Skip to main content
OpenTrials
Completed

NCT Number: NCT05313984

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overactive Bladder Syndrome Digestive System Diseases Dysfunctional Voiding Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fowler Christmas Chapple syndrome Fowler Syndrome Gastrointestinal Diseases Intestinal Diseases Male Urogenital Diseases Rectal Diseases Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Urology, Ghent University Hospital

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sacral Neuromodulation

Device

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

Primary outcomes

  1. Implantation ratio

    Time frame: Through study completion, an average of 3 years

    Proportion of number of patients who received a definitive implant.

  2. True success ratio

    Time frame: 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.

  3. False positive ratio

    Time frame: One month after definitive implant.

    Proportion of patients with discontinued SS although having true success during test phase.

Secondary outcomes

  1. Explantation ratio

    Time frame: Within 12 months after definitive implant.

    Proportion of patients explanted.

  2. Revision ratio

    Time frame: Within 12 months after definitive implant.

    Proportion of patients that received a revision.

  3. Absolute change in diary variables.

    Time frame: Up to 4 weeks, depending on the duration of the test phase.

    Test phase compared to baseline. (Different for each indication).

  4. Evolution of PROM scores over time.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: OptiLUTS

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.