MedTrace Logo

Standardization of Lead Placement for Sacral Neuromodulation. Part 1

NCT03194425 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-10-15

No results posted yet for this study

Summary

Retrospective case-control 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 dysfunction characteristics as the ones with good responses. 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

DIAGNOSTIC_TEST

Pelvic floor EMG

Define pelvic floor EMG template measured by probe

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • Stefan De Wachter, MD PhD FEBU · University Hospital, Antwerp

  • Donald Vaganée · University Hospital, Antwerp

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194425 on ClinicalTrials.gov