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Brain Effects of Sacral Neuromodulation

Brain Effects of Sacral Neuromodulation in Patients With Refractory Lower Urinary Tract Dysfunction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00610064
Enrollment
30
Registered
2008-02-07
Start date
2005-10-31
Completion date
2009-06-30
Last updated
2010-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Disease

Keywords

Refractory lower urinary tract dysfunction, Sacral neuromodulation, Brain effects, Neuroimaging, Neuromodulation

Brief summary

Sacral neuromodulation (SNM) has become an accepted treatment for patients with refractory lower urinary tract dysfunction such as urgency frequency syndrome, urgency incontinence, non-obstructive chronic urinary retention and chronic pelvic pain syndrome. Modulation of central afferent activity is considered critical to this therapeutic effect but the neural mechanisms are poorly understood. We hypothesize that SNM has a significant effect on brain activity detectable by positron emission tomography (PET).

Interventions

RADIATIONBaseline neuroimaging

Baseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation

RADIATIONNeuroimaging during sacral neuromodulation

Neuroimaging during sacral neuromodulation using PET

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with refractory lower urinary tract dysfunction scheduled for sacral neuromodulation

Exclusion criteria

* Pregnancy * Age \<18 years * Claustrophobia

Design outcomes

Primary

MeasureTime frame
Effect of sacral neuromodulation on brain activity2-8 weeks

Secondary

MeasureTime frame
Differences in brain activity effects of sacral neuromodulation (SNM) in patients with successful compared to failed SNM testingimmediately and 2-8 weeks after study inclusion

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026