Secondary Bilateral Sacral Nerve Stimulation in Overactive Bladder Patients

Bladder Hyperactivity Clinical Trial

— NEUROBIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960270
• Other study ID #: 2013/003/HP
• Status: Completed
• Phase: N/A
• Start date: November 12, 2013
• Est. completion date: May 2, 2018

Study information

• Verified date: June 2020
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bladder Hyperactivity
• Urinary Bladder, Overactive

Intervention

Device:
• Device: INTERSTIM II
A second stimulator is implanted on controlateral site

Locations

Country	Name	City	State
France	UH Caen	Caen
France	UH Grenoble	Grenoble
France	GHICL Lille Saint Philibert	Lille
France	Lille University Hospital	Lille
France	Hospices civiles de Lyon	Lyon
France	AP-HM	Marseille
France	UH Nantes	Nantes
France	UH Nîmes	Nîmes
France	AP-HP Pitié Salpetrière	Paris
France	AP-HP Tenon	Paris
France	UH Rouen	Rouen
France	UH Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

References & Publications (3)

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 1 — View Citation

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. — View Citation

van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP, Lycklama á 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 ther — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Secondary	Effect of alone controlateral stimulation	Effect of alone controlateral stimulation on : urgency, frequency, urge incontinence.	Day 30 and day 60
Secondary	Effect of alone controlateral stimulation	Effect of alone controlateral stimulation on : Quality of Life (QoL) scores	Day 30 and day 60
Secondary	Effect of alone controlateral stimulation	Effect of alone controlateral stimulation on : VAS pain scale	Day 30 and day 60
Secondary	Effect of alone controlateral stimulation	Effect of alone controlateral stimulation on : Adverse events.	Day 30 and day 60
Secondary	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.	Day 30 and day 60