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
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.
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.
Complications • Intraoperative • 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.
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. IntUrogynecol 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