Bowel Dysfunction, Multiple Sclerosis, Neurogenic Dysfunction of the Urinary Bladder, Quality of Life, Sacral Neuromodulation, Sexual Dysfunction
Conditions
Brief summary
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
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: Success of SNM for lower urinary tract dysfunction 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) compared to the baseline values. Secondary outcome: To assess the changes in bladder, bowel and sexual function due to SNM by using subjective patient reported outcome measures, quality of life and global assessment score, * To assess the changes in urodynamic variables, * To assess the safety of SNM for NLUTD and * To register the implantation characteristics and the need for reprogramming Data will be collected at Baseline 1: At inclusion Baseline 2: At evaluation after a three weeks test period Baseline 3: At randomization Baseline 4: At the end of study The time frame of the RCT is six months Patients with improvements of bowel symptoms only will be excluded from the trial but followed with the same questionnaires for the same time. The patients will be followed-up every 6 months for a total of 5 years.
Interventions
IPG on
IPG OFF
Sponsors
Odense University Hospital
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
After a month of optimization where the IPG is turned on at subsensory stimulation the participants will be randomly assigned to either intervention or placebo group with a 1:1 allocation as per a computer generated randomization schedule by a clinician who is not involved in the assessment of the clinical outcome.
Intervention model description
After the implantation of the IPG the patients will be grouped into three strata: 1. Patients with urgency frequency syndrome and/or urgency incontinence: at least 50% decrease in number of voids and/or number of leakages and/or increased voided volume and/or more than 50% reduction in pad weight 2. Patients with chronic urinary retention: at least 50% decrease in post void residual and/or reduction in number of CISC 3. Patients with a combination of urgency frequency syndrome and/or urgency incontinence and chronic urinary retention: at least 50% decrease in number of voids and/or number of leakages and/or more than 50% reduction in pad weight, and/or at least 50% decrease in post void residual and/or a reduction in number of CISC After four months all IPG´s are turned on.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Written informed consent * Able to understand the information given about the project
Exclusion criteria
* 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 * Any other intestinal or gynecological pathology but neurological conditional symptoms * Current pelvic malignancy or clinically significant pelvic mass * Previous pelvis radiotherapy * Bladder injections with botulinum neurotoxin type A within 6 months before inclusion in trial * Unable to manage the electronic devices * Inability to give an informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of SNM for neurogenic lower urinary tract dysfunction | Six months | 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 | Six 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 | Six 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in bladder volume | Six months | Change in bladder volume measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation |
| Changes in bladder sensation Mangler | Six 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 | Six 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 | Six 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 | Six 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 |
Countries
Denmark
Contacts
CONTACTHanne Kobberø
CONTACTMads H Poulsen
PRINCIPAL_INVESTIGATORHanne Kobberø
Odense University Hospital
STUDY_DIRECTORMads H Poulsen
Odense University Hospital
STUDY_CHAIRMorten Blaabjerg
Odense University Hospital
STUDY_CHAIRHelle H Nielsen
Odense University Hospital
STUDY_CHAIRMikkel Fode
Herlev/Gentofte
Outcome results
None listed