Our specialists regularly oversee clinical research studies in an effort to contribute to the important area of women's healthcare. Through our research opportunities at NorthShore, we strive to provide our patients with access to leading edge treatment options not widely available elsewhere.
The following studies are open to enrollment. If we are interested in learning more, please ask your physician, nurse or other care team member.
Gynecological Pain and Minimally Invasive Surgery Clinical Trials
Mechanistic Characterization of Uterine Pain to Improve Diagnosis and Treatment for Dysmenorrhea (M-CUP)
Aims: The purpose of this research is to discover the causes of menstrual pain. Additionally, we will study why a common over-the-counter NSAID helps or may not help with cramping pain.
Diagnosis: Women ages 18-45 who have primary dysmenorrhea (painful periods), endometriosis, or fibroids, and healthy controls with none of the aforementioned conditions
Principal Investigator: Kevin Hellman, PhD
Co-Investigator(s): Frank Tu, MD, MPH
IRB Approval Number: EH19-040
Sponsor: NIH
Contact: Interested patients should contact 847.570.2622 or pelvicpainresearch@northshore.org
Open to Enrollment: Yes
Examining the Role of Improved NSAID Management in Treating Dysmenorrhea (NSAID)
Aims: The goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea will improve pain report from baseline. In addition, we will determine whether cross-organ influences from the uterus on bladder sensitivity changes from baseline after reduced menstrual pain experience.
Diagnosis: Women ages 18-45 who have primary dysmenorrhea (painful periods)
Principal Investigator: Frank Tu, MD, MPH
Co-Investigator(s): Kevin Hellman, PhD
IRB Approval Number: EH18-128
Contact: Interested patients should contact 847.570.2622 or pelvicpainresearch@northshore.org
Open to Enrollment: No
Early Menstrual Pain Impact on Multisensory Hypersensitivity (EMPATHY)
Aims: The purpose of this study is to learn more about how menstrual pain affects pain sensitivity development, including at bladder and muscle sites, in girls pre-menarche and for 2 years following menarche.
Diagnosis: Healthy girls ages 10-14 who have not had their first period yet
Principal Investigator: Frank Tu, MD, MPH
Co-Investigator(s): Kevin Hellman, PhD
IRB Approval Number: EH17-338
Sponsor: NIH
Contact: Interested patients should contact 847.570.2622 or thegyrl@northshore.org
Open to Enrollment: Yes
Noninvasive Imaging of Uterine Physiology to Improve Treatment for Dysmenorrhea
Aims: This study uses different MRI imaging methods to look at a woman's uterus to determine what may or may not be causing pain during menses.
Diagnosis: Women ages 18-45 with painful periods or chronic pelvic pain, and healthy controls
Principal Investigator: Kevin Hellman, PhD
Co-Investigator(s): Frank Tu, MD, MPH
IRB Approval Number: EH16-263
Sponsor: NIH
Contact: Interested patients should contact 847.570.2622 or pelvicpainresearch@northshore.org
Open to Enrollment: No
Interstitial Cystitis: Examination of the Central Autonomic Network (ICECAN)
Aims: The purpose of this study is to look at how brain circuits and the autonomic nervous system influence pain responses in women with Interstitial Cystitis/Bladder Pain Syndrome.
Diagnosis: Women ages 18-80 with bladder pain (IC/BPS) or myofascial pelvic pain (MPP), and healthy controls free of any pelvic pain
Principal Investigator: Frank Tu, MD, MPH
Co-Investigator(s): Kevin Hellman, PhD
IRB Approval Number: EH15-029
Sponsor: NIH
Contact: Interested patients should contact 847.570.2622 or pelvicpainresearch@northshore.org
Open to Enrollment: Yes
Deciphering the Hormonal and Nociceptive Mechanisms Underlying Bladder Pain (CRAMPP)
Aims: The purpose of this study is to understand how the menstrual cycle and hormones affect a woman's level of pain sensitivity.
Diagnosis: Women ages 18-45 with painful periods (dysmenorrhea), bladder pain syndrome (BPS), or chronic pain, and healthy controls who do not have any of the aforementioned conditions
Principal Investigator: Frank Tu, MD, MPH
Co-Investigator(s): Kevin Hellman, PhD
IRB Approval Number: EH13-094
Sponsor: NIH
Contact: Interested patients should contact 847.570.2622 or pelvicpainresearch@northshore.org
Open to Enrollment: No
Urogynecology Clinical Trials
Treatment for Recurrent Urinary Tract Infections and its Effect on the Urinary Microbiota and Mycobiota in Post-Menopausal Women
Aims: The purpose of this study is to investigate the relationship between oral antibiotics and the urinary bacteria of patients with recurrent urinary tract infections (UTIs). We want to enroll these women before they begin their antibiotic regimen.
Diagnosis: Post-menopausal status based on history (no menses within 1 year), at least 2 culture positive UTIs within the past 6 months or 3 within the past year
Principal Investigator: Sonia Dutta, MD
Co-Investigator(s): Joseph Pincus, MD
IRB Approval Number: EH19-300
Sponsor: NorthShore
Contact: Interested patients should call 224.251.3492
Open to Enrollment: Yes
Interstitial Cystitis Pain Improvement with Naltrexone: The Effect of Low-Dose Naltrexone on Symptoms and Pain of Patients with Interstitial Cystitis/Painful Bladder Syndrome: A Randomized Placebo-Controlled Prospective Trial (IC PaIN)
Aims: This study aims to determine the effect of using low-dose naltrexone (LDN) on symptoms of patients diagnosed with interstitial cystitis/painful bladder syndrome (IC/PBS). The purpose of this study is to determine whether there is a significant decrease in IC symptoms and pain when treating IC/PBS with LDN.
Diagnosis: Women 18 years and older, newly diagnosed with IC/PBS and have not yet received treatment with medication
Principal Investigator: Nani Moss, MD
IRB Approval Number: EH20-127
Sponsor: NorthShore
Contact: Interested patients should call 224.251.3492
Open to Enrollment: Yes
The Effect of Mid-Urethral Sling on the Urethral Dynamic Shape and Motion
Aims: The purpose of this prospective cohort study is to investigate the effect of a sling on urethral dynamic shape and motion using static and dynamic pelvic floor ultrasound, and to compare findings among women with successful vs. failed surgical outcomes.
Diagnosis: Women 18 years and older with stress urinary incontinence, deciding to proceed with surgical treatment
Principal Investigator: Joel Winer, MD
IRB Approval Number: EH21-027
Sponsor: NorthShore
Contact: Interested patients should call 224.251.3492
Open to Enrollment: Yes
Mesh-free Suture Urethropexy for Treating Stress Urinary Incontinence Efficacy and Durability Trial
Aims: This study aims to evaluate the effecitveness of minimally invasive, mesh-free surgical treatment for stress urinary incontinence.
Diagnosis: Women ages 18 and older who have stress urinary incontinence and are planning to have mid-urethral sling surgery
Principal Investigator: Ghazaleh Rostami Nia, MD
IRB Approval Number: EH21-062
Sponsor: NorthShore
Contact: Interested patients should call 224.251.3492
Open to Enrollment: Yes
A Prospective Study to Assess the Efficacy and Safety of the BlueWind RENOVA iStim™ System for the Treatment of Patients Diagnosed with Overactive Bladder (OASIS - Overactive Bladder Stimulation System Study)
Aims: This study will evaluate the efficacy and safety of the BlueWind RENOVA iStim™ system, which is an implantable tibial nerve stimulator that can be used at home for patients with urgency incontinence or both urgency incontinence and urinary urgency and/or urinary frequency.
Diagnosis: Females ages 21 or older with a diagnosis of overactive bladder (OAB) or urinary urge incontinence (UUI) for at least 6 months
Principal Investigator: Ghazaleh Rostami Nia, MD
IRB Approval Number: EH21-120
Sponsor: BlueWind Medical
Contact: Interested patients should call 224.251.3492
Open to Enrollment: Yes
Pivotal Study of Subcutaneous Tibial Nerve Stimulation with eCoin™ for Urgency Urinary Incontinence
Aims: This study will evaluate the efficacy and safety of the Valencia Technologies eCoin™ to be incorporated in a Pre-Market Approval application. The eCoin™ (electroceutical coni) device is an investigational device to be used in the treatment of patients with overactive bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urinary urge incontinence.
Diagnosis: Women ages 18-80 with a diagnosis of OAB with urge urinary incontinence or mixed urge and stress incontinence for at least 6 months
Principal Investigator:
Co-Investigator(s): Roger Goldberg, MD; Adam Gafni-Kane, MD; Sonia Dutta, MD
IRB Approval Number: EH18-138
Sponsor: Valencia Technologies
Contact: Interested patients should call 224.251.3492
Open to Enrollment: No