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New treatment option for Urge Incontinence
Official title Percutaneous Nerve Evaluation Trial Time
ClinicalTrials.gov ID: NCT06226220
What this study is testing
- What it's testing
- Sacral neuromodulation (SNM) was approved by the Food and Drug Administration (FDA) for the treatment of urgency incontinence (UUI) in 1998. One of two trial phase techniques are utilized prior to placement of the implantable pulse generator (IPG) to predict a patient's success with the device: a percutaneous nerve evaluation (PNE) or a stage implantation.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Non-pregnant women \>/=18 years old undergoing sacral neuromodulation (SNM) treatment for urgency urinary incontinence (UUI) or urgency-frequency...
- \>/=5 UUI episodes on a 3-day bladder diary with urge incontinence representing \>/=50% of total incontinence episodes recorded or \>/=8 per day for...
- Willing and able to complete all study related items and interviews
- Grossly neurologically normal exam
You likely can't join if
- SNM indication of non-obstructive urinary retention or isolated fecal incontinence
- Severe or poorly controlled diabetes (defined as HgbA1c \>/=8.0) or diabetes with peripheral nerve involvement
- Neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy, or complete spinal cord injury
- Surgically altered detrusor muscle (i.e. Augmentation cystoplasty)
- Current or prior bladder malignancy
- Prior pelvic irradiation
See the full eligibility criteria
- Non-pregnant women \>/=18 years old undergoing sacral neuromodulation (SNM) treatment for urgency urinary incontinence (UUI) or urgency-frequency (UF) who have elected to undergo testing phase with a PNE
- \>/=5 UUI episodes on a 3-day bladder diary with urge incontinence representing \>/=50% of total incontinence episodes recorded or \>/=8 per day for 2 days on a 3-day bladder diary
- Willing and able to complete all study related items and interviews
- Grossly neurologically normal exam
- SNM indication of non-obstructive urinary retention or isolated fecal incontinence
- Severe or poorly controlled diabetes (defined as HgbA1c \>/=8.0) or diabetes with peripheral nerve involvement
- Neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy, or complete spinal cord injury
- Surgically altered detrusor muscle (i.e. Augmentation cystoplasty)
- Current or prior bladder malignancy
- Prior pelvic irradiation
- Post void residual (PVR) \>/= 150 mL within 6 months prior to enrollment
- Active urinary tract infection
- Primary stress urinary incontinence or mixed urinary incontinence with stress predominance
- \>/= Stage III pelvic organ or vaginal vault prolapse and/or current pessary use
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.