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Anchor fixation and other modifications of endoscopic bladder neck suspension
ANCHOR FIXATION AND OTHER MODIFICATIONS OF ENDOSCOPIC BLADDER NECK SUSPENSION* THEODORE
V BENDEREV,
M.D.
From the Mission Hospital Regional Medical Center, Mission Viejo, and the Division of Urology, University of California at Irvine Medical Center, Orange, California ABSTRACT-The long-term efficacy of surgical treatment of stress urinary incontinence can be improved by modifications that reduce the possibility of suspending suture detachment. Fifty-three women with stress urinary incontinence underwent consecutive endoscopic bladder neck suspensions with new modifications developed in an effort to decrease suspending suture detachment. Those modifications included: (1) technique of needle passage to capture a maximum volume of urethropelvic fascia lateral to the bladder neck and urethra while avoiding injury to the bladder, (2) pubic bone fixation of the suspending suture using a small anchor developed for orthopedic use, and (3) a simple technique to limit tension of the suspending sutures. Procedures were outpatient in 60 percent of patients (93 % of the last 27 patients). Seventy percent of patients did not require intermittent catheterization beyond the day when their indwelling catheter was removed. The postoperative success rate (absence of stress urinary incontinence) at one month was 100 percent. There were 4 failures on follow-up up to fifteen months. Urgency incontinence decreased from 59 percent preoperatively to 15 percent postoperatively. The complication of osteitis pubis was not noted. Patient rating of satisfaction postoperatively was high. These modifications constitute a safe alternative to procedures that effectively suspend the bladder neck. An assessment of any change in long-term efficacy as a result of these modifications will require continued follow-up.
Stress urinary incontinence (SUI) has been treated effectively by the surgical suspension of the bladder neck. Efforts to improve this form of surgical treatment have focused on (1) reducing surgical morbidity and patient inconvenience, and (2) improving long-term efficacy by decreasing the risk of suspending suture detachment. Through the evolutionary work of Pereyra,’ Stamey,2 Raz, 3 Leach,4 and Gittes and Loughlin,5 these goals have been emphasized. In an effort to further pursue these goals, a series of endoscopic bladder neck suspension modifications have been developed by the author. Herein described are these modifica*This study supportid Products, Inc.
UROLOGY
in part by a grant from Mitek Surgical
/ NOVEMBER
1992
/ VOLUME 40, NUMBER 5
tions of (1) needle passage, (2) fixation of the suspending suture to the pubic bone utilizing an anchor, and (3) limitation of suture tension. Material and Methods Fifty-three women with SUI who were treated with modified endoscopic bladder neck suspensions consecutively by the author were evaluated. Forty-seven patients underwent modified endoscopic bladder neck suspensions alone, while 6 patients had modified endoscopic bladder neck suspensions with concomitant vaginal procedures such as cystocele and/or rectocele repairs. The patients’ ages ranged from thirty-two to seventy-four years. The grading of SUI, based on the Stamey2 system,
409
was grade 1 in 37 percent and grade 2 in 63 percent of the patients. There were no grade 3 patients, Patients had had a mean of 2 vaginal deliveries. Thirty-one patients (58 %) had had a previous hysterectomy. Twelve patients (23 % ) had had at least one previous surgical procedure to correct urinary incontinence. All patients had a history of bothersome urinary leakage with activities and a physical examination demonstrating a hypermobile urethra and pliable urethropelvic fascia. Preoperative complaints included urgency in 72 percent and mild-to-moderate urgency incontinence in 59 percent of the patients. Preoperative testing criteria included a positive Marshall test and a cystometrogram without uninhibited contractions. All patients performed Kegel exercises before electing surgery.
Technique All patients received gentamicin and ampicillin preoperatively unless an allergy existed. Anesthesia was regional in 21 patients and general in 32 patients. A surgical assistant was not used. The patients were placed in the lithotomy position. Preparation emphasized isolation of the anus with a stapled towel or plastic drape. A Foley catheter was passed. Two separate, one-inch transverse incisions were made directly over the pubic bone (Fig. 1) and dissection was carried down to the area of the rectus fascia. The first phase of the needle passage modification was initiated with the intent to safely bring the needle tip to the penetration point in the urethropelvic fascia. Beginning on one side, the wound was stretched cephalad to allow the vertical passage of a Stamey needle* or other needle through the rectus fascia (Fig. 2A). The needle was passed through the rectus fascia near the midline to avoid injuring the ilioinguinal nerve. The needle was then sharply angled onto the abdomen so that the tip rested on the underside of the pubic periosteum (Fig. 2B). The tip of the needle, while maintaining contact with the underside of the pubis, was passed distally toward the introitus. At the completion of this distal passage, the needle could be palpated at the introitus to the side of the urethral meatus (Fig. 2C). Palpation through the vagina was avoided during this distal passage of the needle to avoid pushing the bladder or urethra into the path of the needle. *Cook Urological, Inc., Spencer, Indiana.
410
FIGURE
1.
Location of incision sites.
The tip of the needle was then withdrawn from the pubourethral ligament and gently swept along the urethropelvic fascia to the area of the bladder neck (Fig. 2D) under the guidance of a finger within the vagina. The second phase of the needle passage modification was then initiated with the intent of capturing a maximum amount of lateral urethropelvic fascia. The needle was passed through the urethropelvic fascia and vaginal mucosa at point 1 (Fig. 3A). A number 1 polypropylene suture was passed through the needle hole and withdrawn with the needle through the pubic wound (Fig. 3B). The needle was then reintroduced through the rectus fascia 1 to 2 cm lateral to the initial passage and through the vaginal mucosa at point 2 (Fig. 3C) using the first phase needle passage technique described (Fig. 2A-D). The tip of the needle with the vaginal end of the suture was then withdrawn into the retropubic space (Fig. 3D) and advanced to point 3 where it was passed through the vaginal mucosa (Fig. 3E). The suture was then removed from the needle and the needle tip was once again withdrawn to the retropubic space (Fig. 3F) and passed through the vaginal mucosa at point 4 (Fig. 3G). The vaginal end of the suture was then passed into the needle and pulled up through the pubic wound using the needle (Fig. 3H). An attempt was made with the 4 entry points through the urethropelvic fascia to maximize (1) their separation (1 to 2 cm apart), and (2) their lateralization from the bladder neck and urethra (1 to 2 cm away) (Fig. 6A). Each 1 to 2 cm distance was estimated by interposing an index or middle fingertip between landmarks palpated at the anterior vaginal wall such as the catheter,
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FIGURE2. First phase of needle passage. (A) Entry of Stamey needle to just below rectus fascia. (B) Placement of needle tip on underside of pubic bone. (C) Distal passage of needle to level of introitus. (0) Withdrawal of needle from pubourethral ligament and sweep back along urethropelvic fascia to area of bladder neck and first entry site (point 1).
needle tip, and suture entry point. The identical procedure was performed on the contralatera1 side. At tbe completion of suture placement, cystoscopy was performed to confirm the proper position of the sutures. The Mitek Anchor System* was then used in all patients for pubic bone fixation of the sus*Mitek Surgical
UROLOGY
Products,
I NOVEMBER
Inc.,
Norwood,
1992
pensory sutures. Mitek Gl anchors (Fig. 4A) were used in the first 7 patients and the newer Mitek G2 anchors (Fig. 4B) were used in the remaining 46 patients. Two holes were drilled on each side of the pubic bone approximately 1 to 2 cm lateral to the midline (Fig. 5A). The pubic bone site for drilling on each side was best identified by temporarily embedding two needles into the bone and drilling into the localized
Massachusetts.
/ VOLUME
40, NUMBER
5
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fascia at FIGURE3. Second phase of needle passage. (A) Initial passage of needle through urethropelvic point 1 (proximal and medial). (B) Withdrawal of suture through pubic wound. (C) Passage of needle through lateral aspect of pubic wound and through urethropelvic fascia at point 2 (proximal and lateral). (0) Withdrawal of suture into retropubic space. (E-H) Continued on facing page.
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Continued from facing page. (E) Passage of needle and suture through point 3 (distal and meFIGURE 3. dial). (F) Withdrawal of needle into retropubic space. (G) Passage of needle through point 4 (distal and lateral). (H) Withdrawal of suture through pubic wound.
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FIGURE 4. (A) Early generation and (B) Mitek G2 anchor.
Mitek Gl anchor,
bone between those two needles. The anchor for each side (total of e/patient) was loaded with one suture end. Each anchor was placed into its hole using an inserter (Fig. 5B). The inserter was extracted leaving each anchor in place (Fig. SC). Traction was placed on the sutures only long enough to test for adequate fixation of the anchors and to pull the sutures firmly against the vaginal wall. The sutures on each side were then tied down with sufficient tension to develop a gentle elevation and cradle-like support of the bladder neck (Fig. 6A, B). A modification to limit the
tension on the suspending sutures was instituted in the last 40 patients in the study. The sutures in these patients were tied down on the distal pulp of the index finger (Fig. 7). The wounds were irrigated with a bacitracin solution. The wound edges and rectus fascia at the suture entry points were infiltrated with bupivacaine. A Foley catheter was placed in 46 patients (87 % ). The remaining patients had a suprapubic tube placed because of dexterity problems or their aversion to learning intermittent catheterization. Following surgery, patients were given either ciprofloxacin or ofloxacin for ten days. The patients’ Foley catheters were removed one week after surgery, The patients performed intermittent catheterization until the post-void residuals were less than 75 cc on two consecutive catheterizations. Patients with suprapubic tubes began voiding trials at four days following surgery. The suprapubic tubes were removed when the post-void residuals were less than 75 cc after two consecutive urinations. Results The procedure was performed on an outpatient basis in 60 percent of the total group and in 93 percent of the last 27 patients. Some patients did not require any narcotic analgesics following discharge. Seventy percent of patients did not require intermittent catheterization beyond the day that their indwelling catheter was
FIGURE 5. Anchor fixation of suspending suture. (A) Drilling of hole in pubic bone for anchor (needles not shown). (B) Placement of anchor with suture into pubic bone using an inserter. (C) Extraction of inserter leaving anchor in place.
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FIGURE 6. Suspension of bladder neck wiith anchor fixation. (A) Endon view of urethra emphasizing volume of urethropelvic jascfa captured and showing relative locations of suture entry points. (Csnstriction of captured fascia when suspended not shown.) (B) Lateral view emphasizing length of urethropelvic fascia captured from bladder neck to pubourethral ligament. (The constriction of the captured jascia when suspended not shown.)
removed. All patients became catheter-free. There was 1 case of a subcutaneous wound hematoma. The hematoma caused pain and was evacuated without residual sequelae. There were no wound infections. The complication of osteitis pubis was not noted. All patients denied
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stress urinary incontinence on early postoperative follow-up at approximately one month. Women who undergo this procedure are evaluated periodically after surgery by mail questionnaires. All 53 women in this group were contacted in such a manner up to fifteen
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Number of Patients
+3
Extremely
+2
*I
Satisfied
-1
-2
-3
Extremely
Dissatisfied
Patients’ satisfaction with the results of their bladder neck suspension.
FIGURE 8.
Limitation of suture tension. Tying of FIGURE 7. suspension suture on pulp of finger leaving small amount of suture slack.
months after surgery. Thirteen patients who did not return their questionnaires were surveyed by phone. This postoperative evaluation revealed that only 15 percent of patients complained of urgency incontinence. Four of the 53 patients (8%) had failed in their treatment for stress incontinence: 2 of 7 patients with the early generation Gl anchors (and without the tension limiting technique) and 2 of 46 patients with the G2 anchors. One of the 12 patients (8 % ) who had had previous anti-incontinence surgery failed. Failure was defined as a recurrence of urinary leakage with activity, even if the condition was improved over the preoperative state. Figure 8 indicates the patients’ satisfaction with the results of their procedure. Comment SUI is curable with any surgical procedure that properly suspends the bladder neck. Limitations of each procedure include the extent of surgical morbidity and the ever-present threat of long-term failures. Pereyral introduced the transvaginal bladder neck suspension as a less invasive alternative to open retropubic procedures. Stamey” limited morbidity of the transvaginal bladder neck suspension by introducing endoscopic control and
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confirmation of suture placement. Raz3 also limited morbidity by introducing full palpatory control of needle passage through the retropubit space to avoid injury to the bladder. The first phase of the needle passage modification, described herein, accomplishes a similar goal without finger entry into the retropubic space, by continually maintaining needle tip contact with the roof and floor of the retropubic space. Distal passage of the needle tip to the level of the introitus along the underside of the pubic bone obviates the need to turn the needle down toward a bladder neck that may have been digitally elevated and, therefore, avoids bladder entry. The pubourethral ligament is easily identified with this technique. Extraction of the needle from the pubourethral ligament is necessary to allow a capture of the more pliable urethropelvic fascia alongside the urethra. The subsequent, gentle sweep back of the needle along the surface of the urethropelvic fascia under vaginal digital guidance provides an easy and safe means of introducing the needle to the bladder neck area. Avoiding bladder entry in this manner reduces the time necessary for the occasional incontinence surgeon to perform multiple cystoscopies and to replace misplaced sutures. Gittes and Loughlin5 have further popularized the technique of Pereyra and demonstrated an advantage of increased long-term efficacy by creating an autologous bolster with the transvaginal passage of a curved needle. As a simple alternative of creating an autologous bolster, the second phase of the needle passage modification, described herein, uses a suprapubit needle approach to carry the suture through all of its vaginal passes. Specifically, needle passes 1 and 2 into the vagina are similar to the
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technique of Gittes and Loughlin (Fig. 6A), while needle passes 3 and 4 are finger-guided as opposed to their transvaginal use of the curved needle. The full carriage of the suture by a Stamey needle offers several benefits: (1) improved accuracy by allowing palpation of the needle at each vaginal entry point in reference to the catheter and its balloon (representing the urethra and bladder neck), (2) potentially decreased morbidity by reducing the risk of injury and/or irritation through inadvertent entry into any part of the urethra or bladder, (3) elimination of the need to visualize the anterior vaginal wall, thereby facilitating surgery, especially in cases of tighter vaginal introitus, and (4) potential contribution to long-term efficacy by assuring that a full-thickness layer of urethropelvic fascia is captured. This technique permits the capture of a large volume of lateral urethropelvic fascia similar in surface area to that obtained in open retropubic urethropexies. The distribution of tension across this large volume of tissue may reduce the risk of suspending suture detachment. Midurethral obstruction has not been evident with this technique because only one suture is used on each side of the urethra. Within each suture, the vectors of tension are distributed equally across both the proximal and midurethral suture attachment points to the urethropelvic fascia. Leach4 has limited morbidity by deceasing postoperative pain and has potentially improved long-term efficacy with pubic fixation of the suspending sutures. The trochar needle passage through the pubic bone, as described by Leach, can be difficult, particularly in obese patients, through the limited exposure that is used with many forms of endoscopic bladder neck suspension. Other various forms of pubic bone fixation also have been described with transvaginal and open bladder neck suspension surgery.B-8 To facilitate the anchoring of the suspensory suture to the pubic bone with minimal soft tissue dissection, a new set of devices called the Mitek anchor system has been used. The latest generation of Mitek anchor, the G2, consists of a titanium body coupled to nickel-titanium arcs. These anchors have been used most commonly for tenodesis and ligamentous reconstruction of the shoulder and footg.‘O In the setting of bladder neck suspensions, the Mitek anchor with attached suture is passed into a hole drilled in the pubic bone. Care must be taken to assure that the hole has been drilled
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into the pubic bone and not inferiorly through the tendon of the adductor longus muscle. Once the anchor is passed into the bone, the anchor’s unique memory forces the arcs to spring open to their original shape and to engage in the cancellous portion of the pubic bone. The complication of infection with use of the anchor has not been noted, which may, in part, be due to the emphasis on broad-spectrum antibiotics, avoidance of the symphysis pubis, and sterile technique. The absence of osteitis pubis in this setting is supported by the general orthopedic acceptance of internal fixation of pubic fractures using large plates and screws.” A simple tension-limiting technique of tying the suspending suture to leave a small amount of slack is described. The actual traction applied to the suture when tying down upon the index finger can vary, but some degree of slack is always visible when the finger is removed. Continence is achieved with this limited tension, in part because of the large volume of captured urethropelvic fascia lending support to the bladder neck and urethra. The tolerance of suture slack suggests that the urethropelvic fascia does not have to be released from the pelvic side wall, as described by Raz,3 to allow for adequate elevation and support of the bladder neck. Excessive tension on the bladder neck with this technique of suture tension limitation is essentially impossible. Chronic urinary retention is avoided and the chance of acute retention is minimized, thereby promoting a reduction in the period of catheterization. Chronic retention with endoscopic bladder neck suspension has been reported in as many as 5 to 18.9 percent of patients in other series. 12,13 Excessive tension with overcorrection of the bladder neck is also known to account for bladder instability.‘4 In this study, urgency incontinence diminished following surgery. This reduction in irritative urinary symptoms was also associated with the lateral placement of the sutures in the urethropelvic fascia. The period of hospitalization was short within the tension-limiting group which suggests that reducing tension on the sutures may decrease postoperative pain. Finally, limiting suture tension may be found, over time, to decrease suture pull through at the urethropelvic fascia. The modified endoscopic bladder neck suspension, described herein, has been developed in an effort to decrease the suspending suture
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detachment and minimize patient morbidity. Patient inconvenience in terms of the period of hospitalization and intermittent catheterization was limited. The results indicate that the safety and short-term efficacy of this alternate procedure of bladder neck suspension are good. Satisfaction in the patient group was high. These modifications allow the accurate and secure placement of suspending sutures in a simple manner that minimizes and distributes the tensions placed on the tissues that are suspended. All present surgical techniques of bladder neck suspension are susceptible to failures, with rates of failures that vary greatly between techniques and within the same technique by different surgeons. The modified technique is generally no more time-consuming than present endoscopic techniques and may prove over time and with independent investigation to be beneficial in minimizing failures. 26732 Crown Valley Parkway Suite 321 Mission Viejo, California 92691 ACKNOWLEDGMENT. To Ms. Tay McClellan ical illustrations.
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for the med-
References 1. Pereyra AJ: A simplified surgical procedure for the correction of stress incontinence in women, West J Surg 67: 223 (1959). 2. Stamey TA: Endoscopic suspension of the vesical neck for urinary incontinence in females: report on 203 consecutive patients, Ann Surg 192: 465 (1980). 3. Rax S: Modified bladder neck suspension for female stress incontinence, Urology 17: 82 (1981). 4. Leach GE: Bone fixation technique for transvaginal needle suspension, Urology 31: 388 (1988). 5. Gittes RF, and Loughlin KR: No-incision pubovaginal suspension for stress incontinence, J Urol 138: 568 (1987). 6. Winter CC: Peripubic urethropexy for urinary stress incontinence in women, Urology 20: 408 (1982). 7. McKiel CF Jr, Graf EC, and Callahan DH: Marshall-Marchetti procedure: modification, J Urol96: 737 (1966). 8. Hancock R, Brandstetter LH, and Hodgins TE: Banspubic suspension of the bladder neck for urinary incontinence, J Urol 123: 667 (1980). 9. Richmond JC, Donaldson WR, Fu F, and Harner CD: Modification of the Bankart reconstruction with a suture anchor: report of a new technique, Am J Sports Med 19: 343 (1991). 10. Pederson B, Tesoro D, Wertheime SJ, and Coraci M: Mitek anchor system: a new technique for tenodesis and ligamentous repair of the foot and ankle, J Foot Surg 30: 48 (1991). 11. Schatxker J, and Tile M: The Rationale of Operative Fracture Care, Berlin, Springer-%rlag, 1987, p 159. 12. Spencer JR, O’Conor VJ, and Schaeffer AJ: A comparison of endoscopic suspension of the vesical neck with suprapubic vesicourethrooexv for treatment of stress urinary incontinence, J Urol 137: 411 (1987). 13. Araki T, et al: The loop loosening procedure for urination difficulties after Stamey suspension of the vesical neck, J Urol144: 319 (1990). 14. Webster CD, and Kreder KJ: Voiding dysfunction following cystourethropexy: its evaluation and management, J Urol144: 670 (1990).
UROLOGY
/
NOVEMBER 1992
I VOLUME 40, NUMBER 5
V BENDEREV,
M.D.
From the Mission Hospital Regional Medical Center, Mission Viejo, and the Division of Urology, University of California at Irvine Medical Center, Orange, California ABSTRACT-The long-term efficacy of surgical treatment of stress urinary incontinence can be improved by modifications that reduce the possibility of suspending suture detachment. Fifty-three women with stress urinary incontinence underwent consecutive endoscopic bladder neck suspensions with new modifications developed in an effort to decrease suspending suture detachment. Those modifications included: (1) technique of needle passage to capture a maximum volume of urethropelvic fascia lateral to the bladder neck and urethra while avoiding injury to the bladder, (2) pubic bone fixation of the suspending suture using a small anchor developed for orthopedic use, and (3) a simple technique to limit tension of the suspending sutures. Procedures were outpatient in 60 percent of patients (93 % of the last 27 patients). Seventy percent of patients did not require intermittent catheterization beyond the day when their indwelling catheter was removed. The postoperative success rate (absence of stress urinary incontinence) at one month was 100 percent. There were 4 failures on follow-up up to fifteen months. Urgency incontinence decreased from 59 percent preoperatively to 15 percent postoperatively. The complication of osteitis pubis was not noted. Patient rating of satisfaction postoperatively was high. These modifications constitute a safe alternative to procedures that effectively suspend the bladder neck. An assessment of any change in long-term efficacy as a result of these modifications will require continued follow-up.
Stress urinary incontinence (SUI) has been treated effectively by the surgical suspension of the bladder neck. Efforts to improve this form of surgical treatment have focused on (1) reducing surgical morbidity and patient inconvenience, and (2) improving long-term efficacy by decreasing the risk of suspending suture detachment. Through the evolutionary work of Pereyra,’ Stamey,2 Raz, 3 Leach,4 and Gittes and Loughlin,5 these goals have been emphasized. In an effort to further pursue these goals, a series of endoscopic bladder neck suspension modifications have been developed by the author. Herein described are these modifica*This study supportid Products, Inc.
UROLOGY
in part by a grant from Mitek Surgical
/ NOVEMBER
1992
/ VOLUME 40, NUMBER 5
tions of (1) needle passage, (2) fixation of the suspending suture to the pubic bone utilizing an anchor, and (3) limitation of suture tension. Material and Methods Fifty-three women with SUI who were treated with modified endoscopic bladder neck suspensions consecutively by the author were evaluated. Forty-seven patients underwent modified endoscopic bladder neck suspensions alone, while 6 patients had modified endoscopic bladder neck suspensions with concomitant vaginal procedures such as cystocele and/or rectocele repairs. The patients’ ages ranged from thirty-two to seventy-four years. The grading of SUI, based on the Stamey2 system,
409
was grade 1 in 37 percent and grade 2 in 63 percent of the patients. There were no grade 3 patients, Patients had had a mean of 2 vaginal deliveries. Thirty-one patients (58 %) had had a previous hysterectomy. Twelve patients (23 % ) had had at least one previous surgical procedure to correct urinary incontinence. All patients had a history of bothersome urinary leakage with activities and a physical examination demonstrating a hypermobile urethra and pliable urethropelvic fascia. Preoperative complaints included urgency in 72 percent and mild-to-moderate urgency incontinence in 59 percent of the patients. Preoperative testing criteria included a positive Marshall test and a cystometrogram without uninhibited contractions. All patients performed Kegel exercises before electing surgery.
Technique All patients received gentamicin and ampicillin preoperatively unless an allergy existed. Anesthesia was regional in 21 patients and general in 32 patients. A surgical assistant was not used. The patients were placed in the lithotomy position. Preparation emphasized isolation of the anus with a stapled towel or plastic drape. A Foley catheter was passed. Two separate, one-inch transverse incisions were made directly over the pubic bone (Fig. 1) and dissection was carried down to the area of the rectus fascia. The first phase of the needle passage modification was initiated with the intent to safely bring the needle tip to the penetration point in the urethropelvic fascia. Beginning on one side, the wound was stretched cephalad to allow the vertical passage of a Stamey needle* or other needle through the rectus fascia (Fig. 2A). The needle was passed through the rectus fascia near the midline to avoid injuring the ilioinguinal nerve. The needle was then sharply angled onto the abdomen so that the tip rested on the underside of the pubic periosteum (Fig. 2B). The tip of the needle, while maintaining contact with the underside of the pubis, was passed distally toward the introitus. At the completion of this distal passage, the needle could be palpated at the introitus to the side of the urethral meatus (Fig. 2C). Palpation through the vagina was avoided during this distal passage of the needle to avoid pushing the bladder or urethra into the path of the needle. *Cook Urological, Inc., Spencer, Indiana.
410
FIGURE
1.
Location of incision sites.
The tip of the needle was then withdrawn from the pubourethral ligament and gently swept along the urethropelvic fascia to the area of the bladder neck (Fig. 2D) under the guidance of a finger within the vagina. The second phase of the needle passage modification was then initiated with the intent of capturing a maximum amount of lateral urethropelvic fascia. The needle was passed through the urethropelvic fascia and vaginal mucosa at point 1 (Fig. 3A). A number 1 polypropylene suture was passed through the needle hole and withdrawn with the needle through the pubic wound (Fig. 3B). The needle was then reintroduced through the rectus fascia 1 to 2 cm lateral to the initial passage and through the vaginal mucosa at point 2 (Fig. 3C) using the first phase needle passage technique described (Fig. 2A-D). The tip of the needle with the vaginal end of the suture was then withdrawn into the retropubic space (Fig. 3D) and advanced to point 3 where it was passed through the vaginal mucosa (Fig. 3E). The suture was then removed from the needle and the needle tip was once again withdrawn to the retropubic space (Fig. 3F) and passed through the vaginal mucosa at point 4 (Fig. 3G). The vaginal end of the suture was then passed into the needle and pulled up through the pubic wound using the needle (Fig. 3H). An attempt was made with the 4 entry points through the urethropelvic fascia to maximize (1) their separation (1 to 2 cm apart), and (2) their lateralization from the bladder neck and urethra (1 to 2 cm away) (Fig. 6A). Each 1 to 2 cm distance was estimated by interposing an index or middle fingertip between landmarks palpated at the anterior vaginal wall such as the catheter,
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FIGURE2. First phase of needle passage. (A) Entry of Stamey needle to just below rectus fascia. (B) Placement of needle tip on underside of pubic bone. (C) Distal passage of needle to level of introitus. (0) Withdrawal of needle from pubourethral ligament and sweep back along urethropelvic fascia to area of bladder neck and first entry site (point 1).
needle tip, and suture entry point. The identical procedure was performed on the contralatera1 side. At tbe completion of suture placement, cystoscopy was performed to confirm the proper position of the sutures. The Mitek Anchor System* was then used in all patients for pubic bone fixation of the sus*Mitek Surgical
UROLOGY
Products,
I NOVEMBER
Inc.,
Norwood,
1992
pensory sutures. Mitek Gl anchors (Fig. 4A) were used in the first 7 patients and the newer Mitek G2 anchors (Fig. 4B) were used in the remaining 46 patients. Two holes were drilled on each side of the pubic bone approximately 1 to 2 cm lateral to the midline (Fig. 5A). The pubic bone site for drilling on each side was best identified by temporarily embedding two needles into the bone and drilling into the localized
Massachusetts.
/ VOLUME
40, NUMBER
5
411
fascia at FIGURE3. Second phase of needle passage. (A) Initial passage of needle through urethropelvic point 1 (proximal and medial). (B) Withdrawal of suture through pubic wound. (C) Passage of needle through lateral aspect of pubic wound and through urethropelvic fascia at point 2 (proximal and lateral). (0) Withdrawal of suture into retropubic space. (E-H) Continued on facing page.
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Continued from facing page. (E) Passage of needle and suture through point 3 (distal and meFIGURE 3. dial). (F) Withdrawal of needle into retropubic space. (G) Passage of needle through point 4 (distal and lateral). (H) Withdrawal of suture through pubic wound.
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FIGURE 4. (A) Early generation and (B) Mitek G2 anchor.
Mitek Gl anchor,
bone between those two needles. The anchor for each side (total of e/patient) was loaded with one suture end. Each anchor was placed into its hole using an inserter (Fig. 5B). The inserter was extracted leaving each anchor in place (Fig. SC). Traction was placed on the sutures only long enough to test for adequate fixation of the anchors and to pull the sutures firmly against the vaginal wall. The sutures on each side were then tied down with sufficient tension to develop a gentle elevation and cradle-like support of the bladder neck (Fig. 6A, B). A modification to limit the
tension on the suspending sutures was instituted in the last 40 patients in the study. The sutures in these patients were tied down on the distal pulp of the index finger (Fig. 7). The wounds were irrigated with a bacitracin solution. The wound edges and rectus fascia at the suture entry points were infiltrated with bupivacaine. A Foley catheter was placed in 46 patients (87 % ). The remaining patients had a suprapubic tube placed because of dexterity problems or their aversion to learning intermittent catheterization. Following surgery, patients were given either ciprofloxacin or ofloxacin for ten days. The patients’ Foley catheters were removed one week after surgery, The patients performed intermittent catheterization until the post-void residuals were less than 75 cc on two consecutive catheterizations. Patients with suprapubic tubes began voiding trials at four days following surgery. The suprapubic tubes were removed when the post-void residuals were less than 75 cc after two consecutive urinations. Results The procedure was performed on an outpatient basis in 60 percent of the total group and in 93 percent of the last 27 patients. Some patients did not require any narcotic analgesics following discharge. Seventy percent of patients did not require intermittent catheterization beyond the day that their indwelling catheter was
FIGURE 5. Anchor fixation of suspending suture. (A) Drilling of hole in pubic bone for anchor (needles not shown). (B) Placement of anchor with suture into pubic bone using an inserter. (C) Extraction of inserter leaving anchor in place.
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FIGURE 6. Suspension of bladder neck wiith anchor fixation. (A) Endon view of urethra emphasizing volume of urethropelvic jascfa captured and showing relative locations of suture entry points. (Csnstriction of captured fascia when suspended not shown.) (B) Lateral view emphasizing length of urethropelvic fascia captured from bladder neck to pubourethral ligament. (The constriction of the captured jascia when suspended not shown.)
removed. All patients became catheter-free. There was 1 case of a subcutaneous wound hematoma. The hematoma caused pain and was evacuated without residual sequelae. There were no wound infections. The complication of osteitis pubis was not noted. All patients denied
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stress urinary incontinence on early postoperative follow-up at approximately one month. Women who undergo this procedure are evaluated periodically after surgery by mail questionnaires. All 53 women in this group were contacted in such a manner up to fifteen
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Number of Patients
+3
Extremely
+2
*I
Satisfied
-1
-2
-3
Extremely
Dissatisfied
Patients’ satisfaction with the results of their bladder neck suspension.
FIGURE 8.
Limitation of suture tension. Tying of FIGURE 7. suspension suture on pulp of finger leaving small amount of suture slack.
months after surgery. Thirteen patients who did not return their questionnaires were surveyed by phone. This postoperative evaluation revealed that only 15 percent of patients complained of urgency incontinence. Four of the 53 patients (8%) had failed in their treatment for stress incontinence: 2 of 7 patients with the early generation Gl anchors (and without the tension limiting technique) and 2 of 46 patients with the G2 anchors. One of the 12 patients (8 % ) who had had previous anti-incontinence surgery failed. Failure was defined as a recurrence of urinary leakage with activity, even if the condition was improved over the preoperative state. Figure 8 indicates the patients’ satisfaction with the results of their procedure. Comment SUI is curable with any surgical procedure that properly suspends the bladder neck. Limitations of each procedure include the extent of surgical morbidity and the ever-present threat of long-term failures. Pereyral introduced the transvaginal bladder neck suspension as a less invasive alternative to open retropubic procedures. Stamey” limited morbidity of the transvaginal bladder neck suspension by introducing endoscopic control and
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confirmation of suture placement. Raz3 also limited morbidity by introducing full palpatory control of needle passage through the retropubit space to avoid injury to the bladder. The first phase of the needle passage modification, described herein, accomplishes a similar goal without finger entry into the retropubic space, by continually maintaining needle tip contact with the roof and floor of the retropubic space. Distal passage of the needle tip to the level of the introitus along the underside of the pubic bone obviates the need to turn the needle down toward a bladder neck that may have been digitally elevated and, therefore, avoids bladder entry. The pubourethral ligament is easily identified with this technique. Extraction of the needle from the pubourethral ligament is necessary to allow a capture of the more pliable urethropelvic fascia alongside the urethra. The subsequent, gentle sweep back of the needle along the surface of the urethropelvic fascia under vaginal digital guidance provides an easy and safe means of introducing the needle to the bladder neck area. Avoiding bladder entry in this manner reduces the time necessary for the occasional incontinence surgeon to perform multiple cystoscopies and to replace misplaced sutures. Gittes and Loughlin5 have further popularized the technique of Pereyra and demonstrated an advantage of increased long-term efficacy by creating an autologous bolster with the transvaginal passage of a curved needle. As a simple alternative of creating an autologous bolster, the second phase of the needle passage modification, described herein, uses a suprapubit needle approach to carry the suture through all of its vaginal passes. Specifically, needle passes 1 and 2 into the vagina are similar to the
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technique of Gittes and Loughlin (Fig. 6A), while needle passes 3 and 4 are finger-guided as opposed to their transvaginal use of the curved needle. The full carriage of the suture by a Stamey needle offers several benefits: (1) improved accuracy by allowing palpation of the needle at each vaginal entry point in reference to the catheter and its balloon (representing the urethra and bladder neck), (2) potentially decreased morbidity by reducing the risk of injury and/or irritation through inadvertent entry into any part of the urethra or bladder, (3) elimination of the need to visualize the anterior vaginal wall, thereby facilitating surgery, especially in cases of tighter vaginal introitus, and (4) potential contribution to long-term efficacy by assuring that a full-thickness layer of urethropelvic fascia is captured. This technique permits the capture of a large volume of lateral urethropelvic fascia similar in surface area to that obtained in open retropubic urethropexies. The distribution of tension across this large volume of tissue may reduce the risk of suspending suture detachment. Midurethral obstruction has not been evident with this technique because only one suture is used on each side of the urethra. Within each suture, the vectors of tension are distributed equally across both the proximal and midurethral suture attachment points to the urethropelvic fascia. Leach4 has limited morbidity by deceasing postoperative pain and has potentially improved long-term efficacy with pubic fixation of the suspending sutures. The trochar needle passage through the pubic bone, as described by Leach, can be difficult, particularly in obese patients, through the limited exposure that is used with many forms of endoscopic bladder neck suspension. Other various forms of pubic bone fixation also have been described with transvaginal and open bladder neck suspension surgery.B-8 To facilitate the anchoring of the suspensory suture to the pubic bone with minimal soft tissue dissection, a new set of devices called the Mitek anchor system has been used. The latest generation of Mitek anchor, the G2, consists of a titanium body coupled to nickel-titanium arcs. These anchors have been used most commonly for tenodesis and ligamentous reconstruction of the shoulder and footg.‘O In the setting of bladder neck suspensions, the Mitek anchor with attached suture is passed into a hole drilled in the pubic bone. Care must be taken to assure that the hole has been drilled
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into the pubic bone and not inferiorly through the tendon of the adductor longus muscle. Once the anchor is passed into the bone, the anchor’s unique memory forces the arcs to spring open to their original shape and to engage in the cancellous portion of the pubic bone. The complication of infection with use of the anchor has not been noted, which may, in part, be due to the emphasis on broad-spectrum antibiotics, avoidance of the symphysis pubis, and sterile technique. The absence of osteitis pubis in this setting is supported by the general orthopedic acceptance of internal fixation of pubic fractures using large plates and screws.” A simple tension-limiting technique of tying the suspending suture to leave a small amount of slack is described. The actual traction applied to the suture when tying down upon the index finger can vary, but some degree of slack is always visible when the finger is removed. Continence is achieved with this limited tension, in part because of the large volume of captured urethropelvic fascia lending support to the bladder neck and urethra. The tolerance of suture slack suggests that the urethropelvic fascia does not have to be released from the pelvic side wall, as described by Raz,3 to allow for adequate elevation and support of the bladder neck. Excessive tension on the bladder neck with this technique of suture tension limitation is essentially impossible. Chronic urinary retention is avoided and the chance of acute retention is minimized, thereby promoting a reduction in the period of catheterization. Chronic retention with endoscopic bladder neck suspension has been reported in as many as 5 to 18.9 percent of patients in other series. 12,13 Excessive tension with overcorrection of the bladder neck is also known to account for bladder instability.‘4 In this study, urgency incontinence diminished following surgery. This reduction in irritative urinary symptoms was also associated with the lateral placement of the sutures in the urethropelvic fascia. The period of hospitalization was short within the tension-limiting group which suggests that reducing tension on the sutures may decrease postoperative pain. Finally, limiting suture tension may be found, over time, to decrease suture pull through at the urethropelvic fascia. The modified endoscopic bladder neck suspension, described herein, has been developed in an effort to decrease the suspending suture
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detachment and minimize patient morbidity. Patient inconvenience in terms of the period of hospitalization and intermittent catheterization was limited. The results indicate that the safety and short-term efficacy of this alternate procedure of bladder neck suspension are good. Satisfaction in the patient group was high. These modifications allow the accurate and secure placement of suspending sutures in a simple manner that minimizes and distributes the tensions placed on the tissues that are suspended. All present surgical techniques of bladder neck suspension are susceptible to failures, with rates of failures that vary greatly between techniques and within the same technique by different surgeons. The modified technique is generally no more time-consuming than present endoscopic techniques and may prove over time and with independent investigation to be beneficial in minimizing failures. 26732 Crown Valley Parkway Suite 321 Mission Viejo, California 92691 ACKNOWLEDGMENT. To Ms. Tay McClellan ical illustrations.
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for the med-
References 1. Pereyra AJ: A simplified surgical procedure for the correction of stress incontinence in women, West J Surg 67: 223 (1959). 2. Stamey TA: Endoscopic suspension of the vesical neck for urinary incontinence in females: report on 203 consecutive patients, Ann Surg 192: 465 (1980). 3. Rax S: Modified bladder neck suspension for female stress incontinence, Urology 17: 82 (1981). 4. Leach GE: Bone fixation technique for transvaginal needle suspension, Urology 31: 388 (1988). 5. Gittes RF, and Loughlin KR: No-incision pubovaginal suspension for stress incontinence, J Urol 138: 568 (1987). 6. Winter CC: Peripubic urethropexy for urinary stress incontinence in women, Urology 20: 408 (1982). 7. McKiel CF Jr, Graf EC, and Callahan DH: Marshall-Marchetti procedure: modification, J Urol96: 737 (1966). 8. Hancock R, Brandstetter LH, and Hodgins TE: Banspubic suspension of the bladder neck for urinary incontinence, J Urol 123: 667 (1980). 9. Richmond JC, Donaldson WR, Fu F, and Harner CD: Modification of the Bankart reconstruction with a suture anchor: report of a new technique, Am J Sports Med 19: 343 (1991). 10. Pederson B, Tesoro D, Wertheime SJ, and Coraci M: Mitek anchor system: a new technique for tenodesis and ligamentous repair of the foot and ankle, J Foot Surg 30: 48 (1991). 11. Schatxker J, and Tile M: The Rationale of Operative Fracture Care, Berlin, Springer-%rlag, 1987, p 159. 12. Spencer JR, O’Conor VJ, and Schaeffer AJ: A comparison of endoscopic suspension of the vesical neck with suprapubic vesicourethrooexv for treatment of stress urinary incontinence, J Urol 137: 411 (1987). 13. Araki T, et al: The loop loosening procedure for urination difficulties after Stamey suspension of the vesical neck, J Urol144: 319 (1990). 14. Webster CD, and Kreder KJ: Voiding dysfunction following cystourethropexy: its evaluation and management, J Urol144: 670 (1990).
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