Clinical trial NCT05380856: Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Official title: Sacral Neuromodulation for Patients With Multiple Sclerosis With Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction. A Multicenter Double-blind, Placebo-controlled Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurogenic Dysfunction of the Urinary Bladder
Multiple Sclerosis
Sacral Neuromodulation
Bowel Dysfunction
Sexual Dysfunction
Quality of Life
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Université de Nantes
name: University of Ostrava
First posted: 2022-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success of SNM for neurogenic lower urinary tract dysfunction
timeFrame: Six months
measure: Male bladder function
timeFrame: Six months
measure: Female bladder function
timeFrame: Six months
Secondary outcomes:
measure: Changes in bladder volume
timeFrame: Six months
measure: Changes in bladder sensation Mangler
timeFrame: Six months
measure: Bowel function
timeFrame: Eight months
measure: Male sexual function
timeFrame: Six months
measure: Female sexual function
timeFrame: Six months
measure: Quality of life by standard questionnaire EQ-5D-5L
timeFrame: Six months
Other outcomes:
measure: Adverse events
timeFrame: Six months
measure: Global assessment scale
timeFrame: Six months
measure: Implantation Characteristics
timeFrame: Six months
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Fyn
Study officials:
affiliation: Odense University Hospital
name: Hanne Kobberø
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Mads H Poulsen
role: STUDY_DIRECTOR
affiliation: Odense University Hospital
name: Morten Blaabjerg
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Helle H Nielsen
role: STUDY_CHAIR
affiliation: Herlev/Gentofte
name: Mikkel Fode
role: STUDY_CHAIR
References: