BBI Contributing Writer
SAN DIEGO – The first joint meeting of the American Urogynecologic Society (AUGS; Washington) and the Society of Gynecologic Surgeons (SGS; St. Louis), held here in late July, featured a focus on medical and surgical techniques to treat various forms of incontinence. Clinical presentations included new drugs for overactive bladder (OAB) and a look at practice patterns of physicians regarding female sexual dysfunction (FSD).
Loss of bladder control is far more common than most people realize – 32% of all American men and women ages 30 to 70 have experienced some degree of bladder control loss. The National Association for Continence (NAFC; Charleston, South Carolina) booth at the AUGS/SGS meeting highlighted these facts and more from its nationally sponsored survey published the month prior to the meeting.
"People need to know that loss of bladder control is actually quite common and is always treatable," said Nancy Muller, executive director of NAFC. "This new research shows us that for the approximately 25 million Americans with this condition, life very often improves after diagnosis. The majority of those surveyed continue to lead active, full lives – traveling, shopping and dining out. We're hoping that these findings will encourage more people who may be living with symptoms in silence to discuss them with a healthcare provider, spouse or a family member and to seek out the many options available to them."
A number of drugs for overactive bladder have been introduced to the market during the past five years. One of these, the antimuscarinic agent solifenacin, is effective at reducing the number of urgency episodes in patients with overactive bladder, according to investigators presenting during the AUGS/SGS clinical sessions. "In a pooled analysis of over 2,800 patients with overactive bladder, two doses of once-daily solifenacin were associated with a significant reduction in the number of urgency episodes per day," said principal investigator Vincent Lucente, MD, medical director of the Institute for Female Pelvic Medicine and Reconstructive Surgery (Allentown, Pennsylvania). "It may be the first antimuscarinic agent to have this effect on a hallmark symptom of overactive bladder."
Earlier research showed that solifenacin reduced symptoms of incontinence, urgency, and frequency, and patients reported a low incidence of dry mouth at the suggested starting dose of 5 mg daily. Although urgency is a defining symptom of overactive bladder, it had not often been included as an efficacy variable in trials of therapies for this condition. In the current study, Lucente and his co-investigators pooled four studies of solifenacin and documented changes in the number of urgency episodes in a 24-hour period. All studies were randomized, placebo-controlled, double-blind, 12-week trials and had similar protocols and designs. The investigators in the studies based efficacy outcomes on data collected from the patients in three-day micturition diaries.
The studies involved 2,823 evaluable patients, including 1,124 treated with placebo, 548 treated with 5 mg of solifenacin daily, and 1,151 treated with 10 mg of solifenacin 10 mg daily. At the time of entry into the studies, patients reported a mean of about six urgency episodes per day. Among these patients, 62% of those on the 5 mg dose and 66% of those on the 10 mg reported that the number of urgency episodes was reduced by at least half at the study endpoint, compared with 44 of those treated with placebo. The subset analyses showed that solifenacin was equally effective in reducing urgency episodes in women and men.
Worldwide attention has been focused on the issue of male sexual dysfunction in the past few years, but not much has been published about this syndrome in females. There is speculation that part of the reason female sexual dysfunction is not being addressed is because physicians are not screening for the problem. During the AUGS/SGS clinical sessions, Roger Pauls, MD and his associates at Good Samaritan Hospital (Cincinnati) presented research in which they assessed practice patterns of urogynecologists with respect to female sexual dysfunction (FSD). Physician members of AUGS were surveyed. The majority of the 234 respondents see urogynecology patients only (21%) or urogynecology with some general gynecology patients (42.9%). Asked what percentage of their patients experience FSD, 27.4% said under 20%, 24.4% said 21% to 30%, and 25.9% said over 40%. Some 80% of the respondents received post-residency training in urogynecology. Of those, 47.7% said their training with respect to FSD was unsatisfactory.
Pauls and his co-investigators noted, "While most urogynecologists acknowledge the need to screen for FSD, the majority underestimate its prevalence. Many are unaware of the tools available for screening and potential therapeutic options, and post-residency training programs fail to address this deficiency. More needs to be done to implement awareness and training for this growing aspect of women's health."
New on the exhibit floor
Among the presenting medical manufacturers at the AUGS/SGS meeting there were several new and/ or continuing developments. One of the products most likely to be adopted by women is the FemSoft Insert from Rochester Medical (Stewartville, Minnesota). In women between the ages of 15 and 64, the incidence of urinary incontinence can be as high as 30%. Most suffer from stress urinary incontinence (SUI), which can occur with coughing, sneezing, laughing, or other physical activities that increase intra-abdominal pressure. Though women spend billions of dollars to manage SUI, many never seek professional help. SUI often goes undiagnosed while women live in fear of odor and wetness and restrict their activities.
The FemSoft Insert may change the way women think about SUI. The insert consists of a narrow silicone tube entirely encased in a soft, thin mineral oil-filled sleeve. The sleeve, also silicone, forms a balloon at the internal tip and a soft, oval-shaped external retainer at the opposite end. A disposable applicator is used to provide a means for insertion. As the insert is advanced into the urethra, the fluid within the sleeve moves toward the external retainer to facilitate the insert's passage through the urethra. Once the insert's tip has entered the bladder, the fluid returns to fill the balloon, creating a seal at the bladder neck and urethra.
The FemSoft Insert adjusts to changes in intra-abdominal pressure and body movement to ensure constant contact with the urethral tissue, thereby preventing urge leakage and protecting delicate tissue from trauma and abrasion. When a woman needs to void, she simply grasps the external retainer and gently removes the insert. After voiding, if continued protection from leakage is desired, a new insert is placed.
Incisive Surgical (Plymouth, Minnesota) demonstrated the Insorb 20 Subcuticular Skin Stapler – an interrupted skin closure method that delivers eversion with minimal tension on the incision edges. The company notes the absorbable staple is rapid and easy to use, saving operating room time. The cost and hassle associated with metal staple removal is eliminated and potential needlesticks that occur with traditional sutures are avoided. The absorbable staples are made of a lactide/glycolide co-polymer that has an established history in wound closure. The staple design features a U-shaped curvature with cleats at the two distal ends, providing secure closure during the initial wound healing phases. The absorbable staple is gradually absorbed via hydrolysis.
In his paper evaluating the absorbable staple, K. Anthony Shibley, MD, a Minneapolis physician, noted the absorbable staples demonstrated equivalent efficacy compared to metal skin staples with significantly improved cosmesis and patient satisfaction. "We found a remarkable decrease in tissue irritation over the incisional areas closed with the absorbable staples compared to the regions closed with metal staples." He added, "It has long been understood in the medical community that the optimal incisional closure technique results in minimal tension on the wound edges with good eversion and approximation. Use of the absorbable subcuticular skin staples results in a uniform, interrupted, everted skin closure without the percutaneous tissue insult associated with metal skin staples. Our clinical results indicate that the incisional closure is equivalent to metal skin staples with respect to efficacy while additionally eliminating the cost and patient discomfort associated with removal of metal skin staples."
The SURx transvaginal system from CooperSurgical (Trumbull, Connecticut) uses radio frequency to accomplish bladder neck suspension. SURx is a clear departure from existing procedures for the treatment of genuine stress incontinence (GSI). Using low-power bipolar radio frequency (RF) energy to shrink and stabilize the endopelvic fascia, the system eliminates the need for surgical staples, bone screws, implants or slings. It is the least-invasive form of GSI surgical intervention, with success rates comparable to traditional procedures and complication rates that are significantly lower.
The SURx system shrinks and stabilizes the pelvic tissue supporting the bladder neck using low-power RF energy. CooperSurgical claims no incidence of over-correction, urinary retention, urethral injury or erosion during clinical studies. Cystoscopy is not necessary. This is a straightforward outpatient procedure that can be performed under local anesthesia. Patients are generally discharged in two to four hours with no catheter. The efficacy of the SURx procedure relies on tissue shrinkage and stabilization that occurs during the postoperative healing period. The full effect of the treatment may not be seen until healing is complete – six to eight weeks postoperatively.