Overactive Bladder SyndromeOptiLUTSNCT05313984
OptiLUTS Part C: the Development of a Symptom Assessment Tool in Sacral Neuromodulation.
An observational study of Overactive Bladder Syndrome and Urinary Retention, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Sacral neuromodulation (SNM) is a two-staged 2nd-line therapy for therapy-resistant LUTS and fecal incontinence. Currently, the assessment of symptoms at baseline and after stage I is directed towards a discipline related evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder Syndrome, Urinary Retention, Dysfunctional Voiding
- What is being tested?
- Sacral neuromodulation
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for pelvic organ dysfunctions to the Urology department (UD) and Colorectal Surgery department (CRD) of the Ghent University Hospital and scheduled for a staged SNM procedure using InterstimTM II therapy (Medtronic, Minneapolis, MN) were enrolled.
Who may be able to join
- Subjects ≥ 18 years presenting with one or more of the following indications: Urinary urgency frequency with or without urinary incontinence (OAB dry or wet), non-obstructive urinary retention, dysfunctional voiding with post void residual volume, faecal incontinence and mixed incontinence
- Refractory to conservative treatment (i.e. Lifestyle changes, behavioural modification, pelvic floor muscle training, biofeedback) and refractory to pharmacological treatment.
Who cannot join
- Neurogenic bladder.
- Anal sphincter damage more than 120
- Abnormal sacral anatomy
- Mentally or physically disabled patients not capable to handle a patient programmer device.
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Therapy Resistant LUTS (OptiLUTS) Part C: the Development of a Symptom Assessment Tool in Sacral Neuromodulation: a Prospective Single Centre Study.
Sacral neuromodulation (SNM) is a two-staged 2nd-line therapy for therapy-resistant LUTS and fecal incontinence. Currently, the assessment of symptoms at baseline and after stage I is directed towards a discipline related evaluation. The OptiLUTS trial strives for a more holistic approach, taking all pelvic floor dysfunctions into account.
A holistic assessment tool will be developed and SNM-care pathway will be set-up.
Read the detailed description
A prospective single centre trial is set up. Patients planned for the two-staged tined lead procedure are enrolled.
Bladder and bowel diaries and patient reported outcome measures (PROMS) will be collected at baseline and in between stage I and stage II, and PROMS at one month, 6 months and 12 months after definitive implant.
Phase I Step 1: The current implant rate, true success rate, outcomes and false positive rate will be measured.
Step 2: Development of a holistic symptom assessment tool. Phase II Implementation of the SNM care pathway.
- Conditions
- Overactive Bladder Syndrome, Urinary Retention, Dysfunctional Voiding, Fecal Incontinence, Fowler Syndrome
- Being tested
- Sacral neuromodulation
- Keywords
- Sacral neuromodulation
- Medical subject headings
- Urinary Retention, Fecal Incontinence, Fowler Christmas Chapple syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral neuromodulationDevice
Also called SNM
Sacral neuromodulation: the 2-staged tined lead procedure. (Interstim II therapy, Medtronic).
Stage I: Placement of a tined-lead electrode. 2 - 4 weeks test phase. Stage II: Placement of an implantable pulse generator.
| Study group | Role | What they receive |
|---|---|---|
| Patients planned for the 2-staged tined-lead procedure. | Patients with the following indications:
* Overactive bladder without urgency urinary incontinence.
* Overactive bladder with urgency urinary incontinence.
* Non-obstructive urinary retention.
* Dysfunctional voiding or Fowler Syndrome.
* Fecal incontinence. Receives: Device: Sacral neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation ratio
Proportion of number of patients who received a definitive implant.
Measured: Through study completion, an average of 3 years
True success ratio
Proportion of patients showing both objective (ObS) and subjective success (SS) during the test phase of SNM.
Measured: Through study completion, an average of 3 years
False positive ratio
Proportion of patients with discontinued SS although having true success during test phase.
Measured: One month after definitive implant.
Secondary outcomes (4)
Explantation ratio
Proportion of patients explanted.
Measured: Within 12 months after definitive implant.
Revision ratio
Proportion of patients that received a revision.
Measured: Within 12 months after definitive implant.
Absolute change in diary variables.
Test phase compared to baseline. (Different for each indication).
Measured: Up to 4 weeks, depending on the duration of the test phase.
Evolution of PROM scores over time.
Total PROM scores, based on questionnaires, baseline compared to scores at during the test phase vs. at 1 month, at 6 months and at 12 months follow-up.
Measured: At 12 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Mar 2018
- Primary completion1 Dec 2021
- Study completion31 Dec 2021
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 Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Karel Everaert, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313984
- Sponsor's protocol ID
- EC2018/0244
- Acronym
- OptiLUTS
- Status last verified
- Sep 2024
- First submitted
- 3 Mar 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghijselings L, Verbakel I, Bou Kheir G, Van de Putte D, Herve F, Goessaert AS, Pauwaert K, Beeckman D, Ooms M, Everaert K. Symptom Assessment of Candidates for Sacral Neuromodulation Therapy With Urologic and Colorectal Conditions: Time for a Holistic Approach? Results and Findings From a Prospective Single-Center Study. Neuromodulation. 2025 Jul;28(5):847-857. doi: 10.1016/j.neurom.2024.04.009. Epub 2024 Jun 6.
PubMed 38842955
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Therapy Resistant LUTS (OptiLUTS) Part C: the Development of a Symptom Assessment Tool in Sacral Neuromodulation: a Prospective Single Centre Study.
- ClinicalTrials.gov ID
- NCT05313984
- Acronym / sponsor ID
- OptiLUTS / EC2018/0244
- Conditions
- Overactive Bladder Syndrome, Urinary Retention, Dysfunctional Voiding, Fecal Incontinence, Fowler Syndrome
- Keywords
- Sacral neuromodulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Apr 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.
Sacral neuromodulation (SNM) is a two-staged 2nd-line therapy for therapy-resistant LUTS and fecal incontinence. Currently, the assessment of symptoms at baseline and after stage I is directed towards a discipline related evaluation. The OptiLUTS trial strives for a more holistic approach, taking all pelvic floor dysfunctions into account.
A holistic assessment tool will be developed and SNM-care pathway will be set-up.
Detailed description
A prospective single centre trial is set up. Patients planned for the two-staged tined lead procedure are enrolled.
Bladder and bowel diaries and patient reported outcome measures (PROMS) will be collected at baseline and in between stage I and stage II, and PROMS at one month, 6 months and 12 months after definitive implant.
Phase I Step 1: The current implant rate, true success rate, outcomes and false positive rate will be measured.
Step 2: Development of a holistic symptom assessment tool. Phase II Implementation of the SNM care pathway.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients planned for the 2-staged tined-lead procedure. | – | Device: Sacral neuromodulationPatients with the following indications: * Overactive bladder without urgency urinary incontinence. * Overactive bladder with urgency urinary incontinence. * Non-obstructive urinary retention. * Dysfunctional voiding or Fowler Syndrome. * Fecal incontinence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for pelvic organ dysfunctions to the Urology department (UD) and Colorectal Surgery department (CRD) of the Ghent University Hospital and scheduled for a staged SNM procedure using InterstimTM II therapy (Medtronic, Minneapolis, MN) were enrolled.
Key inclusion criteria (2 listed)
- Subjects ≥ 18 years presenting with one or more of the following indications: Urinary urgency frequency with or without urinary incontinence (OAB dry or wet), non-obstructive urinary retention, dysfunctional voiding with post void residual volume, faecal incontinence and mixed incontinence
- Refractory to conservative treatment (i.e. Lifestyle changes, behavioural modification, pelvic floor muscle training, biofeedback) and refractory to pharmacological treatment.
Key exclusion criteria (5 listed)
- Neurogenic bladder.
- Anal sphincter damage more than 120
- Abnormal sacral anatomy
- Mentally or physically disabled patients not capable to handle a patient programmer device.
- Pregnant patients
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 |
|---|---|---|
| Sacral neuromodulationAlso: SNMSacral neuromodulation: the 2-staged tined lead procedure. (Interstim II therapy, Medtronic). Stage I: Placement of a tined-lead electrode. 2 - 4 weeks test phase. Stage II: Placement of an implantable pulse generator. | Device | Patients planned for the 2-staged tined-lead procedure. |
Primary outcome
Implantation ratio
Time frame: Through study completion, an average of 3 years
Proportion of number of patients who received a definitive implant.
True success ratio
Time frame: Through study completion, an average of 3 years
Proportion of patients showing both objective (ObS) and subjective success (SS) during the test phase of SNM.
False positive ratio
Time frame: One month after definitive implant.
Proportion of patients with discontinued SS although having true success during test phase.
4 secondary outcomes
Explantation ratio
Time frame: Within 12 months after definitive implant.
Revision ratio
Time frame: Within 12 months after definitive implant.
Absolute change in diary variables.
Time frame: Up to 4 weeks, depending on the duration of the test phase.
Evolution of PROM scores over time.
Time frame: At 12 months follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 38842955Ghijselings L, Verbakel I, Bou Kheir G, Van de Putte D, Herve F, Goessaert AS, Pauwaert K, Beeckman D, Ooms M, Everaert K. Symptom Assessment of Candidates for Sacral Neuromodulation Therapy With Urologic and Colorectal Conditions: Time for a Holistic Approach? Results and Findings From a Prospective Single-Center Study. Neuromodulation. 2025 Jul;28(5):847-857. doi: 10.1016/j.neurom.2024.04.009. Epub 2024 Jun 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Karel Everaert, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder Syndrome and Urinary Retention, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 Belgium. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation ratio (time frame: Through study completion, an average of 3 years). 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 NCT05313984, 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 19 Sep 2024.