Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Study Details
Study Description
Brief Summary
A randomized controlled trial (RCT). To evaluate the efficacy of SNM for patients with Multiple Sclerosis (MS) having refractory neurogenic lower urinary tract dysfunction (nLUTD). After a two-step procedure patients (n=60) with more than 50% improvement in the key bladder diary variables will be randomized after implantation of pulse generator (IPG) for sacral neuromodulation, ON or OFF, for four months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Patients with MS often suffer from pelvic-organ dysfunctions, i.e. lower urinary tract (LUT), bowel and sexual dysfunction, aside their cerebral affection. Sacral neuromodulation (SNM) is a reversible minimal invasive procedure affecting the function of the aforementioned pelvic organs. Changes in bladder, bowel and sexual function will be monitored.
Primary outcome:
To evaluate the success of SNM for LUTD in patients with MS defined as improvement of at least 50% improvement of patient symptoms.
Secondary outcome:
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Changes in urodynamic parameters
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Bowel function
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Sexual function
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Quality of life
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Adverse events
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Implantation Characteristics
Data will be collected at inclusion = baseline 1. After three weeks evaluation = baseline 2 for implantation of pulse generator (IPG).
After one week implantation of IPG and randomization to either IPG on or IPG off and followed for four months, including a follow-up after the first month.
The evaluation after four months = baseline 3 and is the end of randomized clinical trial (RCT).
The time frame of the RCT is five months
The study converts into an open label study where all the patients have the IPG ON and are followed for another three months.
The overall time frame is 8 months. The patients will be followed-up every 6 months for a total of 5 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: IPG turned ON Continous neuromodulation |
Device: Turning ON the neuromodulator
IPG on
Other Names:
|
| Placebo Comparator: IPG turned OFF No neuromodulation |
Device: Turning OFF the neuromodulator
IPG OFF
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Success of SNM for neurogenic lower urinary tract dysfunction [Eight months]
Rate of responders to SNM with success defined as improvement of at least 50% in one of 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 evaluation and follow-up.
- Male bladder function [Eight months]
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 [Eight months]
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.
Secondary Outcome Measures
- Changes in bladder volume [Eight months]
Change in bladder volume measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation
- Changes in bladder sensation Mangler [Eight months]
Changes in bladder sensation measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation
- Bowel function [Eight months]
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 [Eight months]
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.
- Female sexual function [Eight months]
Female sexual function by standard questionnaire (09/05). Scale ranges from 0 to 14 points. Higher score indicate greater impact of individual symptoms for the patient. Changes will be compared to basal data.
- Quality of life by standard questionnaire EQ-5D-5L [Eight months]
The EQ-5D-5L is a standard measure of health-related quality of life. EQ-5D-5L consists of two components: a health state profile and a visual analog scale (VAS). EQ-5D health state profile comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where a higher score indicates a better health state. The VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine". Higher scores of EQ VAS indicate better health
Other Outcome Measures
- Adverse events [Eight months]
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 [Eight months]
5 point Likert scale evaluated by: Very satisfied - satisfied - neutral - unsatisfied - very unsatisfied
- Implantation Characteristics [Eight months]
The lowest stimulation value in mA will be monitored and number of the re-programming
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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No effect of medical treatment defined by antimuscarinics, beta3-agonist and alpha-blocker.
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Expanded Disability Status Scale (EDSS) < 5 and no progression of neurological disease within 6 months
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Written informed consent
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Able to understand the information given about the project
Exclusion Criteria:
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EDSS > 5, neurological disease with severe progression within the last 6 months and/or unable to manage the electronic devices
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Age < 18 years
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Any other urological pathology but nLUTD
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Bladder Pain Syndrome/Interstitial cystitis
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Any other intestinal or gynecological pathology but neurological conditional symptoms
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Current pelvic malignancy or clinically significant pelvic mass
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Previous pelvis radiotherapy
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Bladder injections with botulinum neurotoxin type A within 6 months before inclusion in trial
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Unable to manage the electronic devices
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Inability to give an informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Odense University Hospital | Odense | Fyn | Denmark | 5000 |
Sponsors and Collaborators
- Odense University Hospital
Investigators
- Principal Investigator: Hanne Kobberø, Odense University Hospital
- Study Director: Mads H Poulsen, Odense University Hospital
- Study Chair: Morten Blaabjerg, Odense University Hospital
- Study Chair: Helle H Nielsen, Odense University Hospital
- Study Chair: Mikkel Fode, Herlev/Gentofte
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OdenseOUH