Neurogenic Dysfunction of the Urinary BladderNCT05380856
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
A study testing Turning ON the neuromodulator and Turning OFF the neuromodulator in people with Neurogenic Dysfunction of the Urinary Bladder and Multiple Sclerosis, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis, Sacral Neuromodulation
- What is being tested?
- Turning ON the neuromodulator and Turning OFF the neuromodulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Aug 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, Fyn, 5000
Hanne Kobberø, +4565414400, hanne.kobberoe2@rsyd.dk
Mads H Poulsen, +4565414400, mads.poulsen@rsyd.dk
About this study
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.
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
Read the 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.
- Conditions
- Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis, Sacral Neuromodulation, Bowel Dysfunction, Sexual Dysfunction, Quality of Life
- Being tested
- Turning ON the neuromodulator, Turning OFF the neuromodulator
- Medical subject headings
- Urinary Bladder, Neurogenic, Multiple Sclerosis, Intestinal Diseases, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turning ON the neuromodulatorDevice
Also called INTERSTIM X SYSTEM
IPG on
Turning OFF the neuromodulatorDevice
Also called INTERSTIM X SYSTEM
IPG OFF
| Study group | Role | What they receive |
|---|---|---|
| IPG turned ON | Active comparator | Continous neuromodulation Receives: Device: Turning ON the neuromodulator |
| IPG turned OFF | Placebo comparator | No neuromodulation Receives: Device: Turning OFF the neuromodulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
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.
Measured: Six months
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.
Measured: Six months
Secondary outcomes (6)
Changes in bladder volume
Change in bladder volume measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation
Measured: Six months
Changes in bladder sensation Mangler
Changes in bladder sensation measured in ml before and after implantation of implantable pulse generator for sacral neuromodulation
Measured: Six months
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.
Measured: Eight months
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.
Measured: Six months
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.
Measured: Six months
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
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start18 Aug 2023
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Dysfunction of the Urinary BladderStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanne Kobberø, Odense University Hospital
- Investigators
- Hanne Kobberø, Principal investigator, Odense University HospitalMorten Blaabjerg, Study chair, Odense University HospitalHelle H Nielsen, Study chair, Odense University HospitalMikkel Fode, Study chair, Herlev/Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380856
- Sponsor's protocol ID
- OdenseOUH
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study plan will be uploaded online at the Data Management Plan (DMP) Online of the University of Southern Denmark. See website below.
Publications
Kobbero H, Krhut J, Zvara P, Pedersen TB, Fode M, Nielsen HH, Poulsen MH. Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction in Patients With Multiple Sclerosis: A Pilot Trial. Neurourol Urodyn. 2025 Jun;44(5):1109-1119. doi: 10.1002/nau.70052. Epub 2025 Apr 14.
PubMed 40223778
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05380856
- Acronym / sponsor ID
- OdenseOUH
- Conditions
- Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis, Sacral Neuromodulation, Bowel Dysfunction, Sexual Dysfunction, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Aarhus University Hospital, Aalborg University Hospital
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| IPG turned ON | Active comparator | Device: Turning ON the neuromodulatorContinous neuromodulation |
| IPG turned OFF | Placebo comparator | Device: Turning OFF the neuromodulatorNo neuromodulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turning ON the neuromodulatorAlso: INTERSTIM X SYSTEMIPG on | Device | IPG turned ON |
| Turning OFF the neuromodulatorAlso: INTERSTIM X SYSTEMIPG OFF | Device | IPG turned OFF |
Primary outcome
Success of SNM for neurogenic lower urinary tract dysfunction
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Changes in bladder volume
Time frame: Six months
Changes in bladder sensation Mangler
Time frame: Six months
Bowel function
Time frame: Eight months
Male sexual function
Time frame: Six months
Female sexual function
Time frame: Six months
Quality of life by standard questionnaire EQ-5D-5L
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 40223778Kobbero H, Krhut J, Zvara P, Pedersen TB, Fode M, Nielsen HH, Poulsen MH. Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction in Patients With Multiple Sclerosis: A Pilot Trial. Neurourol Urodyn. 2025 Jun;44(5):1109-1119. doi: 10.1002/nau.70052. Epub 2025 Apr 14.
- Individual participant dataSharing planned: Yes. The study plan will be uploaded online at the Data Management Plan (DMP) Online of the University of Southern Denmark. See website below.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanne Kobberø principal investigator
Odense University Hospital
Morten Blaabjerg study chair
Odense University Hospital
Helle H Nielsen study chair
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turning ON the neuromodulator and Turning OFF the neuromodulator in people with Neurogenic Dysfunction of the Urinary Bladder and Multiple Sclerosis, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanne Kobberø (004565414400, hanne.kobberoe2@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of SNM for neurogenic lower urinary tract dysfunction (time frame: Six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05380856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.