Obstetrics & Gynecology 2002;99:1067-1072
© 2002 by The American College of Obstetricians and Gynecologists
Recognition of Occult Bladder Injury During the Tension-free Vaginal Tape Procedure
S. Abbas Shobeiri, MD,
Alan D. Garely, MD,
Ralph R. Chesson, MD and
Thomas E. Nolan, MD, MBA
From the Department of Obstetrics and Gynecology, Section of Female Pelvic Medicine and Reconstructive Surgery, Louisiana State University Health Sciences Center, New Orleans, Louisiana; and the North Shore University Hospital, Great Neck, New York.
Address reprint requests to: S. Abbas Shobeiri, MD, Louisiana State University, Department of Obstetrics and Gynecology, Section of Female Pelvic Medicine and Reconstructive Surgery, 1542 Tulane Avenue, New Orleans, LA 70112; E-mail: Shobeiri{at}yahoo.com.
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ABSTRACT
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OBJECTIVE: To identify signs and the etiology of occult bladder injury during the tension-free vaginal tape sling procedure.
METHOD: The charts of 140 women who underwent a tension-free vaginal tape procedure were reviewed, and complications were tabulated and analyzed. The tension-free vaginal tape procedure was performed in six fresh-frozen pelves to demonstrate the mechanism of the occult bladder injury.
RESULTS: Occult bladder injury was suspected when cystoscopy instillation fluid flowed from the plastic sheath that covers the prolene tape after the extraction of the tension-free vaginal tape trocar. Three of six cases of intraoperative bladder injury had occult bladder injury identified on repeat cystoscopic inspection. The bladder injury caused by the rough edge at the point of attachment of the tension-free vaginal tape to the trocar was reproducible in three of 12 tension-free vaginal tape applications in fresh-frozen pelves. Traction on the tension-free vaginal tape reapproximates the injured bladder edges and potentially promotes spontaneous healing.
CONCLUSION: Bladder injuries may go unrecognized during a tension-free vaginal tape procedure. Continuous seepage of water through the prolene plastic sleeve is suggestive of occult bladder injury and requires repeat cystoscopy to identify the potential site of injury.
Tension-free vaginal tape sling procedure (Gynecare; Ethicon Inc., Somerville, NJ) has gained popularity since late 1998 in the United States. The tension-free vaginal tape procedure’s success relies on the "integral theory," which states incontinence is due to impaired collagen function causing disruption of elements necessary to maintain anatomic structures involved in the closure mechanism of the urethra.1 The tension-free vaginal tape procedure was developed based on this theory to represent an easily performed, ambulatory, minimally invasive surgical procedure for the treatment of female genuine stress urinary incontinence.2–4
As with any new technique, tension-free vaginal tape’s long-term efficacy and possible pitfalls have not been established. A recent study evaluating the outcome of the tension-free vaginal tape procedure in 51 women 3 years after surgery reported that 46 women (90%) were successfully cured.5 The subgroup of patients best suited for tension-free vaginal tape were originally identified as those with stress urinary incontinence due to either intrinsic sphincter deficiency or urethral hypermobility. With increasing experience, surgeons have broadened the application of this procedure to more complex urinary incontinence cases.
A search of the literature published from January 1966 to January 2002 using the National Library of Medicine’s MEDLINE database including (but not limited to) the search terms "injury," "bladder," and "tension-free vaginal tape" did not find any reports of occult bladder injury during the tension-free vaginal tape procedure. A search of the United States Food and Drug Administration’s manufacturer and user facility device experience database (MAUDE) Web site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM found no reported incidence of tension-free vaginal tape–induced occult bladder injury. We reviewed our experience of intraoperative and immediate postoperative complications seeking the etiology of occult bladder injury, which was defined as intraoperative bladder injury not recognized during initial cystoscopy, but diagnosed before conclusion of the procedure. The surgical technique was reproduced in fresh-frozen pelves, and the observations were used to propose a mechanism of injury: the rough edge at the point of insertion of the prolene mesh to the trocars was responsible for occult bladder injuries, especially if trocars were passed too close to the bladder seromuscularis layer (Figure 1
).
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Figure 1. The arrow points to the rough edge at the point of attachment of the prolene tape to tension-free vaginal tape trocar.
Shobeiri. Recognition of Bladder Injury. Obstet Gynecol 2002.
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MATERIALS AND METHODS
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An institutional review board–approved chart review of 140 patients who had undergone a tension-free vaginal tape procedure for stress urinary incontinence or intrinsic sphincter deficiency between February 1999 and March 2000 was performed. The study was performed by the Section of Female Pelvic Medicine and Reconstructive Surgery at Louisiana State Health Sciences Center in New Orleans, Louisiana, and the North Shore Hospital in Great Neck, New York. One of the authors (ADG) was trained to perform the tension-free vaginal tape procedure in Sweden and taught the technique to another author (RRC).
All the complications were tabulated and analyzed, and age, gravity, parity, previous surgical history, concomitant procedures performed at the time of the tension-free vaginal tape procedure, and intraoperative and immediate postoperative complications were reviewed. All patients underwent a full history and physical examination, urinalysis, postvoid residual, and multichannel urodynamics study. Genuine stress urinary incontinence was required for all tension-free vaginal tape candidates. The SPSS 10.0 statistical software (Statistical Package for the Social Sciences, Chicago, IL) was used to obtain exact 95% confidence intervals (CI) for estimated proportions.
The procedure was performed as follows: after obtaining informed consent and reviewing the risk and benefits of the procedure, the patient was taken to the operating room and placed in dorsal lithotomy position under local or general anesthesia. An 18 French Foley catheter was inserted into the urethra and the bladder emptied. If the patient was under intravenous sedation, a dilute anesthetic solution was injected suprapubically into the skin, the rectus fascia, and along the edge of the pubic bone, and into the space of Retzius on both sides of the midline. Local anesthetic was also injected at the level of mid-urethra into the vaginal mucosa and submucosal tissue and then bilaterally into the space of Retzius. Consequently, two suprapubic skin incisions, each 1-cm long, were created horizontally 2 cm from midline. A 2-cm-long sagittal incision was made in the suburethral vaginal wall starting 1–2 cm from the external urethral meatus. The vaginal mucosa was minimally dissected on either side to free it from the paraurethral tissue. A bladder guide was inserted into the Foley catheter and used to retract the bladder away while inserting the tension-free vaginal tape trocar. The tip of the tension-free vaginal tape trocar was inserted into the periurethral incision and, using the introducer, advanced toward the abdominal skin incision. After perforation of the endopelvic fascia, care was taken to guide the trocar through the retropubic space along the backside of the pubic bone. As the trocar passed through the fascial and muscular layers of the abdominal wall more resistance was noted until the tip of the trocar appeared at the abdominal incision. Before extracting the trocar, the catheter guide and the Foley catheter were removed and the bladder was allowed to drain. The fluid was inspected for any terminal hematuria. To inspect the integrity of the bladder we performed cystourethrascopy using a 70-degree cystoscope with 250–300 mL of water in the bladder as irrigant. At this point we expected to see the stainless steel trocar if bladder mucosa was violated. If the trocar was noted to perforate the bladder mucosa, we simply withdrew the trocar assembly and reinserted it while hugging the back of the pubic bone. When we had confirmed integrity of the urethra and bladder using cystourethrascopy, the introducer was detached from the trocar, and the trocar was extracted gently through the abdominal incision and allowed to rest on the abdomen. The technique was then repeated on the contralateral side. The prolene tape was cut close to the trocars, and the bladder was filled with 300 mL of water as irrigant. It was at this point that occult bladder injury was suspected. If any spillage of water through the ends of the plastic covering of the prolene tape was noted, repeat cystoscopy was performed with varying volumes of irrigant. We ensured that as the prolene tape was pulled up, it lay flat against the suburethral tissue. The tip of a Kelly clamp was inserted between the tape and the urethra to assure a tension-free application. The patient was asked to cough while the abdominal ends of the tape were pulled until no leakage of urine was noted through the urethra. First, the plastic sheath of the tape was removed, and then the Kelly clamp was removed from its suburethral position. The ends of the tape were cut below the level of skin incision, and the vaginal and skin incisions were closed using subcuticular absorbable suture material. In patients under general anesthesia, the Kelly clamp was placed between the urethra and the tape until the tape was retracted loosely against it.
The focus of our study was to determine if occult bladder injury had occurred during the course of the tension-free vaginal tape trocar passage under the pubic symphysis. To better understand the dynamics of bladder injury, we performed the tension-free vaginal tape procedure in six fresh-frozen pelves exactly as we would perform it on a patient. Because we had to ensure that our cystoscopic technique had not failed and that a small laceration had not become hemostatic and water tight by the tension-free vaginal tape trocar, a modification was made to our technique. The bladder was opened to inspect the bladder mucosa visually during the trocar insertion. In addition, an index finger was used to assure that the trocar was passing through the submucosa of the lateral wall of the bladder, the point where the occult injuries were noted. The trocars were extracted from the suprapubic incision site while the bladder mucosa was observed through a magnifying lens. The lacerations were measured, and their distance to the ureteral opening and the urethral opening were documented. At the conclusion of the procedure, the bladders were closed using permanent sutures and then filled with methylene blue–tinged water using a Foley catheter. The suprapubic and vaginal incision sites were inspected for seepage of blue dye. The findings were documented.
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RESULTS
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Patient characteristics are summarized in Table 1. Pre-operative urodynamics revealed that our patients had preoperative postvoid residual volumes of 0–80 mL, and mean vesical leak point pressure of 86 ±33 mm Hg. Intrinsic sphincter deficiency (leak point pressure of less than 50 mm Hg) was identified in 48 patients. The mean operative time was 45 ± 22 minutes. Patients who required only a tension-free vaginal tape procedure, (120/140, 85%) had surgery in an ambulatory setting. Six patients in this group had correction of a rectocele at the time of tension-free vaginal tape procedure. All patients in this group were able to micturate 4–6 hours after the procedure. Fourteen percent (20/140) of patients who had surgical correction of genital prolapse simultaneously with tension-free vaginal tape had a mean hospital stay of 2 ± 1 days. They were given voiding trials on the morning after surgery. Three of the patients with vaginal vault prolapse had preoperative incomplete emptying that resolved with restoration of anatomy.
Complications are detailed in Table 2. Four percent (4/107) of patients without history of prior retropubic surgery sustained bladder injury (95% exact CI 0.0103, 0.0930). Six percent (2/33) of patients with history of prior retropubic surgery sustained occult bladder injury (95% exact CI 0.0074, 0.2023), versus 0.09% (1/107) of patients without history of prior retropubic surgery (95% exact CI 0.0002, 0.0510). The operative reports pertaining to the prior anti-incontinence procedures of the patients with occult bladder injury were not available for review. Dense fibrosis could be felt in the retropubic space of both patients during the slow advancement of the trocar. One of the urethral injuries occurred concurrently with a bladder injury in a patient with a possible history of prior retropubic incontinence surgery. In this case the urethra was possibly dragged into the path of the trocar due to dense fibrosis. All occult bladder injuries responded to bladder drainage for 1–2 weeks after the procedure, following replacement of the tension-free vaginal tape. Ordinarily, we drain the bladder for 3 days in case the bladder is perforated during the tension-free vaginal tape procedure. In cases of occult bladder injury, we allowed the catheter to stay in place for a week because we did not know the mechanism of injury. Retrospectively, 3 days of bladder drainage should be enough for occult bladder injuries as well. One case that had concomitant urethral injury was drained for 2 weeks. Three cases of occult bladder injury were identified when cystoscopy fluid flowed from the plastic sheath that covers the prolene tape after extraction of the trocar (Figure 2). Repeat cystoscopy with varying volumes of irrigant confirmed the occult bladder injuries. As the volume of the bladder irrigant increased so would the flow rate of fluid through the end of the prolene tape. Two of the occult bladder injuries were not visible initially, but with the increasing volume of the irrigant they stretched to 1–2 mm in diameter. The occult bladder injuries, like the overt bladder injuries, were located at the anterior bladder wall, 2–3 cm from the urethral inlet at the 10 and 2 o’clock positions behind the pubic bone (Figure 3). One case of retropubic hematoma required evacuation, ligation of an accessory obturator vessel, and blood transfusion. Three patients required intermittent self-catherization for 2 weeks before achieving adequate voiding function (postvoid residual of less than 50 mL).
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Figure 2. Demonstrates spillage of water through the tension-free vaginal tape sheath during an occult bladder injury after the 70-degree cystoscope is withdrawn and the tension-free vaginal tape trocar extracted.
Shobeiri. Recognition of Bladder Injury. Obstet Gynecol 2002.
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Figure 3. Sagittal anatomy detailing (A) the tension-free vaginal tape position, (B) the site of bladder injury with tension-free vaginal tape in place, (C) the pubic symphysis, (D) the bladder cavity, (E) arcus tendineus fasciae pelvis, and (F) the urethral opening.
Shobeiri. Recognition of Bladder Injury. Obstet Gynecol 2002.
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Fresh-frozen cadavers were used to elucidate the mechanism of occult bladder injury. In three of 12 trocar sites in fresh-frozen specimens, the extraction of the trocar resulted in perforation of the bladder mucosa by the advancing edge of the prolene tape. In nondistended bladders the lacerations measured 0.1 cm, 0.1 cm, and 0.2 cm. These injuries were located 2–3 cm lateral to the bladder neck (Figure 3
). Only in the specimens with documented bladder lacerations the expulsion of blue dye from the site of injury was noted at the suprapubic incision site and the plastic sheath covering the prolene mesh. Tugging at the ends of the prolene tape forced the reapproximation of the lacerated edges of the bladder mucosa and deceleration of water spillage (Figure 4).
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Figure 4. Demonstration of (A) the trocar passage shown by a single arrow and the urethral opening by a double arrow, (B) the bladder injury by the trocar base shown by a single arrow, the double-headed arrow points at the ureteral opening, and (C) the re-approximation of the bladder mucosa with traction on the prolene tape; the injury is invisible.
Shobeiri. Recognition of Bladder Injury. Obstet Gynecol 2002.
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DISCUSSION
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Our study’s 4% bladder injury rate may reflect the learning curve associated with tension-free vaginal tape placement in a teaching institution.6 All injuries occurred by private physicians or residents assisting with the procedures under strict supervision. The number of procedures done, prior experience with vaginal surgery, and the type of training for tension-free vaginal tape procedure affects the outcome of the procedure. Although we thought a 4% bladder injury rate was high compared with earlier reports that quoted <1% bladder perforation rate,7 a more recent article reported a bladder perforation rate of 6%.8 No studies to date have identified occult bladder injury as a subset of their total bladder injuries.
Three out of six bladder lacerations in our study went unrecognized at initial cystoscopy. Our cadaveric study supports the belief that at the time of initial cystoscopy the trocar can be close to the bladder wall without violating the bladder mucosa. However, occult bladder injury occurred by the advancing rough edge of the prolene tape after the initial cystoscopy during extraction of the trocar. Seepage of water through the prolene tape sheath should alert the operator that the rough edge of the tension-free vaginal tape trocar might have injured the bladder. Occult bladder injury in our study was not a result of cystoscopic technical failure. Bladder mucosa was intact at the time of initial cystoscopy. No such occult bladder injuries during a tension-free vaginal tape procedure have been reported to date.
Although the numbers are not large (2/33), based on our experience, we inform our patients with prior incontinence procedures that a 6% risk of bladder injury exists, and other techniques may be used to achieve continence if retropubic adhesions make tension-free vaginal tape trocar insertion difficult. Based on our clinical experience with other incontinence procedures, decreased bladder capacity demonstrated during urodynamics testing and/or observation of any distortion of bladder anatomy with preoperative cystoscopy or fluoroscopy may increase the risk for bladder injury.
Occult bladder injuries occur occasionally during the steep learning curve of tension-free vaginal tape procedure. Although the bladder mucosal edges reapproximate with application of tension on the prolene tape and may heal spontaneously, the long-term sequelae of such injury is unknown (ie, mesh erosion, stone formation, and intractable urge). If an occult bladder injury is suspected due to spillage of water from the vaginal or skin incision sites, repeat cystoscopy at varying cystoscopic volumes using a 70-degree cystoscope should be performed. If the site of injury is not discovered despite repeat cystoscopy but the suspicion remains strong, transurethral instillation of methylene blue and subsequent spillage of blue fluid from the prolene tape sheath may confirm the presence of a bladder injury. In such situations the tension-free vaginal tape should be withdrawn and reapplied.
A physician with adequate experience with this technique and a thorough knowledge of pelvic anatomy can easily prevent, recognize, and treat intraoperative complications of the tension-free vaginal tape procedure.
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Footnotes
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PII S0029-7844(02)01955-5
Received June 7, 2001.
Received in revised form January 7, 2002.
Accepted January 23, 2002.
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REFERENCES
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1. Petros PE, Ulmsten U. An integral theory and its method for diagnosis and management of female urinary incontinence. Scand J Urol Nephrol 1993;153(Suppl):1–89.
2. Ulmsten U, Petros P. Intravaginal slingplasty (IVS): An ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol 1995;29:75–82.[Medline]
3. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol 1996; 7:81–6.
4. Nilsson CG. The tension free vaginal tape procedure (TVT) for treatment of female urinary incontinence. Acta Obstet Gynecol Scand 1998;168(Suppl):77:34–7.
5. Olsson I, Kroon UB. A three-year postoperative evaluation of tension-free vaginal tape. Gynecol Obstet Invest 1999;48: 267–9.[Medline]
6. Gordon D, Groutz A, Lessing J. PVT—tension-free vaginal tape—a new minimally invasive surgical technique for female stress incontinence: preliminary results. Harefuah 1999;137:433–5.[Medline]
7. Ulmsten U, Falconer C, Johnson P, Jomaa M, Lanner L, Nilsson CG, et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1998; 9:210–3.[Medline]
8. Meschia M, Pifarotti P, Bernasconi F, Guercio E, Maffiolini M, Magatti F, et al. Tension-free vaginal tape: Analysis of outcomes and complications in 404 stress incontinent women. Int Urogynecol J Pelvic Floor Dysfunct. 2001; 12(Suppl 2):12:S24–7.
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ABSTRACT
MATERIALS AND METHODS
