Bladder Hyperactivity Clinical Trial
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06434831 -
Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
|
N/A |