Stress Urinary Incontinence in Women: Surgical Options

From 9th Annual Female Pelvic Floor Disorders, sponsored by Cleveland Clinic Florida

Educational Objectives

The goal of this program is to improve the management of urinary incontinence in women. After hearing and assimi­lating this program, the clinician will be better able to:

1.   Determine which patients are most likely to benefit from transobturator sling placement.

2.   Identify patients presenting with intrinsic sphincter deficiency and modify treatment appropriately.

3.   Assess whether patients would derive greater long-term benefits from a bladder neck sling.

4.   Inform patients about injectable bulking agents that may support sling function and improve quality of life.

5.   Discuss benefits and disadvantages associated with single-incision “mini-sling” procedures for the treatment of stress urinary incontinence.

Acknowledgments

Drs. Davila, Sand, Ghoniem, and Aguilar were recorded at 9th Annual Female Pelvic Floor Disorders, held March 13-15, 2009, in Fort Lauderdale, FL, and sponsored by Cleveland Clinic Florida. The Audio-Digest Foundation thanks the speakers and the Cleveland Clinic Florida for their cooperation in the production of this program.

Faculty Disclosure

In adherence to ACCME Standards for Commercial Support, Audio-Digest requires all faculty and members of the planning committee to disclose relevant financial relationships within the past 12 months that might create any personal conflicts of in­terest. Any identified conflicts were resolved to ensure that this educational activity promotes quality in health care and not a proprietary business or commercial interest. For this program, the following has been disclosed: Dr. Davila is a consultant and on the Speakers’ Bureau for, and receives research support from, American Medical Systems, and is a consultant and on the Speakers’ Bureau for Watson Pharmaceuticals; Dr. Sand is an advisor, investigator, and lecturer for Allergan, Astel­las/GlaxoSmithKline, Pfizer, and Watson Pharmaceuticals, and an advisor for Coloplast; Dr. Ghoniem is on the Speakers’ Bureau for Astellas, is a consultant and advisor for Coloplast, and does consulting for Uroplasty. Dr. Aguilar adn the plan­ning committee reported nothing to disclose. In their lectures, Drs. Sand and Aguilar present information related to off-label or investigational use of a therapy, product, or device.

Transobturator Sling Procedures

G. Willy Davila, MD, Chair, Department of Gynecology, and Head, Section of Urogynecology and Reconstruc­tive Pelvic Surgery, Cleveland Clinic Florida, Weston/Fort Lauderdale

Tension-free vaginal tape (TVT): relatively safe procedure; associated with less voiding dysfunction than retropubic sling; TVT requires urethral compression during coughing and physical activity to alleviate incontinence; initial results  —  »100 patients; TVT procedures associated with voiding dysfunction in patients with preexisting abnor­mal voiding and vaginal prolapse (possible cause, insufficient tension); needles passed without visual feedback dur­ing retropubic procedure; may cause trauma in patients with uncommon vasculature or bowel placement (or after unexpected movement); complications included vascular injury, urethral injury, and death

Transobturator sling (TOS): needle passes through unique route (bypassing obturator neurovascular bundle); tape passes from medial part of obturator membrane and underneath urethra to other side; helical technique  —  perform suburethral incision; insert finger into incision and palpate pubic ramus; push needle through obturator membrane onto finger; palpate for indentation behind adductor longus tendon (level with clitoris) and insert needle; classified as nonblind procedure due to absence of vasculature and bowel in placement area; internal-to-external vs external-to-internal  —  no measurable difference in outcomes; internal-to-external procedures relatively lateral (in reference to obturator membrane); external-to-internal procedures stay closer to pubic ramus (medial to obturator mem­brane); risk for thigh pain may vary between approaches; cadaver dissection studies  —  evaluated needle and tape passage relative to anatomy of thigh; passage found relatively safe (3-4 cm distance from significant structures); obturator nerve distance  —  external-to-internal procedures maintain 27-mm distance from significant structures (9 mm with internal-to-external); success rates remained high with extended follow-up; subfascial hammock (Monarc) study  —  included 169 patients from United States; operations averaged »14 min (»8 min for experienced practitioners); favorable results after extended follow-up; demonstrated improvements in urgency not observed with retropubic sling; associated with minimal complications; TVT vs TOS  —  similar cure rates and patient satisfac­tion; retropubic procedures associated with elevated risk for hemorrhage and bladder perforation; TVT vs transob­turator tape (TOT) study  —similar cure and improvement rates; TOT showed increased rates of bladder injury; TVT found superior; study later retracted due to issues with approval process ; tension-free vaginal tape-obturator (TVT-O)  —  high success rates with low rates of voiding dysfunction and de novo urge incontinence; operative time study  —  rate of voiding dysfunction similar between internal-to-external and external-to-internal procedures; com­plications arise with lateral passage of needle from inside to outside

Negative issues: initial issues associated with choice of sling material; monofilament polypropylene transobturator sling (ObTape) constructed from type III mesh material performed poorly (type I associated with better outcomes); TOS  —  tape forms horizontal platform (contrasting “U”-shaped suspension in retropubic procedures); with TOS, tape typically remains palpable for 6 to 12 wk after procedure (without obstructing urethra); ultrasonography study  —  tapes show greater proximal urethral support than retropubic slings (possible explanation for increased benefit for urgency); more proximal tapes demonstrated greater benefits for urgency; TOS along proximal urethra, TVT along midurethra (tendency to migrate distally), and TOT along bladder neck (greatest improvements to ur­gency); TOS showed excellent safety and efficacy; performed well without cystoscopy (cystoscopy still recom­mended due to risk for bladder perforation); intrinsic sphincter deficiency (ISD)  —  decreases effectiveness of surgical therapies; among most severe types of stress urinary incontinence (SUI); data lacking due to frequent ex­clusion from studies; associated with lower success rates in TVT procedures; TOS with ISD  —  maximum urethral closure pressure (MUCP) <40 cm H₂O and leak point pressure (LPP) <60 cm H₂O associated with significant de­creases in success rates of TOS procedures; if patient has closure pressure >40 cm H₂O and leak point pressure >60 cm H₂O, speaker does TOT; retropubic sling for patients with lower values; TVT vs TOT study  —145 patients given 3 mo follow-up; relative risk for failure associated with subfascial hammock procedures »6 in patients with MUCP <42 cm H₂O; TVT-O and LPP  —  success rates higher with LPP >60 cm H₂O; identifying ISD  —  focus on assess­ment of sphincter function (eg, supine empty stress test, urodynamics); mesh and tape materials  —  elastic materials (eg, TVT) tend to deform after stretching; retropubic slings tend to shrink after collagen ingrowth (possible cause of progressive voiding dysfunction); in TOS procedures, shrinkage does not typically produce complications; mate­rial less important with TOS; outflow obstruction from TOS  —  rare complication; TOS highly accessible; “take­down” procedures associated with relatively low risk for urethral trauma

Tensioned and Other Slings

Peter K. Sand, MD, Professor, Department of Obstetrics and Gynecology, Director, Division of Urogynecology, North Shore University Health System, Northwestern University, Feinberg School of Medicine, Chicago, IL

Bladder neck sling: speaker recommends for patients with poor intrinsic urethral function; primary use in patients with hypermobility or ISD; benefits patients with morbid obesity, severe chronic obstructive pulmonary disease (COPD; ie, severe coughing), long-term steroid use, or history of radiation therapy; ISD  —   estimated 12% of fe­male population affected; associated with aging; linear decrease of MUCP occurs from age 21 yr onward; de­creased MUCP correlated with decreased success of midurethral slings; patients may experience better long-term results with bladder neck sling (as MUCP declines); in nonrandomized studies, midurethral slings achieve com­plete control of incontinence in only 69% to 82% of patients; urodynamic testing predicts failure rates associated with less obstructive procedures (eg, retropubic urethropexy, mid-urethral sling); bladder neck slings effective for nearly all types of incontinence (excluding absence of urethral hypermobility); American Urological Association guidelines  —  retropubic urethropexy and bladder neck slings found equally effective; slings almost always done as secondary procedures where risk for failure higher, yet effectiveness high; use of slings as primary procedure should be considered

Sling materials: autologous slings, eg, fascia  —  high success rates in uncontrolled studies; excellent durability (³12 yr with SUI and mixed incontinence); scar tissue ingrowth typically benign; autogenous slings  —  do not require leg incision as in fascia lata procedures; avoids harvesting from large abdominal wall site as in rectus fascia proce­dures; cadaveric fascia  —  raises theoretic concerns about prion transmission; xenografts  —  fascia, dermis, pericar­dium, and small intestine submucosa typically from bovine or porcine sources; synthetic slings  —  stronger and potentially more durable; associated with chronic inflammatory processes and increased risk for infection or ero­sion and extrusion; 60% subjective cure rate; completely abdominal approach possible (anchored to Cooper’s Liga­ment or rectus fascia); abdominal-vaginal slings  —  synthetic material applied continuously from sub-bladder neck area and vaginal field to rectus fascia; may use needles to carry sutures to create “sling on a string” (outcomes found equal to full sling); transvaginal bladder neck slings  —  procedures include bone anchored (superiorly to pu­bis or inferior aspect of pubic ramus), transvaginal suture capturing device (Capio CL) to anchor sling to Cooper’s ligament, and tension free slings at bladder neck; “Capio CL transvaginal sling”  —  recommended by speaker; ca­daveric fascia lata placed loosely at bladder neck and anchored to Cooper’s ligament; fast, reproducible operation; adjusted via tensioning suture; at 1 yr, 84% cure rate with pad testing and stress testing; 92% show no urethral hy­permobility on “Q-tip test”; 4.5% exhibit urinary retention or postvoid residuals >100 mL (double to triple rates as­sociated with midurethral slings); recurrent cystoceles  —  successfully prevented by bladder neck slings; speaker does not recommend graft or mesh placement in women with ISD and proper apical support; in nested cohort (67 patients), only 2.6% experienced recurrence of prolapse (with transvaginal bladder neck sling and proper apical support)

Bone-anchored slings: 30,000 to 40,000 performed annually; provides stable fixation point (avoiding continuous mobility of slings anchored to rectus fascia); stable slings anchored to Cooper’s ligament now applied as alterna­tive; Appell and Rackley study  —  assessed slings with or without bone anchors in small series of patients (initial co­hort analysis); results approximately equivalent; bone anchors associated with superior postoperative retention and shorter durations of catheter use; needle-based slings required less surgical dissection; 10- to 15-min procedure re­quiring only one person; Rackley osteomyelitis study  —  >1000 patients; 0.6% risk for osteomyelitis reported; con­cerns prompted many physicians to seek alternatives; suprapubic vs transvaginal bone anchored sling  —  survey of published literature (from 1990 to 2000) found suprapubic procedure not associated with higher infection rates

Injectables: Where Do We Stand Now? 

Gamal M. Ghoniem, MD, Clinical Professor of Surgery and Urology, NOVA, Southeastern University (Fort Lauderdale, FL), Ohio State University (Cleveland, OH), and University of Southern Florida (Tampa); Chair­man of Medical Student Education, Cleveland Clinic Florida (Weston), and Head, Section of Voiding Dysfunc­tion, Female Urology and Reconstruction, Cleveland Clinic Florida (Weston)

Background: minimally-invasive; patient preference; ease of administration; cost-effectiveness; low complication rate; greater safety in patients with low bladder compliance scores; 71% of women surveyed preferred minimally-invasive procedures for SUI; urogenital distress inventory (UDI)-6 study  —patients with severe incontinence showed greater acceptance of small leaks; patients had realistic expectations (only 22% of respondents expected complete cure)

Bulking agents: treat SUI secondary to ISD; some success in treating urethral hypermobility; evolving role in sup­plementing slings; improve quality of life in frail and high-risk patients, but infrequently achieve complete dryness; characteristics of ideal bulking agent  —  nonimmunogenic; hypoallergenic; biocompatible; nontoxic; satisfactory wound healing characteristics; minimal fibrotic ingrowth; minimal extracapsular inflammatory response; does not migrate; persists over time; risks  —migration; granuloma; sterile abscess; erosion; injection methods  —  transurethral injection gaining favor (allows monitoring via cystoscopy); preliminary study results correlate favor­able captation during injection with improved outcomes; glutaraldehyde cross-linked highly purified bovine colla­gen (Contigen)  —  gold standard; 35% bovine collagen in phosphate buffer; 95% type I collagen (1%-5% type III); long-term success rates 18% to 65%; carbon particles vs collagen  —  both groups reported high success rates; in­creased urgency and retention problems observed with carbon particles; synthetic calcium hydroxyapatite ceramic microspheres (Coaptite)  —  easily injected; diameter of 75 to 125 mm; suspended in aqueous gel; approved in 2005; performance similar to collagen; polytetrafluoroethylene paste (Urethrin)  —  older therapy (never received Food and Drug Administration approval); successful in limited compassionate use; small particle size permits migration (potential for granulomas, but no increase in malignancies observed); autologous fat  —inexpensive but inconsis­tent; issues with necrosis and revascularization; magnetic resonance imaging shows 55% volume loss at 6 mo; suc­cess rate 23%; pyrolytic carbon-coated zirconium-oxide beads (Durasphere)  —  complications include urinary retention (£24%), urgency, and migration; periurethral silicone implants (Microplastique)  —  particles measure 100 to 600 mm (migration typically occurs at 60-70 mm); soft, irregular surface promotes tissue ingrowth; procedures performed since early 1990s (outside United States); no specific long-term complications;  Cochrane Database review  —  all products demonstrated improvement equal to collagen

The “Mini-slings”

Vivian C. Aguilar, MD, Staff Physician, Urogynecological and Reconstructive Pelvic Surgery, Department of Gynecology, Cleveland Clinic Florida, Weston

Mini-slings: modification of standard polypropylene synthetic mesh; minimizes risks by avoiding retropubic space (associated with bowel, bladder, and vascular trauma and mortality) and obturator space (associated with thigh and groin pain); advantages  —  minimally invasive; short operating time; outpatient procedure (local anesthesia); re­duced postoperative pain; history  —  developed in 2002; modification of TVT; standard polypropylene mesh laser cut to prevent curling; ends laminated with Vicryl fleece (increases stability after dissolving into tissue)

Third generation sub-midurethral mesh (TVT-SECUR): placement  —  sharp dissection similar to TVT, but larger (1.5 cm vs 1.0 cm); avoid penetrating into urogenital diaphragm and obturator internus muscle or obturator mem­brane (may interfere with anchoring); overinfiltration of local anesthetic may thin tissues (inhibits anchoring); avoid traction when removing wire release to prevent dislodgment; “U”-shaped configuration  —mimics TVT placement; tip of device placed flat against pubic bone and embedded into urogenital diaphragm on both sides; standard rigid catheter guide with deviation of bladder to opposite side and cystoscopy (to assess for injury) recom­mended; hammock configuration  —  mimics obturator placement; tip of device aimed toward inferior border of is­chiopubic ramus at »45° to 90° angle and buried into obturator internus; both placements relatively simple and noninvasive; associated with lower rates of complication, less anesthesia, postoperative pain, and tissue trauma; Cancun data  —  6 abstracts presented in 2007; 495 women with SUI or mixed incontinence (ISD excluded); mean objective cure rate 80.3%; recurrence rate »19.7%; complications included bladder perforation, voiding difficulty, mesh exposure, groin pain, de novo urgency, and hypotensive episodes; short follow-up (5-20 wk)

Single incision sling system (MiniArc): released in 2007; material  —  knitted type I monofilament polypropylene mesh; relatively small placement needle; midline marking indicates placement target beneath midurethra; self-fix­ating polypropylene tip anchors sling; placement  —  perform midurethral incision and tunnel out bilaterally; palpat­ing inferior border of pubic ramus requires slightly larger incision; markings and placement target similar to subfascial hammock procedure; placed into obturator internus (immediately posterior to pubic bone on both sides); typically tensioned flat (eg, with Metzenbaum scissors); mesh anchored at level of clitoris and obturator internus (behind pubic bone); initial results  —  based on 3 mo data; 60 patients with SUI and mixed incontinence from 5 centers (ISD excluded); initial success rates »92%; no pain or bleeding complications reported

Suggested Reading

Abouassaly R et al: Complications of tension-free vaginal tape surgery: a multi-institutional review. BJU International 94:110, 2004; Botros S et al: Following midurethral versus bladder sling procedures. American Journal of Obstetrics and Gynecology 193:2144, 2005; Boyles SH et al: Complications associated with transobturator sling procedures. International Urogynecology Jour­nal 18:19, 2006; Guerrero K et al: A randomised controlled trial comparing two autologous fascial sling techniques for the treat­ment of stress urinary incontinence in women: short, medium and long-term follow-up. International Urogynecology Journal 18:1263, 2007; Jeon M, et al: Comparison of the treatment outcome of pubovaginal sling, tension-free vaginal tape, and transobtura­tor tape for stress urinary incontinence with intrinsic sphincter deficiency. American Journal of Obstetrics and Gynecology 199:76, 2008; Mayer R et al: Multicenter prospective randomized 52-week trial of calcium hydroxylapatite versus bovine dermal collagen for treatment of stress urinary incontinence. Urology 69:876, 2007; Molden SM, Lucente VR: New minimally invasive slings: TVT Secur. Current Urology Reports 9:358, 2008; Moore R et al: Retrospective review of early experience using the ams miniarc single incision sling system to treat stress urinary incontinence in women – intra-operative experience. Journal of Minimally Invasive Gyne­cology 14:S129, 2009; Sokol ER et al: Combined trans- and periurethral injections of bulking agents for the treatment of intrinsic sphincter deficiency. International Urogynecology Journal 19:643, 2008; Tamanini JTN et al: Macroplastique implantation system for female stress urinary incontinence: long-t