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

NCT05313984 | Completed

• 1 other identifier: EC2018/0244
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Sacral neuromodulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Explantation ratio

  Within 12 months after definitive implant.

• Revision ratio

  Within 12 months after definitive implant.

• Absolute change in diary variables.

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

• Evolution of PROM scores over time.

  At 12 months follow-up.

Study Arms (1)

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

Interventions

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.

Also known as: SNM

Patients planned for the 2-staged tined-lead procedure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Medtronic: collaborator

Study Sites (1)

Department of Urology, Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (1)

• Ghijselings L, Verbakel I, Bou Kheir G, Van de Putte D, Herve F, Goessaert AS, Pauwaert K, Beeckman D, Ooms M, Everaert K. Symptom Assessment of Candidates for Sacral Neuromodulation Therapy With Urologic and Colorectal Conditions: Time for a Holistic Approach? Results and Findings From a Prospective Single-Center Study. Neuromodulation. 2025 Jul;28(5):847-857. doi: 10.1016/j.neurom.2024.04.009. Epub 2024 Jun 6.

  PMID: 38842955 DERIVED

MeSH Terms

Conditions

Urinary Retention; Fecal Incontinence; Fowler Christmas Chapple syndrome

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Karel Everaert, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: April 6, 2022
• Study Start: March 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)