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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Overactive Bladder Syndrome, Urinary Retention, Dysfunctional Voiding, Fecal Incontinence, Fowler Syndrome

Intervention / Treatment
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* Device: Sacral neuromodulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients planned for the 2-staged tined-lead procedure.<br>Patients with the following indications: Overactive bladder without urgency urinary incontinence. Overactive bladder with urgency urinary incontinence. Non-obstructive urinary retention. Dysfunctional voiding or Fowler Syndrome. Fecal incontinence. | Device: Sacral neuromodulation<br>* Sacral neuromodulation: the 2-staged tined lead procedure. (Interstim II therapy, Medtronic). Stage I: Placement of a tined-lead electrode. 2 - 4 weeks test phase. Stage II: Placement of an implantable pulse generator.<br>* Other names: SNM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation ratio | Proportion of number of patients who received a definitive implant. | 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. | Through study completion, an average of 3 years | 
| False positive ratio | Proportion of patients with discontinued SS although having true success during test phase. | One month after definitive implant. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explantation ratio | Proportion of patients explanted. | Within 12 months after definitive implant. | 
| Revision ratio | Proportion of patients that received a revision. | Within 12 months after definitive implant. | 
| Absolute change in diary variables. | Test phase compared to baseline. (Different for each indication). | 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. | At 12 months follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacral neuromodulation