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

Fecal Incontinence Clinical Trial

— OptiLUTS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05313984
• Other study ID #: EC2018/0244
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysfunctional Voiding
• Fecal Incontinence
• Overactive Bladder Syndrome
• Syndrome
• Urinary Bladder, Overactive
• Urinary Retention

Intervention

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.

Locations

Country	Name	City	State
Belgium	Department of Urology, Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Medtronic

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation ratio	Proportion of number of patients who received a definitive implant.	Through study completion, an average of 3 years
Primary	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
Primary	False positive ratio	Proportion of patients with discontinued SS although having true success during test phase.	One month after definitive implant.
Secondary	Explantation ratio	Proportion of patients explanted.	Within 12 months after definitive implant.
Secondary	Revision ratio	Proportion of patients that received a revision.	Within 12 months after definitive implant.
Secondary	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.
Secondary	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.