what’s new in urogynecology?€¦ · kaplan and matthew goldstein the food and drug...
TRANSCRIPT
What’s new in urogynecology?
Peggy Norton MDChief of Female Pelvic Medicine and
Reconstructive Surgery, University of Utah
Learning objectives:
• Describe changes in National policy on urinary tract infection and hematuria
• Discuss the impact of the removal of mesh from the US market in treating prolapse in women
• Understand the pros and cons of new treatment options for urinary incontinence
ACOG and AUA guidelines on recurrent UTI
• First line drugs nitrofurantoin, TMP-sulfa DS, and single dose fosfomycin
• Prevention measures like d-mannose and cranberry have small effect compared to vaginal estrogen
• Increasing emphasis on culture, if feasible
New York Times, April 16 2019
F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for WomenThe Food and Drug Administration said there was insufficient evidence that mesh worked better than surgery to repair pelvic organ prolapse. By Sheila Kaplan and Matthew GoldsteinThe Food and Drug Administration on Tuesday ordered the two remaining medical device companies selling surgical mesh for the repair of pelvic organ prolapse to stop all sales and distribution in the United States.
Increasing patient input and shared decision making
• Should a hysterectomy be done in the case of POP, if there is otherwise good apical support?
Dallas et al 2018 reviewed 100,000 cases from California database and while hyst decreased the risk of future POP surgery by 1-3%, this was associated with increased morbidity.
• Should a sling be done at the time of POP surgery, if there is no existing SUI?
Jelosek et al 2013, risk of unmasked SUI is 20-70%. Multiple trials side on offering sling, but Europeans rarely offer this compared to U.S.
More mesh may be removed from the U.S. market
• No mesh slings in Scotland and England, New Zealand, and Australia.
• FDA closely tracks mesh slings in U.S.• Concerns about abdominal sacrocolpopexy
are increasing
• What are the alternatives if mesh slings are removed from market? If mesh sacrocolpopexy is removed from market.
What will you do if mesh slings are removed from the market in the U.S.
• 290,000 procedures annually in U.S. for stress incontinence, 97% are mesh slings
• In other countries, fascial slings and Burch colposuspension have been revived and surgical courses had to be organized quickly in response to these changes
Autologous and donor fascial slings require more expertise
No more effective or durable than mesh sling in women undergoing primary procedures.
Tightness of a fascial sling can be individualized, but voiding problems are much more common.
After six weeks, can divide sling in midline.
What will you do if mesh sacrocolpopexy is no longer performed in the U.S?
Native tissue vaginal repair versus mesh sacrocolpopexy
• No difference in the combined apical repairs from the Pelvic Floor Disorders Network (Rogers et al, ObstetGynec March 2018)
• Uterosacral ligament suspension, sacrospinous ligament suspension, and sacrocolpopexy all remain reconstructive options for now.
• We are seeing increasing complications of robotic mesh sacrocolpopexy, often with surgeons who perform fewer than 25 cases a year.
Urge incontinence
• Mirebegron (Myrbetriq) similar efficacy but dramatic improvement in dry mouth effect
• Cognitive issues are of increasingly concern in elderly: trospium (generic Sanctura) 20 mg b.i.d. has best profile for this as it is a quartenaryamine and does cross the blood brain barrier.
• Consider a bladder diary, as experts almost always use these. 24 hr UO is 40 oz, usual voided volumes 6-8 oz
Botox A is increasingly used in urge incontinence, usually injected in clinical
setting every 6-12 months
Visco AG, Brubaker L, Richter HE, et al. Anticholinergic therapy vs. onabotulinumtoxin A for urgency urinary incontinence. N Engl J Med. 2012 Nov 8;367(19):1803-13.
Justify therapy if failure of two anticholinergics (efficacy and side effects considered)Also document failure of behavioral modification (large voided volumes, excess fluid intake, etc.)
Botox A versus neuromodulation (Interstim) for refractory urge incontinence: the Rosetta trial
• Similar efficacy with Botox and with neuromodulation in these difficult patients
• In every other respect, Botox was superior to neuromodulation
• We now only offer neuromodulation to patients who fail Botox A, or who need neuromodulation for severe voiding problems.
In summary
• Treatment of UTI emphasizes culture if feasible• Mesh was removed last year for the treatment of
POP, but native tissue is still acceptable. If doing sacrocolpopexy, higher volume surgeons may be necessary if we are see this surgery continue.
• If mesh slings are removed from the market, Burch and fascial slings remain good options
• Consider Botox earlier in the management of urge incontinence