CompletedNot Applicable

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

Belgium93 participantsStarted 2018-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Implantation ratio

Timeframe: Through study completion, an average of 3 years

True success ratio

Timeframe: Through study completion, an average of 3 years

False positive ratio

Timeframe: One month after definitive implant.

Trial details

NCT IDNCT05313984

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-01

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