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Brain Effects of Sacral Neuromodulation

Status

Completed

Conditions

Urinary Tract Disease

Treatments

Radiation: Baseline neuroimaging
Radiation: Neuroimaging during sacral neuromodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT00610064
KEK80_05
1025

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Age <18 years
  • Claustrophobia

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 2 patient groups

A
Other group
Description:
Baseline neuroimaging
Treatment:
Radiation: Baseline neuroimaging
B
Other group
Description:
Neuroimaging during sacral neuromodulation
Treatment:
Radiation: Neuroimaging during sacral neuromodulation

Trial contacts and locations

1

There are currently no registered sites for this trial.

Timeline

Last updated: Feb 05, 2010

Start date

Oct 01, 2005 • 19 years ago

End date

Jun 01, 2009 • 15 years ago

Today

Jan 22, 2025

Sponsor of this trial

Data sourced from clinicaltrials.gov