Brain Effects of Sacral Neuromodulation

Urinary Tract Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610064
• Other study ID #: KEK80_05
• Secondary ID: 1025
• Status: Completed
• Phase: N/A
• First received: January 24, 2008
• Last updated: February 4, 2010
• Start date: October 2005
• Est. completion date: June 2009

Study information

• Verified date: February 2010
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

• Age <18 years

• Claustrophobia

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Urinary Tract Disease
• Urologic Diseases

Intervention

Radiation:
• Baseline neuroimaging
Baseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation
• Neuroimaging during sacral neuromodulation
Neuroimaging during sacral neuromodulation using PET

Locations

Country	Name	City	State
Switzerland	Department of Urology, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of sacral neuromodulation on brain activity		2-8 weeks	No
Secondary	Differences in brain activity effects of sacral neuromodulation (SNM) in patients with successful compared to failed SNM testing		immediately and 2-8 weeks after study inclusion	No