Clinical Trials Directory

Trials / Unknown

UnknownNCT03199443

Standardization of Lead Placement for Sacral Neuromodulation Part 2

Pelvic Floor Electromyography Monitoring as Tool to Improve Patient Selection and Outcome - Standardization of Lead Placement for Sacral Neuromodulation.

Status
Unknown
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
Universiteit Antwerpen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Prospective observational study. A substantial number of patients do not respond favourably to sacral neurostimulation (SNS) although clinically, they appear to have the same lower urinary tract (LUT) dysfunction characteristics as the good responders. This may be due to methodological issues (lead position) or patient selection. The purpose of this study is to improve and standardize lead position, in order to increase the patient response to test stimulation and to SNS treatment, and to decrease adverse events.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTEMG pelvic floorEMG activity during tined lead test procedures will be monitored and the response on needle stimulation will be evaluated

Timeline

Start date
2017-10-01
Primary completion
2022-08-01
Completion
2022-08-01
First posted
2017-06-27
Last updated
2019-10-15

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03199443. Inclusion in this directory is not an endorsement.