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

Primary Purpose

Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis, Sacral Neuromodulation

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Turning ON the neuromodulator
Turning OFF the neuromodulator
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurogenic Dysfunction of the Urinary Bladder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  • 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

Sites / Locations

  • Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IPG turned ON

IPG turned OFF

Arm Description

Continous neuromodulation

No neuromodulation

Outcomes

Primary Outcome Measures

Success of SNM for neurogenic lower urinary tract dysfunction
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
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
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
Change in bladder volume measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation
Changes in bladder sensation Mangler
Changes in bladder sensation measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation
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.
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.
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.
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

Full Information

First Posted
December 22, 2021
Last Updated
March 21, 2023
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05380856
Brief Title
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Official Title
Sacral Neuromodulation for Neurogenic Lower Urinary Tract , Bowel and Sexual Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.
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: Changes in urodynamic parameters Bowel function Sexual function Quality of life Adverse events 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis, Sacral Neuromodulation, Bowel Dysfunction, Sexual Dysfunction, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After the implantation of the IPG the patients are randomized into two groups, generated by computer 1:1. One group will have the IPG turned ON (Intervention group) and the other group will have the IPG turned OFF (control group). After four months all IPG´s are turned on.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPG turned ON
Arm Type
Active Comparator
Arm Description
Continous neuromodulation
Arm Title
IPG turned OFF
Arm Type
Placebo Comparator
Arm Description
No neuromodulation
Intervention Type
Device
Intervention Name(s)
Turning ON the neuromodulator
Other Intervention Name(s)
INTERSTIM II SYSTEM
Intervention Description
IPG on
Intervention Type
Device
Intervention Name(s)
Turning OFF the neuromodulator
Other Intervention Name(s)
INTERSTIM II SYSTEM
Intervention Description
IPG OFF
Primary Outcome Measure Information:
Title
Success of SNM for neurogenic lower urinary tract dysfunction
Description
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.
Time Frame
Eight months
Title
Male bladder function
Description
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.
Time Frame
Eight months
Title
Female bladder function
Description
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.
Time Frame
Eight months
Secondary Outcome Measure Information:
Title
Changes in bladder volume
Description
Change in bladder volume measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation
Time Frame
Eight months
Title
Changes in bladder sensation Mangler
Description
Changes in bladder sensation measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation
Time Frame
Eight months
Title
Bowel function
Description
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.
Time Frame
Eight months
Title
Male sexual function
Description
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.
Time Frame
Eight months
Title
Female sexual function
Description
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.
Time Frame
Eight months
Title
Quality of life by standard questionnaire EQ-5D-5L
Description
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
Time Frame
Eight months
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
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
Time Frame
Eight months
Title
Global assessment scale
Description
5 point Likert scale evaluated by: Very satisfied - satisfied - neutral - unsatisfied - very unsatisfied
Time Frame
Eight months
Title
Implantation Characteristics
Description
The lowest stimulation value in mA will be monitored and number of the re-programming
Time Frame
Eight months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanne Kobberø
Phone
004565414400
Email
hanne.kobberoe2@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Mads H Poulsen
Phone
004565414400
Email
mads.poulsen@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne Kobberø
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mads H Poulsen
Organizational Affiliation
Odense University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Morten Blaabjerg
Organizational Affiliation
Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helle H Nielsen
Organizational Affiliation
Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mikkel Fode
Organizational Affiliation
Herlev/Gentofte
Official's Role
Study Chair
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
Fyn
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanne Kobberø
Phone
+4565414400
Email
hanne.kobberoe2@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Mads H Poulsen
Phone
+4565414400
Email
mads.poulsen@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Hanne Kobberø

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study plan will be uploaded online at the Data Management Plan (DMP) Online of the University of Southern Denmark. See website below.
IPD Sharing Time Frame
Within eight months and for ten years
IPD Sharing Access Criteria
Log in to DMP is required.
IPD Sharing URL
https://dmponline.deic.dk/plans

Learn more about this trial

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

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