Status:
COMPLETED
OptiLUTS Part C: the Development of a Symptom Assessment Tool in Sacral Neuromodulation.
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Medtronic
Conditions:
Overactive Bladder Syndrome
Urinary Retention
Eligibility:
All Genders
18+ years
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...
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 col...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT05313984
Start Date
March 1 2018
End Date
December 31 2021
Last Update
September 19 2024
Active Locations (1)
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1
Department of Urology, Ghent University Hospital
Ghent, Belgium, 9000