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Surgical Resection for Suburethral Sling Complications After Treatment for Stress Urinary Incontinence
Surgical Resection for Suburethral Sling Complications After Treatment for Stress Urinary Incontinence Vincent Misrai, Morgan Rouprêt,* Evanguelos Xylinas, Florence Cour, Christophe Vaessen, Alain Haertig, François Richard and Emmanuel Chartier-Kastler From the Department of Urology, Groupe Hospitalo-Universitaire EST, Pitié-Salpétrière Hospital, Assistance Publique-Hôpitaux de Paris, Faculté de Médecine Pierre et Marie Curie, University Paris VI, Paris, France
Abbreviations and Acronyms BOO ⫽ bladder outlet obstruction SUI ⫽ stress urinary incontinence TOT ⫽ transobturator tape TVT ⫽ transvaginal tape Submitted for publication September 15, 2008. * Correspondence: Academic Urology Department, Hospital Pitié-Salpétrière, 47-83 Boulevard de l’Hopital, 75013 Paris, France (e-mail: morgan. [email protected]).
Purpose: Suburethral tapes have been widely adopted to treat stress urinary incontinence. Further resection of such tapes may be necessary in certain cases. We review our experience and assess urinary functional outcomes. Materials and Methods: We retrospectively reviewed the data on all women referred to our institution between 2001 and 2007 for suburethral tape related complications and on those who had the tape surgically removed. Complete or partial resection was achieved after assessment, including endoscopic and urodynamic assessment. Results: A total of 75 women with a mean age of 60.7 years (range 28 to 78) were included in the study. The tape used was transvaginal in 58 cases (77.3%) and transobturator in 17 (22.7%). There were different complications, such as erosion in 16% of cases, vaginal extrusion in 24%, bladder outlet obstruction in 45%, chronic pelvic pain in 21%, and de novo urinary incontinence and urgency in 12%. Resection was done a mean ⫾ SD of 33 ⫾ 22 months (range 6 to 80) after tape placement. Of the 58 women with transvaginal tape the tape was completely removed by laparoscopy in 30 (51%). Four of the 17 transobturator slings (23%) were completely removed by laparoscopy (1) and via a low gynecological approach (3). The remaining slings were partially resected via a gynecological approach. At a mean followup of 38.4 months (range 12 to 72) incontinence recurred in 39 women (52%) after partial (18) and complete (21) resection. Conclusions: In rare women who experience crippling symptoms after suburethral sling implantation urologists must be aware that the decision to completely or partially resect the tape can help resolve symptoms. Key Words: urethra; suburethral slings; urinary incontinence, stress; complications; prostheses and implants
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SUBURETHRAL tapes, ie tension-free TVT and/or TOT, have become the new gold standard treatment for female SUI. Since 1996, more than 1,200,000 TVT procedures have been performed worldwide1 with a 5-year success rate of greater than 80%.2 Although these procedures are minimally invasive, they are currently associated with perioperative complications (bladder perfora-
tion and vascular injury), early postoperative complications (infection and acute urinary retention) and late postoperative complications (bladder outlet obstruction, mesh erosion, chronic pain and de novo detrusor overactivity).3 Starting in 2001 the transobturator approach using TOT and tension-free obturator TVT has been progressively developed to avoid such complications.
0022-5347/09/1815-2198/0 THE JOURNAL OF UROLOGY® Copyright © 2009 by AMERICAN UROLOGICAL ASSOCIATION
Vol. 181, 2198-2203, May 2009 Printed in U.S.A. DOI:10.1016/j.juro.2009.01.036
SURGICAL RESECTION FOR SUBURETHRAL SLING COMPLICATIONS
This approach appears to be as safe and efficient as retropubic access.4,5 Although the incidence of adverse events has decreased, complications are still being reported.5 As a result, partial or complete surgical resection of the tape can be done in specific cases to manage complications. To date the number of published studies of surgical management for such complications in the current literature is limited.6 – 8 Therefore, we present our experience with tape related complications that we have had to manage by tape resection.
MATERIALS AND METHODS We reviewed the files of all women referred between 2001 and 2007 to our department for suburethral tape related complications. All medical charts were retrospectively reviewed to collect certain data, including patient age, body mass index, initial type of incontinence, medical history of previous pelvic support and anti-incontinence procedures, date and type of suburethral tape resection procedure, complications, duration of bladder catheterization and hospital stay, urinary symptoms, continence, pain, outcome and followup. Each clinical evaluation included physical examination, voiding diary, urinalysis, cystoscopy with a 70-degree optical lens and urodynamic assessment with uroflowmetry. When there was chronic pelvic pain, patients were invited to complete the DN4 questionnaire to assess the etiology of undiagnosed neuropathic pain.9 Clinical evaluation, impact on quality of life and failure of first line treatment influenced the surgical decision to remove the suburethral tape. The surgical decision to resect the tape was determined by a combination of objective and subjective symptoms (see figure). We performed complete removal in certain patients, including those with previous unsuccessful first line management with the patient then referred to our institution and those with suspected or proven sling infection. Also, our strategy was to entirely remove the tape as soon as pelvic pain and symptoms were triggered by bladder filling during cystoscopy. In these cases it was difficult to accurately estimate the
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location of the pain and restrict it only to the suburethral portion. Because pain could be linked to partial or total migration of the tape through the bladder wall or even to a manufacturing fault in the conception of the mesh, we performed complete resection in these cases. In other cases the decision to perform partial or complete resection of the tape was made at urologist discretion. In all cases of partial tape resection we used a vaginal approach. Perioperative cystoscopy was done systematically as step 1. A middle anterior vaginal wall incision was made centering on the sling location and the vaginal epithelium was dissected lateral. After the sling was identified it was circumferentially dissected and incised in the midline beneath the urethra. The dissection end point was to restore adequate sagittal plane mobility of the urethra. Complete TOT resection always required a second surgical access from the end point of the tape to the internal side of the whole obturator. For complete resection we used a pure laparoscopic extraperitoneal approach or we performed a combined procedure using a vaginal or laparoscopic approach. Extraperitoneal laparoscopy was performed with 5 mm trocars and a 10 mm umbilical telescope port with 2 trocars placed medial to the anterior superior iliac spine and 1 placed at the mid point between pubis and umbilicus. Step 1 of dissection consisted of releasing the retropubic space. The primary objective was to identify the 2 half tapes in contact with the pubis, corresponding to their normal path. The half tape was then grasped and drawn downward. The transparietal tract of the tape was dissected by remaining in contact with the tape and by successively crossing the rectus abdominis muscle fibers and fascia. Dissection of the fascia revealed adipose tissue, which could be mobilized without resistance, allowing complete extraction of the transparietal tract. Urethral release was performed medial as far as possible without opening the vagina. The left fingers of the surgeon were placed into the vagina to perform dissection of the remaining part of the mesh located across and/or under the urethra. The 2 entire half tapes were extracted via the 10 mm port. Redon suction was then done in the retropubic space. Tape fragments were sent for histological and bacteriological examination. When we looked for intravesical erosion, dissection was continued down to the point of entry of the tape into the bladder. The bladder was opened and the mesh was removed with clean margins. Cystotomy repair was performed using interrupted 3-zero polyglactin suture. Perioperative data were reviewed, especially for laparoscopic approaches, including mean operative time, organ injury and conversion to open surgery. All patients were seen 1, 3, 6 and 12 months after surgery and yearly thereafter to assess the functional outcome. We focused on the resolution of functional disorders and on recurrent SUI.
RESULTS Combination of symptoms leading to surgical suburethral tape resection in women after treatment for SUI.
Overall 75 women with a mean ⫾ SD age of 60.7 ⫾ 12 years (range 28 to 78) were included in analysis. Median body mass index was 27 kg/m2 (range 23 to 31). The tape used was TVT in 58 cases (77.3%) and
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TOT in 17 (22.7%). Of these tapes 73 (93.6%) were implanted elsewhere with the patients referred to our center for further treatment for complications. Patients Seven women (9%) had undergone former incontinence surgery, including Burch colposuspension in 6 and Marshall-Marchetti colposuspension in 1. Of the women 67 (89.3%) were initially treated with a sling for pure SUI, including TVT in 51 and TOT in 16. The remaining 8 women (9.7%), who presented with mixed urinary incontinence, received TVT (7) and TOT (1). Data on the type of tapes removed were missing except in 5 cases, in which type III polypropylene mesh was used. Resection was done a mean of 33 ⫾ 22 months (range 6 to 80) after tape placement. The table lists all complications following the sling procedure. Isolated Mesh Erosion and Extrusion There were isolated mesh erosion in 8 cases and extrusion in 16. A total of 17 women reported symptoms, including vaginal discharge and/or bleeding, dyspareunia or recurrent urinary tract infections (intravesical erosion) related to vaginal extrusion (10), or urethral (4) or bladder (3) tape erosion a mean of 8 months (range 3 to 45) after the TVT procedure. Vaginal examination revealed abnormal findings in the periurethral area or in the vagina, ranging from a small area of granulated tissue to a visible part of biomaterial. Cystoscopic examination revealed cases of urethral and bladder erosion. Urethral erosion was seen as sling material within the urethral lumen or the sinus tract, extending into periurethral tissues, or as localized edema with granulation tissue. Most bladder erosion was located next to the bladder neck. One woman with persistent incontinence had a urethrovaginal fistula. Seven patients experienced vaginal extrusion (6) or intravesical erosion (1) following the TOT procedure.
Main characteristics and surgical approach in 75 women who underwent tape resection No. TVT Overall Complications: Isolated mesh erosion/complete resection Isolated mesh extrusion/complete resection BOO/complete resection De novo incontinence or urgency Isolated chronic pelvic pain/complete resection Surgery: Laparoscopic/complete resection Low gynecological approach/complete resection Double access/complete resection
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No. TOT 17
A total of 16 patients had been initially treated unsuccessfully with repeat vaginal closure (9) or partial suburethral resection (7) at the primary treatment centers. Bladder Outlet Obstruction BOO developed in 29 women, including 23 (30.6%) after the TVT procedure with concomitant vaginal extrusion (1) or vesical tape erosion (2) and 6 (8%) after TOT with concomitant vaginal tape extrusion (1). A total of 20 women (26.7%) were diagnosed with recurrent urinary tract infections and difficult voiding, of whom 7 required bladder self-catheterization. The mean maximal flow rate was 12 ⫾ 3 ml per second. In 1 case renal ultrasound revealed bilateral ureterohydronephrosis. A total of 25 women had previously been treated unsuccessfully with limited section of the suburethral part of the tape. Isolated Chronic Pelvic Pain Isolated chronic pelvic pain developed in 16 women, including 12 (16%) a mean of 15.6 months (range 5 to 29) after the TVT procedure. Pain was located at the suprapubic (3) or vaginal (2) scar, in the vaginal vault (7) and to the left of the TVT. Women complained of dyspareunia (7), voiding burns (2), left leg pain (1) and isolated pelvic pain (3). During cystoscopy increased disabling pelvic pain was triggered in 9 women by bladder filling. Three women had chronic perineal pain after the TOT procedure, which was located bilateral to the whole obturator. Pain was located at the labia major and the origin of the thigh. In all cases symptoms had been refractory to previous symptomatic medical treatment, including pain killers or local infiltration. De Novo Urinary Incontinence and Urgency De novo urinary incontinence and urgency developed in 9 women. Seven women presented with de novo urgency a mean of 3 months (range 1 to 32) following the TVT procedure, which was associated with dysuria in 3 and intravesical mesh erosion in 2. Two women presented with isolated urgency following the TOT procedure. In all cases symptoms were refractory to anticholinergic drugs.
Total No. 75
7/7 10/7
1/1 6
8 16
24/7 5 12/9
5 1 4/3
29 6 16
29/29 27
1/1 16/3
30 43
1/1
0
1
Surgical Resection The table lists all surgical procedures. TVT tapes were completely and partially removed in 31 and 27 cases, respectively. Women who underwent complete resection had intravesical or urethral erosion (11), unsuccessful previous partial resection for vaginal mesh extrusion (7) or BOO (4) and pelvic pain concomitant with bladder filling during cystoscopy (9). Resection was completely performed using a laparoscopic approach in 30 cases and in 1 early case it was combined with the vaginal approach. We noted no complication during these procedures according
SURGICAL RESECTION FOR SUBURETHRAL SLING COMPLICATIONS
to the updated conventional complication classification system of Dindo et al.10 Regarding partial removal, simple resection of the suburethral part was performed in 9 cases of isolated dysuria. Four of the 17 TOT tapes were completely removed by dissection of the transobturator whole to manage bilateral disabling pelvic pain in 3 women and with a laparoscopic step to treat intrabladder erosion in 1. We used the vaginal approach to resect the remaining tapes in 12 women. Mean operative time was 122 minutes (range 50 to 240) in laparoscopic cases. Postoperative Outcomes Bladder catheterization was required a median of 4 days (range 2 to 8) postoperatively. Median hospital stay was 6.4 days (range 3 to 10). At 1 month of followup all patients reported a partial or total decrease in pain and urinary urgency. After 6 months BOO was improved in 28 women (82%) with a mean maximal flow rate of 20 ⫾ 5 ml per second. All patients reported a total decrease in pain. Healing occurred in all cases. At a mean followup of 38.4 months (range 12 to 72) postoperatively, that is by the end of the current study, we observed recurrent incontinence in 39 women (52%) after partial (18) and complete (21) resection. Recurrent incontinence was revealed a mean of 0.8 months (range 0.1 to 3) postoperatively. Urinary incontinence was observed, including stress incontinence in 18 cases and urge incontinence in 10. All 11 women who experienced recurrent urinary incontinence with intrinsic sphincter deficiency had had lower urethral pressure closure preoperatively. Histological and Bacteriological Analysis Cultures of the removed materials were routinely obtained. In 1 patient a suburethral abscess diagnosed on pelvic magnetic resonance imaging had led to vaginal erosion. In other cases only nonspecific chronic signs of inflammation were found.
DISCUSSION In the last few years suburethral slings have been widely developed and adopted for the surgical management of SUI. These procedures have revolutionized surgical management of SUI because they appear to be simple and minimally invasive, and provide a high success rate.1,3 However, a growing number of postoperative complications and unexpected side effects have been reported in the literature. Several recent reports have been published on managing the erosion of tape located in the urethra, the bladder or even the vagina.5,11–13 Although the erosion rate has been reported to be between 0.3% and 14%, therapy remains unclear.14 Despite their paucity these complications require
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surgical intervention in some cases. Whether the tape should be removed early remains unclear. Radical management, eg sling removal with or without a bladder repair procedure, is rarely proposed as first line treatment except in women with concomitant bladder erosion, de novo functional complications (dysuria, chronic retention or urgency) or proven biomaterial infection.3,7,13,14 To our knowledge we report the first large series of tape resections as radical second line management of suburethral sling complications. Regarding our results, we believe that it is difficult to pinpoint systematic and dedicated treatment for mesh extrusion because most women were previously treated conservatively without success. The debate is ongoing in the current literature. Abdel-Fattah et al advocate partial resection of the extruded and, therefore, potentially colonized portion of the tape and they recommend complete removal when there is any suspicion of infection.15 On the other hand, Giri et al suggest a conservative approach with repeat closure of the vaginal mucosa over the tape with minimal dissection in cases of erosion limited to the vagina.16 However, most investigators recommend first line conservative treatment. For instance, Kobashi and Govier reported 4 cases of vaginal erosion that were managed conservatively only by sexual abstinence.17 They noted spontaneous epithelialization of the mesh within a 6-week period. This minimally aggressive management can be explained by the incidence of asymptomatic vaginal erosion, which was reported to be up to 35%.14 Multiple factors, such as sling placement closer to the urethra, inadequate vaginal suture, perioperative infection and poor tissue vascularization, have been postulated as potential explanations for vaginal extrusion. However, the exact etiology of these extrusions has not yet been elucidated. However, we trust that it is of interest to be familiar with the diagnosis of and treatment for this complication for urologists who frequently use synthetic materials, notably because some symptoms, such as urgency and recurrent urinary tract infections, are aspecific and may be confused with postoperative BOO or de novo detrusor instability. When there is a lack of vaginal or urethral pain, these symptoms may indicate the presence of an intravesical tape. Other symptoms, such as vaginal discharge or bleeding, or persistent vaginal or urethral pain, are more suggestive of vaginal or urethral erosion and they must be carefully explored with a systematic gynecological examination and cystoscopy. When women must perform intermittent bladder self-catheterization as first line treatment for urinary chronic retention, associated section or partial resection may be necessary.18,19
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Pelvic chronic pain is another unrecognized complication but it has been reported to develop in up to 30% of patients after TVT placement.20 In an early study we reported that partial or complete resection appears to be appropriate for managing isolated disabling chronic pelvic pain after the failure of analgesia or local infiltration.7 Pikaart et al described the first cases of a laparoscopic approach to remove tension-free polypropylene mesh tape slings from the retropubic space due to pain and/or erosion into the bladder.8 This technique seems to be safe when performed via an extraperitoneal approach. Unlike transurethral resection, it allows removal of the entire portion of the eroded mesh. We also believe that transurethral resection with simple excision or laser incision has a high potential of recurrence at the edges of the mesh that remain in the bladder wall. Laparoscopy seems to be the most appropriate approach to complete tape resection. As soon as the tape is entirely removed, incontinence should theoretically be expected to recur or
even be worse. Surprisingly it appears that continence may be in fact preserved after removing the sling material.19 We observed early recurrence of incontinence in 52% of our cases. Our results are in line with the 58% and 74% incontinence rates after complete resection in previous reports.11
CONCLUSIONS At a time when minimally invasive therapy is being actively developed suburethral slings appear to be the gold standard to efficiently treat SUI. Despite this, rare complications may develop in some women, leading to crippling symptoms. In the rare women who experience symptoms after tape implantation urologists must be aware that the decision to perform complete or partial resection can help resolve symptoms. Although recurrent urinary incontinence cannot be predicted after tape resection, women should be warned of this possibility.
REFERENCES 1. Latthe PM, Foon R and Toozs-Hobson P: Transobturator and retropubic tape procedures in stress urinary incontinence: a systematic review and meta-analysis of effectiveness and complications. Br J Obstet Gynaecol 2007; 114: 522. 2. Tsivian A, Mogutin B, Kessler O, Korczak D, Levin S and Sidi AA: Tension-free vaginal tape procedure for the treatment of female stress urinary incontinence: long-term results. J Urol 2004; 172: 998. 3. Abouassaly R, Steinberg JR, Lemieux M, Marois C, Gilchrist LI, Bourque JL et al: Complications of tension-free vaginal tape surgery: a multi-institutional review. BJU Int 2004; 94: 110. 4. Delorme E, Droupy S, de Tayrac R and Delmas V: Transobturator tape (Uratape): a new minimallyinvasive procedure to treat female urinary incontinence. Eur Urol 2004; 45: 203. 5. Sweat SD, Itano NB, Clemens JQ, Bushman W, Gruenenfelder J, McGuire EJ et al: Polypropylene mesh tape for stress urinary incontinence: complications of urethral erosion and outlet obstruction. J Urol 2002; 168: 144. 6. Huwyler M, Springer J, Kessler TM and Burkhard FC: A safe and simple solution for intravesical tension-free vaginal tape erosion: removal by standard transurethral resection. BJU Int 2008; 102: 582. 7. Misrai V, Chartier-Kastler E, Cour F, Mozer P, Almeras C and Richard F: Surgical management
of chronic refractory pain after TVT treatment for stress urinary incontinence. Prog Urol 2006; 16: 368. 8. Pikaart DP, Miklos JR and Moore RD: Laparoscopic removal of pubovaginal polypropylene tension-free tape slings. JSLS 2006; 10: 220. 9. Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J et al: Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain 2005; 114: 29. 10. Dindo D, Demartines N and Clavien PA: Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240: 205. 11. Clemens JQ, DeLancey JO, Faerber GJ, Westney OL and McGuire EJ: Urinary tract erosions after synthetic pubovaginal slings: diagnosis and management strategy. Urology 2000; 56: 589.
14. Hammad FT, Kennedy-Smith A and Robinson RG: Erosions and urinary retention following polypropylene synthetic sling: Australasian survey. Eur Urol 2005; 47: 641. 15. Abdel-Fattah M, Sivanesan K, Ramsay I, Pringle S and Bjornsson S: How common are tape erosions? A comparison of two versions of the transobturator tension-free vaginal tape procedure. BJU Int 2006; 98: 594. 16. Giri SK, Hickey JP, Sil D, Mabadeje O, Shaikh FM, Narasimhulu G et al: The long-term results of pubovaginal sling surgery using acellular crosslinked porcine dermis in the treatment of urodynamic stress incontinence. J Urol 2006; 175: 1788. 17. Kobashi KC and Govier FE: Management of vaginal erosion of polypropylene mesh slings. J Urol 2003; 169: 2242. 18. Amundsen CL, Guralnick ML and Webster GD: Variations in strategy for the treatment of urethral obstruction after a pubovaginal sling procedure. J Urol 2000; 164: 434.
12. Pit MJ: Rare complications of tension-free vaginal tape procedure: late intraurethral displacement and early misplacement of tape. J Urol 2002; 167: 647.
19. Tsivian A, Kessler O, Mogutin B, Rosenthal J, Korczak D, Levin S et al: Tape related complications of the tension-free vaginal tape procedure. J Urol 2004; 171: 762.
13. Volkmer BG, Nesslauer T, Rinnab L, Schradin T, Hautmann RE and Gottfried HW: Surgical intervention for complications of tension-free vaginal tape procedure. J Urol 2003; 169: 570.
20. Bourrat M, Armand C, Seffert P and Tostain J: Complications and medium-term functional results of TVT in stress urinary incontinence. Prog Urol 2003; 13: 1358.
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EDITORIAL COMMENTS These authors present an exhaustive review of their management for complications related to mid urethral synthetic slings. Their approach is diligent and their outcome reporting is comprehensive. Personally I believe that it is not necessary to be as aggressive when removing all sling components in the absence of pain, infection or other extenuating circumstances. Nonetheless, it is clear that an increasing number of journal articles and case reports are being published on the need for repeat intervention for less than optimal results using mid urethral tapes. A recent regulatory warning that included vaginal mesh for all vaginal indications, including incontinence surgery, underscores this reporting phenomenon. What does this mean? Are we now seeing a delayed signal or increased awareness of issues attendant to all incontinence surgeries? Is there a temporal component to these complications and do specific technique, surgeon experience, patient selection, and underappreciated and immeasurable variables have a role in the outcome? My presumption is that all of these aspects are contributory to a successful outcome or an untoward complication. There is increasing governmental and third party interest in the concept of comparative effec-
tiveness. Simply put, interventions of all types in health care will be increasingly subjected to more evidence-based analysis regarding overall effectiveness, a term that takes into account all aspects of outcomes, including efficacy, safety, cost and patient approbation. Re-intervention skews all effectiveness assessment toward a negative summary conclusion. Therefore, outcome variability will be a touchstone of forward looking health care in the United States and globally as health care costs continue their relentless increase. It is critical that several aspects of comparative effectiveness be universally agreed on, especially for interventions used for conditions that are not life or limb threatening. Standardized efficacy, adverse event and secondary intervention taxonomies are critical, as is assessment of recipient (patient) approbation or the lack thereof for the intervention in question.
These authors report their results of a relatively new laparoscopic approach for various complications of mid urethral tape procedures. The fact that they were able to remove the entire tape using this technique in a large number of patients with relatively few complications is noteworthy and I think that the technique will be a valuable addition in select patients. However, I think that many of these patients would have done well with more limited tape resection. The fact that the incontinence rate was 52% in patients who underwent complete resection makes patient selection critical. Assuming that the tape is made from one of the newer type 3 polypropylene mesh products, in my opinion the entire tape rarely needs to be removed. If the tape is other than a type 3 polypropylene mesh, or the mesh is heat treated or contains silicone, a case can be made for removing the entire mesh in any patient with extrusion, erosion, infection or chronic pelvic pain. The following approach would pertain to one of the newer type 3 polypropylene mesh products in
my practice. 1) If it is simple vaginal extrusion, most patients can be treated with simple observation or local resection. 2) By definition with vaginal extrusion the mesh is infected. Assuming that extrusion is limited and the patient has no systemic signs or symptoms, simple observation or local resection should suffice. 3) Urethral obstruction can almost always be managed via the vaginal approach. 4) For urethral erosion only that portion of tape in and immediately around the urethra must be completely excised. 5) For bladder erosion that portion of the tape in and immediately around the bladder must be completely excised and a laparoscopic approach appears to be a reasonable option. 6) For unrelenting pelvic pain removal of the entire tape via a laparoscopic approach appears to be a reasonable option.
Roger Dmochowski and Harriette Scarpero Department of Urology Vanderbilt University Medical Center Nashville, Tennessee
Fred E. Govier Department of Surgery Virginia Mason Medical Center Seattle, Washington
Abbreviations and Acronyms BOO ⫽ bladder outlet obstruction SUI ⫽ stress urinary incontinence TOT ⫽ transobturator tape TVT ⫽ transvaginal tape Submitted for publication September 15, 2008. * Correspondence: Academic Urology Department, Hospital Pitié-Salpétrière, 47-83 Boulevard de l’Hopital, 75013 Paris, France (e-mail: morgan. [email protected]).
Purpose: Suburethral tapes have been widely adopted to treat stress urinary incontinence. Further resection of such tapes may be necessary in certain cases. We review our experience and assess urinary functional outcomes. Materials and Methods: We retrospectively reviewed the data on all women referred to our institution between 2001 and 2007 for suburethral tape related complications and on those who had the tape surgically removed. Complete or partial resection was achieved after assessment, including endoscopic and urodynamic assessment. Results: A total of 75 women with a mean age of 60.7 years (range 28 to 78) were included in the study. The tape used was transvaginal in 58 cases (77.3%) and transobturator in 17 (22.7%). There were different complications, such as erosion in 16% of cases, vaginal extrusion in 24%, bladder outlet obstruction in 45%, chronic pelvic pain in 21%, and de novo urinary incontinence and urgency in 12%. Resection was done a mean ⫾ SD of 33 ⫾ 22 months (range 6 to 80) after tape placement. Of the 58 women with transvaginal tape the tape was completely removed by laparoscopy in 30 (51%). Four of the 17 transobturator slings (23%) were completely removed by laparoscopy (1) and via a low gynecological approach (3). The remaining slings were partially resected via a gynecological approach. At a mean followup of 38.4 months (range 12 to 72) incontinence recurred in 39 women (52%) after partial (18) and complete (21) resection. Conclusions: In rare women who experience crippling symptoms after suburethral sling implantation urologists must be aware that the decision to completely or partially resect the tape can help resolve symptoms. Key Words: urethra; suburethral slings; urinary incontinence, stress; complications; prostheses and implants
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SUBURETHRAL tapes, ie tension-free TVT and/or TOT, have become the new gold standard treatment for female SUI. Since 1996, more than 1,200,000 TVT procedures have been performed worldwide1 with a 5-year success rate of greater than 80%.2 Although these procedures are minimally invasive, they are currently associated with perioperative complications (bladder perfora-
tion and vascular injury), early postoperative complications (infection and acute urinary retention) and late postoperative complications (bladder outlet obstruction, mesh erosion, chronic pain and de novo detrusor overactivity).3 Starting in 2001 the transobturator approach using TOT and tension-free obturator TVT has been progressively developed to avoid such complications.
0022-5347/09/1815-2198/0 THE JOURNAL OF UROLOGY® Copyright © 2009 by AMERICAN UROLOGICAL ASSOCIATION
Vol. 181, 2198-2203, May 2009 Printed in U.S.A. DOI:10.1016/j.juro.2009.01.036
SURGICAL RESECTION FOR SUBURETHRAL SLING COMPLICATIONS
This approach appears to be as safe and efficient as retropubic access.4,5 Although the incidence of adverse events has decreased, complications are still being reported.5 As a result, partial or complete surgical resection of the tape can be done in specific cases to manage complications. To date the number of published studies of surgical management for such complications in the current literature is limited.6 – 8 Therefore, we present our experience with tape related complications that we have had to manage by tape resection.
MATERIALS AND METHODS We reviewed the files of all women referred between 2001 and 2007 to our department for suburethral tape related complications. All medical charts were retrospectively reviewed to collect certain data, including patient age, body mass index, initial type of incontinence, medical history of previous pelvic support and anti-incontinence procedures, date and type of suburethral tape resection procedure, complications, duration of bladder catheterization and hospital stay, urinary symptoms, continence, pain, outcome and followup. Each clinical evaluation included physical examination, voiding diary, urinalysis, cystoscopy with a 70-degree optical lens and urodynamic assessment with uroflowmetry. When there was chronic pelvic pain, patients were invited to complete the DN4 questionnaire to assess the etiology of undiagnosed neuropathic pain.9 Clinical evaluation, impact on quality of life and failure of first line treatment influenced the surgical decision to remove the suburethral tape. The surgical decision to resect the tape was determined by a combination of objective and subjective symptoms (see figure). We performed complete removal in certain patients, including those with previous unsuccessful first line management with the patient then referred to our institution and those with suspected or proven sling infection. Also, our strategy was to entirely remove the tape as soon as pelvic pain and symptoms were triggered by bladder filling during cystoscopy. In these cases it was difficult to accurately estimate the
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location of the pain and restrict it only to the suburethral portion. Because pain could be linked to partial or total migration of the tape through the bladder wall or even to a manufacturing fault in the conception of the mesh, we performed complete resection in these cases. In other cases the decision to perform partial or complete resection of the tape was made at urologist discretion. In all cases of partial tape resection we used a vaginal approach. Perioperative cystoscopy was done systematically as step 1. A middle anterior vaginal wall incision was made centering on the sling location and the vaginal epithelium was dissected lateral. After the sling was identified it was circumferentially dissected and incised in the midline beneath the urethra. The dissection end point was to restore adequate sagittal plane mobility of the urethra. Complete TOT resection always required a second surgical access from the end point of the tape to the internal side of the whole obturator. For complete resection we used a pure laparoscopic extraperitoneal approach or we performed a combined procedure using a vaginal or laparoscopic approach. Extraperitoneal laparoscopy was performed with 5 mm trocars and a 10 mm umbilical telescope port with 2 trocars placed medial to the anterior superior iliac spine and 1 placed at the mid point between pubis and umbilicus. Step 1 of dissection consisted of releasing the retropubic space. The primary objective was to identify the 2 half tapes in contact with the pubis, corresponding to their normal path. The half tape was then grasped and drawn downward. The transparietal tract of the tape was dissected by remaining in contact with the tape and by successively crossing the rectus abdominis muscle fibers and fascia. Dissection of the fascia revealed adipose tissue, which could be mobilized without resistance, allowing complete extraction of the transparietal tract. Urethral release was performed medial as far as possible without opening the vagina. The left fingers of the surgeon were placed into the vagina to perform dissection of the remaining part of the mesh located across and/or under the urethra. The 2 entire half tapes were extracted via the 10 mm port. Redon suction was then done in the retropubic space. Tape fragments were sent for histological and bacteriological examination. When we looked for intravesical erosion, dissection was continued down to the point of entry of the tape into the bladder. The bladder was opened and the mesh was removed with clean margins. Cystotomy repair was performed using interrupted 3-zero polyglactin suture. Perioperative data were reviewed, especially for laparoscopic approaches, including mean operative time, organ injury and conversion to open surgery. All patients were seen 1, 3, 6 and 12 months after surgery and yearly thereafter to assess the functional outcome. We focused on the resolution of functional disorders and on recurrent SUI.
RESULTS Combination of symptoms leading to surgical suburethral tape resection in women after treatment for SUI.
Overall 75 women with a mean ⫾ SD age of 60.7 ⫾ 12 years (range 28 to 78) were included in analysis. Median body mass index was 27 kg/m2 (range 23 to 31). The tape used was TVT in 58 cases (77.3%) and
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SURGICAL RESECTION FOR SUBURETHRAL SLING COMPLICATIONS
TOT in 17 (22.7%). Of these tapes 73 (93.6%) were implanted elsewhere with the patients referred to our center for further treatment for complications. Patients Seven women (9%) had undergone former incontinence surgery, including Burch colposuspension in 6 and Marshall-Marchetti colposuspension in 1. Of the women 67 (89.3%) were initially treated with a sling for pure SUI, including TVT in 51 and TOT in 16. The remaining 8 women (9.7%), who presented with mixed urinary incontinence, received TVT (7) and TOT (1). Data on the type of tapes removed were missing except in 5 cases, in which type III polypropylene mesh was used. Resection was done a mean of 33 ⫾ 22 months (range 6 to 80) after tape placement. The table lists all complications following the sling procedure. Isolated Mesh Erosion and Extrusion There were isolated mesh erosion in 8 cases and extrusion in 16. A total of 17 women reported symptoms, including vaginal discharge and/or bleeding, dyspareunia or recurrent urinary tract infections (intravesical erosion) related to vaginal extrusion (10), or urethral (4) or bladder (3) tape erosion a mean of 8 months (range 3 to 45) after the TVT procedure. Vaginal examination revealed abnormal findings in the periurethral area or in the vagina, ranging from a small area of granulated tissue to a visible part of biomaterial. Cystoscopic examination revealed cases of urethral and bladder erosion. Urethral erosion was seen as sling material within the urethral lumen or the sinus tract, extending into periurethral tissues, or as localized edema with granulation tissue. Most bladder erosion was located next to the bladder neck. One woman with persistent incontinence had a urethrovaginal fistula. Seven patients experienced vaginal extrusion (6) or intravesical erosion (1) following the TOT procedure.
Main characteristics and surgical approach in 75 women who underwent tape resection No. TVT Overall Complications: Isolated mesh erosion/complete resection Isolated mesh extrusion/complete resection BOO/complete resection De novo incontinence or urgency Isolated chronic pelvic pain/complete resection Surgery: Laparoscopic/complete resection Low gynecological approach/complete resection Double access/complete resection
58
No. TOT 17
A total of 16 patients had been initially treated unsuccessfully with repeat vaginal closure (9) or partial suburethral resection (7) at the primary treatment centers. Bladder Outlet Obstruction BOO developed in 29 women, including 23 (30.6%) after the TVT procedure with concomitant vaginal extrusion (1) or vesical tape erosion (2) and 6 (8%) after TOT with concomitant vaginal tape extrusion (1). A total of 20 women (26.7%) were diagnosed with recurrent urinary tract infections and difficult voiding, of whom 7 required bladder self-catheterization. The mean maximal flow rate was 12 ⫾ 3 ml per second. In 1 case renal ultrasound revealed bilateral ureterohydronephrosis. A total of 25 women had previously been treated unsuccessfully with limited section of the suburethral part of the tape. Isolated Chronic Pelvic Pain Isolated chronic pelvic pain developed in 16 women, including 12 (16%) a mean of 15.6 months (range 5 to 29) after the TVT procedure. Pain was located at the suprapubic (3) or vaginal (2) scar, in the vaginal vault (7) and to the left of the TVT. Women complained of dyspareunia (7), voiding burns (2), left leg pain (1) and isolated pelvic pain (3). During cystoscopy increased disabling pelvic pain was triggered in 9 women by bladder filling. Three women had chronic perineal pain after the TOT procedure, which was located bilateral to the whole obturator. Pain was located at the labia major and the origin of the thigh. In all cases symptoms had been refractory to previous symptomatic medical treatment, including pain killers or local infiltration. De Novo Urinary Incontinence and Urgency De novo urinary incontinence and urgency developed in 9 women. Seven women presented with de novo urgency a mean of 3 months (range 1 to 32) following the TVT procedure, which was associated with dysuria in 3 and intravesical mesh erosion in 2. Two women presented with isolated urgency following the TOT procedure. In all cases symptoms were refractory to anticholinergic drugs.
Total No. 75
7/7 10/7
1/1 6
8 16
24/7 5 12/9
5 1 4/3
29 6 16
29/29 27
1/1 16/3
30 43
1/1
0
1
Surgical Resection The table lists all surgical procedures. TVT tapes were completely and partially removed in 31 and 27 cases, respectively. Women who underwent complete resection had intravesical or urethral erosion (11), unsuccessful previous partial resection for vaginal mesh extrusion (7) or BOO (4) and pelvic pain concomitant with bladder filling during cystoscopy (9). Resection was completely performed using a laparoscopic approach in 30 cases and in 1 early case it was combined with the vaginal approach. We noted no complication during these procedures according
SURGICAL RESECTION FOR SUBURETHRAL SLING COMPLICATIONS
to the updated conventional complication classification system of Dindo et al.10 Regarding partial removal, simple resection of the suburethral part was performed in 9 cases of isolated dysuria. Four of the 17 TOT tapes were completely removed by dissection of the transobturator whole to manage bilateral disabling pelvic pain in 3 women and with a laparoscopic step to treat intrabladder erosion in 1. We used the vaginal approach to resect the remaining tapes in 12 women. Mean operative time was 122 minutes (range 50 to 240) in laparoscopic cases. Postoperative Outcomes Bladder catheterization was required a median of 4 days (range 2 to 8) postoperatively. Median hospital stay was 6.4 days (range 3 to 10). At 1 month of followup all patients reported a partial or total decrease in pain and urinary urgency. After 6 months BOO was improved in 28 women (82%) with a mean maximal flow rate of 20 ⫾ 5 ml per second. All patients reported a total decrease in pain. Healing occurred in all cases. At a mean followup of 38.4 months (range 12 to 72) postoperatively, that is by the end of the current study, we observed recurrent incontinence in 39 women (52%) after partial (18) and complete (21) resection. Recurrent incontinence was revealed a mean of 0.8 months (range 0.1 to 3) postoperatively. Urinary incontinence was observed, including stress incontinence in 18 cases and urge incontinence in 10. All 11 women who experienced recurrent urinary incontinence with intrinsic sphincter deficiency had had lower urethral pressure closure preoperatively. Histological and Bacteriological Analysis Cultures of the removed materials were routinely obtained. In 1 patient a suburethral abscess diagnosed on pelvic magnetic resonance imaging had led to vaginal erosion. In other cases only nonspecific chronic signs of inflammation were found.
DISCUSSION In the last few years suburethral slings have been widely developed and adopted for the surgical management of SUI. These procedures have revolutionized surgical management of SUI because they appear to be simple and minimally invasive, and provide a high success rate.1,3 However, a growing number of postoperative complications and unexpected side effects have been reported in the literature. Several recent reports have been published on managing the erosion of tape located in the urethra, the bladder or even the vagina.5,11–13 Although the erosion rate has been reported to be between 0.3% and 14%, therapy remains unclear.14 Despite their paucity these complications require
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surgical intervention in some cases. Whether the tape should be removed early remains unclear. Radical management, eg sling removal with or without a bladder repair procedure, is rarely proposed as first line treatment except in women with concomitant bladder erosion, de novo functional complications (dysuria, chronic retention or urgency) or proven biomaterial infection.3,7,13,14 To our knowledge we report the first large series of tape resections as radical second line management of suburethral sling complications. Regarding our results, we believe that it is difficult to pinpoint systematic and dedicated treatment for mesh extrusion because most women were previously treated conservatively without success. The debate is ongoing in the current literature. Abdel-Fattah et al advocate partial resection of the extruded and, therefore, potentially colonized portion of the tape and they recommend complete removal when there is any suspicion of infection.15 On the other hand, Giri et al suggest a conservative approach with repeat closure of the vaginal mucosa over the tape with minimal dissection in cases of erosion limited to the vagina.16 However, most investigators recommend first line conservative treatment. For instance, Kobashi and Govier reported 4 cases of vaginal erosion that were managed conservatively only by sexual abstinence.17 They noted spontaneous epithelialization of the mesh within a 6-week period. This minimally aggressive management can be explained by the incidence of asymptomatic vaginal erosion, which was reported to be up to 35%.14 Multiple factors, such as sling placement closer to the urethra, inadequate vaginal suture, perioperative infection and poor tissue vascularization, have been postulated as potential explanations for vaginal extrusion. However, the exact etiology of these extrusions has not yet been elucidated. However, we trust that it is of interest to be familiar with the diagnosis of and treatment for this complication for urologists who frequently use synthetic materials, notably because some symptoms, such as urgency and recurrent urinary tract infections, are aspecific and may be confused with postoperative BOO or de novo detrusor instability. When there is a lack of vaginal or urethral pain, these symptoms may indicate the presence of an intravesical tape. Other symptoms, such as vaginal discharge or bleeding, or persistent vaginal or urethral pain, are more suggestive of vaginal or urethral erosion and they must be carefully explored with a systematic gynecological examination and cystoscopy. When women must perform intermittent bladder self-catheterization as first line treatment for urinary chronic retention, associated section or partial resection may be necessary.18,19
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Pelvic chronic pain is another unrecognized complication but it has been reported to develop in up to 30% of patients after TVT placement.20 In an early study we reported that partial or complete resection appears to be appropriate for managing isolated disabling chronic pelvic pain after the failure of analgesia or local infiltration.7 Pikaart et al described the first cases of a laparoscopic approach to remove tension-free polypropylene mesh tape slings from the retropubic space due to pain and/or erosion into the bladder.8 This technique seems to be safe when performed via an extraperitoneal approach. Unlike transurethral resection, it allows removal of the entire portion of the eroded mesh. We also believe that transurethral resection with simple excision or laser incision has a high potential of recurrence at the edges of the mesh that remain in the bladder wall. Laparoscopy seems to be the most appropriate approach to complete tape resection. As soon as the tape is entirely removed, incontinence should theoretically be expected to recur or
even be worse. Surprisingly it appears that continence may be in fact preserved after removing the sling material.19 We observed early recurrence of incontinence in 52% of our cases. Our results are in line with the 58% and 74% incontinence rates after complete resection in previous reports.11
CONCLUSIONS At a time when minimally invasive therapy is being actively developed suburethral slings appear to be the gold standard to efficiently treat SUI. Despite this, rare complications may develop in some women, leading to crippling symptoms. In the rare women who experience symptoms after tape implantation urologists must be aware that the decision to perform complete or partial resection can help resolve symptoms. Although recurrent urinary incontinence cannot be predicted after tape resection, women should be warned of this possibility.
REFERENCES 1. Latthe PM, Foon R and Toozs-Hobson P: Transobturator and retropubic tape procedures in stress urinary incontinence: a systematic review and meta-analysis of effectiveness and complications. Br J Obstet Gynaecol 2007; 114: 522. 2. Tsivian A, Mogutin B, Kessler O, Korczak D, Levin S and Sidi AA: Tension-free vaginal tape procedure for the treatment of female stress urinary incontinence: long-term results. J Urol 2004; 172: 998. 3. Abouassaly R, Steinberg JR, Lemieux M, Marois C, Gilchrist LI, Bourque JL et al: Complications of tension-free vaginal tape surgery: a multi-institutional review. BJU Int 2004; 94: 110. 4. Delorme E, Droupy S, de Tayrac R and Delmas V: Transobturator tape (Uratape): a new minimallyinvasive procedure to treat female urinary incontinence. Eur Urol 2004; 45: 203. 5. Sweat SD, Itano NB, Clemens JQ, Bushman W, Gruenenfelder J, McGuire EJ et al: Polypropylene mesh tape for stress urinary incontinence: complications of urethral erosion and outlet obstruction. J Urol 2002; 168: 144. 6. Huwyler M, Springer J, Kessler TM and Burkhard FC: A safe and simple solution for intravesical tension-free vaginal tape erosion: removal by standard transurethral resection. BJU Int 2008; 102: 582. 7. Misrai V, Chartier-Kastler E, Cour F, Mozer P, Almeras C and Richard F: Surgical management
of chronic refractory pain after TVT treatment for stress urinary incontinence. Prog Urol 2006; 16: 368. 8. Pikaart DP, Miklos JR and Moore RD: Laparoscopic removal of pubovaginal polypropylene tension-free tape slings. JSLS 2006; 10: 220. 9. Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J et al: Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain 2005; 114: 29. 10. Dindo D, Demartines N and Clavien PA: Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240: 205. 11. Clemens JQ, DeLancey JO, Faerber GJ, Westney OL and McGuire EJ: Urinary tract erosions after synthetic pubovaginal slings: diagnosis and management strategy. Urology 2000; 56: 589.
14. Hammad FT, Kennedy-Smith A and Robinson RG: Erosions and urinary retention following polypropylene synthetic sling: Australasian survey. Eur Urol 2005; 47: 641. 15. Abdel-Fattah M, Sivanesan K, Ramsay I, Pringle S and Bjornsson S: How common are tape erosions? A comparison of two versions of the transobturator tension-free vaginal tape procedure. BJU Int 2006; 98: 594. 16. Giri SK, Hickey JP, Sil D, Mabadeje O, Shaikh FM, Narasimhulu G et al: The long-term results of pubovaginal sling surgery using acellular crosslinked porcine dermis in the treatment of urodynamic stress incontinence. J Urol 2006; 175: 1788. 17. Kobashi KC and Govier FE: Management of vaginal erosion of polypropylene mesh slings. J Urol 2003; 169: 2242. 18. Amundsen CL, Guralnick ML and Webster GD: Variations in strategy for the treatment of urethral obstruction after a pubovaginal sling procedure. J Urol 2000; 164: 434.
12. Pit MJ: Rare complications of tension-free vaginal tape procedure: late intraurethral displacement and early misplacement of tape. J Urol 2002; 167: 647.
19. Tsivian A, Kessler O, Mogutin B, Rosenthal J, Korczak D, Levin S et al: Tape related complications of the tension-free vaginal tape procedure. J Urol 2004; 171: 762.
13. Volkmer BG, Nesslauer T, Rinnab L, Schradin T, Hautmann RE and Gottfried HW: Surgical intervention for complications of tension-free vaginal tape procedure. J Urol 2003; 169: 570.
20. Bourrat M, Armand C, Seffert P and Tostain J: Complications and medium-term functional results of TVT in stress urinary incontinence. Prog Urol 2003; 13: 1358.
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EDITORIAL COMMENTS These authors present an exhaustive review of their management for complications related to mid urethral synthetic slings. Their approach is diligent and their outcome reporting is comprehensive. Personally I believe that it is not necessary to be as aggressive when removing all sling components in the absence of pain, infection or other extenuating circumstances. Nonetheless, it is clear that an increasing number of journal articles and case reports are being published on the need for repeat intervention for less than optimal results using mid urethral tapes. A recent regulatory warning that included vaginal mesh for all vaginal indications, including incontinence surgery, underscores this reporting phenomenon. What does this mean? Are we now seeing a delayed signal or increased awareness of issues attendant to all incontinence surgeries? Is there a temporal component to these complications and do specific technique, surgeon experience, patient selection, and underappreciated and immeasurable variables have a role in the outcome? My presumption is that all of these aspects are contributory to a successful outcome or an untoward complication. There is increasing governmental and third party interest in the concept of comparative effec-
tiveness. Simply put, interventions of all types in health care will be increasingly subjected to more evidence-based analysis regarding overall effectiveness, a term that takes into account all aspects of outcomes, including efficacy, safety, cost and patient approbation. Re-intervention skews all effectiveness assessment toward a negative summary conclusion. Therefore, outcome variability will be a touchstone of forward looking health care in the United States and globally as health care costs continue their relentless increase. It is critical that several aspects of comparative effectiveness be universally agreed on, especially for interventions used for conditions that are not life or limb threatening. Standardized efficacy, adverse event and secondary intervention taxonomies are critical, as is assessment of recipient (patient) approbation or the lack thereof for the intervention in question.
These authors report their results of a relatively new laparoscopic approach for various complications of mid urethral tape procedures. The fact that they were able to remove the entire tape using this technique in a large number of patients with relatively few complications is noteworthy and I think that the technique will be a valuable addition in select patients. However, I think that many of these patients would have done well with more limited tape resection. The fact that the incontinence rate was 52% in patients who underwent complete resection makes patient selection critical. Assuming that the tape is made from one of the newer type 3 polypropylene mesh products, in my opinion the entire tape rarely needs to be removed. If the tape is other than a type 3 polypropylene mesh, or the mesh is heat treated or contains silicone, a case can be made for removing the entire mesh in any patient with extrusion, erosion, infection or chronic pelvic pain. The following approach would pertain to one of the newer type 3 polypropylene mesh products in
my practice. 1) If it is simple vaginal extrusion, most patients can be treated with simple observation or local resection. 2) By definition with vaginal extrusion the mesh is infected. Assuming that extrusion is limited and the patient has no systemic signs or symptoms, simple observation or local resection should suffice. 3) Urethral obstruction can almost always be managed via the vaginal approach. 4) For urethral erosion only that portion of tape in and immediately around the urethra must be completely excised. 5) For bladder erosion that portion of the tape in and immediately around the bladder must be completely excised and a laparoscopic approach appears to be a reasonable option. 6) For unrelenting pelvic pain removal of the entire tape via a laparoscopic approach appears to be a reasonable option.
Roger Dmochowski and Harriette Scarpero Department of Urology Vanderbilt University Medical Center Nashville, Tennessee
Fred E. Govier Department of Surgery Virginia Mason Medical Center Seattle, Washington