Clinical trial NCT05313984: OptiLUTS Part C: the Development of a Symptom Assessment Tool in Sacral Neuromodulation.
Official title: Optimization of Therapy Resistant LUTS (OptiLUTS) Part C: the Development of a Symptom Assessment Tool in Sacral Neuromodulation: a Prospective Single Centre Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder Syndrome
Urinary Retention
Dysfunctional Voiding
Fecal Incontinence
Fowler Syndrome
Keywords: Sacral neuromodulation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2022-04-06
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for pelvic organ dysfunctions to the Urology department (UD) and Colorectal Surgery department (CRD) of the Ghent University Hospital and scheduled for a staged SNM procedure using InterstimTM II therapy (Medtronic, Minneapolis, MN) were enrolled.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implantation ratio
timeFrame: Through study completion, an average of 3 years
measure: True success ratio
timeFrame: Through study completion, an average of 3 years
measure: False positive ratio
timeFrame: One month after definitive implant.
Secondary outcomes:
measure: Explantation ratio
timeFrame: Within 12 months after definitive implant.
measure: Revision ratio
timeFrame: Within 12 months after definitive implant.
measure: Absolute change in diary variables.
timeFrame: Up to 4 weeks, depending on the duration of the test phase.
measure: Evolution of PROM scores over time.
timeFrame: At 12 months follow-up.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Urology, Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Karel Everaert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: