Complications associated with SUI and POP surgery Ju Tae Seo, MD Department of Urology Cheil General Hospital Kwandong University College of Medicine

Introduction Women have an 11% lifetime risk of one operation for POP or SUI Midurethral sling for SUI 1) retropubic MUS ; TVT, SPARC, IVS, TVA, Iris, Serapren tape, Advantage, T-sling, Continence, Safyre, Seratom 2) transobturator MUS ; TVT-O, TOA, MONARC, TOT, CM-sling, Osiris, Lynx 3) New slings ; TVT-Secur, MiniArc Mesh for POP surgery ; Prolift, Apogee, Perigee

The incidence of major complications may be underreported. A significant discrepancy between scientific reports and FDA/MAUDE reports 1) reports may understate complications 2) surgeons with higher complication rates do not answer questionnaires 3) differences exist between high- and low-volume surgeon 4) Complication rates accounted for by surgeons who manage the complication

Co-morbidities increase the incidence of complications Diabetes and vascular lesion ; a 2-fold increase in the risk of major Cxs (sepsis, pulmonary failure, MI and thrombo-embolic events) Obesity (BMI≥35kg/㎡) ; increase technical difficulty and Cx rates (deep vein thrombosis, arrhythmia, pneumonia) Previous radiation for pelvic cancers

Complications after midurethral sling procedure and POP surgery Intra-operative complications : clinically significant bleeding & hematoma : bladder, urethral, vaginal wall perforation : bowel, nerve injury Postoperative complications : UTI : Mesh erosion (vaginal & urethral) : De novo urgency : postoperative voiding dysfunction

Operative complications of MUS procedure

Bleeding and hematoma Highly vascular venous space of Retzius(pelvic floor vein, epigastric vessel) or obturator or iliac vessels Mean distance from TVT trocar to the major vessels is 3.2 to 4.9 cm and vascular injuries involving large arteries(ext. iliac, femoral, obturator, epigastric, inf. Vesical) are rare Minor bleeding in retropubic procedure may related to the close positioning of dorsal vein of clitoris under the inferomedial aspect of pubic bone Risk is high in patients with previous surgery in Retzius space In TVT ; significant blood loss from 1.1 to 2.3% ; retropubic hematoma from 2.0 to 4.1% In TOT ; 1-2% of the cases - heavy intraoperative bleeding, pelvic, retropubic hematoma, and perineal, labial, or thigh hematoma

Management depend on extent of bleeding : transfusion embolization hematoma drainage laparotomy Most retropubic venous bleeding - managed with observation only - two finger or gauze compression for 5 minutes just after surgery

Bladder perforation More common in retropubic sling (0.7~24%), lower in transobturator sling(0~1%) Risk factors ; previous anti-incontinence surgery, pelvic surgery, surgeon’s experience Austrian TOT tape registry comprising of 2,541 cases - 10 bladder and 2 urethral perforation A retrospective study by Barber et al of 390 patients treated with TOT - 2 bladder and 2 urethral injuries were reported Careful and circumferential cystoscopic examination of distended bladder  trocar is removed and repassed  cystoscopy is repeated with each pass of the trocar

Bladder and urethral injury Tips in difficult situation - injection of normal saline behind the pubic bone in the intended path of needle - passing the needle from the suprapubic incision to the vaginal tunnel Recommendation of universal intra-operative cystoscopy in cases of previous extensive pelvic surgery and difficulty of needle passage No need any further therapy except catheter drainage for 2-4 days Undiagnosed bladder & urethral injuries - hematuria, pain(suprapubic/urethra), recurrent UTI, stone, voiding dysfunction, fistula The mesh must be removed completely. The earlier a misplaced tape is explanted, the fewer the scar, the less inflammation will develop, and the easier complete removal will be.

Urethral perforation by TOT procedure

Vaginal wall perforation majority occurred in the transobturator slings (2.3~12.9%) Especially in pts without lateral defect of cystocele ( high position of lateral sulcus), risk of vaginal wall perforation is increased. Careful vaginal wall inspection just after trocar or introducer passage (inside-out & outside-in) Management – repositioning of trocar and simple suture of vaginal wall

Bowel injury A rare complication documented in case report A greater risk in patients with Hx of previous abdominal or pelvic surgery - adhesion in the Retzius space No data on bowel injury with transobturator approach Rectal perforation is not rare in post. transvaginal mesh repair (4~5%) : simple suture and NPO for 5~7 days

Rare cases of major complications Bowel, vascular, and nerve injuries Necrotizing fasciitis Ischiorectal, obturator abscess Sepsis Patient deaths Extremely uncommon (86/11,800 cases) - 32 vascular, 33 bowel injuries - 8 patients death after TVT placement Major complications might be underrepoted in the literature.

Operative complications of POP surgery

Complications Intraoperative During and after surgery Hemorrhage < 2% with injuries (Ureteral, bladder, urethral, gastrointestinal ) During and after surgery Infections (cuff cellulitis, abscess) Bleeding Urinary retention, bowel obstruction Rectal injury, bladder injury Mesh erosion, infection, vaginal granulation Fistulas (ureterovaginal, vesicovaginal) Ileus Recurrence Leg pain (esp, transobturator approach) Persistent dyspareunia, pelvic pain, vaginal stenosis Voiding dysfunctions

New Pelvic Symptoms after Reconstructive Pelvic Surgery Thythy Pham et al. Am J Obstet Gynecol 2009;200:88.e1-e5.

A Long-Term Treatment Outcome of Abdominal Sacrocolpopexy 57 women who underwent ASC with mesh for symptomatic uterine or vault prolapse The median follow-up was 66 months (range 60-108) Jeon MJ et al. Yonsei Med J 2009;50: 807-13.

Meshes and trocars for POP surgeries

Ant. and Post. mesh(Prolift) for POP surgery

Prolift System for Repair of Pelvic Organ Prolapse Early outcome results from a retrospective study of 687 pts in 7 centers of France : Intra-operative and short-term post-operative complication rates ranged from 0.15% to 1.75% : Mesh erosion rates ranged from 0% to 13.3% : Cure rate at 10 months – 95% US based study including 350 pts : Cure rate at 14 months – 91% : Mesh erosion rates were <2%, conservative treatment or “in office” surgical correction : Intra-operative complications ranged from 0.3% to 2.6% (cystotomy - most common Cx) : Post-operative de novo OAB, voiding dysfunction, and SUI were seen in 4%, 2% and 3% of pts, respectively

Mechanism or Hypothesis Postoperative voiding dysfunction may be caused by Detrusor instability Urethral obstruction Recurrence of the cyctocele Factors related to the development of urinary retention following SUI surgery - Pre-operative Qmax - Decreased detrusor pressure - Straining during voiding - Bladder neck elevation during surgery

Mechanism or Hypothesis Increased amount of blood loss is associated with postoperative urinary retention - First, more blood loss may result in hematoma formation acting as a non- functional, obstructive sub-urethral mass - Second, more blood loss may be related to more extensive damage to the innervation of the detrusor muscle when surgery gets more complicated Disturbed pelvic floor relaxation due to post-operative pain, intrinsic damage to the innervation of the bladder and BOO can contribute to the development of urinary retention following vaginal prolapse surgery These hypotheses will be tested in future prospective studies. Robert A et al. Neurourology and Urodynamics 2009;28:225–8.

Postoperative voiding dysfunction Resolution of preoperative urgency in ≥63% of patients De novo detrusor instability in 5% Prolonged urinary retention in <1% of women Nguyen et al. J Urol 2001;166:2263-6.

Postoperative voiding dysfunction New urge incontinence was the most commonly cited reason for patient dissatisfaction 1 year after surgery Patients dissatisfied after retropubic midurethral slings were more likely to report urinary leakage, overactive bladder symptoms, and voiding dysfunction Development of new pelvic symptoms after reconstructive pelvic surgery can adversely affect patient satisfaction, symptom improvement, and quality-of-life measures Mahajan ST et al. Am J Obstet Gynecol 2006;194:722-8. Davis TL et al. Am J Obstet Gynecol 2004;191:176-81. Thythy Pham et al. Am J Obstet Gynecol 2009;200:88.e1-e5.

Stress urinary incontinence after transobturator mesh for cystocele repair Cystocele repair can lead to de novo SUI or exacerbate pre-existing SUI 93 patients after a transobturator mesh procedure 57 women had not undergone a concomitant anti-incontinence procedure Median follow-up: 9 months 87.5% (21/24) of patients with preoperatively SUI reported cure/improvement one patient (4.2%) reported worsened SUI 21.2% (7/33) complained of de novo SUI  Transobturator mesh for cystocele repair appears to have a net positive effect on SUI. Shek KL et al. Int Urogynecol J Pelvic Floor Dysfunct 2009;20:421-5.

Conclusions High rates of new symptoms after MUS & reconstructive pelvic surgery were reported These symptoms are associated with decreased self-reported improvement and satisfaction despite objective cure Patients should be counseled carefully prior to surgery