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

NCT05380856 | Recruiting DMC FDA Device

• 1 other identifier: OdenseOUH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Neurogenic Dysfunction of the Urinary Bladder; Multiple Sclerosis; Sacral Neuromodulation; Bowel Dysfunction; Sexual Dysfunction; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Changes in bladder volume

  Six months

• Changes in bladder sensation Mangler

  Six months

• Bowel function

  Eight months

• Male sexual function

  Six months

• Female sexual function

  Six months

Other Outcomes (3)

• Adverse events

  Six months

• Global assessment scale

  Six months

• Implantation Characteristics

  Six months

Study Arms (2)

IPG turned ON

ACTIVE COMPARATOR

Continous neuromodulation

Device: Turning ON the neuromodulator

IPG turned OFF

PLACEBO COMPARATOR

No neuromodulation

Device: Turning OFF the neuromodulator

Interventions

Turning ON the neuromodulator DEVICE

IPG on

Also known as: INTERSTIM X SYSTEM

IPG turned ON

Turning OFF the neuromodulator DEVICE

IPG OFF

Also known as: INTERSTIM X SYSTEM

IPG turned OFF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Unable to manage the electronic devices
• Inability to give an informed consent

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Copenhagen: collaborator
• Université de Nantes: collaborator
• University of Ostrava: collaborator

Study Sites (1)

Odense University Hospital

Odense, Fyn, 5000, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 40223778 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Multiple Sclerosis; Intestinal Diseases; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Gastrointestinal Diseases; Digestive System Diseases; Genital Diseases

Study Officials

• Hanne Kobberø

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Mads H Poulsen

  Odense University Hospital

  STUDY DIRECTOR

• Morten Blaabjerg

  Odense University Hospital

  STUDY CHAIR

• Helle H Nielsen

  Odense University Hospital

  STUDY CHAIR

• Mikkel Fode

  Herlev/Gentofte

  STUDY CHAIR

Central Study Contacts

Hanne Kobberø

CONTACT

004565414400; hanne.kobberoe2@rsyd.dk

Mads H Poulsen

CONTACT

004565414400; mads.poulsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: May 19, 2022
• Study Start: September 26, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From 2027 and for ten years
• Access Criteria: Log in to DMP is required.

Locations

DK (1)