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NCT Number: NCT06983470

Predictive Utility and Mechanisms of Sacral Evoked Responses in Sacral Neuromodulation

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Priyanka Gupta, MD

SUB_INVESTIGATOR

Tim Bruns, PhD

PRINCIPAL_INVESTIGATOR

Yike Lui

CONTACT

[email protected]

734-763-7104

About this study

Some surgical procedures will be conducted at the Chealsea Hospital (75 S Main St, Chelsea, MI 48118) and all others will be done at Michigan Medicine facilities.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SNM based on visual-motor responses (VMRs)

Device

SNM using parameters that elicited the best VMRs in the stage-1 implant procedure

SNM based on sacral evoked responses (SERs)

Device

SNM using parameters that elicited the best SERs in the stage-1 implant procedure

Primary outcomes

  1. Change in bladder function score during SNM using visual-motor responses (VMR)-selected stimulation programs

    Time frame: Baseline through the conclusion of study participation, approximately 3 months

    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.

  2. Change in bladder function score during SNM using sacral evoked responses (SER)-selected stimulation programs

    Time frame: Baseline through the conclusion of study participation, approximately 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yike Liu

CONTACT

[email protected]

734-763-7104

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 21, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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