Randall Leong

Cost-effectiveness analysis of sacral neuromodulation and botulinum toxin A treatment for patients with idiopathic overactive bladder.

Study Type – Therapy (economic analysis)

Current Information on Sacral Neuromodulation and Botulinum Toxin Treatment for Refractory Idiopathic Overactive Bladder Syndrome: A Review

The overactive bladder syndrome (OAB) negatively affects the daily life of many people. Conservative treatments, such as antimuscarinics, do not always lead to sufficient improvement of the complaints and/or are often associated with considerable side effects resulting in treatment failure. In the case of failure or intolerable side effects, sacral neuromodulation (SNM) and botulinum toxin are minimally invasive and reversible alternatives. Currently, of these alternatives only SNM with InterStimTM therapy has FDA approval for use in OAB patients. This review attempts to provide an update on the current position of SNM and botulinum toxin in the second-line management of adults with idiopathic OAB, based on the available clinical evidence concerning the efficacy and safety.

Long-Term Results of Sacral Neuromodulation With the Tined Lead Procedure

PURPOSE We present long-term followup data on the outcome of sacral neuromodulation using the tined lead procedure. MATERIALS AND METHODS We conducted a single center study including all patients who received an implantable neurostimulator between 2002 and 2005 using the tined lead technique. Treatment efficacy was evaluated by comparing the data of a 3-day voiding diary filled out in May 2009 to the data before the onset of sacral neuromodulation treatment (baseline). Clinical success was defined as more than 50% improvement in at least 1 of the relevant voiding diary parameters. RESULTS A total of 64 patients underwent implantation with an implantable neurostimulator using the tined lead procedure. Mean followup was 53 months (range 35 to 77). Five patients died of causes unrelated to sacral neuromodulation and they were not included in analysis. The implantable neurostimulator was removed from 7 patients and 3 stopped using the neurostimulator. Voiding diary analysis showed that 38 of 59 patients (64%) were successfully treated. There were 21 patients (33%) who underwent a surgical revision due to an adverse event and 1 (1.6%) who underwent lead revision because of suspected lead migration. CONCLUSIONS Sacral neuromodulation with the tined lead procedure is a safe and effective treatment for patients with overactive bladder symptoms or urinary retention.

The Use of Bilateral Sacral Nerve Stimulation in Patients With Loss of Unilateral Treatment Efficacy

PURPOSE We evaluated whether bilateral sacral nerve stimulation can be effective to restore treatment efficacy in patients in whom unilateral sacral neuromodulation fails. MATERIALS AND METHODS Patients in whom unilateral sacral neuromodulation failed were included in analysis. The percutaneous nerve evaluation test was used to evaluate the effect of contralateral and bilateral stimulation. The stimulation electrode was placed in the contralateral S3 foramen and symptoms were self-recorded using a 3-day voiding diary. Clinical success was defined as more than 50% improvement in at least 1 relevant voiding diary parameter vs baseline. RESULTS The 15 study patients underwent test stimulation with percutaneous nerve evaluation. In 3 patients lead migration was suspected and, thus, they were not included in analysis. Four of the remaining 12 patients had a successful response to percutaneous nerve evaluation, of whom 3 were eventually implanted with a contralateral lead. After 12 months of treatment 2 of the 3 patients had a successful outcome. CONCLUSIONS In this pilot study only a select group of patients appeared to benefit from bilateral stimulation after unilateral therapy failure. Further investigation is needed to determine the predictive factors and cost-effectiveness of this treatment.

Is the Screening Method of Sacral Neuromodulation a Prognostic Factor for Long-Term Success?

PURPOSE We evaluated whether there is a difference in long-term outcomes between patients screened with percutaneous nerve evaluation and a first stage tined lead procedure. We also evaluated the outcome in patients who only responded to screening with the tined lead procedure after failed initial percutaneous nerve evaluation. MATERIALS AND METHODS We evaluated all patients screened for eligibility to receive sacral neuromodulation treatment since the introduction of the tined lead technique in our center in 2002. In May 2009 all implanted patients were asked to maintain a voiding diary to record the effect of sacral neuromodulation on urinary symptoms. Chi-square analysis was used to evaluate differences in the long-term outcomes of the separate screening methods. RESULTS A total of 92 patients were screened for sacral neuromodulation. Of the 76 patients screened with percutaneous nerve evaluation 35 (46%) met the criteria for permanent implantation. In 11 of the 16 patients (69%) who underwent direct screening with the tined lead procedure permanent stimulators were placed. Of the 41 patients in whom percutaneous nerve evaluation failed and who subsequently underwent screening with tined lead procedure 18 (44%) were implanted with a neurostimulator after a successful response. Statistical analysis showed no difference between screening type and long-term success (p = 0.94). CONCLUSIONS The first stage tined lead procedure is a more sensitive screening tool than percutaneous nerve evaluation but long-term success seems to be independent of the screening method. Patients in whom percutaneous nerve evaluation initially failed but who responded to prolonged screening the with tined lead procedure appeared to be as successful as those who directly responded to percutaneous nerve evaluation or the tined lead procedure.

Psychological and psychiatric factors as predictors for success in sacral neuromodulation treatment

Study Type – Therapy (preference)