Stress Urinary Incontinence

Stress Urinary Incontinence MONARC vs. Paravaginal wall Repair: A system and surgeon perspective Dr. Richard McClain, MD, FACOG Chief of OB/GYN, Chickasaw Nation Health System

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The Problem • Symptom- the complaint of involuntary leakage of urine during effort, exertion, coughing or sneezing • Sign-The observation of leakage from the urethra synchronous with cough or exertion or spontaneously

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DEFINITION OF URINARY INCONTINENCE The objective loss of urine that presents a social or hygienic problem to the individual. Incontinence is not a normal part of aging nor is it a disease.

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IN THE U.S. • Approximately 11 million women suffer from incontinence4 • Urinary incontinence occurs in1: – 50% of otherwise healthy women at some stage in their lives – Roughly 20% of women between the age of 15 and 64 – About one-half of the elderly have episodes of incontinence

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STRESS URINARY INCONTINENCE (SUI) Involuntary loss of urine during exertion (lifting, jogging, sneezing, laughing) CAUSES x Pregnancy and childbirth x Pelvic injury or surgery x Estrogen deficiency x Weak pelvic floor muscles x Back injury or surgery

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(SUI Continued) TWO MAIN CATEGORIES xHYPERMOBILITY Most Common in Women Loss of urine related to movement of the bladder neck and urethra triggered by abdominal straining (lifting, jogging) xINTRINSIC SPHINCTER DEFICIENCY (ISD) Leakage of urine with minimal exertion related to an intrinsic weakening of the bladder outlet closure mechanism

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URGE INCONTINENCE Sudden, uncontrollable urge to void, resulting in leakage of urine CAUSES xUrinary tract or vaginal infectionsxBladder tumor/stonesxNeurological causes (MS, Parkinson’s, spinal cord injury)

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CLINICAL EVALUATION by a Thorough evaluation physician: x History: symptoms, bowel habits, medical history x Physical Examination: neurologic examination, abdominal exam, pelvic examination x Urodynamics: a series of diagnostic tests used to measure how the bladder fills, stores and expels urine

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My Approach • Subjective- affects lifestyle/activity, Sandvik Severity Scale and Incontinence Quality of Life Questionaire (included) • Objective- leaking with cough or Valsalva in the clinic • Conservative therapy- one month trial of Kegel’s exercises and Ditropan • Urodynamics for special cases

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SURGICAL TREATMENTS The goal of a surgical procedure to correct SUI is to: • Reposition the bladder neck to minimize hypermobility of the urethra during stress • Improve the coaptation of the urethra so it closes more effectively

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HYPERMOBILITY: x Needle suspensions (Urethropexies) qStamey, Raz, Gittes x Retropubic suspensions (Urethropexies) qBurch, MMK x Sling procedures qSuprapubic and Transvaginal

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ParaVaginal Wall Repair -Retro pubic repair that seeks to recreate normal anatomy-Modified to include a mid-urethral stitch in some patients-Requires transverse incision-Equivalent success to Burch Colposuspension-Gold Standard for SUI surgery

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SLINGS vs. OTHER SURGICAL INTERVENTIONS x Addresses hypermobility and ISDx More durable than bulking9 x Least invasive surgical procedure – same day surgery is common x AUA Guidelines indicate slings most effective surgical procedure for long-term treatment of female SUI

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The Monarc® Subfascial Hammock: a Transobturator Approach • Helical needles centered over shaft designed to avoid retropubic space perforation • Outside-to-in design optimizes safety • Loosely knitted polypropylene mesh for fibroblast in-growth and integration • Unique, patented tensioning suture prevents distortion during sling placement to minimize potential for overcorrection • 3 needle choices for physician preference

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Reasons to Consider Monarc® • Reproduces natural suspension mechanism – Minimizes risk for overcorrection / dysuria • Safe passage – Needles move immediately away from obturator canal– Anatomical y designed needles minimize risk for vascular, bowel, bladder injury – Cystoscopy optional • Designed to be easy to learn and to teach• Salvage procedure after failed retropubic surgery

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Inferior Epigastric Vessels y Obturator vessels tefas f Ext. Iliac o Vessels enoZ 3-4 cm medial from the obturator Monarc mesh canal lies below the endopelvic fascia Courtesy of Dr. Walters, Cleveland, USA

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Monarc® Mesh Position SPARC™/TVT™ Monarc™ Reiffenstuhl ,Platzer & Knapstein

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Needle Path • Use thumb of hand in vaginal incision to perforate • Rotate the needle after obturator membrane perforation to exit the vaginal incision

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Why Utilize the Monarc (Outside-In) Transobturator Approach? • Reproduces natural suspension mechanism – Minimizes risk for overcorrection / dysuria • Safe passage – Needles move immediately away from obturator canal – Anatomical y designed needles with centered helix minimize risk for vascular, bowel, bladder injury • High efficacy with relatively little post-operative pain • Backed by clinical data!

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System Issues • Efficacy of current procedures• Patient Benefit of new procedure• Safety of new procedures• Cost of the procedure/kit• Credentialing for new procedures

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System Issues • Efficacy of current procedure- were doing Burch with 50% effectiveness, had been doing TVT and SPARC • Higher than expected bladder perforation rate • Post operative hospitalization for Retro- pubic procedures was 76 hours (3rd day)

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MONARC- Pre op post op pre op post op Sandvik Scale-8/8 0/8 Incontinence quality of life- 35/92 92/92 *6/8 6/8 30/92 34/92 3/8 0/8 60/92 92/92 8/8 0/8 35/92 92/92 6/8 0/8 54/92 92/92 8/8 1/8 28/92 71/92 3/8 1/8 58/92 88/92 8/8 0/8 35/92 92/924/8 0/8 43/92 90/928/8 0/8 23/92 92/92 6/8 0/8 35/92 92/92 Complications- one pt with hesitancy/slow flow, one patient with continued self cath and subsequent release, one repeat procedure for recurrence due to pneumonia PVW repair Pre op post op pre op post op Sandvik Scale- 8/8 0/8 Incontinence quality of life- 28/92 91/92 8/8 0/8 25/92 92/92 *6/8 6/8 66/92 87/92 8/8 1/8 44/92 92/92 8/8 0/8 28/92 91/92 3/8 0/8 59/92 92/92 Complications- return to OR for bowel complications

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System Issues • Have health system policy that addresses cost, safety and workload impact issues • Credentialed based on evidence for didactic and practical training with appropriate review of outcomes • Did cost analysis and subsequent bulk buy of kits based on need

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Outcome for our Facility • Monarc/SPARC- 70 procedures done• Average operative time- 45 minutes• Post-operative stay- 34 hours• 10% done as an outpatient• Decreased bed usage translated to fewer transfers • Patient recovery time markedly improved

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Outcome for our Facility (cont) • Reproducible between providers• Significant improvement in patient satisfaction • Enhanced reputation/standing in the eyes of the patients and community

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Pearls from Experience • Make sure patients understand that some will have to be tightened, loosened or replaced • Not all incontinence is treated with surgery• No one can guarantee they’ll never leak again • Cystoscope everyone!!

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