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

University Hospital, Ghent93 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Overactive Bladder Syndrome Urinary Retention Dysfunctional Voiding Fecal Incontinence Fowler Syndrome

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Implantation ratio

Proportion of number of patients who received a definitive implant.

Time frame: Through study completion, an average of 3 years

True success ratio

Proportion of patients showing both objective (ObS) and subjective success (SS) during the test phase of SNM.

Time frame: Through study completion, an average of 3 years

False positive ratio

Proportion of patients with discontinued SS although having true success during test phase.

Time frame: One month after definitive implant.

Secondary Outcomes

Explantation ratio

Proportion of patients explanted.

Time frame: Within 12 months after definitive implant.

Revision ratio

Proportion of patients that received a revision.

Time frame: Within 12 months after definitive implant.

Absolute change in diary variables.

Test phase compared to baseline. (Different for each indication).

Time frame: Up to 4 weeks, depending on the duration of the test phase.

Evolution of PROM scores over time.

Total PROM scores, based on questionnaires, baseline compared to scores at during the test phase vs. at 1 month, at 6 months and at 12 months follow-up.

Time frame: At 12 months follow-up.