Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation
ConditionOveractive Bladder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
Electrical stimulation of the sacral nerve can help with bladder problems and pelvic pain but researchers don't understand exactly how the stimulation helps. The goal of this study is to examine signals evoked during sacral neuromodulation (SNM or electrical stimulation of the sacral nerve) and their relationship to the selection of stimulation parameters that improve pelvic function symptoms. This study uses SNM parameters based on visual-motor responses (VMR) or sacral evoked responses (SER). It is investigating how the parameter selection impacts change in bladder function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Determined by the research team to be fully eligible to receive a sacral neuromodulation implant at a sacral nerve as part of their normal clinical care for overactive bladder (OAB).
Adult (18 or older), capable of providing own informed consent and communicating clearly with research team.
Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English.
Disqualifiers
Areflexive or atonic bladder.
Pregnant or planning to become pregnant. If a woman of child-bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy.
Diagnosed neurogenic bladder, sacral nerve damage, lower motor dysfunction, or other conditions that would affect the neural circuits involved in micturition.
Trial design
Design model
Crossover
Treatments tested in this trial
SNM based on visual-motor responses (VMRs)
DeviceSNM using parameters that elicited the best VMRs in the stage-1 implant procedure
SNM based on sacral evoked responses (SERs)
DeviceSNM using parameters that elicited the best SERs in the stage-1 implant procedure
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: VMR followed by SERExperimental treatment 2 interventions
Group B: SER followed by VMRExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in bladder function score during SNM using visual-motor responses (VMR)-selected stimulation programs
Bladder function score is assessed using the American Urological Association Symptom Index. The American Urological Association Symptom Index has a range of 0 (no dysfunction) to 35 (maximum dysfunction). A decrease in score indicates improvement.
Time frame
Baseline through the conclusion of study participation, approximately 3 months2
Change in bladder function score during SNM using sacral evoked responses (SER)-selected stimulation programs
Bladder function score is assessed using the American Urological Association Symptom Index. The American Urological Association Symptom Index has a range of 0 (no dysfunction) to 35 (maximum dysfunction). A decrease in score indicates improvement.
Time frame
Baseline through the conclusion of study participation, approximately 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov