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Search / Trial NCT06983470

Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation

Launched by UNIVERSITY OF MICHIGAN · May 17, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking into a treatment called sacral neuromodulation (SNM), which involves using electrical stimulation on a nerve in the lower back to help with bladder issues and pelvic pain, particularly for those with overactive bladder (OAB). Researchers want to better understand how this stimulation works and how they can choose the best settings to improve bladder function. They will be examining specific signals that occur during the stimulation to see how these might relate to positive changes in symptoms.

To participate in this study, you need to be an adult (18 years or older) who is eligible for a sacral neuromodulation implant for overactive bladder as part of your usual medical care. You should be able to communicate clearly and understand English, as the study materials are only available in that language. Participants will not be able to join if they have certain conditions like a weak bladder or are pregnant. While the study is not yet recruiting participants, if you qualify, you would likely undergo assessments to see how the stimulation affects your bladder function. This research could help improve treatment options for many people with bladder problems in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.

About University Of Michigan

The University of Michigan, a leading academic institution renowned for its commitment to advancing healthcare and medical research, serves as a prominent clinical trial sponsor. With a robust infrastructure that supports innovative research initiatives, the university leverages its multidisciplinary expertise to conduct a wide array of clinical trials aimed at improving patient outcomes and advancing medical knowledge. Through its state-of-the-art facilities and collaborative environment, the University of Michigan fosters partnerships between researchers, clinicians, and industry leaders, ensuring the development of cutting-edge therapies and interventions that address pressing health challenges.

Locations

Ann Arbor, Michigan, United States

Patients applied

0 patients applied

Trial Officials

Tim Bruns, PhD

Principal Investigator

University of Michigan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported