Overactive Bladder Syndrome, Urinary Retention, Dysfunctional Voiding, Fecal Incontinence, Fowler Syndrome
Conditions
Keywords
Sacral neuromodulation
Brief summary
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
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.
Interventions
DEVICESacral neuromodulation
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.
Sponsors
Medtronic
University Hospital, Ghent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| False positive ratio | One month after definitive implant. | Proportion of patients with discontinued SS although having true success during test phase. |
| Implantation ratio | Through study completion, an average of 3 years | Proportion of number of patients who received a definitive implant. |
| True success ratio | Through study completion, an average of 3 years | Proportion of patients showing both objective (ObS) and subjective success (SS) during the test phase of SNM. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Explantation ratio | Within 12 months after definitive implant. | Proportion of patients explanted. |
| Evolution of PROM scores over time. | At 12 months follow-up. | 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. |
| Revision ratio | Within 12 months after definitive implant. | Proportion of patients that received a revision. |
| Absolute change in diary variables. | Up to 4 weeks, depending on the duration of the test phase. | Test phase compared to baseline. (Different for each indication). |
Countries
Belgium
Outcome results
None listed