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

Completed

• Conditions: Overactive Bladder Syndrome; Urinary Retention; Fowler Syndrome; Fecal Incontinence; Dysfunctional Voiding
• Interventions: Device: Sacral neuromodulation

• Registration Number: NCT05313984
• Lead Sponsor: University Hospital, Ghent

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.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Study First Posted: 2022-04-06
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients planned for the 2-staged tined-lead procedure.	Sacral neuromodulation	Patients with the following indications: * Overactive bladder without urgency urinary incontinence. * Overactive bladder with urgency urinary incontinence. * Non-obstructive urinary retention. * Dysfunctional voiding or Fowler Syndrome. * Fecal incontinence.

Primary Outcome Measures

Name	Time	Method
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.
Implantation ratio	Through study completion, an average of 3 years	Proportion of number of patients who received a definitive implant.
False positive ratio	One month after definitive implant.	Proportion of patients with discontinued SS although having true success during test phase.

Secondary Outcome Measures

Name	Time	Method
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).
Revision ratio	Within 12 months after definitive implant.	Proportion of patients that received a revision.
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.

Trial Locations

Locations (1)

Department of Urology, Ghent University Hospital; 🇧🇪 Ghent, Belgium