MS, urinary tract complaints MS, voiding complaints
Conditions
Interventions
Sacral Neuromodulator is a surgical technique in which an electrode is placed 
adjacent to the sacral nerves. An electrical current is generated by an 
implanted pulse generator (IPG) and stimulates sacral nerves, usually the 
third, which modulates bladder function. Not all patients are responders to SNM 
and for this reason the implantation of a definitive SNM is preceded by a test 
phase. This procedure is called Peripheral Nerve Evaluation (PNE) which happens 
in two stages. It can be done either with a PNE test wire or with the final 
electrode with the Tined Lead, also known as a Tined Lead Procedure (TLP). In 
this study we will use the TLP which will be performed under general 
anaesthesia.
Lead placement and acute phase
The first phase is the acute phase which happens under local or general 
anaesthesia and we look for an appropriate motor response. Local differences in 
anaesthesia technique are allowed. A needle is used to puncture the skin and 
fascia overlying the parasacral muscles which are also punctured. The third 
sacral foramen is visualised using X-ray and is subsequently punctured in order 
to stimulate S3. By external electrical stimulation motor reactions like 
contraction of the pelvic floor and the flexion of the hallux can be observed. 
When an insufficient reaction of S3 stimulation is obtained, the contralateral 
S3 foramen is tried in order to have the best response. If this fails the S4 
foramina can be tried. After identifying a motor response a stylet reassures 
the position while the needle is removed. Subsequently an introducer sheath is 
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Diagnosis of Multiple sclerosis according to the McDonald criteria with its latest revision in 2017. 2. Stable Relapsing-remitting MS 3. Storage LUTD with Urgency Frequency (UF) or Urgency Urinary Incontinence (UUI) 4. Insufficient treatment with conventional therapy such as lifestyle changes, anticholinergics and/or beta-3 agonists or catheterisation or patients with side effects of these treatments. 5. Frequency: Urgency Frequency (UF) >=9 times a day (average of 3 day Voiding Diary) or Incontinence: at least 1 UUI episode a day (average of 3 day voiding Diary) 6. Expanded Disability Status Scale (EDSS) ranging from 0 to 6 7. Age > 18 years 8. Patients must have an adequate motor response during tined lead placement and placement of a unilateral electrode 9. Willing to fill out voiding diaries and questionnaires at different time points throughout the study 10. Willing to comply to the study protocol, sign the informed consent form and travel to the institution for follow up visits.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Any other form of MS (Primary progressive or secondary progressive) 2. EDSS >6.0 3. Evidence of increasing disease disability or an MS relapse in the last 6 month or more than 1.0 point EDSS deterioration in the preceding 12 months 4. Changes in immunomodulation medication in the past 3 months 5. Having newly diagnosed MS lesions on the last MRI-scan (within 12 months of inclusion) when comparing to the previous scan. If the MRI is older than 12 months and the patient is clinically stable, they can be included 6. Post-void residual > 150 ml and unwilling to perform Clean Intermittent Self-Catheterisation (CISC) 7. Treatment with intravesical Botulinum toxin injections in the past 9 month prior to study inclusion 8. Other urological diseases such as bladder or kidney stones, persistent or recurrent Urinary Tract Disease, upper urinary tract deterioration, prostate obstruction, urethral stricture, pelvic pains or pelvic cancer 9. A history of other illnesses causing bladder dysfunction such as spinal cord injury, cauda equine compression, cerebral ischemic attack etcetera in the preceding 12 months 10. Severe and uncontrolled diabetes; or diabetes with peripheral nerve involvement. 11. Moderate to severe ureteral reflux or moderate to severe hydronephrosis 12. Symptomatic urinary tract infection (UTI). Upon completion of therapy for UTI, or if the patient is receiving prophylactics for UTI, patients can be considered for implant 13. History of SNM therapy trial or implantation 14. Primary diagnosis of stress urinary incontinence, determined by symptom assessment and physical examination, or mixed urinary incontinence in which the stress component is more profound 15. Mental disorders which could lead to a disturbance in filling out diaries or questionnaires as determined by the investigator 16. Pregnancy 17. Patient is not willing to undergo a wash out period for medication or percutaneous tibial nerve stimulation treating overactive bladder symptoms 18. Patient is currently participating in or planning on participating in another clinical trial that is subjected to the CTR or MDR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first primary study parameter will be the difference between groups when comparing the percentage of responders at 3 months (IPG ON group vs IPG OFF group), defined as a decrease in symptom severity of at least 50% compared to baseline in the primary symptom (urge, frequency or leaks). This percentage is calculated by comparison of voiding diaries. The second primary study parameter is the safety of the device evaluated through adverse events (number of infections, urinary tract infections, lead breakage or displacement, explantations, etc) at 3 and 12 months, and by assessing EDSS difference from baseline between groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of responders - Individual response of urinary frequency (voids/day) - Individual response of urgency urinary incontinence (leaks/day) - Need for CIC (CIC/day) - Wexner Scale difference - Patient outcome measurement all expressed in numeric values: SF-Qualiveen, ICIQ-FLUTS, ICIQ-FLUTSsex, ICIQ-MLUTS, ICIQ-MLUTSsex, FIQL, PGI-I | — |
Countries
Belgium, Netherlands, United Kingdom
Contacts
Public ContactJ.F. Timmermans
Maastricht Universitair Medisch Centrum +
Outcome results
None listed