Fecal Incontinence Clinical Trial
— OptiLUTSOfficial title:
Optimization of Therapy Resistant LUTS (OptiLUTS) Part C: The Development of a Symptom Assessment Tool in Sacral Neuromodulation: A Prospective Single Centre Study.
NCT number | NCT05313984 |
Other study ID # | EC2018/0244 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | December 31, 2021 |
Verified date | March 2022 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 93 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Department of Urology, Ghent University Hospital | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent | Medtronic |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implantation ratio | Proportion of number of patients who received a definitive implant. | Through study completion, an average of 3 years | |
Primary | 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 | |
Primary | False positive ratio | Proportion of patients with discontinued SS although having true success during test phase. | One month after definitive implant. | |
Secondary | Explantation ratio | Proportion of patients explanted. | Within 12 months after definitive implant. | |
Secondary | Revision ratio | Proportion of patients that received a revision. | Within 12 months after definitive implant. | |
Secondary | 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. | |
Secondary | 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. |
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