UROGYNECOLOGY Tradition Is Yielding to New Technology’S Advantages, Time-Tested Though They Are Not—Yet

UPDATE NEW DEVELOPMENTS THAT ARE CHANGING PATIENT CARE

UROGYNECOLOGY Tradition is yielding to new technology’s advantages, time-tested though they are not—yet

ven as we scramble to gather defini- ❚ Transobturator sling tive evidence on the immediate and The needle-guided synthetic mesh Neeraj Kohli, MD, MBA long-term benefits of new technolo- midurethral sling was rapidly adopted as OBG MANAGEMENT E Board of Editors gies, they are supplanting tradition in the the treatment of choice for stress urinary Director, Division of Urogynecology, Brigham surgical treatment of incontinence and pro- incontinence due to urethral hypermobility and Women's Hospital, lapse. Surgeons have been swift to adopt and intrinsic sphincter deficiency, soon Assistant Professor, 1 Harvard Medical School synthetic mesh and the new generation of after it was described in 1995. needle suspension procedures, which offer With the transvaginal tape (TVT) pro- the double advantage of a shorter operative cedure, the learning curve was shorter and time and shorter postoperative recovery. so were hospital stays and recovery, com- Yet, we lack well-designed randomized pared with abdominal Burch colposuspen- prospective clinical studies on whether out- sion and traditional bladder neck slings. comes and complication rates are better Furthermore, cost efficiency improved,2 than traditional therapies such as vaginal and the persistent cure rate was 85% from colporrhaphy and paravaginal repair. 2 to 8 years.3 IN THIS ARTICLE There hasn’t been time. However, needle passage through the These innovations came onto the mar- retropubic space can cause vascular, ❙ Indications ket in rapid succession, accompanied by bowel, or bladder injury, even in the hands and advantages aggressive corporate promotion, physician of experienced surgeons. An August 2005 of transvaginal interest, and, in turn, pressure from French survey4 of 92 surgeons who per- and transobturator patients. Improved reimbursement for formed 12,280 TVT procedures reported quicker, easier procedures also entices these complications: perioperative bladder slings many physicians to become “early injuries, 901 (7.34%); cases of complete Page 36 adopters.” (Recent addition of the CPT postoperative urinary retention requiring code for mesh/graft use in prolapse surgery catheterization, 809 (6.59%); vaginal [CPT 57267], increases reimbursement mesh exposure, 26 (0.21%); retropubic or over traditional procedures.) vulvovaginal hematoma, 39 (0.32%); and It is important to keep a cautious but major organ injuries, 10 (0.08%). open mind. Given the blind needle tech- The transobturator (TOT) approach, niques and use of biomaterial grafts and introduced in 2003,5 is simpler, with synthetic meshes, these procedures may fewer complications. The sling is placed in not be for every surgeon or every patient. a similar manner in the midurethral posi- As always, astute clinical judgment and tion, but the insertion points overlie the critical analysis of the data and anecdotal obturator space in the genitofemoral experience are recommended. crease lateral to the vagina. A needle pass-

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ing through the obturator membrane exits whether it is effective in patients with the vaginal incision without entering the intrinsic sphincter deficiency, especially retropubic space, theoretically averting with a fixed or lead-pipe urethra. We need risk of bowel, bladder, and major blood studies to determine how to match the vessel injury. right procedure to the right patient. Although the TOT is thought to be safer in this regard, complications includ- Which sling for which patients? ing urinary retention, obturator hematoma My indications for TOT vs. TVT, which and nerve injury, and urethral injury/ero- are based on personal experience and sion have been reported.6 available data, may change as data accu- A variety of TOT sling kits are avail- mulate (TABLE). Indications are often able, none with proven superiority. surgeon-specific, depending on clinical In a recent randomized, prospective experience. trial in which 61 women had TVT or TOT, In our review of 210 TOT slings over there were no bladder injuries in the TOT a 16-month period at 2 centers, we found group, and 9.7% (n=3) in the TVT group a cure rate of 88% and an improvement (P>.05). The postoperative urinary reten- rate of 1.9%. The complication rate was tion rate was 25.8% (n=8) in the TVT 24%; intraoperative and postoperative group and 13.3% (n=4) in the TOT group complications were all minor and mostly (P>.05). Cure rates (83.9% vs 90%), self-limited8: 1 cystotomy, 1 urethral injury, improvement (9.7% vs 3.3%), and failure 2 hematomas, 1 erosion, 16 complaints of (6.5% vs 6.7%) were similar.7 transient groin pain, 5 cases of urinary The transobturator suburethral sling retention requiring reoperation, and 23 is encouraging, although it is unclear cases of de novo urge incontinence.

t W h a m a r k w i l l y o u l e a v e o n f e m a l e s t e r i l i z a t i o n ? N o n e .

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❚ Adjustable suburethral sling with increased risk of postoperative void- One of the challenges in placing a subu- ing dysfunction, as well as limited urethral rethral sling is adjustment for efficacy with- hypermobility/fixed urethra, because the out overcorrection and resultant bladder sling can be adjusted long after the opera- neck obstruction, urinary retention, or per- tion. Risks include infection due to foreign sistent and refractory overactive bladder body (indwelling placement of the tension- symptoms. An adjustable transvaginal ing device) as well as palpation and inci- midurethral synthetic sling procedure was sional discomfort in very thin patients. recently introduced in the United States: the Further clinical experience is needed, but Remeex Tensionfree Readjustable Tape, the concept of a sling that can be adjusted (Neomedic International, Spain). A retro- immediately or even years later is appealing. pubic minimally invasive midurethral sling is attached to sutures that are taken through a tensioning device placed above ❚ Graft/mesh augmentation the fascia in the suprapubic region. The tensioning device has a small adjustment for prolapse repair kit similar to a screwdriver, which is left in Augmentation of pelvic prolapse repair place at the time of surgery. The sling is using mesh and graft materials is used intentionally left loose for postoperative increasingly in an effort to improve long- adjustment. Following surgery, a filling cys- term outcomes, although we lack random- tometrogram confirms stress incontinence. ized prospective data and long-term out- The sling is then progressively tightened come studies. Synthetic materials offer until the leaking ceases. This technology is ready availability, consistent tissue proper- designed to prevent or correct overtighten- ties, cost effectiveness, and permanent ing, and avert bladder outlet obstruction. placement, although there are risks: infec- The sling can be adjusted via a small supra- tion, dyspareunia, and erosion or expo- pubic incision, even years later; adjustment sure. Success and complications may has been reported up to 7 years later. depend on surgical technique, choice of In a recent study of 62 patients with material, patient selection, postoperative stress urinary incontinence, 58 patients management, or other factors. FAST TRACK (94%) were completely dry and cured, and The overall success rate was 94% at a The adjustable 4 patients (6%) reported occasional slight mean of 17 months after operation, in a urine leakage. Operative time was 20 to 40 study of 63 women in whom polypropylene sling may be minutes (only stress urinary incontinence mesh was used for augmentation of cysto- especially useful and cystocele). Six patients required long- cele and rectocele. However, the authors in patients at risk term readjustment (5 to increase tension recommended abandonment of the proce- of postoperative and 1 to reduce tension). No major intra- dure due to an unacceptably high rate of operative complications occurred. Late complications.10 In the 32 women undergo- voiding dysfunction complications included suprapubic wound ing anterior repair, sexual activity rate did pain (12 transitional and relieved with not alter, but dyspareunia increased in 20%. analgesics), 3 urinary tract infections, 2 Urge and stress incontinence did not wound seromas, 1 case requiring prosthe- change, but urgency improved in 10%; sis removal due to infection, and 3 cases of 13% had vaginal erosion of the mesh. Of hyperactivity de novo, which required the 31 patients undergoing posterior repair, anticholinergic treatment.9 sexual activity decreased by 12% and dys- Although postoperative urinary reten- pareunia increased in 63%. Constipation tion or postoperative failure is relatively improved in 15% and anal incontinence in uncommon in transvaginal or transobtura- 4%; 6.5% had vaginal erosion of mesh and tor suburethral sling procedures performed 1 required mesh removal for abscess. by experienced surgeons, the adjustable In another study, results were sling may be especially useful in patients improved and complications were fewer.

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TABLE REFERENCES 1. Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an Transvaginal vs transobturator sling ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol. 1995;29:75–82. INDICATIONS ADVANTAGES 2. Kilonzo M, Vale L, Stearns SC, et al. Cost effectiveness of tension-free vaginal tape for the surgical manage- Transvaginal (retropubic) ment of female stress incontinence. Int J Technol Physically active patient Avoids groin discomfort with activity Assess Health Care. 2004;20:455–463. Thin, young patient Long term data available 3. Holmgren C, Nilsson S, Lanner L, Hellberg D. Long- term results with tension-free vaginal tape on mixed Limited urethral hypermobility/ Data supports use/ and stress urinary incontinence. Obstet Gynecol. internal sphincter dysfunction dynamic backboard 2005;106:38–43. 4. Agostini A, Bretelle F, Franchi F, Roger V, Cravello L, Transobturator Blanc B. Immediate complications of tension-free vagi- Elderly patient Less postop voiding dysfunction nal tape (TVT): results of a French survey. Eur J Obstet Gynecol Reprod Biol. 2005 Aug 8; [Epub ahead of Significant overactive bladder/ Less urethral obstruction print]. urge incontinence 5. Delorme E, Droupy S, de Tayrac R, Delmas V. Transobturator tape (Uratape). A new minimally inva- Previous retropubic surgery Less risk of retropubic complication sive method in the treatment of urinary incontinence in Obesity Less risk of needle-passage women. Prog Urol. 2003;13:656–659. complication 6. Game X, et al. Obturator infected hematoma and urethral erosion following transobturator tape implanta- Inexperience with TVT Less risk of periop complications tion. J Urol. 2004;171:1629. 7. deTayrac R, Deffieux X, Droupy S, et al. A prospective randomized trial comparing tension-free vaginal tape and transobturator suburethral tape for surgical treat- After 2 years, 24 of 26 women who had ment of stress urinary incontinence [retracted in: Am J posterior repair with polypropylene mesh Obstet Gynecol. 2005;192:339]. Am J Obstet Gynecol. 2004;190:602–608. were cured (92.3%) and 1 had asympto- 8. Rajan S, Diwadkar G, Hurwitz S, Kohli N, Roberts L, matic stage 2 rectocele. All but 1 reported Moore R, Miklos J. Transobturator (TOT) suburethral sling: early US data on safety and efficacy. Abstract improved symptoms and quality of life. presented at: 2005 Meeting of the International No postop infection or rectovaginal fistula Urogynecology Association; August 9–12, 2005; was reported; there were 3 vaginal ero- Copenhagen, Denmark. Poster 52, abstract ID 982. 9. Cabrera Pérez J, Bravo Fernández I, Pérez G, González sions (12%), and 2 patients had de novo Enguita C, Vela Navarrete R. Analysis of the subu- 11 rethral sling TRT (tension free readjustable tape) dyspareunia (7.7%). results in female SUI treatment. Abstract presented at: To make graft/mesh augmentation eas- LXX Congreso Nacional de Urología; June 4–7, 2005; FAST TRACK ier and faster, needle-suspension tech- San Sebastián, Spain. 10. Milani R, Salvatore S, Soligo M, Pifarotti P, Meschia M, Complication rates niques were recently introduced. Needles Cortese M. Functional and anatomical outcome of are inserted either through the transobtu- anterior and posterior vaginal prolapse repair with may reflect Prolene mesh. BJOG. 2005;112:107–111. rator space (anterior mesh placement) or 11. de Tayrac R, Picone O, Chauveaud-Lambling A, early evolution, ischiorectal fascia (posterior placement) Fernandez H. A 2-year anatomical and functional assessment of transvaginal rectocele repair using a and may improve and exit through the pelvic sidewall in polypropylene mesh. Int Urogynecol J Pelvic Floor proximity to the ischial spine. A multi-arm Dysfunct. 2005 May 21; [Epub ahead of print]. with time and 12. Rane AM, Naidu AK, Barry CL, Nyok LY, Corstiaans AC. mesh is then attached to the needles, which A novel transobturator system for the repair of anteri- experience are withdrawn. Tension secures the mesh or vaginal wall prolapse: a pilot study. Abstract presented at: 2005 Meeting of the International and provides “tension-free” anterior or Urogynecology Association; August 9–12, 2005; posterior wall support. Colporrhaphy can Copenhagen, Denmark. 13. Cosson M, Caquent F, Collinet P, Rosenthal C, Clave H, be performed prior to mesh placement at Debodinance P, Garbin O, Berrocal J, Villet R, the surgeon’s discretion. Jacquetin B. Prolift mesh for pelvic organ prolapse surgical treatment using the TVM group technique: a ret- Because we have few data on patient rospective study of 687 patients. Abstract presented selection or long-term safety and efficacy at: 2005 Meeting of the International Urogynecology Association; August 9–12, 2005; Copenhagen, (most of it presented at recent meet- Denmark. ings12,13), these techniques call for caution. 14. Hilger WS, Cornella JL. Rectovaginal fistula after posterior intravaginal slingplasty and polypropylene mesh Blind needle passage can be associated augmented rectocele repair. Int Urogynecol J Pelvic with complications such as rectal injury Floor Dysfunct. 2005 Jul 29; [Epub ahead of print]. and rectovaginal fistula.14 But complication The author receives grant/research support and/or serves as rates may reflect early evolution and may a consultant for American Medical Systems, Boston improve with time and experience. ■ Scientific, CR Bard, Mentor, Novartis, and Pfizer.

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