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
ASPIRe
Apical Suspension Repair for Vault Prolapse
The purpose of the “ASPIRe” study is to find out how the results of the surgical procedures 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. Physicians can choose from these different types of surgeries to repair vaginal vault (apical) prolapse, but there is not enough information or evidence that demonstrates which surgery provides the best symptom relief and durability while causing the fewest risks.
More InformationBioLIFT
Biofabrication of Vaginal Support Using Vaginally Derived Cells
The Biofabrication of Vaginal Support Using Vaginally Derived Cells (BioLIFT) feasibility study is looking at whether it is possible to grow ligaments in a laboratory from cells taken from a woman’s vagina during surgery. If this is possible, then the researchers will study whether the ligaments could be used in a vaginal or uterine prolapse repair surgery for that same woman to improve how long the surgical repair lasts.
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.)
More InformationMUSA
Mixed Urinary Incontinence: Mid-urethral Sling vs.
Botox A
The primary objective is to estimate the effect of intradetrusor injections Botulinum toxin A (Botox A ®) compared to mid-urethral sling for treatment of MUI in 146 women 6 months after treatment. The change in severity of MUI symptoms will be measured using the Urogenital Distress Inventory.
Secondary objectives include identifying predictors of treatment failure and cost-effectiveness of treatments in this MUI population.
MUSA-PRoMISe
Proteomics and Pathway Analysis of Women With Mixed Urinary Incontinence-MUSA Supplementary
The primary aim of the PRoMISe study is to characterize baseline putative proteins/protein pathways in women with MUI associated with change in UDI after treatment with MUS or onabotulinum toxin A (i.e., MUSA Trial original subjects, N=110).
More InformationPaPPR
Patient Perception of Postoperative Recovery
PaPPR is a supplemental study to characterize a patient’s assessment of postoperative recovery and to determine the optimal outcome measure to capture a patient’s quantitative assessment of postoperative recovery following minimally invasive surgery for apical prolapse via an individual virtual cognitive interview.
More InformationSUPeR
Study of Uterine Prolapse Procedures
The investigators of the Pelvic Floor Disorders Network have been very interested in comparing various treatments for prolapse in order to provide information that will help doctors develop the best treatment plan for their patients.
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