Active Studies
Currently Enrolling
BASIS
Transurethral Bulking Agent Injection versus Single-Incision Sling for Stress Urinary Incontinence
The purpose of the “BASIS” trial is to compare two treatments for people with stress urinary incontinence (SUI). Stress urinary incontinence is the leakage of urine upon exertion, for example, when laughing, coughing, or lifting something heavy. The two treatments in this study are transurethral bulking agent (TBA) and single-incision sling (SIS). There is current evidence suggesting that TBA and SIS may be less effective at treating SUI, but these procedures are important to study because they are less invasive treatment options with fewer complications than traditional full-length mid-urethral sling procedures. These treatments are outpatient procedures that are commercially available and FDA-approved for patients with SUI, and have either no mesh material or less mesh material than traditional full-length mid-urethral sling procedures. The trial’s primary purpose is to evaluate how TBA and SIS compare to one another as treatments for SUI at one year after treatment.
More InformationTULIP
Training for Urinary Leakage Improvement after Pregnancy
For new mothers, bladder leakage may be upsetting or bothersome. As a TULIP study participant, you will learn strategies for improving bladder control and how your pelvic muscles support your bladder. The purpose of this research study is to determine the effectiveness of education about lifestyle changes (e.g., being thoughtful about what you eat and drink, exercising, weight loss) and pelvic muscle strengthening in the treatment of bothersome bladder leakage after delivery of your first baby. This education will be with or without additional training in pelvic muscle strengthening, either using in-person exercise coaching (i.e., 2 sessions with a skilled teacher at baseline and 3 months after delivery) or an at-home motion-based device (i.e., a vaginal insert device that communicates wirelessly to an app on your smartphone telling you when correct exercises are being performed).
More InformationOngoing Studies
E-ASPIRE
Extension of the Apical Suspension Repair for Vault Prolapse
The E-ASPIRe clinical trial extends the follow-up of women in the ASPIRe clinical trial up to 10 years from the time of surgery. The primary aim for ASPIRe was to find out how the results of the surgical procedures (abdominal sacral colpopexy, native tissue repair, or apical transvaginal mesh repair) compare to each other as well as the advantages and/or disadvantages, risks and benefits, and the effect on quality of life of each surgery when used to repair vaginal vault (apical) prolapse. The ASPIRe cohort represents a unique opportunity to understand the longer-term efficacy and safety outcomes of a native tissue repair, transvaginal mesh, and abdominal sacral colpopexy for post-hysterectomy apical (vault) prolapse. Participants will complete annual study visits either in-person or remotely, and will complete a reduced set of questionnaires (PFDI-20, PFIQ, PGI-I, PISQ-IR, SF-12, DRS-SDS).
More InformationE-SUPeR
Extension of the Study of Uterine Prolapse Procedures
The E-SUPeR study extends the follow-up of women in the SUPeR clinical trial up to 10 years from the time of surgery. The primary aim of SUPeR was to determine whether treatment success in women with symptomatic uterovaginal prolapse undergoing transvaginal mesh augmented hysteropexy differs in women undergoing vaginal hysterectomy and native tissue cuff suspension at time points through 3 years. The SUPeR participant population represents a unique opportunity to understand the longer term efficacy and safety outcomes of a native tissue repair and a mesh hysteropexy. Participants will be seen annually for a physical exam and will be asked to complete a reduced set questionnaires (PFDI-20, PFIQ, PGI-I, ISI, and PISQ-IR.)
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