In This Article
- Stress urinary incontinence (SUI) is the complaint of any involuntary loss of urine on effort or physical exertion (e.g., sporting activities) or on sneezing or coughing
- While the Food and Drug Administration (FDA) allows the use of synthetic mesh in vaginal slings to treat SUI, an FDA ban on transvaginal repair of pelvic organ prolapse with mesh has some SUI sufferers seeking non-mesh alternatives
- Massachusetts General Hospital urologists Ajay Singla, MD, and Elise J. B. De, MD, are among a few providers offering only non-mesh surgical alternatives, including Burch colposuspension and fascial pubovaginal sling
- Burch colposuspension and pubovaginal sling offer fast recovery and minimal complications and long-term efficacy
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Two Massachusetts General Hospital urologists have returned to traditional surgical methods for women seeking to avoid synthetic mesh sling implants for the treatment of stress urinary incontinence (SUI).
After initial warnings in 2008 and 2011, the Food and Drug Administration (FDA) in 2019 banned the sale and distribution of urogynecologic surgical mesh for transvaginal repair of pelvic organ prolapse (POP). Pelvic organ prolapse is a condition in which the pelvic organs surrounding the vagina form a hernia, and there can be relaxation or bulging of the bladder, uterus or rectum beyond the vaginal entrance.
The FDA still allows synthetic surgical mesh slings to treat SUI and for the transabdominal repair of POP, and the warning do not apply to mesh applied from within the sterile abdominal cavity (abdominal sacrocolpopexy), where complications are much lower. However, the negative publicity surrounding the use of surgical mesh has resulted in more women wishing to avoid it entirely.
"These women are specifically requesting alternatives to the mesh," says Ajay Singla, MD, urologist in the Department of Urology and director of the Harvard Urologic Surgery Residency Program at Mass General. Dr. Singla stopped using synthetic mesh altogether in 2012 in favor of long-established fascia pubovaginal sling (PVS) and Burch colposuspension procedures.
"I was seeing too many women with complications from synthetic permanent implants," he says, citing genitourinary erosion, vaginal extrusion and removal difficulty.
Dr. Singla and Urologist Elise J. B. De, MD, a colleague with Mass General Urology, are among a limited number of providers currently offering only non-mesh surgical therapies for SUI.
"It is the mesh for prolapse that has been banned, not slings for SUI," says Dr. De. "Although data supports that the mesh midurethral sling is safe, and it is still the most commonly used technique, we have a hard time offering it. Since our job is to help when there has been an unexpected outcome, we have seen people who do not do well. Although I know that statistically my patient is likely to do well with a mesh sling, I feel more secure offering native tissue."
Prevalence, Types and Causes of Stress Urinary Incontinence
Approximately 50% of women experience SUI during their lifetimes. A distressing condition that carries social stigma, SUI is the involuntary leakage of urine caused by increased intra-abdominal pressures from coughing, sneezing, laughing, exercising or intercourse. Factors that increase the risk of SUI include aging, pregnancy and childbirth, prior pelvic surgery, obesity, chronic coughing, straining and smoking.
"Women delay care thinking it is just a natural part of aging," says Dr. De. "As the urinary leakage worsens, it slowly impacts life—going to the gym, clothing, going for hikes. Three years later we see them, when we could have helped so much earlier!"
SUI for women falls into three categories:
- Type I, the mildest form, is urine loss without urethral hypermobility
- Type II, also known as genuine SUI, is urine loss due to urethral hypermobility
- Type III causes urine leakage resulting from an intrinsic sphincter deficiency
First-line treatments for SUI are nonsurgical and include Kegel exercises, pelvic floor physical therapy, pessaries, transurethral bulking agents and behavior modification. If first-line treatments fail, women may seek surgery to relieve SUI, the most common of which is synthetic mesh midurethral slings (MUS). Some patients are candidates for a transurethral injection of bulking agent, which is minimally invasive but also less successful than slings.
Synthetic Mesh Midurethral Slings Replace Traditional Methods
After its introduction in the mid-1990s, the synthetic MUS became the gold standard for surgical treatment of SUI, replacing native tissue pubovaginal slings and Burch colosuspension, which produce strong outcomes but are more invasive.
"A mesh sling requires only a four-centimeter vaginal incision and can take just 30 minutes. And the patient goes home the same day, so it was attractive to patients, urologists and urogynecologists," says Dr. Singla.
MUS is also a popular choice because of synthetic material consistency, availability and durability. After the introduction of mesh options, most urological surgery trainees were taught primarily mesh options for midurethral slings.
The Return to Native-tissue Sling and Burch Colposuspension Procedures
As experienced urologists, Drs. Singla and De were trained in traditional surgical treatments for SUI, including PVS and Burch colposuspension. Both demonstrate long-term durability and efficacy.
"Synthetic mesh sling procedures are easier, faster, and the patient goes home the same day, but the trade-off is increased potential risk for complication over traditional methods," Dr. Singla says.
"In 2017, UT Southwestern Medical Center urologist Phillippe Zimmern, MD, and I published a surgical video atlas with our expert colleagues, including Dr. Singla, to reteach the techniques, called: Native Tissue Repair for Incontinence and Prolapse," says Dr. De. "We knew returning to basics of anatomy and surgical principles, rather than industry product marketing, would be the strongest path forward."
Autologous fascia graft procedures to treat SUI started in the 1940s and evolved into present-day pubovaginal sling (PVS) surgeries. These use "rectus fascia"—borrowing a strong strip of support tissue underneath the lower abdominal surface—or "fascia lata," a strip from the outside thigh. If alternative tissue strips are needed rather than mesh, human donor "acellular cadaveric allograft" or animal "xenograft" tissue can be safely used. As with MUS supporting the mid urethra, PVS procedures elevate and support the bladder neck in a hammock-like fashion. The sling material naturally stimulates organized fibrosis that immobilizes the bladder neck and restores urethral resistance while allowing voluntary urination.
Dr. Singla recommends PVS for older patients (for whom mesh is contraindicated, as their tissues are typically not strong enough to sustain the mesh reaction) or those with a weak sphincter muscle. "The mesh is supposed to be a tension-free sling but for those who have a very weak sphincter muscle, you need tension to tie the sling," he says. "However, tension can damage the wall of the urethra, causing the mesh to go inside the lumen, so better to use native tissue in this circumstance."
Also known as Burch retropubic urethropexy, this method was developed in 1961. The surgeon suspends and stabilizes the urethra by suturing the paravaginal fascia to Cooper's ligaments, attached to the pubis. The procedure elevates the urethra and decreases its mobility, thereby increasing its functional length and closure pressure.
"Dr. De and I are proud to offer Burch colposuspension," says Dr. Singla. He and colleague Nirmish Singla, MD, of Johns Hopkins Medicine, contributed a chapter about Burch colposuspension to the aforementioned Native Tissue Repair for Incontinence and Prolapse.
Dr. Singla recommends Burch colposuspension for younger patients. "In younger women, the problem is not a weak sphincter muscle but that the bladder has dropped," he says. "These women need bladder support by suspension to alleviate the pressure that causes urine leakage."
Urologists can perform Burch colposuspension using open incision surgery, laparoscopy or robot-assisted surgery. Open Pfannenstiel incision is Dr. Singla's choice because it leaves a minimal scar, and the procedure only takes about an hour.
Advancing SUI Care by Going Back to Basics
Dr. Singla wants physicians and patients to know that while PVS and Burch colposuspension are older procedures, they demonstrate long-term efficacy for women wishing to avoid mesh implants.
Dr. De says "I like to counsel all options, including pelvic floor physical therapy, injection of bulking agent (filler), midurethral mesh sling, pubovaginal sling, and burch colposuspension. Most of my patients try physical therapy; if that's not successful, we then move on to the bulking agent or the PVS."
"Regardless of the underlying cause of stress incontinence, regardless of the age of the patient, non-mesh options are available for SUI with a sling using the patient's own tissues or via a burch colposuspension," says Dr. Singla.
No matter the approach, patients should know that stress urinary incontinence, while not dangerous, often impacts quality of life. Fortunately, it can be treated safely and effectively.
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