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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Overactive Bladder Syndrome Urinary Retention Dysfunctional Voiding Fecal Incontinence Fowler Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Sacral neuromodulation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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SNM

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No