Investigating the effect of different stimulation settings during sacral neuromodulation treatment for patients with detrusor overactivity and dysfunctional voiding
| ISRCTN | ISRCTN10473878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10473878 |
| IRAS number | 311461 |
| Secondary identifying numbers | 12024, CPMS 62199 |
- Submission date
- 26/09/2024
- Registration date
- 08/11/2024
- Last edited
- 16/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Sacral neuromodulation (SNM) is a relatively new treatment for patients with overactive bladders (OAB, increase urinary frequency, urgency and incontinence) and dysfunctional voiding (difficulty emptying the bladder secondary to a non-relaxing urinary sphincter). The mechanisms of action for SNM is still not fully understood, in particular, how the same therapy (same surgical procedure and neuromodulator stimulating parameters), can treat two contrasting bladder conditions.
It is thought that both diseases (OAB and DV) result from inappropriate activity of the pudendal nerve (PN) activity which controls the external urethral sphincter with OAB and DV patients having decreased and increased PN activity respectively. Electrical stimulation of the PN aims to ‘normalise’ the activity to the urethral sphincter.
Currently, the frequency of the electrical stimulation is the same when treating both OAB and VD patients. However, the effect of PN stimulation, that is whether it results in excitation or relaxation of the sphincter, may be frequency dependant. We aim to assess the effects of different stimulation frequencies to determine of we can improve efficacy of SNM for patients with DO and DV.
Who can participate?
Patients diagnosed with detrusor overactivity or dysfunctional voiding during urodynamic assessment
What does the study involve? (for participants)
Undergoing a trial of sacral neuromodulation and varying the stimulation frequencies. Outcomes will be measured by urodynamic assessment, bladder diaries and patient questionnaires.
What are the possible benefits and risks of participating?
Risks:
1. Pain or discomfort during frequency change of SNM
2. Pain or discomfort when undergoing additional UDS investigations.
3. Risk of urinary tract infection due to urethral catheterisation for UDS investigations
Risk to benefit rationale:
UDS investigations are a low-risk routinely performed test. All usual precautions will be taken in order to minimise patient discomfort and ensure dignity.
Patients will have the benefit of receiving individualised objective data regarding the efficacy of their SNM trial as well as optimal SNM settings. The outcome of this trial could improve SNM therapy for all patients by optimising stimulation parameters for the various indications.
Where is the study run from?
Guy’s Urology Centre (UK)
When is the study starting and how long is it expected to run for?
October 2021 to October 2026
Who is funding the study?
Medtronic (USA)
Who is the main contact?
Eskinder Solomon, Eskinder.Solomon@gstt.nhs.uk
Contact information
Public, Scientific, Principal Investigator
Urology centre, Southwark wing, Guy's Hospital, Great Maze Pond
London
SE19RT
United Kingdom
 ORCID ID |
0000-0003-4382-0394 |
|---|---|
| Phone | +44 7958766421 |
| Eskinder.Solomon@gstt.nhs.uk |
Study information
| Study design | Single centre observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 46135 IRAS 311461 SNM Stimulation Parameters PIS Pilot 1 V3.0 10.07.24.pdf |
| Scientific title | Single-centre pilot-study to determine the optimal sacral neuromodulation (SNM) stimulation parameters to treat idiopathic detrusor overactivity and dysfunctional voiding |
| Study acronym | SNMLUTS |
| Study objectives | There will be an optimum stimulation frequency (5, 14 or 130Hz) which increases QOL score and bladder capacity, delays sensation milestones and/or reduces the amplitude of detrusor overactivity amplitude for OAB patients and improves voiding efficiency in patients with DV. |
| Ethics approval(s) |
Approved 30/07/2024, London - Brighton & Sussex Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048016; brightonandsussex.rec@hra.nhs.uk), ref: 24/LO/0354 |
| Health condition(s) or problem(s) studied | Detrusor overactivity, dysfunctional voiding |
| Intervention | This protocol covers a series of pilot studies. All patients will receive the SNM standard of care if involved in this study with the addition of UDS investigations at different time points (see flow chart overleaf). The purpose of this trial is to better understand the benefit of varying stimulation frequency and potentially identifying a conditional stimulation trigger signal. If these concept show promise, and is feasible, a larger trial, with appropriate sample size, will be conducted. Participants within pilot studies 1 and 2 will undergo 1 and 3 Urodynamics procedures respectively to objectively assess the change in bladder function during the trial. On arrival to the department the participant will be asked to empty their bladder and change into a hospital gown. Using aseptic techniques, local anaesthetic and lubrication a member of the clinical team will insert a small catheter into the bladder and another into the anus (back passage). Once the catheters are in place the participant can stand or be seated while the bladder is filled slowly, which will last approximately ten minutes. Only a small amount of fluid will enter the rectum. During the filling phase the participant will be asked to report when they need to urinate and how this feeling progresses. When bladder capacity or urgency is reproduced the participant will void (urinate) with the catheters in place, appropriate privacy will be provided at this point. Once voided the catheters will be removed. and the patient may leave the department once changed. Pilot 1: Patients with detrusor overactivity. -Eligibility screening and PIS given to patient during clinical visit to Urology centre. -Verbal consent to participate via a telephone call ~2 weeks after PIS given. -3 day bladder diary performed (the volume and time of fluid consumed and urinated). -Day 1: Written informed consent obtained prior to SNM lead implantation. -Day 7-14 (one visit): Urodynamics procedure, including four bladder filling cycles at different stimulation parameters 5, 14, 40 and 130Hz. -Day 14: End of trial, SNM system either implanted permanently or removed. Pilot 2: Patients with detrusor overactivity. -Eligibility screening and PIS given to patient during clinical visit to Urology centre. -Verbal consent to participate via a telephone call ~2 weeks after PIS given. -3 day bladder diary performed (the volume and time of fluid consumed and urinated). -Day 1: Written informed consent obtained prior to SNM lead implantation and stimulation frequency set to 5, 14 or 130Hz. -Day 4: 1st Urodynamics procedure and complete patient questionnaire ICIQ-OAB.. -Day 5: SNM program changed to either 5, 14 or 130Hz. -Day 9: 2nd Urodynamics procedure and complete patient questionnaire ICIQ-OAB.. -Day 10 : SNM program changed to final program, either 5, 14 or 130Hz. -Day 14: End of trial, 3rd Urodynamics procedure and complete patient questionnaire ICIQ-OAB, SNM system either removed or permanently implanted. -Throughout study: a bladder diary is kept each day. Pilot 3: Patients with dysfunctional voiding. -Eligibility screening and PIS given to patient during clinical visit to Urology centre. -Verbal consent to participate via a telephone call ~2 weeks after PIS given. -3 day bladder diary performed (the volume and time of fluid consumed and urinated). -Day 1: SNM lead implanted and stimulation frequency set to 5, 14 or 130Hz. -Day 4: Complete patient questionnaire ICIQ-FLUTS. -Day 5: SNM program changed to either 5, 14 or 130Hz. -Day 9: Complete patient questionnaire ICIQ-FLUTS. -Day 10 : SNM program changed to final program, either 5, 14 or 130Hz. -Day 14: End of trial, complete patient questionnaire ICIQ-FLUTS, SNM system either permanently implanted or removed. -Throughout study: a bladder diary is kept each day using the Minze HomeFlow device (which automatically records volume of urination and flow rate). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pilot 1: Bladder function measured during a urodynamic assessment between day 7 and 14 at each of the following stimulation frequencies 5, 14 and 130Hz (the assessment will include four filling phases). Parameters include: capacity (ml), compliance (ml/cmH2O), detrusor overactivity peak pressure and onset (cmH2O and ml respectively), voided volume (ml), detrusor pressure at peak flowrate, Pdet.Qmax (cmH2O), maximum flowrate, Qmax (ml/s), post void residual (ml). Pilot 2: Bladder function parameters measured during urodynamic assessments on day 4, 9 and 14 at a different stimulation frequency (5, 14 or 130Hz). Parameters include: capacity (ml), compliance (ml/cmH2O), detrusor overactivity peak pressure and onset (cmH2O and ml respectively), voided volume (ml), detrusor pressure at peak flowrate, Pdet.Qmax (cmH2O), maximum flowrate, Qmax (ml/s), post void residual (ml). Pilot 3: Uroflowmetry parameters measured using the Minze HomeFlow device throughout the two week trial. Parameters include voided volume (ml), maximum flow rate (ml/s), average flow rate (ml/s) and shape of flow. |
| Secondary outcome measures | Pilot 1 and 2: -Bladder diary parameters recorded during the two week trial. Parameters include voided volume (ml), number of voids /day and number of incontinence episodes / day. -Patients subjective response to treatment measured using the ICIQ-OAB questionnaire on day 4, 9 and 14. Pilot 3: -Patients subjective response to treatment measured using the ICIQ-FLUTS questionnaire on day 4, 9 and 14. |
| Overall study start date | 05/10/2021 |
| Completion date | 01/10/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 36 (12 in each pilot) |
| Total final enrolment | 36 |
| Key inclusion criteria | Study 1 and 2: Male and female patients with refractory OAB symptoms, diagnosed with DO on UDS Study 3: Female patients with refractory voiding dysfunction and evidence of high-tone non-relaxing sphincter on UDS and urethral pressure profilometry |
| Key exclusion criteria | 1. Anatomical abnormalities in the genitalia or pelvic region 2. Women who plan to become pregnant 3. Patients expecting to have diathermy treatment 4. Patients with neurological disease 5. Anticoagulants 6. Any other condition that would prevent the patient from completing the study, as judged by the principal investigator 7. Involvement in other current or recent research trials (3 months) 8. Non-English speaking and those lacking capacity |
| Date of first enrolment | 01/11/2024 |
| Date of final enrolment | 02/11/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SE19RT
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department,16th Floor, Tower Wing, Guy's Hospital, Great Maze pond
London
SE19RT
England
United Kingdom
| Phone | +44 2071889811 |
|---|---|
| R&D@gstt.nhs.uk | |
| Website | http://www.guysandstthomas.nhs.uk/Home.aspx |
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medtronic Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | 03/11/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Once the analysis has been completed a lay summary of the results will be submitted to the HRA. Which will be published on the HRA website, ensuring research participants and the public can easily find and understand the outcome of the studies. Anonymised study findings will be sent via email to all participants in a suitable format unless the participant stated otherwise. The study findings will be presented as abstracts in research meetings and published in scientific journals. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.0 | 10/07/2024 | 26/09/2024 | No | Yes |
| Participant information sheet | version 3.0 | 10/07/2024 | 26/09/2024 | No | Yes |
| Participant information sheet | version 3.0 | 10/07/2024 | 26/09/2024 | No | Yes |
Additional files
Editorial Notes
16/01/2025: Internal review.
26/09/2024: Trial's existence confirmed by NHS HRA.
