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A Modified Percutaneous Outpatient Bladder Neck Suspension System
0022-534 7/94/1526-2316$03.00/0 THE JOURNAL OF UROLOGY
Copyright© 1994 by
Vol. 152, 2316-2320, December 1994 Printed in U.S.A.
AMERICAN UROLOGICAL ASSOCIATION, INC.
A MODIFIED PERCUTANEOUS OUTPATIENT BLADDER NECK SUSPENSION SYSTEM THEODORE V. BENDEREV From the Incontinence Treatment Center, Mission Viejo and Division of Urology, University of California at Irvine, Irvine, California
ABSTRACT
During the last 8 years the original percutaneous needle suspension of Pereyra has been enhanced with the goal to reestablish safely and simply support of the pubocervical fascia in a reproducible and secure manner. Refinements include changes in points of suture attachment, limitation of suture tension and devices to perform the procedure simply and anchor the suspending suture in bone. A path along 2 planes of landmarks is used to guide the needle in capturing a maximum amount of mobile pubocervical fascia with a minimum risk of injury to the bladder or ureter. In 3 years over 150 patients have undergone this procedure. Early problems included suture breakage and inaccurate anchor placement. There have been no cases of chronic urinary retention. During the last 2 years the procedure has been performed on an outpatient basis. When suprapubic infection has been suspected, symptoms and signs have resolved with antibiotics. No sutures have been removed and osteitis pubis has not been noted. Any improvement in long-term durability has not yet been determined due to the history of ongoing refinements and the need for subsequent long-term followup. The specifics of this suspension system are described. KEY WORDS:
urinary incontinence, stress; ambulatory surgery; suture techniques; pubic bone
I am pleased to submit this article to the Festschrift to Doctor Grayhack, who taught me to seek better answers. The problem of stress urinary incontinence is found in 26% of all women with 14% actually complaining of hygienic or social problems. 1 Through organizations such as the Simon Foundation and Help for Incontinent People public awareness of this problem has increased. At the urging of women afflicted with incontinence, primary care physicians are looking for specialists who can treat this problem. The Federal Agency for Health Care Policy and Research has formalized a treatment plan that emphasizes conservative therapy before surgery. Urologists are uniquely positioned to meet the challenge of providing comprehensive therapy. They are already well versed in various suspension procedures. With their ability to learn new skills, they can become skilled in conservative therapies such as biofeedback and electrical stimulation. Patients and their referring physicians have a need for improved conservative and surgical therapy. The remainder of this article will focus on efforts to meet 3 goals in the surgery of bladder neck suspension: 1) reduced morbidities of urinary retention, irritative urinary symptoms and pain so that more patients can choose a surgical cure and return quickly to a normal life-style, 2) improved long-term efficacy and 3) improved reproducibility so that more patients can reliably expect to be cured. These goals have been pursued and partially achieved in the past with different bladder neck suspensions developed by urologists and gynecologists. 2- 7 A new modified percutaneous technique 8 and devices have been developed to meet these goals further while maintaining simplicity.
problem of stress urinary incontinence. Previous surgical suspension failure and the need for a concomitant anterior/ posterior colporrhaphy with/without hysterectomy were not contraindications. A set of instruments* (self-retaining vaginal retractor, Bone Locator,* Duratak* anchor system, Protecta Pass* suture passer and Suture Spacer*) was used to facilitate this new surgical technique (fig. 1). The suture passer consists of a handle with thumb lever, a shaft and a sharp tip needle. The thumb lever controls the mechanism at the needle tip end of the shaft (fig. 2). The needle has 3 positions. The extended position with the thumb lever all the way down causes the sharp needle tip to extend. This position is used during the initial penetration of the rectus fascia and subsequent penetrations of the pubocervical fascia and vaginal wall. Upon release of the thumb lever, the sharp tip passively retracts into the protective sheath, which is the closed position. The open position is achieved by * Vesica Medical, Inc., San Clemente, California.
MATERIALS AND METHODS
In 3 years more than 150 patients have undergone a modified percutaneous bladder neck suspension. Each patient had a hypermobile urethra. They had stress urinary incontinence of grades/types 1 to 3. Urgency incontinence, when Fm. 1. Devices used for modified percutaneous bladder neck present, has been only a secondary problem after the primary suspension. 2316
MODIFIED PERCUTANEOUS OUTPATIENT BLADDER NECK SUSPENSION SYSTEM
2317
FIG. 2. Positions of suture passer used to penetrate fascia and cap~1:1"e suture. A, extended position. B, closed position. C, open pos1t10n.
pushing the thumb lever up, which opens the suture capture slot. A suture can be captured by sliding it into the small slot of the suture passer in the open position. The thumb lever is brought back to the closed position to lock the suture in place. The suture passer allows a cyclical action of tissue penetration and suture passage. TECHNIQUE
For each side a suture is anchored into the pubic bone. One end of the suture is passed through the pubocervical fascia at 4 points to capture a large amount of tissue alongside the bladder neck and urethra (fig. 3). The sutures are tied over a spacer and cut. Within a few days the vaginal epithelium grows over the exposed suture. Now the patient is placed in the dorsal lithotomy position, prepared and draped. The vaginal retractor, consisting of a buttock plate and a vaginal insert, is placed. The buttock plate is positioned under the patient. The vaginal insert is inserted into the vagina and locked to the buttock plate. A Foley catheter is inserted into the bladder. Two 1-inch incisions are made directly over the superior aspect of the pubic tubercle on either side of the midline. Using electrocautery, dissection is carried down to the rectus fascia. This process yields access to the pubic bone without the need for its visu-
FIG. 3. End on view of bladder neck suspension with anchor fixation. Inset emphasizes large amount of pubocervical fascia captured.
Fm. 4. A, identification of pubic bone by extension of locator probes. B, placement of anchor into pubic bone. alization. At this point, a local anesthetic may be injected into the skin edges. The pubic bone is then identified with the locator for placement of the anchors. The locator is placed into the incision at the superior aspect of the pubic tubercle with the probes in the sagittal plane. The superior probe is depressed and if the probe extends to its maximum depth, the bone has been missed. The locator is then moved inferiorly within the incision until the superior probe makes contact with the bone. At this point the inferior probe should also be in contact with the pubic bone, which is confirmed by both probes being approximately the same height when fully depressed (fig. 4, A). The bone anchor with driver assembly and a monofilament polybutester nonabsorbable elastic suture* is loaded into a drill. The anchor and driver are then inserted down the channel of the locator and the assembly is drilled into the pubic bone. Placement is complete when the driver no longer advances indicating that the shoulder of the driver has contacted th~ bone cortex (fig. 4, B). The driver is removed followed by the locator, leaving the suture and bone anchor in place. Traction is then placed on the anchor to confirm its secure placement. To maintain suture integrity the traction is applied to the part of the suture that is 3 to 4 inches from the end (that portion of the suture that will later be discarded). Anchor placement is repeated on the other side. The process of suture attachment to the pubocervical fascia is then begun. The sagittal and axial planes with clear landmarks are used to identify safely the path of the needle tip to the 4 attachment points on each side. The sagittal plane is followed to bring the needle tip safely to the bladder neck area (fig. 5). The landmarks are the backside of the pubic bone, the pubourethral ligaments and the floor of the retropubic space. The needle tip should always maintain contact with one of these landmarks to avoid injuring the bladder. The axial plane is used to identify the location of the 4 attachment points (fig. 6). The landmarks are the catheter and its balloon junction, the pubourethral liganent and the pelvic sidewall. The suture should be captured by the suture passer 2 to 4 inches from its end to avoid suture damage. Contact by any instruments during suspension procedures should occur in this length· of the suture, which will later be discarded. The suture passer is first positioned in the wound with the tip on the rectus fascia immediately superior to the pubic tubercle. The thumb lever is depressed to extend the sharp tip and, * Novafil, Davis and Geck, Inc., Division of American Cyanimid Wayne, New Jersey. '
2318
MODIFIED PERCUTANEOUS OUTPATIENT BLADDER NECK SUSPENSION SYSTEM
Fm. 5. Sagittal plane used to guide needle tip to bladder neck area.
Fm. 6. Axial plane used to identify location of 4 corners of available mobile pubocervical fascia. Interposition of fingertips are used to identify 4 attachment points and to avoid inadvertent suture fixation of pelvic sidewall or urinary tract. @, fingertip. 0, attachment point. 0, mobile fascia.
with the shaft stabilized, the suture passer is pushed through the rectus fascia. The lever is released, allowing the needle tip to retract. The suture passer handle is now lowered back towards the abdomen so that the blunt, curved tip makes contact with the underside of the pubic bone. The tip is advanced distally towards the introitus, always maintaining contact with the backside of the pubic bone (the safety zone). Only when the tip has come alongside the urethral meatus is a finger inserted in the vagina back to the level of the bladder neck as identified by the catheter-balloon junction. The blunt tip of the suture passer is then guided along the surface of the finger to attachment point 1 (fig. 5), which is 1 fingertip away from the bladder neck (fig. 6). The thumb lever is depressed slightly, extending the needle tip enough to hold the position.
The finger is then withdrawn and the tip is extended fully by depressing the thumb lever. The suture passer is pushed through the pubocervical fascia and vaginal wall. The thumb lever is flipped to the open position and the suture is released from the suture passer into the vagina. The lever is then depressed to the closed position and the suture passer is pulled back to the backside of the pubic bone (the safety zone). The passage of the needle tip is then repeated along the sagittal plane to find attachment point 2 (fig. 5). The blunt tip is advanced to a position alongside the urethral meatus. Two finger tips are passed back along the vaginal wall to 1 side of the bladder neck. The medial finger tip is placed at the bladder neck. The lateral finger tip is placed against the pelvic side wall in line with the finger tip at the bladder neck. The blunt needle tip is guided along the surface of the lateral finger to attachment point 2, which is on the posteromedial aspect of the lateral finger tip (fig. 6). This slight posterior bias in point 2 in reference to point 1 is especially helpful in those patients with a cystocele, a tight pelvis to maximize point 1 and 2 separation, and to avoid locking point 2 in the pelvic side wall. An effort is always made to maximize the separation between points 1 and 2 to prevent overlap and to create a broad support. Point 2 and all attachment points should be in mobile fascia. Again, with the needle extended the suture passer tip is pushed through the pubocervical fascia into the vagina. The suture is now captured by the suture passer and the tip is once again withdrawn to the safety zone. The tip is then advanced in the same sagittal plane to attachment point 3. Attachment point 3 is located 1 fingertip from the catheter at the mid urethra (fig. 6). Point 3 is inside the vaginal introitus, in a mobile portion of the fascia and near the pubourethral ligaments (the female equivalent of the puboprostatic ligaments), which can be palpated with the tip of the suture passer as dense bands of tissue. The sharp tip is extended, the suture passer is pushed through the fascia and vaginal wall, and the suture is released. The suture passer is then pulled back to the retropubic space and passed to attachment point 4, which is lateral to point 3, near the side wall in the mobile portion of the fascia (fig. 6). A final penetration of the suture passer is made. The suture is captured and withdrawn completely through the pubic wound. The same steps are repeated on the other side. Cystoscopy is then performed to assure that suture penetration of the bladder has not occurred. Gentle traction on the nonanchor end of the suture should close off the bladder neck if the suspension sutures have been properly placed in mobile pubocervical fascia. The final step of tying off the sutures involves use of the spacer. The tip of the instrument is a ball with a slot to hold the suture during tying. Use of the spacer ensures an appropriate amount of slack to limit suture tension and to avoid over correction of the bladder neck. Before proceeding with suture tying, the vaginal retractor should be loosened to minimize traction on the fascia. The spacer is placed partially into the pubic wound with the slot lined up with the suture ends. The knot is tied down snugly pulling the spacer onto the pubic bone (fig. 7, A). The spacer is then removed allowing the bladder neck to assume its newly suspended position (fig. 7, B). The identical steps are followed on the other side. The wounds are again irrigated with an antibiotic solution and closed. A Foley or suprapubic catheter is placed at the completion of the procedure. Patients are usually discharged home the same day. The patient is given an oral fluoroquinolone antibiotic preoperatively in 1 dose and postoperatively for 10 days. Patients usually resume near normal activity within 1 to 2 weeks but avoid strenuous activity for 4 to 6 weeks.
MODIFIED PERCUTANEOUS OUTPATIENT BLADDER NECK SUSPENSION SYSTEM
Fm. 7. A, tying of suture onto spacer to avoid over correction of bladder neck. B, suspended bladder neck in nontaut position following removal of spacer. RESULTS
Chronic urinary retention has not been observed following this technique. Suspected infections of the suprapubic area, associated with suprapubic pain, have been rare and resolved with a fluoroquinilone antibiotic without suture or anchor removal. In such cases the duration of antibiotic has been for 1 week beyond the resolution of suprapubic pain (usually a total of 3 weeks). Osteitis pubis has not been noted. Explorations during subsequent open repair of failed cases demonstrated retropubic scarring with laxity, breaks or pullthrough of suture material. Changes in technique to address these problems account for the majority of changes from the originally described procedure. 8 Due to the evolutionary changes in the technique long-term durability has not been determined for the present technique. From an engineering standpoint, a durability greater than that found with more conventional techniques is anticipated but independent, long-term study will be required for affirmation. DISCUSSION
While the procedure is relatively simple to learn for surgeons who have performed other needle suspensions, there are some rules to be followed to help minimize postoperative problems. The 4 attachment points should be maximally separated. Only mobile fascia should be captured. Handling by any device of any section of suture that will remain later to suspend fascia is to be avoided. With the use of an implant, it is especially important to maintain sterility. The suprapubic wound is frequently irrigated with an antibiotic solution. Cystoscopy should be done with sterile technique instead of clean technique. Helpful hints include changing gloves after
2319
direct vision cystoscopy or using a video system with a 120degree lens to examine the anterior wall of the bladder for any suture material. During needle passage the tip should always maintain contact with either the safety zone or the floor of the retropubic space, thereby avoiding penetration of the bladder. This rule is particularly helpful when this operation is done in a patient who has had a previous open or needle suspension failure. The described procedure is a minimally invasive technique used to obtain broad support of the bladder neck in a near normal anatomic position. The modifications were designed as common-sense solutions to difficulties encountered by urologists. This procedure requires no greater time to perform than any other Pereyra-derived technique and does not require an assistant. It may also have additional advantages over conventional techniques. Tolerance of slack in the suspending suture with this technique indicates that the already lax pubocervical fascia does not have to be incised and released from the pelvic side wall before suspension as needed with some other techniques. Therefore, finger entry into the retropubic space with disruption of the pubocervical fascia is not necessary. Suture entry into the bladder can be minimized by avoiding digital elevation of the bladder neck toward the needle tip during needle passage. The entire needle passage via a suprapubic approach minimizes any chance of injuring the intravesical ureter as can occur with a transvaginal repair and avoids the need to visualize the anterior vaginal wall, which can facilitate surgery, especially in cases of a tighter vaginal introitus. Use of landmarks of the catheter and pelvic side wall allows the identification of the available mobile fascia and its 4 corners for suture attachment. The full thickness capture of a maximum amount of supportive pubocervical fascia matches or surpasses that of open suspensions and may reduce the risk of suspending suture detachment. The absence of suture overlap may protect the blood supply of the pubocervical fascia and reduce any tissue necrosis with resultant suture detachment. The procedure also creates a vaginal wall sling, which might explain its usefulness in intrinsic sphincteric deficiency with urethral hypermobility. Mid urethral obstruction has not been evident with this technique because only 1 suture is used on each side of the urethra, which results in equal tension distribution from the bladder neck to the mid urethral suture attachment points. In suspension surgery proper fixation of the suspending suture is all important. Fixation in bone is valuable in establishing anterior suture attachment in a stable, secure and nonmobile manner. Leach demonstrated a reduction in postoperative pain with pubic bone fixation using a curved needle to drive the suture through the bone. 9 An anchor further simplifies this fixation by minimizing the need for exposure and soft tissue dissection. The anchor also negates the need for a bridge of rectus fascia to support the suture at the abdominal wall level. Therefore, at the abdominal wall level only a single needle pass becomes necessary on each side of the midline. Limiting suspending suture tension may have some additional advantages. The complications of over correction of the bladder neck, such as urinary retention and de novo urgency incontinence, may be reduced. There may be less postoperative pain. Improved reproducibility would allow for favorable outcomes in a more predictable and larger number of patients. Decreased tension might also be expected to result in a decrease in suture pull-through at the pubocervical fascia. The addition of an elastic suture may augment such an advantage by providing a shock absorber in times of great stress on the suspension. These modifications and associated devices enhance the ease of learning and creating a secure bladder neck suspension. This system approach offers the opportunity for an improved surgical therapy that may make surgery a more
2320
MODIFIED PERCUTANEOUS OUTPATIENT BLADDER NECK SUSPENSION SYSTEM
attractive option for patients suffering with stress urinary incontinence. REFERENCES 1. Urinary incontinence in adults. In: Clinical Practice Guidelines. U. S. Department of Health and Human Services, Agency for Health Care Policy and Research, March, 1992. 2. Marshall, V. F., Marchetti, A. A. and Krantz, K. E.: The correction of stress urinary incontinence by simple vesicourethral suspension. Surg., Gynec. & Obst., 88: 134, 1949. 3. Pereyra, A. J.: A simplified surgical procedure for the correction of stress incontinence in women. West. J. Surg., 67: 223, 1959.
4. Burch, J. C.: Urethrovaginal fixation to Cooper's ligament for correction of stress incontinence, cystocele, and prolapse. Amer. J. Obst. Gynec., 81: 281, 1961. 5. Stamey, T. ~.: Endoscopic suspension of the vesical neck for urinary incontinence. Surg., Gynec. & Obst., 136: 547, 1973. 6. Raz, S.: Modified bladder neck suspension for female stress incontinence. Urology, 17: 82, 1981. 7. Gittes, R. F. and Loughlin, K. R.: No-incision pubovaginal suspension for stress incontinence. J. Urol., 138: 568, 1987. 8. Benderev, T. V.: Anchor fixation and other modifications of endoscopic bladder neck suspension. Urology, 40: 409, 1992. 9. Leach, G. E.: Bone fixation technique for transvaginal needle suspension. Urology, 31: 388, 1988.
Copyright© 1994 by
Vol. 152, 2316-2320, December 1994 Printed in U.S.A.
AMERICAN UROLOGICAL ASSOCIATION, INC.
A MODIFIED PERCUTANEOUS OUTPATIENT BLADDER NECK SUSPENSION SYSTEM THEODORE V. BENDEREV From the Incontinence Treatment Center, Mission Viejo and Division of Urology, University of California at Irvine, Irvine, California
ABSTRACT
During the last 8 years the original percutaneous needle suspension of Pereyra has been enhanced with the goal to reestablish safely and simply support of the pubocervical fascia in a reproducible and secure manner. Refinements include changes in points of suture attachment, limitation of suture tension and devices to perform the procedure simply and anchor the suspending suture in bone. A path along 2 planes of landmarks is used to guide the needle in capturing a maximum amount of mobile pubocervical fascia with a minimum risk of injury to the bladder or ureter. In 3 years over 150 patients have undergone this procedure. Early problems included suture breakage and inaccurate anchor placement. There have been no cases of chronic urinary retention. During the last 2 years the procedure has been performed on an outpatient basis. When suprapubic infection has been suspected, symptoms and signs have resolved with antibiotics. No sutures have been removed and osteitis pubis has not been noted. Any improvement in long-term durability has not yet been determined due to the history of ongoing refinements and the need for subsequent long-term followup. The specifics of this suspension system are described. KEY WORDS:
urinary incontinence, stress; ambulatory surgery; suture techniques; pubic bone
I am pleased to submit this article to the Festschrift to Doctor Grayhack, who taught me to seek better answers. The problem of stress urinary incontinence is found in 26% of all women with 14% actually complaining of hygienic or social problems. 1 Through organizations such as the Simon Foundation and Help for Incontinent People public awareness of this problem has increased. At the urging of women afflicted with incontinence, primary care physicians are looking for specialists who can treat this problem. The Federal Agency for Health Care Policy and Research has formalized a treatment plan that emphasizes conservative therapy before surgery. Urologists are uniquely positioned to meet the challenge of providing comprehensive therapy. They are already well versed in various suspension procedures. With their ability to learn new skills, they can become skilled in conservative therapies such as biofeedback and electrical stimulation. Patients and their referring physicians have a need for improved conservative and surgical therapy. The remainder of this article will focus on efforts to meet 3 goals in the surgery of bladder neck suspension: 1) reduced morbidities of urinary retention, irritative urinary symptoms and pain so that more patients can choose a surgical cure and return quickly to a normal life-style, 2) improved long-term efficacy and 3) improved reproducibility so that more patients can reliably expect to be cured. These goals have been pursued and partially achieved in the past with different bladder neck suspensions developed by urologists and gynecologists. 2- 7 A new modified percutaneous technique 8 and devices have been developed to meet these goals further while maintaining simplicity.
problem of stress urinary incontinence. Previous surgical suspension failure and the need for a concomitant anterior/ posterior colporrhaphy with/without hysterectomy were not contraindications. A set of instruments* (self-retaining vaginal retractor, Bone Locator,* Duratak* anchor system, Protecta Pass* suture passer and Suture Spacer*) was used to facilitate this new surgical technique (fig. 1). The suture passer consists of a handle with thumb lever, a shaft and a sharp tip needle. The thumb lever controls the mechanism at the needle tip end of the shaft (fig. 2). The needle has 3 positions. The extended position with the thumb lever all the way down causes the sharp needle tip to extend. This position is used during the initial penetration of the rectus fascia and subsequent penetrations of the pubocervical fascia and vaginal wall. Upon release of the thumb lever, the sharp tip passively retracts into the protective sheath, which is the closed position. The open position is achieved by * Vesica Medical, Inc., San Clemente, California.
MATERIALS AND METHODS
In 3 years more than 150 patients have undergone a modified percutaneous bladder neck suspension. Each patient had a hypermobile urethra. They had stress urinary incontinence of grades/types 1 to 3. Urgency incontinence, when Fm. 1. Devices used for modified percutaneous bladder neck present, has been only a secondary problem after the primary suspension. 2316
MODIFIED PERCUTANEOUS OUTPATIENT BLADDER NECK SUSPENSION SYSTEM
2317
FIG. 2. Positions of suture passer used to penetrate fascia and cap~1:1"e suture. A, extended position. B, closed position. C, open pos1t10n.
pushing the thumb lever up, which opens the suture capture slot. A suture can be captured by sliding it into the small slot of the suture passer in the open position. The thumb lever is brought back to the closed position to lock the suture in place. The suture passer allows a cyclical action of tissue penetration and suture passage. TECHNIQUE
For each side a suture is anchored into the pubic bone. One end of the suture is passed through the pubocervical fascia at 4 points to capture a large amount of tissue alongside the bladder neck and urethra (fig. 3). The sutures are tied over a spacer and cut. Within a few days the vaginal epithelium grows over the exposed suture. Now the patient is placed in the dorsal lithotomy position, prepared and draped. The vaginal retractor, consisting of a buttock plate and a vaginal insert, is placed. The buttock plate is positioned under the patient. The vaginal insert is inserted into the vagina and locked to the buttock plate. A Foley catheter is inserted into the bladder. Two 1-inch incisions are made directly over the superior aspect of the pubic tubercle on either side of the midline. Using electrocautery, dissection is carried down to the rectus fascia. This process yields access to the pubic bone without the need for its visu-
FIG. 3. End on view of bladder neck suspension with anchor fixation. Inset emphasizes large amount of pubocervical fascia captured.
Fm. 4. A, identification of pubic bone by extension of locator probes. B, placement of anchor into pubic bone. alization. At this point, a local anesthetic may be injected into the skin edges. The pubic bone is then identified with the locator for placement of the anchors. The locator is placed into the incision at the superior aspect of the pubic tubercle with the probes in the sagittal plane. The superior probe is depressed and if the probe extends to its maximum depth, the bone has been missed. The locator is then moved inferiorly within the incision until the superior probe makes contact with the bone. At this point the inferior probe should also be in contact with the pubic bone, which is confirmed by both probes being approximately the same height when fully depressed (fig. 4, A). The bone anchor with driver assembly and a monofilament polybutester nonabsorbable elastic suture* is loaded into a drill. The anchor and driver are then inserted down the channel of the locator and the assembly is drilled into the pubic bone. Placement is complete when the driver no longer advances indicating that the shoulder of the driver has contacted th~ bone cortex (fig. 4, B). The driver is removed followed by the locator, leaving the suture and bone anchor in place. Traction is then placed on the anchor to confirm its secure placement. To maintain suture integrity the traction is applied to the part of the suture that is 3 to 4 inches from the end (that portion of the suture that will later be discarded). Anchor placement is repeated on the other side. The process of suture attachment to the pubocervical fascia is then begun. The sagittal and axial planes with clear landmarks are used to identify safely the path of the needle tip to the 4 attachment points on each side. The sagittal plane is followed to bring the needle tip safely to the bladder neck area (fig. 5). The landmarks are the backside of the pubic bone, the pubourethral ligaments and the floor of the retropubic space. The needle tip should always maintain contact with one of these landmarks to avoid injuring the bladder. The axial plane is used to identify the location of the 4 attachment points (fig. 6). The landmarks are the catheter and its balloon junction, the pubourethral liganent and the pelvic sidewall. The suture should be captured by the suture passer 2 to 4 inches from its end to avoid suture damage. Contact by any instruments during suspension procedures should occur in this length· of the suture, which will later be discarded. The suture passer is first positioned in the wound with the tip on the rectus fascia immediately superior to the pubic tubercle. The thumb lever is depressed to extend the sharp tip and, * Novafil, Davis and Geck, Inc., Division of American Cyanimid Wayne, New Jersey. '
2318
MODIFIED PERCUTANEOUS OUTPATIENT BLADDER NECK SUSPENSION SYSTEM
Fm. 5. Sagittal plane used to guide needle tip to bladder neck area.
Fm. 6. Axial plane used to identify location of 4 corners of available mobile pubocervical fascia. Interposition of fingertips are used to identify 4 attachment points and to avoid inadvertent suture fixation of pelvic sidewall or urinary tract. @, fingertip. 0, attachment point. 0, mobile fascia.
with the shaft stabilized, the suture passer is pushed through the rectus fascia. The lever is released, allowing the needle tip to retract. The suture passer handle is now lowered back towards the abdomen so that the blunt, curved tip makes contact with the underside of the pubic bone. The tip is advanced distally towards the introitus, always maintaining contact with the backside of the pubic bone (the safety zone). Only when the tip has come alongside the urethral meatus is a finger inserted in the vagina back to the level of the bladder neck as identified by the catheter-balloon junction. The blunt tip of the suture passer is then guided along the surface of the finger to attachment point 1 (fig. 5), which is 1 fingertip away from the bladder neck (fig. 6). The thumb lever is depressed slightly, extending the needle tip enough to hold the position.
The finger is then withdrawn and the tip is extended fully by depressing the thumb lever. The suture passer is pushed through the pubocervical fascia and vaginal wall. The thumb lever is flipped to the open position and the suture is released from the suture passer into the vagina. The lever is then depressed to the closed position and the suture passer is pulled back to the backside of the pubic bone (the safety zone). The passage of the needle tip is then repeated along the sagittal plane to find attachment point 2 (fig. 5). The blunt tip is advanced to a position alongside the urethral meatus. Two finger tips are passed back along the vaginal wall to 1 side of the bladder neck. The medial finger tip is placed at the bladder neck. The lateral finger tip is placed against the pelvic side wall in line with the finger tip at the bladder neck. The blunt needle tip is guided along the surface of the lateral finger to attachment point 2, which is on the posteromedial aspect of the lateral finger tip (fig. 6). This slight posterior bias in point 2 in reference to point 1 is especially helpful in those patients with a cystocele, a tight pelvis to maximize point 1 and 2 separation, and to avoid locking point 2 in the pelvic side wall. An effort is always made to maximize the separation between points 1 and 2 to prevent overlap and to create a broad support. Point 2 and all attachment points should be in mobile fascia. Again, with the needle extended the suture passer tip is pushed through the pubocervical fascia into the vagina. The suture is now captured by the suture passer and the tip is once again withdrawn to the safety zone. The tip is then advanced in the same sagittal plane to attachment point 3. Attachment point 3 is located 1 fingertip from the catheter at the mid urethra (fig. 6). Point 3 is inside the vaginal introitus, in a mobile portion of the fascia and near the pubourethral ligaments (the female equivalent of the puboprostatic ligaments), which can be palpated with the tip of the suture passer as dense bands of tissue. The sharp tip is extended, the suture passer is pushed through the fascia and vaginal wall, and the suture is released. The suture passer is then pulled back to the retropubic space and passed to attachment point 4, which is lateral to point 3, near the side wall in the mobile portion of the fascia (fig. 6). A final penetration of the suture passer is made. The suture is captured and withdrawn completely through the pubic wound. The same steps are repeated on the other side. Cystoscopy is then performed to assure that suture penetration of the bladder has not occurred. Gentle traction on the nonanchor end of the suture should close off the bladder neck if the suspension sutures have been properly placed in mobile pubocervical fascia. The final step of tying off the sutures involves use of the spacer. The tip of the instrument is a ball with a slot to hold the suture during tying. Use of the spacer ensures an appropriate amount of slack to limit suture tension and to avoid over correction of the bladder neck. Before proceeding with suture tying, the vaginal retractor should be loosened to minimize traction on the fascia. The spacer is placed partially into the pubic wound with the slot lined up with the suture ends. The knot is tied down snugly pulling the spacer onto the pubic bone (fig. 7, A). The spacer is then removed allowing the bladder neck to assume its newly suspended position (fig. 7, B). The identical steps are followed on the other side. The wounds are again irrigated with an antibiotic solution and closed. A Foley or suprapubic catheter is placed at the completion of the procedure. Patients are usually discharged home the same day. The patient is given an oral fluoroquinolone antibiotic preoperatively in 1 dose and postoperatively for 10 days. Patients usually resume near normal activity within 1 to 2 weeks but avoid strenuous activity for 4 to 6 weeks.
MODIFIED PERCUTANEOUS OUTPATIENT BLADDER NECK SUSPENSION SYSTEM
Fm. 7. A, tying of suture onto spacer to avoid over correction of bladder neck. B, suspended bladder neck in nontaut position following removal of spacer. RESULTS
Chronic urinary retention has not been observed following this technique. Suspected infections of the suprapubic area, associated with suprapubic pain, have been rare and resolved with a fluoroquinilone antibiotic without suture or anchor removal. In such cases the duration of antibiotic has been for 1 week beyond the resolution of suprapubic pain (usually a total of 3 weeks). Osteitis pubis has not been noted. Explorations during subsequent open repair of failed cases demonstrated retropubic scarring with laxity, breaks or pullthrough of suture material. Changes in technique to address these problems account for the majority of changes from the originally described procedure. 8 Due to the evolutionary changes in the technique long-term durability has not been determined for the present technique. From an engineering standpoint, a durability greater than that found with more conventional techniques is anticipated but independent, long-term study will be required for affirmation. DISCUSSION
While the procedure is relatively simple to learn for surgeons who have performed other needle suspensions, there are some rules to be followed to help minimize postoperative problems. The 4 attachment points should be maximally separated. Only mobile fascia should be captured. Handling by any device of any section of suture that will remain later to suspend fascia is to be avoided. With the use of an implant, it is especially important to maintain sterility. The suprapubic wound is frequently irrigated with an antibiotic solution. Cystoscopy should be done with sterile technique instead of clean technique. Helpful hints include changing gloves after
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direct vision cystoscopy or using a video system with a 120degree lens to examine the anterior wall of the bladder for any suture material. During needle passage the tip should always maintain contact with either the safety zone or the floor of the retropubic space, thereby avoiding penetration of the bladder. This rule is particularly helpful when this operation is done in a patient who has had a previous open or needle suspension failure. The described procedure is a minimally invasive technique used to obtain broad support of the bladder neck in a near normal anatomic position. The modifications were designed as common-sense solutions to difficulties encountered by urologists. This procedure requires no greater time to perform than any other Pereyra-derived technique and does not require an assistant. It may also have additional advantages over conventional techniques. Tolerance of slack in the suspending suture with this technique indicates that the already lax pubocervical fascia does not have to be incised and released from the pelvic side wall before suspension as needed with some other techniques. Therefore, finger entry into the retropubic space with disruption of the pubocervical fascia is not necessary. Suture entry into the bladder can be minimized by avoiding digital elevation of the bladder neck toward the needle tip during needle passage. The entire needle passage via a suprapubic approach minimizes any chance of injuring the intravesical ureter as can occur with a transvaginal repair and avoids the need to visualize the anterior vaginal wall, which can facilitate surgery, especially in cases of a tighter vaginal introitus. Use of landmarks of the catheter and pelvic side wall allows the identification of the available mobile fascia and its 4 corners for suture attachment. The full thickness capture of a maximum amount of supportive pubocervical fascia matches or surpasses that of open suspensions and may reduce the risk of suspending suture detachment. The absence of suture overlap may protect the blood supply of the pubocervical fascia and reduce any tissue necrosis with resultant suture detachment. The procedure also creates a vaginal wall sling, which might explain its usefulness in intrinsic sphincteric deficiency with urethral hypermobility. Mid urethral obstruction has not been evident with this technique because only 1 suture is used on each side of the urethra, which results in equal tension distribution from the bladder neck to the mid urethral suture attachment points. In suspension surgery proper fixation of the suspending suture is all important. Fixation in bone is valuable in establishing anterior suture attachment in a stable, secure and nonmobile manner. Leach demonstrated a reduction in postoperative pain with pubic bone fixation using a curved needle to drive the suture through the bone. 9 An anchor further simplifies this fixation by minimizing the need for exposure and soft tissue dissection. The anchor also negates the need for a bridge of rectus fascia to support the suture at the abdominal wall level. Therefore, at the abdominal wall level only a single needle pass becomes necessary on each side of the midline. Limiting suspending suture tension may have some additional advantages. The complications of over correction of the bladder neck, such as urinary retention and de novo urgency incontinence, may be reduced. There may be less postoperative pain. Improved reproducibility would allow for favorable outcomes in a more predictable and larger number of patients. Decreased tension might also be expected to result in a decrease in suture pull-through at the pubocervical fascia. The addition of an elastic suture may augment such an advantage by providing a shock absorber in times of great stress on the suspension. These modifications and associated devices enhance the ease of learning and creating a secure bladder neck suspension. This system approach offers the opportunity for an improved surgical therapy that may make surgery a more
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MODIFIED PERCUTANEOUS OUTPATIENT BLADDER NECK SUSPENSION SYSTEM
attractive option for patients suffering with stress urinary incontinence. REFERENCES 1. Urinary incontinence in adults. In: Clinical Practice Guidelines. U. S. Department of Health and Human Services, Agency for Health Care Policy and Research, March, 1992. 2. Marshall, V. F., Marchetti, A. A. and Krantz, K. E.: The correction of stress urinary incontinence by simple vesicourethral suspension. Surg., Gynec. & Obst., 88: 134, 1949. 3. Pereyra, A. J.: A simplified surgical procedure for the correction of stress incontinence in women. West. J. Surg., 67: 223, 1959.
4. Burch, J. C.: Urethrovaginal fixation to Cooper's ligament for correction of stress incontinence, cystocele, and prolapse. Amer. J. Obst. Gynec., 81: 281, 1961. 5. Stamey, T. ~.: Endoscopic suspension of the vesical neck for urinary incontinence. Surg., Gynec. & Obst., 136: 547, 1973. 6. Raz, S.: Modified bladder neck suspension for female stress incontinence. Urology, 17: 82, 1981. 7. Gittes, R. F. and Loughlin, K. R.: No-incision pubovaginal suspension for stress incontinence. J. Urol., 138: 568, 1987. 8. Benderev, T. V.: Anchor fixation and other modifications of endoscopic bladder neck suspension. Urology, 40: 409, 1992. 9. Leach, G. E.: Bone fixation technique for transvaginal needle suspension. Urology, 31: 388, 1988.