Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction

Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380856
• Other study ID #: OdenseOUH
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: March 1, 2027

Study information

• Verified date: November 2023
• Source: Odense University Hospital
• Contact: Hanne Kobberø
• Phone: 004565414400
• Email: hanne.kobberoe2[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Dysfunction
• Intestinal Diseases
• Multiple Sclerosis
• Neurogenic Dysfunction of the Urinary Bladder
• Quality of Life
• Sacral Neuromodulation
• Sclerosis
• Sexual Dysfunction
• Urinary Bladder, Neurogenic

Intervention

Device:
• Turning ON the neuromodulator
IPG on
• Turning OFF the neuromodulator
IPG OFF

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Fyn

Sponsors (4)

Lead Sponsor	Collaborator
Odense University Hospital	Aarhus University Hospital, University Hospital Ostrava, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Six months
Other	Global assessment scale	5 point Likert scale evaluated by: Very satisfied - satisfied - neutral - unsatisfied - very unsatisfied	Six months
Other	Implantation Characteristics	The lowest stimulation value in mA will be monitored and number of the re-programming	Six months
Primary	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.	Six months
Primary	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.	Six months
Primary	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.	Six months
Secondary	Changes in bladder volume	Change in bladder volume measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation	Six months
Secondary	Changes in bladder sensation Mangler	Changes in bladder sensation measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation	Six months
Secondary	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.	Eight months
Secondary	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.	Six months
Secondary	Female sexual function	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.	Six months
Secondary	Quality of life by standard questionnaire EQ-5D-5L	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	Six months