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Sacral neuromodulation (SNM) is a two-staged 2nd-line therapy for therapy-resistant LUTS and fecal incontinence. Currently, the assessment of symptoms at baseline and after stage I is directed towards a discipline related evaluation. The OptiLUTS trial strives for a more holistic approach, taking all pelvic floor dysfunctions into account.
A holistic assessment tool will be developed and SNM-care pathway will be set-up.
Full description
A prospective single centre trial is set up. Patients planned for the two-staged tined lead procedure are enrolled.
Bladder and bowel diaries and patient reported outcome measures (PROMS) will be collected at baseline and in between stage I and stage II, and PROMS at one month, 6 months and 12 months after definitive implant.
Phase I Step 1: The current implant rate, true success rate, outcomes and false positive rate will be measured.
Step 2: Development of a holistic symptom assessment tool. Phase II Implementation of the SNM care pathway.
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93 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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