Indianapolis, INNCT05200923Now EnrollingIRB Ready

Overactive Bladder Clinical Trial in Indianapolis, IN

Access cutting-edge overactive bladder treatment through this clinical trial at a research site in Indianapolis. Study-provided care at no cost to qualified participants.

Sponsored by MedtronicNeuro

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Expert Care in Indianapolis

Access overactive bladder specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related overactive bladder treatment provided free

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Check if you qualify for this overactive bladder clinical trial in Indianapolis, IN

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Why Participate?

  • No-Cost Study Care

  • Local to Indianapolis

    Convenient for IN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Indianapolis site if eligible
  4. 4Begin participation

About This Overactive Bladder Study in Indianapolis

To collect physiological signals at several timepoints during the therapy evaluation period.

Sponsor: MedtronicNeuro

Who Can Participate

Inclusion Criteria

Overactive Bladder Criteria Inclusion Criteria
18 years of age or older
Candidate for or undergoing Medtronic InterStim lead implant for labeled indication\
requiring an advanced evaluation
Willing and able to provide signed and dated informed consent
Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol
Willing to maintain current regimen (dosage and frequency) of any OAB medication from baseline diary through the end of therapy evaluation
For subjects with urinary urge incontinence, have a diagnosis of OAB as demonstrated on a voiding diary by having a minimum of 3 episodes of urinary urge incontinence in the first 72 hours (Episodes must have a mild, moderate, or severe degree of urgency to meet this criterion) of the voiding diary.
For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on a voiding diary with greater than or equal to 8 urgency frequency episodes per day within the first 72 hours of the voiding diary. Note\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study. Non-Obstructive Urinary Retention Inclusion Criteria
18 years of age or older
Candidate for or undergoing Medtronic InterStim lead implant for labeled indication\
requiring an advanced evaluation
Willing and able to provide signed and dated informed consent
Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol
Willing to maintain current regimen (dosage and frequency) of any NOUR medication from baseline diary through the end of therapy evaluation
Have a diagnosis of non-obstructive urinary retention with an elevated postvoid residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions. Note\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study. Fecal Incontinence Inclusion Criteria
18 years of age or older
Candidate for or undergoing Medtronic InterStim lead implant labeled indication\
requiring an advanced evaluation
Willing and able to provide signed and dated informed consent
Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol
Willing to maintain current regimen (dosage and frequency) of any FI medication from baseline diary through the end of therapy evaluation
Have a diagnosis of fecal incontinence as demonstrated by 3-day a bowel diary as greater than or equal to 1 incontinent episode of more than staining (i.e., either slight, moderate, or severe soiling) Note\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Exclusion Criteria

Overactive Bladder Criteria Exclusion Criteria
Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)
Implanted with a neurostimulator, pacemaker or defibrillator
Pelvic floor muscle dysfunction due to surgical intervention or injury
Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
History of diabetes unless the diabetes is well-controlled through diet and/or medications
Have symptomatic urinary tract infection (UTI)
Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
Treatment of voiding behavior with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
Treatment of symptoms with tibial neuromodulation therapy in the last 3 months
Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study
Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
Women who are pregnant or planning to become pregnant
Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements Non-Obstructive Urinary Retention Exclusion Criteria
Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)
Implanted with a neurostimulator, pacemaker or defibrillator
Pelvic floor muscle dysfunction due to surgical intervention or injury
Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
History of diabetes unless the diabetes is well-controlled through diet and/or medications
Have symptomatic urinary tract infection (UTI)
Treatment of symptoms with tibial neuromodulation therapy in the last 3 months
Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study
Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
Women who are pregnant or planning to become pregnant
Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements Fecal Incontinence Exclusion Criteria
Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)
Implanted with a neurostimulator, pacemaker or defibrillator
Pelvic floor muscle dysfunction due to surgical intervention or injury
Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
Have uncorrected high grade internal rectal prolapse
Treatment of symptoms with tibial neuromodulation therapy in the last 3 months
Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study
Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
Women who are pregnant or planning to become pregnant
Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Indianapolis?

Yes, this clinical trial (NCT05200923) has an active research site in Indianapolis, IN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Overactive Bladder Treatment Options in Indianapolis, IN

If you're searching for overactive bladder treatment options in Indianapolis, IN, this clinical trial (NCT05200923) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Indianapolis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced overactive bladder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all overactive bladder clinical trials near you to find additional studies recruiting in your area.

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