A Study Evaluating the Efficacy and Safety of BOTOX and Solifenacin in Patients with Overactive Bladder and Urinary Incontinence, Protocol 191622-125
Aims: The purpose of this study is to investigate the effectiveness and safety of Botox® and Solifenacin (an oral anticholinergic) compared to placebo (saline and/or dummy pill) for the treatment of overactive bladder.
Diagnosis: Female patients with Overactive bladder (OAB) whose symptoms have not been adequately managed with anticholinergic therapy ( a medication used to treat overactive bladder symptoms). Overactive bladder means that you have frequent urination and urgency (a sudden and urgent need to urinate) and may also have urinary incontinence (accidental loss of urine).
Principal Investigator: Peter Sand, MD
Co-Investigator(s): Roger Goldberg, MD; Sylvia Botros, MD; Janet Tomezsko, MD; Adam Gafni-Kane, MD; Kelly Jirschele, DO; Miriam Seitz, MD
IRB Approval Number: EH13-171
Sponsor: Allergan Sales, LLC
Contact: Interested patients should contact the research nurse Mary Keller at 224.251.3492
Open to Enrollment: Yes

Postoperative Voiding Dysfunction and Predictors of Postoperative Urinary Retention Following Pelvic Reconstructive Surgery
Aims: To determine the incidence of post urinary retention (PUR) requiring catheterization after pelvic reconstructive surgery with or without a midurethral sling, and after a midurethral sling alone.  To also identify risk factors associated with PUR requiring catheterization. 
Diagnosis: Post operative urinary Retention associated with pelvic reconstructive surgery and or midurethral sling.
Principal Investigator: Kelly Jirschele, DO
Co-Investigator(s): Adam Gafni-Kane, MD; Lopa Pandya
IRB Approval Number: EH13-262
Sponsor: N/A
Contact: N/A
Open to Enrollment: Chart review study

Threshold Scores for Help-seeking on the short form of the Pelvic Floor Distress Inventory (PFDI-20)
Aims: To further improve the interpretability of the Pelvic Floor Distress Inventory (PFDI-20) a retrospective cohort study will be done in order to establish a threshold PFDI-20 score at which women with PFD seek the care of urogynecologist/women in the general population who report PFD but have not sought the care of a physician.
Diagnosis: N/A
Principal Investigator: Adam Gafni-Kane, MD
Co-Investigator(s): Sylvia Botros, MD
IRB Approval Number: EH12-309
Sponsor: N/A 
Contact: N/A
Open to Enrollment: N/A

Treatment of Postoperative Urinary Retention – What Do Women Want?
Aims:  Patient’s preference and satisfaction with the choice of catheterization after urogynecologic surgery for urinary incontinence, anal incontinence and or pelvic organ prolapsed.
Diagnosis: Urinary retention after urogynecologic surgery
Principal Investigator: Miriam Seitz, MD
Co-Investigator(s): Roger Goldberg, MD; Sylvia Botros, MD; Janet Tomezsko, MD; Adam Gafni-Kane, MD; Kelly Jirschele, DO
IRB Approval Number: EH11-096
Sponsor: N/A
Contact: If interested please speak with the physician in charge of your scheduled surgery
Open to Enrollment: Yes

Post-Operative Pain, and Perceptions of Recuperation, After Suture-Based, versus Mesh-Based Sacrospinous Suspension
Aims: Looking at recovery response from two different types of pelvic surgery which either suspend the uterus or the top of the vagina to the ligaments with either sutures or a mesh device.  We are interested in understanding the recovery particularly the location and intensity of any pain experienced after the surgery.  We are also interested in understanding whether there are any differences in recovery between women who have had suture suspensions compared to those who have had mesh suspensions.
 Diagnosis: outcome comparing the two types of surgeries to correct prolapse
Principal Investigator: Peter Sand, MD
Co-Investigator(s): Sylvia Botros, MD; Janet Tomezsko, MD; Adam Gafni-Kane, MD; Kelly Jirschele, DO; Miriam Seitz, MD
IRB Approval Number: EH10-402
Sponsor: Boston Scientific Corporation 
Contact: Closed to enrollment
Open to Enrollment: N/A

A Multicenter, Long-Term Follow-Up Study of the Safety and Efficacy of BOTOX (Boulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Idiopathic Overactive Bladder with Urinary Incontinence (Protocol 191622-096)
Aims: To study the long-term safety and effectiveness of BOTOX® injections into the bladder in patients with accidental loss of urine due to neurogenic overactive bladder.
Diagnosis: Neurogenic detrsor overactivity (incontinence resulting from disease or damage to the nervous system) due to either spinal cord injury or multiple sclerosis, to qualify for participation patients must have participated in the previous BOTOX® neurogenic overactive bladder study.
Principal Investigator: Peter Sand, MD
Co-Investigator(s): Roger Goldberg, MD; Sylvia Botros, MD; Janet Tomezsko, MD; Adam Gafni-Kane, MD; Kelly Jirschele, DO
IRB Approval Number: EH09-208
Sponsor: Allergan Sales, LLC
Contact: N/A
Open to Enrollment: No

Prospective Trial to Evaluate Mesh Augmented Sacrospinous Hysteropexy for Uterovaginal Prolapse
Aims: To track the outcomes of women that undergo mesh augmented sacrospinous hysteropexy (surgery used for the treatment of uterine prolapsed, by supporting the uterus. This surgery allows women to repair their prolapsed without hysterectomy, removal of the uterus.)
Diagnosis: Uterine prolapse (fallen uterus possibly protruding from the body)
Principal Investigator: Peter Sand, MD
Co-Investigator(s): Sylvia Botros, MD; Janet Tomezsko, MD; Adam Gafni-Kane, MD; Kelly Jirschele, DO
IRB Approval Number: EH09-220
Sponsor: Boston Scientific Corporation 
Contact: N/A
Open to Enrollment: No

A Multicenter, Long-Term Follow-Up Study of the Safety and Efficacy of BOTOX (Boulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Idiopathic Overactive Bladder with Urinary Incontinence (Protocol 191622-096)
Aims: This study will gather information on the effects of the study drug for idiopathic overactive bladder over a long term period of time.
 Diagnosis: Overactive Bladder in patients that completed participation in the Allergan 191622-095 study.
Principal Investigator: Peter Sand, MD
Co-Investigator(s): Roger Goldberg, MD; Sylvia Botros, MD; Janet Tomezsko, MD; Adam Gafni-Kane, MD; Kelly Jirschele, DO; Miriam Seitz, MD
IRB Approval Number: EH09-457
Sponsor: Allergan
Contact: N/A
Open to Enrollment: No

Incontinence and Pelvic Floor Dysfunction: The NorthShore University HealthSystem Twins Study
Aims: Urinary incontinence, prolapsed (dropping of the uterus, bladder, and vagina), anal incontinence (loss of control over feces, or gas), and sexual dissatisfaction; known obstetrical risk factors for these pelvic floor disorder include forceps delivery, episiotomy, and large newborns.  The objective of the survey-based study is to determine the prevalence of these disorder among female twin sister pairs.  The study sample size will be collected one time a year at the Twins Day Festival in Twinsburg, Ohio.   
Diagnosis: Urinary incontinence, prolapsed, anal incontinence and sexual dissatisfaction.
Principal Investigator: Roger Goldberg, MD
Co-Investigator(s): Sylvia Botros, MD; Janet Tomezsko, MD; Adam Gafni-Kane, MD; Kelly Jirschele, DO; Miriam Seitz, MD
IRB Approval Number: EH03-260
Sponsor: NorthShore University HealthSystem 
Contact: N/A
Open to Enrollment: Yes. Visit the Twins Days Festival website to learn more.

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