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

NCT05313984 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 93

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Karel Everaert, MD, PhD · University Hospital, Ghent

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2021-12-01
Completion
2021-12-31

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05313984 on ClinicalTrials.gov