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

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

Urinary Retention
Fowler Syndrome
Dysfunctional Voiding
Fecal Incontinence
Overactive Bladder Syndrome

Treatments

Device: Sacral neuromodulation

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05313984
EC2018/0244

Details and patient eligibility

About

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.

Full 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.

Enrollment

93 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

93 participants in 1 patient group

Patients planned for the 2-staged tined-lead procedure.
Description:
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.
Treatment:
Device: Sacral neuromodulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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