Editing Functional: Female SUI (section)

===== Midurethral Slings (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>'''
====== Mechanism of Action (2) ======
#'''<span style="color:#ff0000">Restricts movement of the posterior urethral wall above the sling</span>''' , directing its motion in an anteroinferior or anterior direction.
#*'''<span style="color:#ff0000">Patients without urethral hypermobility do not respond as well to MUS surgery'''
#** '''<span style="color:#ff0000">Lack of urethral mobility is an indication that the patient has a fixed urethra and ISD'''
#'''<span style="color:#ff0000">Narrows (compresses) the urethral lumen</span> due to inward movement of the posterior urethral wall after placement of a MUS'''

====== Anatomy ======
*'''<span style="color:#ff0000">Anatomy of the Retropubic Midurethral Sling'''
** '''The left and right dorsal nerves of the clitoris (DNCs) run along the inferior surface of the ischiopubic rami''' and cross under the pubic bone approximately 1.4 cm from the midline
** '''<span style="color:#ff0000">The obturator vessels are the closest major vascular structures to a retropubic MUS'''
* '''<span style="color:#ff0000">Anatomy of the Transobturator Midurethral Sling'''
** '''The transobturator technique is unique because (when done correctly) it avoids entry into the true pelvis and the levator group.'''
*** '''Muscle’s traversed by this technique include the obturator internus muscle, obturator membrane, and obturator externus muscle as it goes through the obturator foramen, and the adductor muscles (adductor magnus, adductor brevis, and gracilis), lateral to the obturator foramen'''
**** '''<span style="color:#ff0000">Errant sling placement through the adductor longus tendon can result in substantial pain.'''
** '''The obturator vessels are lateral and superior to the area of insertion of the device.'''
** '''The dorsal nerve of the clitoris is separated from the trajectory of the device by ≥1-2 cm'''

====== Synthetic Sling Materials ======
* The initial MUSs were made of materials with smaller pore sizes
* '''Currently, a soft, loosely woven, polypropylene monofilament mesh with a pore size > 75 μm is the most commonly used material'''
**Trend in the contemporary literature toward the use of '''macroporous polypropylene slings'''
***'''The increased pore size of these materials allows for: excellent tissue ingrowth, promotes integration with the surrounding host tissues, and decreases encapsulation and infection'''

====== Contraindications ======
*'''<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>'''
====== Technique ======
* '''<span style="color:#ff0000">Should be placed loosely at the midurethra</span>''' because its function is not primarily related to compression.
**'''A loosely placed MUS combined with a mobile urethra may allow the sling to compress the urethra during times of Valsalva and stress while remaining nonobstructive when the urethra is at rest.'''
***'''For single-incision MUSs, tension should be tighter than the classic retropubic or transobturator MUS surgeries to achieve the same result'''
****Unlike retropubic and transobturator MUSs, for single-incision MUSs it appears that restriction of urethral mobility after surgery is associated with a better outcome
*'''<span style="color:#ff0000">Cystoscopy is performed to exclude trocar penetration of the lower urinary tract.'''
** '''<span style="color:#ff0000">If bladder perforation is noted, the trocar is withdrawn and passed once more with an effort to avoid further perforation'''

====== Outcomes ======
*'''Predominantly SUI'''
** '''<span style="color:#ff0000">Retropubic vs. Trans-obturator synthetic midurethral sling</span>'''
***'''Similar outcomes, regardless of urethral function'''
***'''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>'''
** '''Single-Incision MUS in Patients with Predominantly SUI'''
*** There are fewer data available regarding the safety and efficacy of this new generation of slings compared with the retropubic and transobturator MUSs.
*** '''Single-incision slings have decreasing efficacy with longer follow-up.'''
* '''MUI'''
** '''Results with mixed incontinence are acceptable compared with other types of interventions for urinary incontinence but are less than those obtained in pure SUI.'''
* '''Intrinsic Sphincteric Deficiency'''
** '''The success of MUSs is lower in patients with ISD/fixed urethra (no urethral mobility) and low leak point pressures'''
*** '''Fixed urethras have poor outcomes after MUS surgery regardless of leak point pressure'''
*** '''Retropubic MUS are more effective than transobturator MUS in patients with ISD'''
** Low leak point pressures are not necessarily a contraindication to retropubic MUS surgery
** '''MUS is beneficial in the management of SUI in patients with ISD as long as there is preoperative urethral mobility; urethral mobility before MUS procedures has been shown to be predictive of success; the more the proximal urethra moves during a Valsalva maneuver, the better the cure rate for incontinence'''
* '''Efficacy and safety of MUSs are not compromised in those undergoing concomitant vaginal surgery, the elderly, or the obese.'''
**'''Pelvic Organ Prolapse'''
*** '''Results suggest that the MUS can be added to prolapse surgery with minimal morbidity.'''
**** The Cochrane Incontinence Group reviewed 22 randomized trials of surgical prolapse repair including 2368 women. They concluded that '''the addition of a retropubic MUS to endopelvic fascial plication, Burch colposuspension, and abdominal sacrocolpopexy may reduce the incidence of postoperative SUI''', but issues of cost and associated adverse effects were unclear
**** Women who underwent prolapse repair at the time of the sling surgery were significantly more likely to be diagnosed with postoperative outlet obstruction (9.4% vs. 5.5%, ''P'' < .007), but less likely to undergo a repeat procedure for stress incontinence or reoperation for prolapse within 1 year after sling surgery.
**** '''When MUSs are placed for urodynamic or occult SUI at time of prolapse repair, the risk of intervention because of obstruction is equivalent to the risk of intervention for SUI if no MUS was placed''' (8.5% and 8.3%, respectively)
*** MUSs placed with either transvaginal or laparoscopic-assisted vaginal hysterectomy and anterior or posterior colporrhaphy have been shown to have success rates similar to those in published series of MUS surgery alone. Complication rates are also in accordance with other MUS series
** '''Elderly Patients'''
*** '''Cure rates in older women with urethral hypermobility are comparable to those in younger women.'''
**** '''Elderly women should not be excluded from potentially curative MUS surgery based on their age alone.'''
**** Mixed urinary incontinence resolution rates are similar to those of the younger population
**** Possibly because of preoperative factors such as MUI or even decreased urethral hypermobility, '''the rate of persistent SUI after retropubic or transobturator MUS procedures appears higher in the elderly population'''.
*** Complication rates vary, with some studies citing a higher rate of age-related morbidities but '''no apparent increase in intraoperative complications.'''
**** '''Elderly patients experience higher rates of postoperative de novo urgency and urgency incontinence associated with any sling material, including MUS'''
**** Postoperative retention occurs to a similar degree as in younger patients
** '''Obese Patients'''
*** '''Controversial whether obesity affects surgical outcome with MUSs'''
*** Overall, the rate of complications appears to be similar in obese versus non-obese patients undergoing MUS surgery.
**** Higher rate of bladder trocar injury in non-obese patients
* '''Recurrent Stress Urinary Incontinence'''
** '''As salvage procedures, MUS have overall efficacy similar to their use in primary implantation procedures.'''
** '''The procedure can be performed in the same way as it is performed for primary SUI.'''
** '''The complication rate is similar to that of retropubic MUSs done for primary SUI, but the risk of bladder perforation appears to be higher''' in females who have had ≥1 prior retropubic suspensions.
** As is the case with primary surgery, the failure rate is higher in females with immobile urethras.
** '''No significant difference in subjective cure rates in patients after retropubic vs. transobturator MUS surgery for recurrent SUI.'''

====== <span style="color:#ff0000">Adverse events ======
* '''Patient counselling'''
**'''Permanent nature of these products since''' MUS surgery involves the implantation of a synthetic, prosthetic material
**'''Unique and sometimes serious complications related to their use'''
**'''Risk of''' '''transient and permanent voiding dysfunction after surgery, including''' '''postoperative difficulty emptying the bladder and de novo urgency and frequency'''
*'''<span style="color:#ff0000">Overall, relatively low rates of complications (10)'''
*# '''<span style="color:#ff0000">Bladder trocar injury: 2.7-3.8%; higher with retropubic'''
*# '''<span style="color:#ff0000">Voiding dysfunction: 7.6%'''
*# '''<span style="color:#ff0000">Wound healing problems: 1%'''
*# '''<span style="color:#ff0000">Vaginal mesh exposure</span>: 0.5-8.1%'''
*# '''<span style="color:#ff0000">Mesh perforation of urethra</span>''' (transobturator and retropubic): '''0-0.6%'''
*# '''<span style="color:#ff0000">Mesh perforation of bladder</span>: 0.5-0.6%'''
*# '''<span style="color:#ff0000">Sexual dysfunction'''
*# '''<span style="color:#ff0000">Groin pain; higher with transobturator</span>'''; conservative therapy with NSAIDs should resolve the majority of symptoms. If pain persists after 6-8 weeks, consider referral to a pain clinic for trigger point injections and physical therapy.
*# '''<span style="color:#ff0000">Bleeding, vascular injury; higher with retropubic'''
*# '''Infection, bowel perforation, and death'''
* '''<span style="color:#ff0000">Bladder Trocar Injury'''
** '''<span style="color:#ff0000">Rate of trocar injury is higher with retropubic vs. trans-obturator MUS'''
*** '''The rate of bladder or urethral trocar injury:'''
**** '''Retropubic MUS surgery: 2.7-23.8%'''
**** '''Trans-obturator MUS surgery: 0-1.3%'''
** '''<span style="color:#ff0000">Management'''
***'''<span style="color:#ff0000">If occurs intra-operatively, remove trocar and pass trocar again more laterally and leave foley catheter in 3-7 days.'''
****'''Trocar injury is generally thought of as a benign condition.''' 
* '''<span style="color:#ff0000">Vaginal Mesh Exposure'''
** '''Most cases manifest within a few weeks to a few months after the MUS procedure'''
** '''Risk factors (5):'''
**#'''Diabetes'''
**#'''History of smoking'''
**#'''Older age'''
**#'''>2 cm vaginal incision length'''
**#'''Previous vaginal surgery'''
**'''<span style="color:#ff0000">Diagnosis and Evaluation'''
***'''<span style="color:#ff0000">History and Physical Exam'''
****'''<span style="color:#ff0000">Signs and Symptoms (6):'''
****# '''<span style="color:#ff0000">Vaginal discharge</span>''' (with variable constituents and different amounts of blood and inflammatory components)
****# '''<span style="color:#ff0000">Palpable rough surface in the vagina'''
****# '''<span style="color:#ff0000">Sexual discomfort</span>''' (including partner related)
****# '''<span style="color:#ff0000">Pelvic pain'''
****# '''<span style="color:#ff0000">Inguinal discomfort'''
****# '''<span style="color:#ff0000">LUTS (urgency, frequency, persistent incontinence, hematuria)'''
** '''<span style="color:#ff0000">Management'''
*** The management of this complication is not standardized, composition of mesh is particularly important in the event of mesh exposure
***'''<span style="color:#ff0000">Options (2)'''
****'''<span style="color:#ff0000">Conservative management with conjugated estrogen and possibly antibiotic creams''' 
*****'''<span style="color:#ff0000">Option in well-selected patients who are relatively asymptomatic and have small-caliber exposures (<1 cm)'''
**** '''<span style="color:#ff0000">Excision should be reserved for failure of conservative therapy or when local symptoms mitigate against observational management (e.g., bothersome dyspareunia).''' 
*****'''Limited excision and trimming with vaginal closure can be attempted.''' 
******'''Even with partial excision of the mesh, continence is maintained in the majority of patients.'''
***** '''If these options fail, excision of most of the mesh from a transvaginal approach should be pursued in most cases.'''
****** '''Operative management typically involves excision of the exposed mesh''', thorough irrigation with antibiotic solution, and closure of vaginal flaps. Good results have also been observed in selected patients with vaginal advancement flaps and suture approximation of the debrided vaginal mucosa over the exposed mesh.
* '''<span style="color:#ff0000">Mesh Perforation of the Urethra'''
** '''<span style="color:#ff0000">Diagnosis and Evaluation'''
***'''History and Physical Exam'''
****'''History'''
*****'''Presenting symptoms are variable'''
*****'''Voiding dysfunction is predominant'''
** '''<span style="color:#ff0000">Management'''
*** Management of this complication is extremely challenging
*** '''<span style="color:#ff0000">Observation should never be considered when there is urethral perforation'''
*** '''Options (2)'''
***#'''Endoscopic management of small areas of mesh perforation'''
***#'''Transvaginal surgical excision'''
***#* '''For slings that perforate into the urethra an inverted-U incision is best''' because this allows for exposure of the proximal urethra, bladder neck, and endopelvic fascia as well as providing a vaginal epithelial flap that avoids overlapping suture lines
***#* An autologous fascial sling or a Martius labial fat pad graft can be used for repair, at the discretion of the surgeon.
***#** '''An autologous fascial sling can be placed at the time of surgery to augment the repair or in a delayed fashion to treat recurrent SUI.'''
* '''<span style="color:#ff0000">Mesh Perforation of the Bladder'''
** '''Pathogenesis'''
***'''Most likely the result of an unrecognized cystotomy or placement of the mesh within the urinary bladder at the time of surgery'''.
** '''<span style="color:#ff0000">Diagnosis and Evaluation'''
***'''History and Physical Exam'''
****'''Signs and Symptoms'''
****#'''Lower abdominal pain'''
****#'''Intermittent gross hematuria'''
****#'''Recurrent UTI'''
****#'''Urgency'''
****#'''Frequency'''
****#'''Dysuria'''
****#'''Urinary incontinence'''
** '''<span style="color:#ff0000">Management'''
*** '''<span style="color:#ff0000">Observation should never be considered when there is intravesical perforation'''
***'''Options (2)'''
***#'''If small area of mesh perforation: endoscopic management (excision with scissors or ablation with the holmium laser) is an appropriate initial step if complete excision of all exposed material can be achieved'''
***# '''If endoscopic excision fails or as initial treatment for large areas of mesh perforation, transvaginal or retropubic excision'''
***## Reconstruction should involve nonoverlapping suture lines and interposition of tissue such as a labial fat pad or greater omentum.
***## An autologous fascial sling can be placed at the time of surgery to augment the repair or in a delayed fashion to treat recurrent SUI.
* '''Pain and Infection after MUS Surgery'''
** '''Groin and suprapubic pain are potential problems after MUS placement.''' 
***'''Thigh and groin pain appear to be more commonly associated with the transobturator approach'''
** '''Severe infection is a rare complication after MUS surgery'''
***Diagnosis of this complication is variable and can take as long as several years
*** '''Obesity, diabetes, and hypertension are associated with fasciitis after pelvic surgery.'''
** '''Management of MUS Severe Infection or Pain'''
*** '''In most cases, postoperative groin or leg pain after MUS surgery can be managed with NSAIDs, rest, and physical therapy.''' 
****'''Most groin pain resolves after postoperative day 2'''
*****Pain persists longer after the transobturator midurethral slings
*** In instances of chronic mesh pain and severe infection when nonoperative therapy has failed, it may be necessary to attempt a complete mesh excision from both sides of the bone.
*** For the complete excision of transobturator mesh we typically consult an orthopedic surgeon to aid with lateral dissection of the sling.
* '''<span style="color:#ff0000">Voiding Dysfunction after MUS Surgery'''
** '''Epidemiology'''
***De novo urgency occurs with postoperative voiding dysfunction in as many as 12% of patients
***'''Voiding dysfunction after MUS is substantially less than with PVS (bladder neck) slings'''
**'''Usually transient'''
***Long-term urinary retention and obstructive voiding dysfunction are rare after the MUS procedure
**'''Pathogenesis'''
***'''Typically the result of obstruction'''
****'''From the sling being placed too tightly or in the wrong location (too proximally)'''
****'''Associated with pelvic organ prolapse (unrecognized preoperatively or de novo)'''
*****Some patients may have voiding dysfunction without evidence of obstruction
** '''Risk factors'''
***'''Type of MUS'''
****'''In general, similar rates of de novo urgency and perioperative urinary retention among the different types of MUSs'''
****'''However, an RCT found significantly higher rate of voiding dysfunction necessitating surgery (or permanent catheter) after a retropubic MUS compared with a transobturator sling procedure (3% vs. 0%)[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4367868/ §]'''
**** In addition, the rate of urinary retention (catheter for longer than 6 weeks) was also higher in the retropubic MUS group (3.7% vs. 0.7%).
** '''<span style="color:#ff0000">Diagnosis and Evaluation'''
***'''<span style="color:#ff0000">History and Physical Exam'''
****'''<span style="color:#ff0000">History'''
*****'''<span style="color:#ff0000">Most common symptoms of obstruction are''' 
******'''<span style="color:#ff0000">Inability to void (urinary retention)'''
******'''<span style="color:#ff0000">Incomplete emptying'''
******'''<span style="color:#ff0000">De novo urgency and frequency'''
*****Over several weeks to a month, the storage symptoms (urgency and frequency) and pain become more prevalent as the bladder attempts to adjust to the obstruction.
****'''<span style="color:#ff0000">Physical Exam'''
*****'''<span style="color:#ff0000">Pelvic organ prolapse'''
******'''A key factor in assessing voiding dysfunction is the presence of prolapse that was either uncorrected at time of surgery or that occurred postoperatively.''' Prolapse of sufficient size may kink or angulate and externally compress the urethra. '''After surgery, apical, anterior, and posterior prolapse must be ruled out as a cause of the urethral obstruction'''
***'''<span style="color:#ff0000">Cystoscopy'''
****'''<span style="color:#ff0000">Useful to rule out bladder pathology, urethral mesh perforation, and a hypersuspended bladder neck'''
***The optimal evaluation for patients with postoperative voiding dysfunction is poorly defined in the literature. The decision to perform urethrolysis is usually based on a clear temporal relationship between onset of symptoms and the surgical procedure.
** '''<span style="color:#ff0000">Management''' 
*** '''<span style="color:#ff0000">Urinary obstruction after MUS surgery is usually transient and can be managed with short-term intermittent catheterization'''
*** '''<span style="color:#ff0000">If persistently elevated residual urine, bothersome symptoms refractory to conservative management, and within first 3 months of surgery, then perform transvaginal sling release'''
**** '''Cutting the MUS in the midline through a single vertical vaginal incision using minimal dissection is the preferred method to manage persistent voiding dysfunction that results from an obstructive sling within the first 3 months after surgery'''
*****'''Transvaginal sling release consistently provide resolution of symptoms with maintenance of continence in the majority of patients'''
******The entire sling does not need to be excised; majority of patients maintain continence with single incision
**** '''Timing'''
*****'''The exact timing of sling incision is variable; however, most recommend waiting at least 2 weeks; the sling should be incised within 4 weeks of surgery'''
*** '''<span style="color:#ff0000">If after 3 months, perform a more formal sling excision and urethrolysis'''
****'''Sling may be fixed along its entire course, and midline sling incision may not achieve enough sling relaxation to resolve voiding dysfunction'''
***'''<span style="color:#ff0000">Urethral dilation is of limited usefulness and, if used too aggressively, may be detrimental.'''
* '''<span style="color:#ff0000">Sexual Dysfunction after MUS'''
** '''Contradictory evidence in the literature that MUS surgery improves and worsens sexual function'''
*** Some attribute improved sexual function after MUS surgery to a significant decrease in coital incontinence
*** '''The rate of de novo dyspareunia after MUS surgery is between 3-14%; sling removal can improve dyspareunia'''
* '''Other Complications after MUS Surgery'''
** Infection, bleeding, vascular injury, bowel perforation, and death.
*** '''<span style="color:#ff0000">Risk of major vascular injury higher with retropubic vs. transobturator'''
*** '''The majority of postoperative hematomas resolve without intervention'''
** '''<span style="color:#ff0000">UTI is the most common and easily treatable complication of MUS surgery.'''

====== Regulatory and Legal Issues Related to Sling Mesh Complications ======
* '''See [[AUA & CUA Mesh Position Statement (2019)|AUA/CUA Mesh Position Statements]]'''
* The success of MUSs for incontinence led to the development of mesh products for pelvic organ prolapse repair. However, while the use of mesh during pelvic organ prolapse repairs has increased, so too have complications related to its use.
* Synthetic mesh for pelvic organ prolapse
**In October 2008, the FDA released a public health notification (PHN) alerting the public about “rare” complications and problems related to transvaginal mesh products used for pelvic organ prolapse. 
**'''In 2011, the FDA''' modified this alert by removing the term “rare” and '''stating that surgical mesh for pelvic organ prolapse repair does not conclusively improve outcomes over traditional nonmesh or native tissue repairs and is associated with unique potentially serious adverse outcomes'''
* '''Synthetic mesh for midurethral slings'''
**'''FDA advisory panel deemed existing MUS products “safe and effective”'''
** Even though the FDA has determined that existing MUS products are safe and effective, this unfortunately does not prevent MUSs from being caught up in the fervor of litigation related to products used for pelvic organ prolapse repair.
** '''Single-incision sling manufacturers are required to perform 522 postmarket surveillance studies'''