symptom or a partial failure with a decrease of the efficacy that may impact on quality of life. However, a non clinical evident effect could have a summation effect if a contralateral stimulator was implanted, and possibly better than contralateral alone.

Research have shown in a small study on 15 patients that a selected group of patients appear to benefit from bilateral stimulation test (PNE test) after failure of unilateral S3 stimulation. A successful response was observed in 4/11 (36%) OAB patients. Bilateral stimulation induced a higher clinical response than stimulation of a controlateral lead alone in voiding parameters. In the patients who showed a successful response to PNE test, 3 were implanted bilaterally with more than 50% improvement for 2 of them at one year follow-up, and 41% improvement for the third. No painful stimulation or side effects were reported with chronic bilateral stimulation. In one study, a lead migration was suspected in 3/15 patients and was the cause of failure. Therefore the proposed study will use systematically a tined lead electrode that avoid lead migration.

According to these preliminary data, test stimulation with a contralateral lead might be considered in secondary unsuccessful patient and evaluated. Further investigation is necessary to determine in a larger cohort the result of contralateral alone or bilateral stimulator implantation. There is no established guidelines in secondary unsuccessful patients, therefore contralateral stimulation is used in clinical practice according to patient and practitioner opinion. This protocol is presented as a standard clinical practice evaluation.

Being tested
Device: INTERSTIM II
Keywords
relapse after an initial clinical response
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Device: INTERSTIM IIDevice

    A second stimulator is implanted on controlateral site

Study groups in NCT01960270
Study groupRoleWhat they receive
Alone controlateral stimulationExperimentalDevice: INTERSTIM II * Stimulator II activated * Stimulator I not activated * Measure of efficacy on bladder hyperactivity
Receives: Device: Device: INTERSTIM II
2 sides-stimulationExperimentalDevice: INTERSTIM II * Stimulator I and II activated * Measure of efficacy on bladder hyperactivity
Receives: Device: Device: INTERSTIM II

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success of Test Period

    A successful response is defined as greater than 50% improvement in at least one relevant voiding parameters, with bilateral stimulation versus baseline without stimulation. Relevant voiding diary parameters are: urgency number, frequency, urge incontinence number. These criteria are commonly used in the studies on sacral neuromodulation.

    Measured: Day 0

Secondary outcomes (5)

  1. Effect of alone controlateral stimulation

    Effect of alone controlateral stimulation on : urgency, frequency, urge incontinence.

    Measured: Day 30 and day 60

  2. Effect of alone controlateral stimulation

    Effect of alone controlateral stimulation on : Quality of Life (QoL) scores

    Measured: Day 30 and day 60

  3. Effect of alone controlateral stimulation

    Effect of alone controlateral stimulation on : VAS pain scale

    Measured: Day 30 and day 60

  4. Effect of alone controlateral stimulation

    Effect of alone controlateral stimulation on : Adverse events.

    Measured: Day 30 and day 60

  5. Effect of alone controlateral stimulation

    Prognostic factors of success will be evaluated concerning age, sex, urodynamic parameters, period of time of symptoms before first implant, period of time between first implant and controlateral/bilateral stimulation, complete failure or a partial failure of efficiency of initial stimulator.

    Measured: Day 30 and day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2013 (estimated)
  2. Study start12 Nov 2013
  3. Primary completion2 May 2018
  4. Study completion2 May 2018

Resources

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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01960270
Sponsor's protocol ID
2013/003/HP
Acronym
NEUROBIL
Status last verified
Jun 2020
First submitted
4 Jul 2013
Last updated
29 Jun 2020
Results posted
No
Data monitoring committee
No

Publications

  • van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP, Lycklama a Nijholt AA, Siegel S, Jonas U, Fowler CJ, Fall M, Gajewski JB, Hassouna MM, Cappellano F, Elhilali MM, Milam DF, Das AK, Dijkema HE, van den Hombergh U. Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. J Urol. 2007 Nov;178(5):2029-34. doi: 10.1016/j.juro.2007.07.032. Epub 2007 Sep 17.

    PubMed 17869298

  • Pham K, Guralnick ML, O'Connor RC. Unilateral versus bilateral stage I neuromodulator lead placement for the treatment of refractory voiding dysfunction. Neurourol Urodyn. 2008;27(8):779-81. doi: 10.1002/nau.20577.

    PubMed 18551562

  • Marcelissen TA, Leong RK, Serroyen J, van Kerrebroeck PE, De Wachter SG. The use of bilateral sacral nerve stimulation in patients with loss of unilateral treatment efficacy. J Urol. 2011 Mar;185(3):976-80. doi: 10.1016/j.juro.2010.10.065. Epub 2011 Jan 19.

    PubMed 21247601

Questions about this trial

What is this clinical trial studying?

A study testing Device: INTERSTIM II in people with Bladder Hyperactivity, run by University Hospital, Rouen at 12 sites 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success of Test Period (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01960270, which also lists 3 linked publications.

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 29 Jun 2020.

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