NCT00610064

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 5, 2010

Status Verified

February 1, 2010

Enrollment Period

3.7 years

First QC Date

January 24, 2008

Last Update Submit

February 4, 2010

Conditions

Urinary Tract Disease

Keywords

Refractory lower urinary tract dysfunctionSacral neuromodulationBrain effectsNeuroimagingNeuromodulation

Outcome Measures

Primary Outcomes (1)

  • Effect of sacral neuromodulation on brain activity

    2-8 weeks

Secondary Outcomes (1)

  • 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

Study Arms (2)

A

OTHER

Baseline neuroimaging

Radiation: Baseline neuroimaging

B

OTHER

Neuroimaging during sacral neuromodulation

Radiation: Neuroimaging during sacral neuromodulation

Interventions

Baseline neuroimagingRADIATION

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

A
Neuroimaging during sacral neuromodulationRADIATION

Neuroimaging during sacral neuromodulation using PET

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Age \<18 years
  • Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, University of Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Thomas M Kessler, MD

    Department of Urology, University of Bern, 3010 Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 7, 2008

Study Start

October 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 5, 2010

Record last verified: 2010-02

Locations

CH(1)