A multi-center double-blinded placebo-controlled randomized clinical trial.
The patients will be randomized into two groups.
To investigate the efficacy of SNM to improve the key bladder diary variables compared to placebo (i.e. sham) for patients with MS having refractory neurogenic lower urinary tract dysfunction (NLUTD).
After first step SNM-procedure and a 3-4 weeks test period patients with more than 50% improvement in the key bladder diary variables will have the IPG implanted. After a month of optimization patients will into two groups: IPG ON or IPG OFF.
Period of randomization: four months. Number anticipated to be included: 60 patients
Refractory neurogenic lower urinary tract dysfunction (nLUTD) defined by visual analogue scale on treatment satisfaction ranging from 0 to 100 (100 means maximal satisfaction with the current treatment). All patients indicating satisfaction less than 50 are considered non-responders/having refractory overactive bladder (OAB) to current treatment
No effect of medical treatment defined by antimuscarinics, beta3-agonist and alpha-blocker.
Patients having refractory nLUTD who intend to try SNM for relief of their symptoms
Expanded Disability Status Scale (EDSS) < 5 and no progression of neurological disease within 6 months
EDSS > 5, neurological disease with severe progression within the last 6 months and/or unable to manage the electronic devices
Age < 18 years
Any other urological pathology but nLUTD
Bladder Pain Syndrome/Interstitial cystitis
Parallel
Turning ON the neuromodulator
DeviceIPG on
Turning OFF the neuromodulator
DeviceIPG OFF
Success of SNM for neurogenic lower urinary tract dysfunction
Success is defined as improvement of at least 50% in the key bladder diary variables, i.e. number of voids and/or number of leakages, post void residual volumen, compared to the baseline values using BLADDER DIARY for three days before inclusion and at evaluation.
Male bladder function
Male lower urinary tract symptoms (MLUTS) by standard International Consultation on Incontinence Questionnaire (ICIQ)-MLUTS 10/06. Scale ranges from 0 to 44 points. Higher score indicate greater impact of individual symptoms for the patient. Changes will be compared to basal data.
Female bladder function
Female lower urinary tract symptoms (FLUTS) by standard questionnaire ICIQ-FLUTS 12/07. Scale ranges from 0 to 48 points. Higher score indicate greater impact of individual symptoms for the patient. Changes will be compared to basal data.
Changes in bladder volume
Change in bladder volume measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation
Changes in bladder sensation Mangler
Changes in bladder sensation measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation
Bowel function
Bowel function by standard questionnaire ICIQ-B (04/08). Scale ranges from 0 to 75 points. Higher score indicate greater impact of individual symptoms for the patient. Changes will be compared to basal data.
Male sexual function
Male sexual function by standard questionnaire (07/05). Scale ranges from 0 to 12 points. Higher score indicate greater impact of individual symptoms for the patient. Changes will be compared to basal data.
Adverse events
Rate of adverse events evaluated by the Medical Device Coordination Group, (MDCG)-202010/1, safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
Global assessment scale
5 point Likert scale evaluated by: Very satisfied - satisfied - neutral - unsatisfied - very unsatisfied
Implantation Characteristics
The lowest stimulation value in mA will be monitored and number of the re-programming
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Odense University Hospital
Lead sponsor
University of Copenhagen
Collaborator
