Skip to main content
OpenTrials
Completed

NCT Number: NCT00610064

Brain Effects of Sacral Neuromodulation

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Tract Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, University of Bern

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Age <18 years
  • Claustrophobia

Treatment and study plan

Baseline neuroimaging

Radiation

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

Neuroimaging during sacral neuromodulation

Radiation

Neuroimaging during sacral neuromodulation using PET

Primary outcomes

  1. Effect of sacral neuromodulation on brain activity

    Time frame: 2-8 weeks

Secondary outcomes

  1. Differences in brain activity effects of sacral neuromodulation (SNM) in patients with successful compared to failed SNM testing

    Time frame: immediately and 2-8 weeks after study inclusion

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Feb 7, 2008
Registry last updated
Feb 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.