Screening Method in Sacral Neuromodulation
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Is the Method of Screening in Sacral Neuromodulation a Prognostic Factor for Long-term Success?|
- long-term success measured with voiding diaries [ Time Frame: 5 years ] [ Designated as safety issue: No ]Successful treatment was defined as more than 50 percent improvement in the key voiding diary variables compared to baseline.
|Study Start Date:||May 2002|
|Study Completion Date:||July 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
|Patients treated with sacral neuromodulation|
Purpose: To evaluate if there is a difference in long-term outcome of sacral neuromodulation (SNM) between patients screened with the percutaneous nerve evaluation (PNE) and first stage tined lead procedure (TLP). Furthermore, we wanted to evaluate the outcome in patients who only responded to screening with TLP after failure of initial PNE.
Materials and methods: We evaluated all patients screened for eligibility to receive SNM treatment since the introduction of the tined lead technique in our centre in 2002. In May 2009, all implanted patients were asked to keep a voiding diary to record the effect of SNM on urinary symptoms. Success was defined as more than 50% improvement in at least one of the relevant voiding diary parameters compared to baseline. Chi square analysis was used to evaluate differences in long-term outcome for the separate screening methods.
Results: In total, 92 patients were screened for SNM. Of the 76 patients who were screened with PNE, 35 (46%) met the criteria for permanent implantation, whereas 11 of the 16 patients (69%) who underwent direct screening with TLP had permanent stimulators placed. Of the 41 patients who failed PNE and subsequently underwent screening with TLP, 18 (44%) were implanted with an INS after showing a successful response. The mean follow-up was 53 months (range 35-77 months) at the time of voiding diary analysis. Statistical analysis showed no difference between type of screening and long-term success (p=0.94).
Conclusion: Although first stage TLP is a more reliable screening tool than PNE, the long-term success rate does not seem to be dependent on the screening method. Furthermore, patients who initially failed PNE but responded to prolonged screening with TLP, appear to be at least as successful in the long-term as patients who directly responded to PNE or TLP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130415
|Maastricht University Medical Centre|
|Maastricht, Limburg, Netherlands, P.O. box 5800, 6202 AZ|
|Study Director:||Philip van Kerrebroeck, Prof||Maastricht University Medical Center|