Effect of nerve stimulation on urinary pressure in women
The Effect of Acute Peri-Urethral Neurostimulation on Intra-Urethral Pressure In Women With Stress Urinary Incontinence (SUI) - Urodynamic Early Feasibility Study
This study is testing if stimulating certain nerves can help women with stress urinary incontinence by looking at changes in bladder pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Corewell Health East Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Royal Oak, Michigan) |
| Trial ID | NCT05900570 on ClinicalTrials.gov |
What this trial studies
This early feasibility study aims to understand how peri-urethral neurostimulation affects intra-urethral pressure in women with stress urinary incontinence. Participants will undergo urodynamic testing to collect data on intra-urethral pressure with and without stimulation. The study will utilize commercially available stimulation devices to apply neurostimulation to the perineal nerves, gradually increasing the amplitude until discomfort is noted or no further pressure increases are observed. The findings may provide insights into the potential benefits of neurostimulation for managing urinary incontinence.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older diagnosed with stress urinary incontinence or stress-predominant mixed incontinence for at least six months.
Not a fit: Patients with predominant urge incontinence or active bladder conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new non-invasive treatment option for women suffering from stress urinary incontinence.
How similar studies have performed: While this approach is novel, similar studies exploring neurostimulation for urinary incontinence have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female aged 18 years old or older * Capable of understanding the clinical study procedures and giving informed consent * Willing and able to undergo the study procedure * Diagnosis of SUI or stress predominant mixed incontinence, for at least 6 months * Provided authorization to use and disclose information for research purposes Exclusion Criteria: * Predominant urge incontinence per patient report or medical record * Active symptomatic uncontrolled bladder instability as determined by the investigator * Regularly or intermittently used a urethral catheter * Active bladder cancer (currently undergoing or scheduled to undergo treatment for bladder cancer). * Previous radiation treatment in the pelvic floor * History or symptoms of cystocele, enterocele or rectocele of grade 3 or 4. Per the medical record or as determined by the investigator * Current infection (urethritis, cystitis or vaginitis) as determined by investigator. * Active herpes genitalis * Unevaluated hematuria * Currently taking, or has taken within 4 weeks prior to the screening/baseline visit, pharmacological treatment for SUI (including but not limited to, alpha adrenergics, and tricyclic antidepressants) * Severe or uncontrolled diabetes, (defined as being a diabetic with a hemoglobin A1c of ≥10%) per patient medical record. * History of drug/alcohol abuse, mental dysfunction, or other factors limiting her ability to cooperate fully * Pregnancy test with positive result during screening or women who are breastfeeding * Women who are pregnant and/or have given birth in the previous 12 months * Have implanted active neurostimulators, pacemakers, or defibrillators; neurostimulators which are passive or that can be briefly turned off for the stimulation procedure are acceptable * Known systemic neurological dysfunctions * Severe coagulation disorders * Medically unstable at time of study and unsafe to undergo urodynamic testing (UDT) as determined by the investigator * Presence of an artificial urinary sphincter * Any medical condition (e.g. Multiple Sclerosis, spinal cord injury, mobility) or uncontrolled chronic disease (e.g. renal diseases that requires dialysis) that would interfere with the patient's ability to comply with the protocol and/or may affect the outcome of this study or safety of the subject as determined by the investigator
Where this trial is running
Royal Oak, Michigan
- Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Kenneth Peters, MD — Corewell Health William Beaumont University Hospital
- Study coordinator: Jennifer Giordano, BSN
- Email: Jennifer.Giordano@corewellhealth.org
- Phone: 248-551-3517
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.