Screening Method in Sacral Neuromodulation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01130415|
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : May 26, 2010
|Condition or disease|
|Overactive Bladder Urinary Retention|
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.
|Study Type :||Observational|
|Actual Enrollment :||64 participants|
|Official Title:||Is the Method of Screening in Sacral Neuromodulation a Prognostic Factor for Long-term Success?|
|Study Start Date :||May 2002|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||July 2009|
|Patients treated with sacral neuromodulation|
- long-term success measured with voiding diaries [ Time Frame: 5 years ]Successful treatment was defined as more than 50 percent improvement in the key voiding diary variables compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130415
|Maastricht University Medical Centre|
|Maastricht, Limburg, Netherlands, P.O. box 5800, 6202 AZ|
|Study Director:||Philip van Kerrebroeck, Prof||Maastricht University Medical Center|