Voiding Dysfunction Following Removal of Eroded Synthetic Mid Urethral Slings

Voiding Dysfunction Following Removal of Eroded Synthetic Mid Urethral Slings Jonathan S. Starkman, Christopher Wolter, Alex Gomelsky,* Harriette M. Scarpero† and Roger R. Dmochowski‡,§ From the Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, and Department of Urology, Louisiana State University-Shreveport (AG), Shreveport, Louisiana

Purpose: Voiding dysfunction following genitourinary erosion of synthetic mid urethral slings is not clearly reported. We investigated the incidence of voiding dysfunction in patients following sling excision due to vaginal, urethral or intravesical mesh erosion. Materials and Methods: Retrospective review identified 19 patients with genitourinary erosion of polypropylene mesh slings. Comprehensive urological evaluation was performed in all patients, and perioperative and postoperative data were analyzed. Voiding dysfunction was defined as refractory storage symptoms, emptying symptoms and pelvic pain. All subsequent medical and surgical interventions were recorded. Results: In 19 patients a total of 11 vaginal, 7 intravesical and 5 urethral erosions occurred. Mean patient age was 52 years (range 32 to 69) and average followup was 8.4 months (range 3 to 34). Average time from symptom onset to sling removal was 10.1 months (range 1.5 to 38). Of the 19 patients 14 (74%) presented with multiple symptoms. Symptoms varied, including refractory pain, recurrent infections and bladder storage/emptying dysfunction. Urodynamic studies were abnormal preoperatively and postoperatively in 9 of 13 (69%) and 4 of 6 patients (67%), respectively. Following surgery lower urinary tract symptoms resolved completely in only 4 of the 19 patients (21%). Stress incontinence recurred in 8 of the 19 patients (42%). Five patients underwent simultaneous pubovaginal sling, of whom none had recurrent stress urinary incontinence. Only 9 patients (47%) considered themselves dry with no pads following surgery. Four patients required further surgery for refractory voiding symptoms. Conclusions: Voiding dysfunction is not an uncommon finding after sling excision in the setting of genitourinary erosion. It may cause additional patient morbidity. Key Words: urinary incontinence, vagina, urethra, bladder, prostheses and implants

n the last decade a number of new, minimally invasive surgical procedures have been developed for SUI. The TVT™ procedure emphasizes the importance of the mid urethral continence mechanism and it has gained widespread acceptance due to its systematic and prospective evaluation.1 It is estimated that more than 1 million TVT™ procedures have been performed worldwide since 1997. In a recent review of surgical techniques used to correct SUI at European hospitals 84% of all procedures were synthetic mid urethral slings and these operations have emerged as the most common anti-incontinence procedure worldwide.2 In 2001 Delorme described the placement of a synthetic polypropylene mesh using a transobturator approach.3 Since being introduced in the United States in 2003, transobturator slings have become widely accepted and they appear to offer similar efficacy and fewer complications.3

I

Submitted for publication March 28, 2006. Study received Institutional Review Board approval. * Financial interest and/or other relationship with Novartis. † Financial interest and/or other relationship with Pfizer. ‡ Correspondence: Department of Urologic Surgery, Vanderbilt University Medical Center, A-1302 Medical Center North, Nashville, Tennessee 37232-2765 (telephone: 615-343-5602; FAX: 615322-8990; e-mail: [email protected]). § Financial interest and/or other relationship with Allergan, Novartis and Watson Pharma.

0022-5347/06/1763-1040/0 THE JOURNAL OF UROLOGY® Copyright © 2006 by AMERICAN UROLOGICAL ASSOCIATION

The biological properties of each synthetic mesh clearly influence the erosion rate with large pore polypropylene mesh considered to have the most reliable tissue biocompatibility.4 In a large meta-analysis of 1,515 synthetic bladder neck PVSs the 1997 American Urological Association Guidelines Panel quoted vaginal and urethral erosion rates of 0.7% and 1.8%, respectively.5 Certain synthetic slings, ie ProtoGen™ and OBtape™, have been recalled due to unacceptably high erosion rates. In 2003 Gynecare reported a vaginal erosion rate of 0.012% to the Food and Drug Administration in the United States based on 500,000 TVT™ procedures.6 Although genitourinary erosion remains infrequent, there is potential for significant patient morbidity. Furthermore, voiding dysfunction and LUTS are not yet well described following the removal of eroded mid urethral slings. We describe the incidence of voiding dysfunction in our patients following surgical management of synthetic sling erosion into the genitourinary tract.

MATERIALS AND METHODS Institutional Review Board approval was obtained for this retrospective review. From April 2001 through August 2005 a total of 19 patients underwent partial or complete sling excision for the indication of genitourinary erosion at

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Vol. 176, 1040-1044, September 2006 Printed in U.S.A. DOI:10.1016/j.juro.2006.04.103

VOIDING DYSFUNCTION AFTER REMOVAL OF ERODED SYNTHETIC MID URETHRAL SLINGS our 2 university hospitals. All patients underwent the sling procedure elsewhere and were referred for treatment. Urological evaluation, consisting of history, physical examination, urinalysis and culture, and cystoscopy, were performed in all patients. VUDS were done in select cases at the discretion of the treating physician. Perioperative and postoperative data were recorded on all patients. Sling excision was accomplished by a vaginal, retropubic or combined surgical approach. When the vaginal route was used to expose the eroded mesh, a midline incision or inverted U incision was used. In cases of vaginal extrusion the mesh was identified in the midline, dissected sharply from the periurethral fascia and excised segmentally. Urethral erosion required isolation of the mesh laterally with sharp dissection of the tape medially until the mesh perforated the urethral lumen. Midline urethrotomy facilitated complete extraction of the mesh from the urinary tract, followed by urethral reconstruction. Cases requiring retropubic access were approached through a Pfannenstiel incision. The retropubic space was entered and mobilized with a combination of sharp and blunt dissection. The arms of the sling were identified and sharply dissected toward the endopelvic fascia. Cases involving intravesical erosion required sharp dissection until the mesh was seen perforating the bladder. The mesh was subsequently excised via cystotomy or limited partial cystectomy. Voiding dysfunction was defined as persistent or de novo storage symptoms (frequency, urgency and urinary urge incontinence), emptying symptoms (urinary retention, increased post-void residual urine greater than 200 cc or a high pressure-low flow voiding pattern on VUDS), SUI or refractory pelvic pain. All subsequent medical and surgical interventions following sling excision were reviewed and reported at the time of last followup. RESULTS A total of 19 patients underwent surgical intervention to remove a synthetic mid urethral sling that had eroded into the genitourinary tract (table 1). Mean patient age was 52 years (range 32 to 69) and the mean time from sling place-

TABLE 1. Patient characteristics No. pts Mean age (range) Mean time to sling removal (range) Mean mos followup (range) No. synthetic mid urethral sling type: TVTTM SPARCTM MONARCTM TTM No. erosion:* Vaginal Urethral Bladder No. surgical approach: Vaginal Retropubic Combined No. sling excision extent: Partial Complete

19 52 (32–69) 10.1 Mos (6 wks–38 mos) 8.4 (3–34) 16 1 1 1

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TABLE 2. Presenting symptoms in Patients with synthetic sling erosion Symptom

No. Pts (%)

Pelvic pain Storage symptoms* Vaginal discharge SUI MUI Recurrent urinary tract infection Obstructive urinary symptoms† Total incontinence Asymptomatic Continence Multiple symptoms

10 (53) 8 (42) 8 (42) 5 (26) 1 (5) 6 (32) 3 (16) 1 (5) 1 (5) 11 (56) 14 (74)

* Frequency, urgency, and/or urge incontinence. † Urinary retention, post-void residual urine greater than 200 cc and/or urodynamic evidence of BOO (detrusor pressure at Qmax greater than 25 cm water and Qmax less than 12 cc per second).

ment to removal was 10.1 months (range 6 weeks to 38 months). Mean followup was 8.4 months and all patients were followed a minimum of 3 months. There were 11 vaginal, 7 intravesical and 5 urethral erosions. Four patients were noted to have multiple erosions simultaneously, including vaginal/urethral in 1, bladder/urethral in 1 and vaginal/bladder in 2. One vaginal/bladder erosion presented as a VVF. Cystoscopy identified bladder and urethral erosion in all cases. The polypropylene mesh was seen penetrating the lateral aspect of the dome in cases of intravesical erosion and traversing the urethral lumen in cases of urethral erosion. All vaginal extrusions were identified as mesh exposure from the anterior vaginal wall on pelvic examination. Patients presented with various LUTS, including pelvic pain, recurrent urinary tract infections, vaginal discharge and bladder storage/emptying dysfunction (table 2). Multiple symptoms were present in 74% of patients and the mean number of symptoms per patient before surgical intervention was 2.2 (range 0 to 4). Overall incontinence was a component of the presenting symptom complex in 8 patients (44%). Of the 13 VUDS performed before sling excision abnormal findings were observed in 9 (69%). Recurrent SUI was diagnosed in 5 patients, MUI was diagnosed in 1, detrusor overactivity was diagnosed in 2 and BOO, defined as detrusor pressure at Qmax more than 25 cm water and Qmax less than 12 cc per second, was diagnosed in 1. Mean Valsalva leak point pressure in patients with recurrent SUI was 100 cm water (range 49 to 134). Following surgery only 4 patients (21%) achieved complete resolution of symptoms and were considered cured. Persistent voiding dysfunction was present in 15 patients (79%), including persistent or de novo pelvic pain, storage symptoms and SUI (table 3). Ten patients (53%) were incon-

11 5 7 10 3 6 15 4

* Four patients presented with combined genitourinary erosion involving more than 1 site, including 2 with vaginal and bladder erosion (in 1 vaginal/bladder erosion presented as a VVF), 1 with vaginal and urethral erosion, and 1 with urethral and bladder erosion.

TABLE 3. Postoperative voiding symptoms and continence Postop Voiding Dysfunction

No. Pts (%)

Storage symptoms* SUI MUI Pelvic pain Asymptomatic Continence

6 (32) 4 (21) 4 (21) 2 (10) 4 (21) 9 (47)

* Frequency, urgency and/or urge incontinence.

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VOIDING DYSFUNCTION AFTER REMOVAL OF ERODED SYNTHETIC MID URETHRAL SLINGS

tinent following surgery, of whom 4 had SUI, 4 had MUI and 2 had UUI. VUDS were performed in 6 patients following sling excision. Abnormal findings were present in 4 cases (67%), including SUI in 1, detrusor overactivity in 2 and SUI with detrusor overactivity in 1. Of the 6 postoperative studies 2 patients underwent VUDS preoperatively. One patient had persistent detrusor overactivity and another achieved BOO resolution. Five patients had a PVS placed at surgery, including autologous rectus fascia in 3 and Pelvicol® porcine dermis in 2. Indications for concomitant PVS were documented preoperative SUI in the absence of storage symptoms and augmentation of surgical repair in select cases. PVS augmented surgical repair in 4 cases, including urethral erosion in 2, vaginal/urethral erosion in 1 and VVF in 1. Four of these patients were incontinent preoperatively, including 3 due to SUI and 1 due to VVF. Following PVS 4 patients were continent and 1 had UUI. Patients who received a PVS did not have SUI during followup. Four patients (21%) with refractory voiding dysfunction went on to further surgical intervention. Two patients with bladder erosion were implanted with an InterStim® continence control system. One patient with urethral erosion received a PVS following failed Durasphere® injection for recurrent SUI. The remaining patient had significant pelvic pain and MUI following vaginal extrusion. They underwent enterocystoplasty with PVS. Three of these patients received failed multiple anticholinergics and all were significantly improved at last followup. An additional 7 patients were treated aggressively with anticholinergic medications following sling removal to ameliorate recalcitrant storage symptoms. DISCUSSION Genitourinary erosion is a rare but well recognized complication following anti-incontinence surgery performed with synthetic materials. The incidence of mesh erosion reported in the literature with polypropylene mid urethral slings (ie TVT™) is between 0.5% and 1.3%.7–9 This low incidence is thought to be related to the large pore size (more than 75 ␮m) and monofilament structure of the polypropylene mesh, which allows the ingrowth of fibroblasts and macrophages. Tissue ingrowth facilitates integration of the mesh with host tissues and decreases encapsulation, theoretically minimizing the risk of erosion. The term erosion is also confusing since it implies that the mesh was placed in a location outside of the genitourinary tract at the initial surgical procedure. This is of particular importance when discussing vaginal mesh exposure, and the more precise term may be vaginal extrusion, rather than vaginal erosion. While the mechanism of erosion is not completely understood, a number of theories exist, including subclinical infection, poor tissue ingrowth and wound healing, excessive friction between host tissues, and mesh and iatrogenic injury/technical error.4,10,11 While vaginal extrusion may involve wound healing and/or technical factors, it is our belief that urethral and bladder erosion is more likely related to errors in surgical technique, rather than to spontaneous erosion across intact tissue planes. Because LUTS related to sling erosion are nonspecific and they may often be confused with postoperative de novo

urgency, UUI and BOO, a high index of suspicion is required to avoid a delay in diagnosis and therapy. Mean time from symptom onset to diagnosis and sling excision in our series was 10.1 months. A similar delay was observed by other investigators, who noted an average symptom duration of 912 and 1113 months before definitive therapy.12,13 Our current approach has been to carefully evaluate patients presenting with LUTS and antecedent synthetic slings systematically with pelvic examination and cystoscopy to rule out the possibility of genitourinary erosion as the etiology. Furthermore, after mesh erosion is identified we currently advocate studying patients with VUDS to completely assess lower urinary tract function. While some patients may defer urodynamic evaluation, such as asymptomatic patients with vaginal mesh extrusion, we think that objective findings identified on VUDS may guide concomitant therapy, ie PVS, and document abnormalities in lower urinary tract function that may persist and require treatment following surgery. After the diagnosis was made surgery was performed to remove the synthetic mesh and alleviate the source of patient symptoms. Ten vaginal and urethral erosions were initially approached transvaginally, while a retropubic approach was used for 3 bladder erosions, excluding the VVF. Six patients ultimately underwent transvaginal and retropubic surgery to remove the mesh. The combined approach was used to completely excise all foreign material at the request of 4 patients and address refractory pelvic pain secondary to suspected ilioinguinal nerve entrapment in 2. Although recurrent SUI occurred in 8 patients postoperatively, it was diagnosed preoperatively in 6. Only 3 of the 6 patients (50%) had a sling placed at surgery and none had recurrent SUI. Six patients had recurrent SUI following sling excision. While some groups support PVS placement if SUI is determined preoperatively,13 we did not place a sling in 3 cases, believing that it may confound the interpretation of irritative LUTS. Others have speculated that new onset or progressive storage symptoms could be due to the urethrolysis procedure itself or secondary to the concomitant placement of the PVS.12,14 Furthermore, some investigators have recommended against simultaneous sling placement due to the contaminated operative field in some cases of erosion.6 Isolated vaginal extrusion occurred in 8 patients. All patients underwent transvaginal mesh excision, including the suburethral portion, while in 1 the entire sling was excised. Following intervention all patients complained of LUTS, including 3 with recurrent SUI, 2 with MUI, 2 with bothersome frequency and urgency, and 1 with persistent pelvic pain. Historically most published reports of vaginal extrusions have advocated removal of the exposed suburethral portion to resolve the problem.6,10,15 Extrapolation from the literature on managing postoperative BOO with sling excision reveals that continence outcomes are maintained in the majority of patients.14 –16 Other forms of management have included re-suturing the vaginal epithelium, observation and the application of vaginal estrogen cream with or without antibiotics. Most cases reported in the literature had good outcomes with symptom resolution and maintenance of continence (table 4). Our results with managing vaginal mesh extrusion with transvaginal excision failed to reproduce the favorable outcomes in the literature. Recurrent SUI occurred in 5 patients, urgency/frequency occurred in 4 and refractory pelvic

VOIDING DYSFUNCTION AFTER REMOVAL OF ERODED SYNTHETIC MID URETHRAL SLINGS

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TABLE 4. Genitourinary sling erosion management and results References Vaginal erosion: Huang et al10 15

Tsivian et al Kuuva and Nilsson7 Levin et al8 Kobashi and Govier18 Karram et al16

No. Pts 6 4 10

Sling TVTTM (5 pts), SPARCTM (1 pt) TVTTM TVTTM

Management (No. pts)

Continence

Transvaginal excision

Yes

Yes

Transvaginal excision (3), observation (1) Re-sutured (4), partial (3), excision (2), observation unknown (1) Transvaginal excision (4) Observation Re-sutured vaginal epithelium (1), estrogen cream (1) Transvaginal excision

Yes Yes

Yes Yes

Not reported Yes Yes

Not reported Yes Yes

Yes

Yes

No Yes

No Yes

Yes Yes

Recurrent SUI Yes

Not reported No Yes Not reported Yes

Not reported Urge incontinence Yes Yes with collagen Yes

4 4 2

TVTTM SPARCTM ⫹ TVTTM TVTTM

Domingo et al6 Urethral erosion: Sweat et al11 Pit19

9

ObtapeTM/Uratape

2 2

TVT TVTTM

Karram et al16 McLennan17 Bladder erosion: Levin et al8 Huang et al10 Tsivian et al15 Sweat et al11 Jorion20

1 1

TVTTM TVTTM

Transvaginal sling excision Transvaginal sling excision, tissue interposition, repeat TVTTM Transvaginal sling excision Endoscopy

2 1 1 1 1

TVTTM TVTTM TVTTM TVTTM TVTTM

Endoscopy Vaginal/abdominal excision Endoscopic/abdominal excision Vaginal/abdominal excision Endoscopy

TM

Symptom Resolution

pain occurred in 2. Upon review of our results we suspect that aggressive sling excision for vaginal extrusion may not be the optimal approach in all situations. Three patients may have been reasonable candidates for more conservative treatment, such as re-closure of the vaginal epithelium over the extruded mesh. Although patients with pelvic pain were believed to warrant more aggressive sling excision to alleviate this symptom, it may be prudent to offer at least a trial of conservative management initially. One patient went on to require augmentation cystoplasty. Although this is an atypical postoperative course for vaginal extrusion, it is our belief that this patient was inappropriately selected for the initial TVT™ procedure and subsequently had exacerbation of baseline UUI, leading to debilitating bladder storage dysfunction. To our knowledge the exact incidence of urethral erosion following polypropylene mid urethral slings is currently unknown. In our series we report 3 cases of isolated urethral erosion, 1 associated with vaginal extrusion and 1 associated with bladder erosion. All 5 patients had severe LUTS. Our approach to managing these cases included transvaginal mesh excision with a controlled midline urethrotomy and urethral reconstruction. Three patients had a PVS placed to augment the urethral repair, of whom 2 also had recurrent SUI. Following surgery 2 patients had complete symptom resolution and were continent. Each concomitantly received a PVS. There were no cases of urethrovaginal fistula following surgical reconstruction. As reported in other series, urethral erosion typically presents with evidence of voiding dysfunction and LUTS.11–13 Management has typically involved transvaginal urethrotomy and excision of the exposed mesh. Previous studies have documented an intense inflammatory reaction with extensive urethral loss with certain synthetic materials.12,13 In select cases an autologous fascial sling and Martius labial fat pad graft can be used at the discretion of the surgeon. In our experience the polypropylene mesh did not elicit a significant inflammatory response, necessitating aggressive tissue débridement. Following surgery outcomes are unpredictable with recurrent SUI, urethrovaginal fistula and overactive bladder

symptoms further contributing to patient morbidity.11,12,16 Table 4 shows the management and results of urethral erosion reported in the literature following a TVT™ procedure. Acceptable results following endoscopic management of urethral erosion have been described anecdotally.17 True erosion of polypropylene mesh across the seromuscular wall of the bladder is unlikely and in the majority of circumstances it is due to unrecognized cystotomy and mesh insertion intravesically at surgery. Patients typically present with various LUTS, including pelvic pain, hematuria, recurrent urinary tract infections and storage symptoms. A number of groups have reported symptom resolution and maintenance of continence using various techniques to excise the intravesical portion of the mesh (table 4). In our series 7 patients underwent intravesical mesh removal, of whom 5 with persistent voiding dysfunction were treated with anticholinergics, including 2 with urgency/frequency, 1 with UUI and 2 with MUI. As noted, 2 patients underwent sacral neuromodulation for bothersome MUI with a dominant urge component. The mechanism of bladder storage symptoms in our patients following surgery is unclear but it may have been related to a decrease in functional bladder capacity or alterations in afferent somatosensory processing from the bladder, urethra or pelvic floor.

CONCLUSIONS In our series 15 patients (79%) had persistent voiding dysfunction following surgical excision of an eroded synthetic mid urethral sling and 10 (53%) were incontinent, further contributing to patient morbidity and affecting quality of life. A high index of suspicion is warranted to begin appropriate therapy because delays in diagnosis were common. Due to the high prevalence of LUTS we believe strongly that VUDS should be liberally used to fully characterize lower urinary tract function before surgical intervention and postoperatively if voiding dysfunction persists. There appears to be some benefit in preventing recurrent SUI with concomitant PVS. This finding must be further substantiated.

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VOIDING DYSFUNCTION AFTER REMOVAL OF ERODED SYNTHETIC MID URETHRAL SLINGS 8.

Abbreviations and Acronyms BOO LUTS MUI PVS Qmax SUI U/F UUI VUDS VVF

⫽ ⫽ ⫽ ⫽ ⫽ ⫽ ⫽ ⫽ ⫽ ⫽

bladder outlet obstruction lower urinary tract symptoms mixed urinary incontinence pubovaginal sling maximum urine flow stress urinary incontinence urgency/frequency urinary urge incontinence video urodynamics vesicovaginal fistula

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