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| Name | Class |
|---|---|
| Leiden University Medical Center | OTHER |
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Prospective observational study.
A substantial number of patients do not respond favourably to sacral neurostimulation (SNS) although clinically, they appear to have the same lower urinary tract (LUT) dysfunction characteristics as the good responders. This may be due to methodological issues (lead position) or patient selection. The purpose of this study is to improve and standardize lead position, in order to increase the patient response to test stimulation and to SNS treatment, and to decrease adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overactive bladder patients |
| ||
| Non Obstructive Urinary Retention patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMG pelvic floor | Diagnostic Test | EMG activity during tined lead test procedures will be monitored and the response on needle stimulation will be evaluated |
|
| Measure | Description | Time Frame |
|---|---|---|
| EMG pelvic floor | Latency and amplitude measured by probe | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of adverse events | Prevalence of adverse events, which are defined as: pain, decrease in efficacy and number of reprogramming sessions. | 2 years |
| Voiding diary | Determine the success rate of tined lead test period based upon changes in 3 days. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with OAB (wet and dry) or non obstructive urinary retention who are therapy resistant to pelvic floor physiotherapy and medical management and wish to undergo a tined lead procedure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan De Wachter, MD PhD FEBU | Contact | +323 821 59 34 | +32 | stefan.dewachter@uantwerpen.be |
| Donald Vaganée | Contact | +323 821 30 47 | +32 | donald.vaganee@uantwerpen.be |
| Name | Affiliation | Role |
|---|---|---|
| Stefan De Wachter, MD PhD FEBU | University Hospital, Antwerp | Study Director |
| Donald Vaganée | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Recruiting | Edegem | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 1 year |
| Validated questionnaires (KHQ and PeLFis) | Determine the success rate of tined lead test period based upon changes in validated questionnaires (KHQ and PeLFis). | 1 year |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |