Trials / Completed
CompletedNCT05313984
OptiLUTS Part C: the Development of a Symptom Assessment Tool in Sacral Neuromodulation.
Optimization of Therapy Resistant LUTS (OptiLUTS) Part C: the Development of a Symptom Assessment Tool in Sacral Neuromodulation: a Prospective Single Centre Study.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 93 (actual)
- Sponsor
- University Hospital, Ghent · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sacral neuromodulation | 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. |
Timeline
- Start date
- 2018-03-01
- Primary completion
- 2021-12-01
- Completion
- 2021-12-31
- First posted
- 2022-04-06
- Last updated
- 2024-09-19
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT05313984. Inclusion in this directory is not an endorsement.