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

Optimization of Therapy Resistant LUTS (OptiLUTS) Part C: The Development of a Symptom Assessment Tool in Sacral Neuromodulation: A Prospective Single Centre Study.

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.

Study Overview

• Status: Completed
• Conditions: Urinary Retention; Fecal Incontinence; Overactive Bladder Syndrome; Dysfunctional Voiding; Fowler Syndrome
• Intervention / Treatment: Device: Sacral neuromodulation

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 Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Department of Urology, Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients planned for the 2-staged tined-lead procedure.; 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.	Device: Sacral neuromodulation; Sacral neuromodulation: the 2-staged tined lead procedure. (Interstim II therapy, Medtronic). Stage I: Placement of a tined-lead electrode. 2 - 4 weeks test phase. Stage II: Placement of an implantable pulse generator.; Other Names: SNM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explantation ratio	Proportion of patients explanted.	Within 12 months after definitive implant.
Revision ratio	Proportion of patients that received a revision.	Within 12 months after definitive implant.
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.
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.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (ACTUAL): April 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Sacral neuromodulation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Disease; Gastrointestinal Diseases; Urination Disorders; Intestinal Diseases; Rectal Diseases; Urinary Bladder, Overactive; Syndrome; Urinary Retention; Fecal Incontinence
• Other Study ID Numbers: EC2018/0244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No