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AUA: Female SUI (2023)
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===== Options (4): ===== #'''<span style="color:#ff0000">Bulking agents</span>''' #'''<span style="color:#ff0000">Synthetic midurethral slings (MUS)</span>''' #'''<span style="color:#ff0000">Autologous pubovaginal sling (PVS)</span>''' #'''<span style="color:#ff0000">Burch culposuspension</span>''' ====== Bulking agents ====== * Trade name: Bulkamid **FDA approved in 2020[https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170023B.pdf §] *'''Little long-term data''' * '''<span style="color:#ff0000">Indications (2):</span>''' *#'''<span style="color:#ff0000">Patients who wish to avoid more invasive surgical management or are concerned with the lengthier recovery time after surgery</span>''' *#'''<span style="color:#ff0000">Patients who experience insufficient improvement following a previous anti-incontinence procedure.</span>''' *'''<span style="color:#ff0000">Disadvantage (1)</span>''' *#'''<span style="color:#ff0000">Patients should be counseled on the expected need for repeat injections</span>''' *Adverse events[https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170023C.pdf §] **Pain at implantation (13%) **Acute urinary retention (6%) **Urinary tract infection (4%) **Blood in urine (2%) ====== Synthetic Midurethral Sling (MUS) ====== * Most studied surgical treatment for female SUI *Other than bulking agents, MUS is also the least invasive surgical options to treat SUI *'''<span style="color:#ff0000">Classification (3):</span>''' *#'''<span style="color:#ff0000">Retropubic MUS (RMUS, e.g. TVT-R);</span>''' top-down or bottom-up *#'''<span style="color:#ff0000">Transobturator MUS (TMUS e.g. TVT-O);</span>''' inside-out or outside-in *#*TVT without specification refers to TVT-R *#'''<span style="color:#ff0000">Single incision sling (SIS)/adjustable sling types</span>''' * '''<span style="color:#ff0000">Retropubic vs. Trans-obturator synthetic midurethral sling</span>''' ** '''<span style="color:#ff0000">Efficacy</span>''' ***'''Short-term analyses found them to be equivalent''' ***'''Long-term comparisons are relatively lacking, however, data from increasing follow up appear to be demonstrating a <span style="color:#ff0000">lack of durability of Transobturator MUS, compared to Retropubic MUS</span>''' ** '''<span style="color:#ff0000">Adverse events:</span>''' ***'''<span style="color:#ff0000">Significant differences:</span>''' **** '''<span style="color:#ff0000">Retropubic MUS more likely to have (4):</span>''' ****# '''<span style="color:#ff0000">Major vascular or visceral injuries</span>''' ****# '''<span style="color:#ff0000">Bladder or urethral perforations</span>''' ****# '''<span style="color:#ff0000">Voiding dysfunction</span>''' ****# '''<span style="color:#ff0000">Suprapubic pain</span>''' **** '''<span style="color:#ff0000">Transobturator MUS more likely to have (3):</span>''' ****# '''<span style="color:#ff0000">Groin pain</span>''' ****# '''<span style="color:#ff0000">Repeat incontinence surgery between 1-5 years</span>''' ****# '''<span style="color:#ff0000">Repeat incontinence surgery after >5 years</span>''' **** '''Briefly, Retropubic MUS riskier but lasts longer</span>''' ***** '''<span style="color:#ff00ff">TOMUS (Trial of Mid-Urethral Slings) (NEJM 2010)</span>''' ****** Population: 597 women with SUI ****** Randomized to retropubic vs. transobturator midurethral sling ****** Primary outcome: treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment) ******Results: ******* At 12 months, retropubic slings equivalent efficacy and greater risk of post-operative voiding dysfunction compared to transobturator slings ******[https://pubmed.ncbi.nlm.nih.gov/20479459/ Richter, Holly E., et al. "Retropubic versus transobturator midurethral slings for stress incontinence." ''New England Journal of Medicine'' 362.22 (2010): 2066-2076.] * Single incision sling **Introduced as a less invasive, lower morbidity surgery with the potential to maintain the efficacy of the existing MUS techniques *Single incision sling vs. Retropubic MUS vs. Trans-obturator MUS MUS ** SIS demonstrates similar efficacy to TMUS; however, there is limited comparative data to RMUS. * '''<span style="color:#ff0000">Guideline Recommendations on choice of MUS</span>''' **<span style="color:#ff0000">'''Both Retropubic MUS (either the bottom-up or the top-down) and Transobturator MUS (either the in-to-out) or out-to-in can be offered for MUS.'''</span> **'''<span style="color:#ff0000">SIS can be offered with patient understanding that long-term data on safety and efficacy is lacking</span>''' * '''<span style="color:#ff0000">Patient counselling</span>''' ** '''<span style="color:#ff0000">Must discuss the specific risks and benefits of mesh as well as the alternatives to a mesh sling.</span>''' **'''<span style="color:#ff0000">Patients considering MUS should be made aware of the prior FDA public health notifications regarding the use of transvaginal mesh to treat SUI or pelvic organ prolapse and be advised of possible mesh-related risks, such as vaginal exposure (which can also be associated with dyspareunia) and perforation into the lower urinary tract or other neurovascular or visceral symptoms</span>''' '''<span style="color:#ff0000">either of which could require additional procedures for surgical removal of the involved mesh</span> and, if necessary, repair of the lower urinary tract.''' ***'''Risk factors for mesh erosion (5):''' ***#'''Diabetes''' ***#'''History of smoking''' ***#'''Older age''' ***#'''>2 cm vaginal incision length''' ***#'''Previous vaginal surgery''' ** '''<span style="color:#ff0000">Abdominal, pelvic, vaginal, groin, and thigh pain can be seen after sling placement</span>''' ** '''The literature does not definitively suggest that MUS is more or less effective to alternative interventions, such as PVS or colposuspension''' * '''<span style="color:#ff0000">Technique</span>''' ** '''<span style="color:#ff0000">Do not place a mesh sling if the urethra is inadvertently injured at the time of planned MUS procedure</span>''' ***If the surgeon feels it is appropriate to proceed with sling placement in the face of an inadvertent entry into the urethra, then a non-synthetic sling should be utilized * '''<span style="color:#ff0000">Contraindications</span>''' **'''<span style="color:#ff0000">Should not utilize a synthetic MUS in patients undergoing concomitant (3):</span>''' **# '''<span style="color:#ff0000">Urethral diverticulectomy</span>''' **# '''<span style="color:#ff0000">Repair of urethrovaginal fistula</span>''' **# '''<span style="color:#ff0000">Urethral mesh excision</span>''' *** Mesh placed in close proximity to a concurrent urethral incision can theoretically affect wound healing, potentially resulting in mesh perforation. ***Instead, an anti-incontinence procedure that does not involve placement of synthetic material suburethrally, or use of a biologic material, preferably autologous fascia, should be considered. ** '''<span style="color:#ff0000">Consider avoiding the use of mesh in patients undergoing SUI surgery who are at risk for poor wound healing, including</span>''' **#'''<span style="color:#ff0000">Following radiation therapy</span>''' **#'''<span style="color:#ff0000">Presence of significant scarring</span>''' **#'''<span style="color:#ff0000">Poor tissue quality</span>''' **#'''<span style="color:#ff0000">Long-term steroid use</span>''' **#'''<span style="color:#ff0000">Impaired collagen associated with systemic autoimmune disorders, such as visceral Sjogren’s disease or systemic lupus erythematosus</span>''' **#'''<span style="color:#ff0000">Immune suppression</span>''' ====== Autologous Fascia Pubovaginal Sling ====== * '''<span style="color:#ff0000">Involves the placement of autologous fascia lata or rectus fascia beneath the urethra to provide support</span>''' **'''<span style="color:#ff0000">Procedure more morbid than MUS</span>''' **Efforts to use other materials, such as porcine dermis and cadaveric fascia, as substitution for the autologous fascia have shown inferior results. * '''<span style="color:#ff0000">Adverse events:</span>''' *#'''<span style="color:#ff0000">Wound infection</span>''' *#'''<span style="color:#ff0000">Seroma formation</span>''' *#'''<span style="color:#ff0000">Ventral incisional or leg hernia depending on the fascial harvest site</span>''' *'''<span style="color:#ff00ff">SISTEr (NEJM 2007)</span>''' **Population: 655 women with SUI **Randomized to autologous rectus fascia PVS vs. Burch colposuspension ** Results ***Success rates higher for PVS *** Voiding dysfunction (63% vs. 47%, ''P'' < .001), UTI, difficulty voiding, and postoperative urgency incontinence higher for PVS **[https://pubmed.ncbi.nlm.nih.gov/17517855/ Albo, Michael E., et al. "Burch colposuspension versus fascial sling to reduce urinary stress incontinence." ''New England Journal of Medicine'' 356.21 (2007): 2143-2155.] ====== Burch colposuspension ====== *Largely replaced by MUS **Several RCTs showed essentially equivalent outcomes with the Burch colposuspension vs. TVT *Likely inferior to pubovaginal fascial sling *'''<span style="color:#ff0000">Indications (2):</span>''' *#'''<span style="color:#ff0000">Patient preference to avoid mesh and avoid the morbidity of fascial harvest</span>''' *# '''<span style="color:#ff0000">Undergoing a simultaneous abdominal procedure, such as open or minimally invasive hysterectomy</span>'''
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