The Ohio State University College of Medicine’s Division of Urogynecology and Reconstructive Pelvic Surgery at The Ohio State University Wexner Medical Center was selected to be a key site in a multicenter trial comparing outcomes between a new bladder neck bulking agent, Bulkamid, and the mid-urethral sling for treating selected patients with stress urinary incontinence.
The aim of the Patient-Centered Outcomes Research Institute (PCORI) study is to evaluate which anti-incontinence treatment works best from a patient’s perspective when performed at the time of a vaginal prolapse repair.
Site lead investigator Lisa Hickman, MD, clinical associate professor of Obstetrics and Gynecology in the Ohio State College of Medicine, and her colleagues will enroll 43 patients undergoing surgery for pelvic organ prolapse and randomize them to treatment with either a mid-urethral sling or Bulkamid.
Understanding the Conditions
Stress urinary incontinence is the involuntary leakage of urine with increases in intra-abdominal pressure, such as with coughing, laughing, sneezing or physical exertion. Pelvic organ prolapse is a condition in which the pelvic organs descend into or outside of the vagina, similarly to a hernia, due to weakness in the organ supports. The bladder, bowels, rectum, uterus and cervix or vaginal cuff (for those who’ve had a hysterectomy) can all be involved.
Similarly, stress urinary incontinence commonly occurs when there’s weakness in the suburethral support.
Prolapse Treatment Dilemma
Approximately 35% of women experience stress incontinence at some point in their lifetime. Additionally, 80% of women with pelvic organ prolapse will also experience bothersome stress incontinence, either present before surgery or discovered when the prolapse is reduced.
“This can have a significant negative impact on quality of life and the ability for patients to do the things they need to do,” Dr. Hickman says. “We are hoping the findings of this study will give patients another less-invasive and effective treatment option for managing their incontinence.”
Currently, pelvic floor physical therapy and vaginal pessaries are good initial nonsurgical options for treating both stress incontinence and pelvic organ prolapse. However, this requires a significant commitment to multiple office and treatment visits, as well as to a long-term home exercise regimen.
When patients elect to undergo surgical correction for bothersome pelvic organ prolapse, concurrent correction of their stress urinary incontinence is important.
A Superior Bulking Agent
Bulking agents are not new, dating back to the 1990s, and a variety of materials have been utilized over the years. Dr. Hickman says these agents had poor short- and long-term success rates, which resulted in the mid-urethral sling becoming the preferential treatment of choice for stress incontinence, with bulking reserved as a salvage procedure for patients who weren’t suitable surgical candidates. However, not all people wish to have a mesh implant to address their incontinence.
The newer Bulkamid injection, formulated of polyacrylamide and 97.5% water, is injected cystoscopically at the level of the bladder neck to create four cushions, typically, underneath the lining of urethra. There, the soft gel creates a natural cushioning effect, providing resistance inside the urethra to prevent urine leakage.
Since its FDA approval in 2020, this treatment has been used by urogynecologists to manage uncomplicated stress urinary incontinence, with 70% of patients reporting significant improvement after treatment. Studies in Europe that followed women seven years out found only one in five will undergo a subsequent incontinence procedure after bulking.
“I do tell patients they may require retreatment of the bulking agent at some point in the future, whereas the mid-urethral sling is a permanent polypropylene mesh, so once we place it, it does not lose its effectiveness over time and repeat surgery is unlikely unless there is an atypical need to revise it,” Dr. Hickman says. “But the good news is that bulking is a very short minimally invasive procedure, so if retreatment is necessary, patients can have it performed without any down time.”
Challenging the Gold Standard
Slings have been the gold standard for their high efficacy in treating stress incontinence.
“But there are greater risks both intraoperatively and postoperatively, including changes in voiding, worsening of overactive bladder symptoms or even a mesh exposure in the vagina,” Dr. Hickman says. “While the sling has high efficacy, we don’t have head-to-head data for its role at the time of prolapse repair.
“This study will help us close the research gap and be in a better position to counsel patients about how to choose the best treatment for them.”