OptiLUTS Part C: the Development of a Symptom Assessment Tool in Sacral Neuromodulation.

Optimization of Therapy Resistant LUTS (OptiLUTS) Part C: the Development of a Symptom Assessment Tool in Sacral Neuromodulation: a Prospective Single Centre Study.

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.

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.

Inclusion Criteria:

• Subjects ≥ 18 years presenting with one or more of the following indications: Urinary urgency frequency with or without urinary incontinence (OAB dry or wet), non-obstructive urinary retention, dysfunctional voiding with post void residual volume, faecal incontinence and mixed incontinence
• Refractory to conservative treatment (i.e. Lifestyle changes, behavioural modification, pelvic floor muscle training, biofeedback) and refractory to pharmacological treatment.

Exclusion Criteria:

• Neurogenic bladder.
• Anal sphincter damage more than 120
• Abnormal sacral anatomy
• Mentally or physically disabled patients not capable to handle a patient programmer device.
• Pregnant patients