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A NEW OPERATION FOR GENITOURINARY PROLAPSE
0022-5347/98/1603-0741$03.00/0
THE JOIXSAI.OF UROLOGY
Val 160. 741-745. September 1998 Printed in U S.A.
Copyright 0 1998 by AMERICAN UROLOOICAL &SOCIATION, INC
A NEW OPERATION FOR GENITOURINARY PROLAPSE GIULIO NICITA From the Clinica Urologica II, Uniuersita’ degli Studi di Firenze, Florence, Italy
ABSTRACT
Purpose: A new method to support female prolapsed pelvic organs is presented, which involves use of nonabsorbable mesh c u t in a hammock shape. The approach is transvaginal a n d the novelties are the way in which the m e s h is anchored and its considerable size. Materials a n d Methods: The m e s h is anchored transversally between the 2 arcus tendineus of the endopelvic fascia a n d in the anteroposterior direction between the bladder and uterine necks. The anteroposterior dimension of the m e s h m u s t completely cover t h e cystocele. From J a n u a r y 1996 to June 1997 this technique w a s used in 44 patients ranging in age from 43 to 86 years. The patients presented with various degrees of incontinence and combinations of cystocele, uterine or vaginal vault prolapse, rectocele a n d o r enterocele. Cystocele and incontinence were classified according to the SEAPI QMM scales a n d the other anatomical defects according t o the Beecham classification. Preoperative analysis of all patients included cystography, video urodynamics, a n d pelvic a n d abdominal echography. Results: All patients affected by some degree of incontinence were cured. Patients with prolapse without incontinence were completely satisfied with the operation. Uterine prolapse w a s third degree in 6 of 20 patients and it partially recurred in 3. Cystography in all patients demonstrated excellent repair of the descensus. Sexual life a n d menses did not change, a n d no pelvic fibrosis o r hydroureteronephrosis occurred. Followup ranges from 9 to 2 3 months (median
13.9). Conclusions: This technique has broad application and is simple to perform. Longer followup will prove its merits definitively. KEYWORDS:urinary incontinence, prolapse urination disorders, stress A The existence of numerous surgical techniques for treating genitourinary prolapse and incontinence proves that none of them is completely satisfactory. No matter which approach is used, most have the common goal to replace the descended organs in the abdominal cavity. The frequency with which new operations are proposed is confirmation of the need for better solutions than those presently adopted. A transvaginal operation is described for reconstructing a support for the pelvic viscera made of polypropylene mesh. The theoretical presupposition is that the primary cause of prolapsed pelvic viscera and consequent physiopathological alterations, for example incontinence, is diastasis of the levator ani muscles and connective tissue that connects them to the lateral walls of the vagina. The majority of current FIG.1. Shape of mesh. A, anterior edge. B , posterior edge. C and procedures of prolapse surgery fail because the method used D, lateral wings. Distance between A and B is equal to anteroposteto replace the descended organs in the pelvic cavity counter- nor dimension of cystocele. act the effect but not the underlying cause of the prolapse, which is levator ani muscle diastasis. Therefore, analogous to what occurs in hernia surgery when the herniated viscera are first degree incontinence can be treated successfully with retracted without closing the hernia aperture, recurrence is pelvic rehabilitation exercises.s.6 likely. With this new technique prolapse is corrected by returning MATERIALS AND METHODS the viscera to their correct anatomical seat and using a Surgical technique. The patient is placed on the operating polypropylene mesh support to substitute for the compro- table as for a vaginal approach. The field is prepared and the mised levator ani muscle function. Polypropylene mesh has anteroposterior dimension of the cystocele (the distance bebeen used previously in the treatment of female inconti- tween the uterine and bladder necks) is measured with a nence.1.2 The novelties3.4 of the technique are the way in sterile ruler, which determines the size of the anteroposterior which the mesh is anchored and its considerable size. The polypropylene mesh (fig. l , A to B ) .The transverse dimension mesh is taut and anchored transversally between the 2 arcus is determined and the mesh is cut to size (average meastendineus of the endopelvic fascia and in the anteroposterior urement 10 cm.) (fig. 1, C to D).A 16Ch Foley catheter is direction between the bladder and uterine necks (fig. 1).This introduced into the bladder and the front wall of the vagina technique is appropriate for cystocele and/or second or third is incised from the bladder neck to the uterine neck (fig. 2). degree prolapse repair. First degree cystocele associated with The vaginal wall is separated from the flaccid cellular tissue, improperly called the perivesical or perivaginal fascia, which Accepted for publication April 17, 1998.
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NEW OPERATION FOR GENITOURINARY PROLAPSE
FIG.2. Schematic of incision from bladder neck to cervix (0.V, vagina.
lies between the bladder and vagina, and which will be used as a buffer between the mesh and the pericystium. A Scott retractor is positioned in this vaginal incision, and the bladder is separated from the cervix and pushed upward. The cystocele must be completely freed bilaterally. The following steps must be performed on each side. The space lateral to the bladder neck is penetrated with the tip of a finger to reach the inferior branch of the pubic bone. As pressure is exerted with the finger medial on the bladder (to avoid lesions), the tip of a Metzenbaum scissors is inserted along the path of the finger until it reaches the pubic bone. A 3 to 4 cm. opening is cut in the arcus tendineus of the endopelvic fascia t o gain access to the pelvic cavity. The opening, analogous to that made in bladder neck suspension surgery, must allow for easy insertion of the index finger but it does not reach the ischial spine, which is posterior and inferior to the incision. A 3-zero prolene suture is placed at each end of each incision. The obturator fossa can be palpated dorsally and below but it is 1 to 2 cm. from the location of the sutures. Thus 4 lateral sutures are placed securely in the arcus tendineus of the endopelvic fascia. They are not tied but are held with a Kelly clamp. The lateral edges of the mesh will be fxed later t o these 4 sutures. With respect to the horizontal position of the patient, the 2 upper sutures of the lateral lie on a vertical transverse plane about 1 cm. above a parallel plane corresponding to the bladder neck (fig. 3, C to D).The polypropylene mesh is cut in a hammock-like shape (fig. 1). The central part of the mesh is fixed to the uterine cervix with 3, 3-zero polyglycolic acid sutures (fig. 3, B). If hysterectomy has been performed previously, the posterior edge of the bladder is fixed to the hysterectomy scar without isolating the uterosacral ligaments, which are presumed to be encompassed in the scar tissue. The lateral wings of the mesh are introduced through the holes of the arcus tendineus of the endopelvic fascia and they are pulled tight. The 4, 3-Zero prolene sutures previously inserted in the arcus tendineus are passed through the mesh near the junctures of the lateral wings and left untied. The anterior edge of the net is cut precisely to fit the bladder neck to which it is sutured with 3, 3-Zero polyglycolic acid stitches (fig. 1,A). The Scott retractor is removed before knotting the 4 prolene stitches to avoid counteracting the elevating action of the net. After the 4 sutures are tied the mesh is taut a t the level of the levator ani muscle. The mesh pulled taut between the lateral sutures raises the bladder neck toward the head, functioning like a broad sling,7 which is the key to resolving incontinence if it exists. The main support system for the mesh consists of the 4 lateral sutures (fig. 3, C to D),each of
FIG. 3. Schematic of vagina with mesh in situ. Stitch A fixes mesh to bladder neck, stitch B to cervix, and stitches C and D to openings through pubic bone insertions of arcus tendineus of endopelvic fascia.
which anchors the mesh to 1 of the 2 ends of each incision, thus leaving 2 stitches on the left and 2 on the right sides. The other stitches on the anterior and posterior edges of the mesh anchor the bladder and uterine necks to the mesh so that the mesh supports these organs rather than vice versa (fig. 3,A to B).The bladder and cervix lie on this physiological level (fig. 3). The vaginal edges are trimmed and sutured with 2-zero polyglycolic acid. Care must be taken not to reduce the vaginal wall excessively, on the contrary redundance is preferred. A fundamental issue is how tautly to pull the mesh. The mesh must be stretched between the lateral and the anteroposterior anchoring points without forming folds or being too lax. In practice it must lie flat as if it were suspended on a plane. Before sufficient experience was gained with this technique the mesh was used to suspend the pelvic organs using a vagino-abdominal approach. This method was used in 4 patients not included in this series, whose previous operations had resulted in dense pelvic fibrosis, and proceeding blindly with a vaginal approach might have proved risky. A small complementary abdominal incision was made t o suture the lateral wings of the mesh, which proved to be overly cautious, and a vaginal approach alone was used in future cases. The lateral extremities of the mesh can also be fixed with prolene sutures passed through the skin to the abdominal rectus muscles in the same system adopted for bladder neck suspension.8-10 In cases in which the uterus has been removed the anterior vaginal wall is incised from the bladder neck to the hysterectomy scar to which the posterior edge of the mesh is attached with stitches that do not fully penetrate the vaginal wall. An enterocele must be included in the vaginal incision and sectioned, the hole in the peritoneum must be closed and the mesh must cover the aperture. Then the mesh must be sutured t o the enterocele edges and the vaginal wall must be sutured to the mesh, again with stitches that do not fully penetrate the vaginal wall. If enterocele coexists with the uterus 2 incisions are made, including 1in the anterior vaginal wall from the bladder neck to the anterior edge of the uterine neck, and 1from the posterior edge of the uterine neck to the enterocele. The enterocele is sectioned, the peritoneum is sutured, another piece of mesh is inserted between the peritoneum and vagina as for a hernia repair (enterocele can be intussuscepted instead of sectioned in either case) and the vagina is closed. Patients. From January 1996 through June 1997 this technique was used in 44 patients 43 to 86 years old (mean age
NEW OPERATION FOR GENITOURINARY PROLAPSE
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64.8). Preoperative analysis of all patients included cystogra- der descensus (fig. 4). All 10 patients with vaginal vault phy, video urodynamics, and pelvic and abdominal echography. prolapse were cured as were the 14 patients with first and Cystocele and incontinence were classified according to the second degree uterine prolapse. The result was a partial SEAPI QMM scales,ll whereas the uterine or vaginal vault success in 3 of the 6 patients with third degree uterine prolapse, rectocele and enterocele were evaluated according to prolapse. Although the cystocele was cured first degree prothe Beecham classification.12 lapse recurred a t 3 months postoperatively. Of the 44 patients 29 complained of various degrees of type At present no patient has pelvic fibrosis or hydroureteroI or I1 incontinence,13 12 had a cystocele and the others had nephrosis. Of those who are sexually active all but 1 with combinations of various degrees of cystocele, uterine or vag- vaginal erosion report no difficulty in sexual relations. The 6 inal vault prolapse, rectocele and/or enterocele (see table). premenopausal patients report no alteration of normal menOne patient had been operated on unsuccessfully for incon- ses. In 1 patient operated on 15 months ago third degree tinence with another technique, 11 had undergone hysterec- rectocele developed and now requires surgery. The patients tomy (5 abdominal, 6 vaginal) and 1 had undergone cervical were evaluated before and after the operation by the suramputation. The 4 patients with enterocele, including 3 with geons, which allowed verbal rather than written questioning second or third degree vaginal vault prolapse and 1 with second regarding status. The next series of patients will be evaludegree uterine prolapse were operated on using the previ- ated with a preoperative and postoperative score system ously described technique. Only 1 rectocele patient was op- obtained from questioning the surgeons and others not dierated on for this disorder simultaneously. Followup ranged rectly involved with the operation. from 9 to 23 months (median 13.9). DISCUSSION
RESULTS
Average hospital stay was 4 days but in theory stay could be reduced to 24 hours. The bladder catheter was removed on postoperative day 3. No patient had urinary retention requiring catheterization, blood transfusions were not required and no vaginal suppuration was confirmed. During postoperative month 1, 3 patients complained of urge incontinence, which resolved after 3 months. No patient had a post-void residual of more than 60 cc. Urgency and frequency were confirmed in postoperative month 1 in all patients but after 2 months these symptoms were considerably reduced. After 3 months 4 patients still complained of urgency without incontinence and 3 affected by obstructive cystocele had voiding frequency (about every 2 hours). All 7 of these patients were older than 70 years. Patients affected by urge incontinence were excluded from this study. However, some of the older patients with obstructive cystocele and possibly with latent urge incontinence manifested modest urge incontinence after the operation but these symptoms were not prevalent. One patient manifested erosion of the vaginal wall about as large as a quarter. Vaginal reduction had been considerable and the vagina had been sutured under tension. The section of mesh that had protruded into the vagina was removed at a n outpatient visit. Mesh function was not compromised and prolapse has not recurred. Erosion of the mucous membrane of the vagina healed but to date the husband and wife complain of pain during intercourse. All patients affected by some degree of incontinence were cured. Cure is defined as patient satisfaction with the results of the operation and requirement of absorbent pads. In postoperative month 1, 18 patients used absorbent pads but this number decreased to 6 who used 1 to 2 mini pads a day at 2 months. Some patients change a pad as soon as it is moist while others wait until it is completely wet. Also some patients use a pad for psychological reasons acknowledging that they have no real need. Patients were followed every 3 months in postoperative year 1 and at 6 months in year 2. Every 6 months abdominal and pelvic echography, cystography and urodynamics were performed. At followup there were no recurrent cystoceles and cystography demonstrated excellent repair of the blad-
Pathological Condition Cystocele Uterine prolapse Vaginal vault prolapse Rectocele Enterocele Incontinence
Degree 1 7 2 15
16
Degree 2 14 12 4 8 2 9
Degree 3 ~~
23
6
6 1 2 4
The goal of this technique is to create a support for organs in the anterior area of the pelvis with a hammock of polypropylene. The hammock is disposed transverse and fixed bilaterally to the arcus tendineus of the endopelvic fascia. The bladder neck is connected to the anterior margin of the hammock and the uterine cervix is sutured to its posterior margin so that the cystocele lies on it completely. Because the mesh is as large as the cystocele and anchored to the pubic bone insertions of the arcus tendineus of the levator ani, which are relatively fixed structures, there is no difference in treating distention (central defect) or displacement (lateral defect) cystocele. Although there has been no cystocele recurrence it is not possible to exclude deterioration of the arcus tendineus with time, especially in obese patients. However, the fibrosis induced by the mesh should reinforce the pelvic structures. Thus, with the pelvic organs firmly attached to the mesh, which in turn is strongly anchored to the arcus tendineus of the endopelvic fascia, correct statics for the pelvic viscera are reestablished. Recovery of the continence mechanism is due to the reestablishment of the correct anatomical position of the bladder, bladder neck and proximal urethra, as demonstrated on postoperative cystography, with abolition of the defects of transmission. The mesh should work to create a broad sling under the bladder neck and under the entire cystocele. The stitches on the anterior and posterior edges of the mesh fix the bladder and uterine necks to the mesh and not vice versa. In contrast to the pubovaginal sling, with this new broad sling the risk of overly compressing the bladder neck is avoided. In fact the mesh, which is taut between the levator ani muscles, raises the bladder and bladder neck no higher than the correct anatomical position. Postoperative urinary retention has not been observed because the urethra is never touched and it is impossible for the mesh anchored at the insertion of the endopelvic fascia to be pulled beyond this physiological level, which is the original bladder height. The posterior bladder wall rests normally on the front vaginal wall without any connection to it. The laxus connective tissue lying between these 2 organs is slippery, which explains why no surgical technique that blocks the vagina alone can prevent the formation or incrementation of a preexisting cystocele. This technique creates a fixed support plane for the bladder and on this support a definitive fibrosis develops, which impedes slippage. An aspect of this technique that remains to be clarified is the evolution of the fibrosis. Although no ureterohydronephrosis or any other significant complication has occurred to date, longer followup is required. Erosion provoked by the mesh could occur even after a year but would probably be preceded by prodromal symptoms, such as frequency, bum-
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NEW OPERATION FOR GENITOURINARY PROLAPSE
FIG.4. Preoperative (A, B ) and 6 months postoperative (C, D)cystograms of third degree cystocele. A, preoperative frontal view. B , preoperative lateral view during Valsalva maneuver. C , 6 month postoperative orthostatic frontal view during Valsalva maneuver. D ,6 month postoperative lateral projections. Arrows indicate mesh position.
ing, pain, hematuria and so forth. If the theoretical basis of the operation is correct, then bladder erosion would be due only to a technical mistake, such as a fold in the mesh, an excessively deep stitch and so forth, and not to exaggerated tension on the bladder, which is the most frequent cause of bladder neck and urethral erosion. If the mesh is taut without folds or sharp corners erosion should not occur. In this series there was 1 case of erosion due to stressed vaginal wall. To avoid any bladder erosion, in addition to suspending the mesh without creases or irregular protrusions, we place the cellular tissue lying between the vagina and bladder between the bladder and mesh. However, this empirical hy-
pothesis should be verified by comparing 1group of patients with to 1group without the cellular buffer tissue between the bladder and mesh. If the uterus is healthy hysterectomy should be avoided even if there is a high degree of uterine prolapse. Prolapse of the uterus is the consequence and not the cause of anatomical alteration of the pelvic floor. Therefore, hysterectomy is useless especially if the pelvic floor is not repaired. If hysterectomy is superfluous, then any risk it represents, even if remote, is unacceptable (bladder dennervation, vesicovaginal or ureterovaginal fistulas, hemorrhage, and so forth). All pelvic organs are indirectly
NEW OPERATION FOR GENITOURINARY PROLAPSE
linked to the uterus and, therefore, its removal creates a predisposition for a complex alteration of pelvic statics. Removal of the uterus is equivalent to depriving the pelvic organs of the principal means of junction. When the causes that provoked uterine prolapse endure after hysterectomy it is not rare t o confirm vaginal vault prolapse, cystocele, rectocele and enterocele. If the cervix is sutured to the posterior edge of the mesh, even if the support of the uterosacral ligaments is weakened, the uterus cannot fall because i t is attached to the mesh. In the 3 cases of uterine prolapse recurrence the cystocele was cured. This recurrence was probably due to failure of the stitches between the cervix and posterior edge of the mesh. Therefore, the posterior sutures of the mesh have been modified for cases of third degree uterine prolapse. Vaginal vault prolapse can be treated by suturing the posterior edge of the mesh to the vaginal vault instead of the cervix. The mesh furnishes the principal support for the pelvic organs and absorbs all of the forces that tend to make those organs protrude, just as the mesh used in abdominal hernia surgery. Although rectocele coexisted often with the other anterior defects in these patients, only 1 case required repair. Usually rectocele causes little disturbance and rarely requires surgery. Generally gastrointestinal symptoms are better tolerated than urinary symptoms and, while patients complain about voiding disturbances, they need t o be asked about gastrointestinal symptomatology. Any patient who demonstrated some degree of rectocele was asked about constipation and other rectocele symptoms. Recently, we operated on one of the first patients in the series who presented with a symptomatic rectocele. Rectocele repair during prolapse surgery can result in a reduction in vaginal dimension as to impede sexual relations, and this must be discussed with the patient before surgery. Type I or I1 incontinence is cured by suspension of the bladder neck and urethra due to the higher level of the urethra by the 2 superior anchoring stitches attached to the arcus tendineus of the endopelvic fascia. No infections have occurred, which may be due to the fact that the open fabric of the mesh prevents exudates from accumulating and suppurating. Reexplorations have not been performed but may be difficult because of the fibrosis. Iatrogenic lesions of the ureters can be avoided by sectioning the tissues near the pubic branches and not near the bladder. This technique is particularly suited for patients with serious cystocele and/or genital prolapse. The greater the degree of prolapse, the larger the vagina and the easier it is to maneuver when performing the operation.
745
CONC1,IJSIONS
These preliminary results are encouraging even if median followup is only 13.9months (range 23 to 9).Nonetheless, the majority of recurrence after prolapse surgery results in first few postoperative months.14 This operation is remarkably simple technically and easy to perform. The vaginal approach minimizes surgical trauma and hospitalization is reduced to a minimum. Application of this procedure is broad and includes cystocele, genitourinary prolapse and vaginal vault prolapse, all with or without incontinence. If these preliminary results are confirmed in the future, the mesh used according to this technique could become for vaginal hernia what it already is for inguinal hernia. REFERENCES
1. Hilton, P. and Stanton, S. L.: Clinical and urodynamic evaluation of the polypropylene (Marlex) sling for genuine stress incontinence. Neurourol. Urodynam., 2 145. 1983. 2. Morgan, J. E., Farrow, G. A. and Stewart, F. E.: The Marlex sling operation for the treatment of recurrent stress urinary incontinence: a 16-year review. Amer. J. Obst. Gynec., 151: 224, 1985. 3. Moore, J., Armstrong, J. T. and Wills, S. H.: The use of tantalum mesh in cystocele with critical report of ten cases. Amer. J. Obst. Gynec., 69 1127, 1955. 4. Friedman, E. A. and Meltzer, R. M.: Collagen mesh prosthesis for repair of endopelvic fascia1 defect. Amer. J. Obst. Gynec.. 106: 430, 1970. 5. Bums, P. A,, F’ranikoff, K.. Nochajski, T., Desotelle, P. and Harwood. M. K.: Treatment of stress incontinence with pelvic floor exercises and biofeedback. J. h e r . Geriat. Soc., 38: 341, 1990. 6. ODonnell, P. D. and Doyle, R.: Biofeedback therapy technique for treatment of urinary incontinence. Urology, 37: 432, 1991. 7. Blaivas, J. G.: Pubovaginal sling. In: Female Urology. Edited by E. D. Kursh and E. J. McGuire. Philadelphia: J. B. Lippincott Co., chapt. 17, pp. 239-250, 1994. 8. Pereyra, A. J.:A simplified procedure for the correction of stress incontinence in women. West. J. Surg., 67: 223, 1959. 9. Raz, S.: Modified bladder neck suspension for female stress incontinence. Urology, 17: 82, 1981. 10. Stamey, T. A,: Endoscopic suspension of the vesical neck for urinary incontinence. Surg. Gynec. & Obst., 136 547, 1973. 11. Raz, S. and Erickson, D. R.: SEAPI QMM incontinence classification system. Neurourol. Urodynam., 11: 187, 1992. 12. Beecham, C. T.: Classification of vaginal relaxation. Amer. J. Obst. Gynec., 136 957, 1980. 13. Blaivas, J. G. and Olsson, C. A.: Stress incontinence: classification and surgical approach. J. Urol., 139 727. 1988. 14. Raz, S., Sussman, E. M., Erickson, D. B., Bregg, K. J. and Nitti, V. W.: The Raz bladder neck suspension: results in 206 patients. J. Urol., 148. 845, 1992.
THE JOIXSAI.OF UROLOGY
Val 160. 741-745. September 1998 Printed in U S.A.
Copyright 0 1998 by AMERICAN UROLOOICAL &SOCIATION, INC
A NEW OPERATION FOR GENITOURINARY PROLAPSE GIULIO NICITA From the Clinica Urologica II, Uniuersita’ degli Studi di Firenze, Florence, Italy
ABSTRACT
Purpose: A new method to support female prolapsed pelvic organs is presented, which involves use of nonabsorbable mesh c u t in a hammock shape. The approach is transvaginal a n d the novelties are the way in which the m e s h is anchored and its considerable size. Materials a n d Methods: The m e s h is anchored transversally between the 2 arcus tendineus of the endopelvic fascia a n d in the anteroposterior direction between the bladder and uterine necks. The anteroposterior dimension of the m e s h m u s t completely cover t h e cystocele. From J a n u a r y 1996 to June 1997 this technique w a s used in 44 patients ranging in age from 43 to 86 years. The patients presented with various degrees of incontinence and combinations of cystocele, uterine or vaginal vault prolapse, rectocele a n d o r enterocele. Cystocele and incontinence were classified according to the SEAPI QMM scales a n d the other anatomical defects according t o the Beecham classification. Preoperative analysis of all patients included cystography, video urodynamics, a n d pelvic a n d abdominal echography. Results: All patients affected by some degree of incontinence were cured. Patients with prolapse without incontinence were completely satisfied with the operation. Uterine prolapse w a s third degree in 6 of 20 patients and it partially recurred in 3. Cystography in all patients demonstrated excellent repair of the descensus. Sexual life a n d menses did not change, a n d no pelvic fibrosis o r hydroureteronephrosis occurred. Followup ranges from 9 to 2 3 months (median
13.9). Conclusions: This technique has broad application and is simple to perform. Longer followup will prove its merits definitively. KEYWORDS:urinary incontinence, prolapse urination disorders, stress A The existence of numerous surgical techniques for treating genitourinary prolapse and incontinence proves that none of them is completely satisfactory. No matter which approach is used, most have the common goal to replace the descended organs in the abdominal cavity. The frequency with which new operations are proposed is confirmation of the need for better solutions than those presently adopted. A transvaginal operation is described for reconstructing a support for the pelvic viscera made of polypropylene mesh. The theoretical presupposition is that the primary cause of prolapsed pelvic viscera and consequent physiopathological alterations, for example incontinence, is diastasis of the levator ani muscles and connective tissue that connects them to the lateral walls of the vagina. The majority of current FIG.1. Shape of mesh. A, anterior edge. B , posterior edge. C and procedures of prolapse surgery fail because the method used D, lateral wings. Distance between A and B is equal to anteroposteto replace the descended organs in the pelvic cavity counter- nor dimension of cystocele. act the effect but not the underlying cause of the prolapse, which is levator ani muscle diastasis. Therefore, analogous to what occurs in hernia surgery when the herniated viscera are first degree incontinence can be treated successfully with retracted without closing the hernia aperture, recurrence is pelvic rehabilitation exercises.s.6 likely. With this new technique prolapse is corrected by returning MATERIALS AND METHODS the viscera to their correct anatomical seat and using a Surgical technique. The patient is placed on the operating polypropylene mesh support to substitute for the compro- table as for a vaginal approach. The field is prepared and the mised levator ani muscle function. Polypropylene mesh has anteroposterior dimension of the cystocele (the distance bebeen used previously in the treatment of female inconti- tween the uterine and bladder necks) is measured with a nence.1.2 The novelties3.4 of the technique are the way in sterile ruler, which determines the size of the anteroposterior which the mesh is anchored and its considerable size. The polypropylene mesh (fig. l , A to B ) .The transverse dimension mesh is taut and anchored transversally between the 2 arcus is determined and the mesh is cut to size (average meastendineus of the endopelvic fascia and in the anteroposterior urement 10 cm.) (fig. 1, C to D).A 16Ch Foley catheter is direction between the bladder and uterine necks (fig. 1).This introduced into the bladder and the front wall of the vagina technique is appropriate for cystocele and/or second or third is incised from the bladder neck to the uterine neck (fig. 2). degree prolapse repair. First degree cystocele associated with The vaginal wall is separated from the flaccid cellular tissue, improperly called the perivesical or perivaginal fascia, which Accepted for publication April 17, 1998.
741
742
NEW OPERATION FOR GENITOURINARY PROLAPSE
FIG.2. Schematic of incision from bladder neck to cervix (0.V, vagina.
lies between the bladder and vagina, and which will be used as a buffer between the mesh and the pericystium. A Scott retractor is positioned in this vaginal incision, and the bladder is separated from the cervix and pushed upward. The cystocele must be completely freed bilaterally. The following steps must be performed on each side. The space lateral to the bladder neck is penetrated with the tip of a finger to reach the inferior branch of the pubic bone. As pressure is exerted with the finger medial on the bladder (to avoid lesions), the tip of a Metzenbaum scissors is inserted along the path of the finger until it reaches the pubic bone. A 3 to 4 cm. opening is cut in the arcus tendineus of the endopelvic fascia t o gain access to the pelvic cavity. The opening, analogous to that made in bladder neck suspension surgery, must allow for easy insertion of the index finger but it does not reach the ischial spine, which is posterior and inferior to the incision. A 3-zero prolene suture is placed at each end of each incision. The obturator fossa can be palpated dorsally and below but it is 1 to 2 cm. from the location of the sutures. Thus 4 lateral sutures are placed securely in the arcus tendineus of the endopelvic fascia. They are not tied but are held with a Kelly clamp. The lateral edges of the mesh will be fxed later t o these 4 sutures. With respect to the horizontal position of the patient, the 2 upper sutures of the lateral lie on a vertical transverse plane about 1 cm. above a parallel plane corresponding to the bladder neck (fig. 3, C to D).The polypropylene mesh is cut in a hammock-like shape (fig. 1). The central part of the mesh is fixed to the uterine cervix with 3, 3-zero polyglycolic acid sutures (fig. 3, B). If hysterectomy has been performed previously, the posterior edge of the bladder is fixed to the hysterectomy scar without isolating the uterosacral ligaments, which are presumed to be encompassed in the scar tissue. The lateral wings of the mesh are introduced through the holes of the arcus tendineus of the endopelvic fascia and they are pulled tight. The 4, 3-Zero prolene sutures previously inserted in the arcus tendineus are passed through the mesh near the junctures of the lateral wings and left untied. The anterior edge of the net is cut precisely to fit the bladder neck to which it is sutured with 3, 3-Zero polyglycolic acid stitches (fig. 1,A). The Scott retractor is removed before knotting the 4 prolene stitches to avoid counteracting the elevating action of the net. After the 4 sutures are tied the mesh is taut a t the level of the levator ani muscle. The mesh pulled taut between the lateral sutures raises the bladder neck toward the head, functioning like a broad sling,7 which is the key to resolving incontinence if it exists. The main support system for the mesh consists of the 4 lateral sutures (fig. 3, C to D),each of
FIG. 3. Schematic of vagina with mesh in situ. Stitch A fixes mesh to bladder neck, stitch B to cervix, and stitches C and D to openings through pubic bone insertions of arcus tendineus of endopelvic fascia.
which anchors the mesh to 1 of the 2 ends of each incision, thus leaving 2 stitches on the left and 2 on the right sides. The other stitches on the anterior and posterior edges of the mesh anchor the bladder and uterine necks to the mesh so that the mesh supports these organs rather than vice versa (fig. 3,A to B).The bladder and cervix lie on this physiological level (fig. 3). The vaginal edges are trimmed and sutured with 2-zero polyglycolic acid. Care must be taken not to reduce the vaginal wall excessively, on the contrary redundance is preferred. A fundamental issue is how tautly to pull the mesh. The mesh must be stretched between the lateral and the anteroposterior anchoring points without forming folds or being too lax. In practice it must lie flat as if it were suspended on a plane. Before sufficient experience was gained with this technique the mesh was used to suspend the pelvic organs using a vagino-abdominal approach. This method was used in 4 patients not included in this series, whose previous operations had resulted in dense pelvic fibrosis, and proceeding blindly with a vaginal approach might have proved risky. A small complementary abdominal incision was made t o suture the lateral wings of the mesh, which proved to be overly cautious, and a vaginal approach alone was used in future cases. The lateral extremities of the mesh can also be fixed with prolene sutures passed through the skin to the abdominal rectus muscles in the same system adopted for bladder neck suspension.8-10 In cases in which the uterus has been removed the anterior vaginal wall is incised from the bladder neck to the hysterectomy scar to which the posterior edge of the mesh is attached with stitches that do not fully penetrate the vaginal wall. An enterocele must be included in the vaginal incision and sectioned, the hole in the peritoneum must be closed and the mesh must cover the aperture. Then the mesh must be sutured t o the enterocele edges and the vaginal wall must be sutured to the mesh, again with stitches that do not fully penetrate the vaginal wall. If enterocele coexists with the uterus 2 incisions are made, including 1in the anterior vaginal wall from the bladder neck to the anterior edge of the uterine neck, and 1from the posterior edge of the uterine neck to the enterocele. The enterocele is sectioned, the peritoneum is sutured, another piece of mesh is inserted between the peritoneum and vagina as for a hernia repair (enterocele can be intussuscepted instead of sectioned in either case) and the vagina is closed. Patients. From January 1996 through June 1997 this technique was used in 44 patients 43 to 86 years old (mean age
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743
64.8). Preoperative analysis of all patients included cystogra- der descensus (fig. 4). All 10 patients with vaginal vault phy, video urodynamics, and pelvic and abdominal echography. prolapse were cured as were the 14 patients with first and Cystocele and incontinence were classified according to the second degree uterine prolapse. The result was a partial SEAPI QMM scales,ll whereas the uterine or vaginal vault success in 3 of the 6 patients with third degree uterine prolapse, rectocele and enterocele were evaluated according to prolapse. Although the cystocele was cured first degree prothe Beecham classification.12 lapse recurred a t 3 months postoperatively. Of the 44 patients 29 complained of various degrees of type At present no patient has pelvic fibrosis or hydroureteroI or I1 incontinence,13 12 had a cystocele and the others had nephrosis. Of those who are sexually active all but 1 with combinations of various degrees of cystocele, uterine or vag- vaginal erosion report no difficulty in sexual relations. The 6 inal vault prolapse, rectocele and/or enterocele (see table). premenopausal patients report no alteration of normal menOne patient had been operated on unsuccessfully for incon- ses. In 1 patient operated on 15 months ago third degree tinence with another technique, 11 had undergone hysterec- rectocele developed and now requires surgery. The patients tomy (5 abdominal, 6 vaginal) and 1 had undergone cervical were evaluated before and after the operation by the suramputation. The 4 patients with enterocele, including 3 with geons, which allowed verbal rather than written questioning second or third degree vaginal vault prolapse and 1 with second regarding status. The next series of patients will be evaludegree uterine prolapse were operated on using the previ- ated with a preoperative and postoperative score system ously described technique. Only 1 rectocele patient was op- obtained from questioning the surgeons and others not dierated on for this disorder simultaneously. Followup ranged rectly involved with the operation. from 9 to 23 months (median 13.9). DISCUSSION
RESULTS
Average hospital stay was 4 days but in theory stay could be reduced to 24 hours. The bladder catheter was removed on postoperative day 3. No patient had urinary retention requiring catheterization, blood transfusions were not required and no vaginal suppuration was confirmed. During postoperative month 1, 3 patients complained of urge incontinence, which resolved after 3 months. No patient had a post-void residual of more than 60 cc. Urgency and frequency were confirmed in postoperative month 1 in all patients but after 2 months these symptoms were considerably reduced. After 3 months 4 patients still complained of urgency without incontinence and 3 affected by obstructive cystocele had voiding frequency (about every 2 hours). All 7 of these patients were older than 70 years. Patients affected by urge incontinence were excluded from this study. However, some of the older patients with obstructive cystocele and possibly with latent urge incontinence manifested modest urge incontinence after the operation but these symptoms were not prevalent. One patient manifested erosion of the vaginal wall about as large as a quarter. Vaginal reduction had been considerable and the vagina had been sutured under tension. The section of mesh that had protruded into the vagina was removed at a n outpatient visit. Mesh function was not compromised and prolapse has not recurred. Erosion of the mucous membrane of the vagina healed but to date the husband and wife complain of pain during intercourse. All patients affected by some degree of incontinence were cured. Cure is defined as patient satisfaction with the results of the operation and requirement of absorbent pads. In postoperative month 1, 18 patients used absorbent pads but this number decreased to 6 who used 1 to 2 mini pads a day at 2 months. Some patients change a pad as soon as it is moist while others wait until it is completely wet. Also some patients use a pad for psychological reasons acknowledging that they have no real need. Patients were followed every 3 months in postoperative year 1 and at 6 months in year 2. Every 6 months abdominal and pelvic echography, cystography and urodynamics were performed. At followup there were no recurrent cystoceles and cystography demonstrated excellent repair of the blad-
Pathological Condition Cystocele Uterine prolapse Vaginal vault prolapse Rectocele Enterocele Incontinence
Degree 1 7 2 15
16
Degree 2 14 12 4 8 2 9
Degree 3 ~~
23
6
6 1 2 4
The goal of this technique is to create a support for organs in the anterior area of the pelvis with a hammock of polypropylene. The hammock is disposed transverse and fixed bilaterally to the arcus tendineus of the endopelvic fascia. The bladder neck is connected to the anterior margin of the hammock and the uterine cervix is sutured to its posterior margin so that the cystocele lies on it completely. Because the mesh is as large as the cystocele and anchored to the pubic bone insertions of the arcus tendineus of the levator ani, which are relatively fixed structures, there is no difference in treating distention (central defect) or displacement (lateral defect) cystocele. Although there has been no cystocele recurrence it is not possible to exclude deterioration of the arcus tendineus with time, especially in obese patients. However, the fibrosis induced by the mesh should reinforce the pelvic structures. Thus, with the pelvic organs firmly attached to the mesh, which in turn is strongly anchored to the arcus tendineus of the endopelvic fascia, correct statics for the pelvic viscera are reestablished. Recovery of the continence mechanism is due to the reestablishment of the correct anatomical position of the bladder, bladder neck and proximal urethra, as demonstrated on postoperative cystography, with abolition of the defects of transmission. The mesh should work to create a broad sling under the bladder neck and under the entire cystocele. The stitches on the anterior and posterior edges of the mesh fix the bladder and uterine necks to the mesh and not vice versa. In contrast to the pubovaginal sling, with this new broad sling the risk of overly compressing the bladder neck is avoided. In fact the mesh, which is taut between the levator ani muscles, raises the bladder and bladder neck no higher than the correct anatomical position. Postoperative urinary retention has not been observed because the urethra is never touched and it is impossible for the mesh anchored at the insertion of the endopelvic fascia to be pulled beyond this physiological level, which is the original bladder height. The posterior bladder wall rests normally on the front vaginal wall without any connection to it. The laxus connective tissue lying between these 2 organs is slippery, which explains why no surgical technique that blocks the vagina alone can prevent the formation or incrementation of a preexisting cystocele. This technique creates a fixed support plane for the bladder and on this support a definitive fibrosis develops, which impedes slippage. An aspect of this technique that remains to be clarified is the evolution of the fibrosis. Although no ureterohydronephrosis or any other significant complication has occurred to date, longer followup is required. Erosion provoked by the mesh could occur even after a year but would probably be preceded by prodromal symptoms, such as frequency, bum-
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FIG.4. Preoperative (A, B ) and 6 months postoperative (C, D)cystograms of third degree cystocele. A, preoperative frontal view. B , preoperative lateral view during Valsalva maneuver. C , 6 month postoperative orthostatic frontal view during Valsalva maneuver. D ,6 month postoperative lateral projections. Arrows indicate mesh position.
ing, pain, hematuria and so forth. If the theoretical basis of the operation is correct, then bladder erosion would be due only to a technical mistake, such as a fold in the mesh, an excessively deep stitch and so forth, and not to exaggerated tension on the bladder, which is the most frequent cause of bladder neck and urethral erosion. If the mesh is taut without folds or sharp corners erosion should not occur. In this series there was 1 case of erosion due to stressed vaginal wall. To avoid any bladder erosion, in addition to suspending the mesh without creases or irregular protrusions, we place the cellular tissue lying between the vagina and bladder between the bladder and mesh. However, this empirical hy-
pothesis should be verified by comparing 1group of patients with to 1group without the cellular buffer tissue between the bladder and mesh. If the uterus is healthy hysterectomy should be avoided even if there is a high degree of uterine prolapse. Prolapse of the uterus is the consequence and not the cause of anatomical alteration of the pelvic floor. Therefore, hysterectomy is useless especially if the pelvic floor is not repaired. If hysterectomy is superfluous, then any risk it represents, even if remote, is unacceptable (bladder dennervation, vesicovaginal or ureterovaginal fistulas, hemorrhage, and so forth). All pelvic organs are indirectly
NEW OPERATION FOR GENITOURINARY PROLAPSE
linked to the uterus and, therefore, its removal creates a predisposition for a complex alteration of pelvic statics. Removal of the uterus is equivalent to depriving the pelvic organs of the principal means of junction. When the causes that provoked uterine prolapse endure after hysterectomy it is not rare t o confirm vaginal vault prolapse, cystocele, rectocele and enterocele. If the cervix is sutured to the posterior edge of the mesh, even if the support of the uterosacral ligaments is weakened, the uterus cannot fall because i t is attached to the mesh. In the 3 cases of uterine prolapse recurrence the cystocele was cured. This recurrence was probably due to failure of the stitches between the cervix and posterior edge of the mesh. Therefore, the posterior sutures of the mesh have been modified for cases of third degree uterine prolapse. Vaginal vault prolapse can be treated by suturing the posterior edge of the mesh to the vaginal vault instead of the cervix. The mesh furnishes the principal support for the pelvic organs and absorbs all of the forces that tend to make those organs protrude, just as the mesh used in abdominal hernia surgery. Although rectocele coexisted often with the other anterior defects in these patients, only 1 case required repair. Usually rectocele causes little disturbance and rarely requires surgery. Generally gastrointestinal symptoms are better tolerated than urinary symptoms and, while patients complain about voiding disturbances, they need t o be asked about gastrointestinal symptomatology. Any patient who demonstrated some degree of rectocele was asked about constipation and other rectocele symptoms. Recently, we operated on one of the first patients in the series who presented with a symptomatic rectocele. Rectocele repair during prolapse surgery can result in a reduction in vaginal dimension as to impede sexual relations, and this must be discussed with the patient before surgery. Type I or I1 incontinence is cured by suspension of the bladder neck and urethra due to the higher level of the urethra by the 2 superior anchoring stitches attached to the arcus tendineus of the endopelvic fascia. No infections have occurred, which may be due to the fact that the open fabric of the mesh prevents exudates from accumulating and suppurating. Reexplorations have not been performed but may be difficult because of the fibrosis. Iatrogenic lesions of the ureters can be avoided by sectioning the tissues near the pubic branches and not near the bladder. This technique is particularly suited for patients with serious cystocele and/or genital prolapse. The greater the degree of prolapse, the larger the vagina and the easier it is to maneuver when performing the operation.
745
CONC1,IJSIONS
These preliminary results are encouraging even if median followup is only 13.9months (range 23 to 9).Nonetheless, the majority of recurrence after prolapse surgery results in first few postoperative months.14 This operation is remarkably simple technically and easy to perform. The vaginal approach minimizes surgical trauma and hospitalization is reduced to a minimum. Application of this procedure is broad and includes cystocele, genitourinary prolapse and vaginal vault prolapse, all with or without incontinence. If these preliminary results are confirmed in the future, the mesh used according to this technique could become for vaginal hernia what it already is for inguinal hernia. REFERENCES
1. Hilton, P. and Stanton, S. L.: Clinical and urodynamic evaluation of the polypropylene (Marlex) sling for genuine stress incontinence. Neurourol. Urodynam., 2 145. 1983. 2. Morgan, J. E., Farrow, G. A. and Stewart, F. E.: The Marlex sling operation for the treatment of recurrent stress urinary incontinence: a 16-year review. Amer. J. Obst. Gynec., 151: 224, 1985. 3. Moore, J., Armstrong, J. T. and Wills, S. H.: The use of tantalum mesh in cystocele with critical report of ten cases. Amer. J. Obst. Gynec., 69 1127, 1955. 4. Friedman, E. A. and Meltzer, R. M.: Collagen mesh prosthesis for repair of endopelvic fascia1 defect. Amer. J. Obst. Gynec.. 106: 430, 1970. 5. Bums, P. A,, F’ranikoff, K.. Nochajski, T., Desotelle, P. and Harwood. M. K.: Treatment of stress incontinence with pelvic floor exercises and biofeedback. J. h e r . Geriat. Soc., 38: 341, 1990. 6. ODonnell, P. D. and Doyle, R.: Biofeedback therapy technique for treatment of urinary incontinence. Urology, 37: 432, 1991. 7. Blaivas, J. G.: Pubovaginal sling. In: Female Urology. Edited by E. D. Kursh and E. J. McGuire. Philadelphia: J. B. Lippincott Co., chapt. 17, pp. 239-250, 1994. 8. Pereyra, A. J.:A simplified procedure for the correction of stress incontinence in women. West. J. Surg., 67: 223, 1959. 9. Raz, S.: Modified bladder neck suspension for female stress incontinence. Urology, 17: 82, 1981. 10. Stamey, T. A,: Endoscopic suspension of the vesical neck for urinary incontinence. Surg. Gynec. & Obst., 136 547, 1973. 11. Raz, S. and Erickson, D. R.: SEAPI QMM incontinence classification system. Neurourol. Urodynam., 11: 187, 1992. 12. Beecham, C. T.: Classification of vaginal relaxation. Amer. J. Obst. Gynec., 136 957, 1980. 13. Blaivas, J. G. and Olsson, C. A.: Stress incontinence: classification and surgical approach. J. Urol., 139 727. 1988. 14. Raz, S., Sussman, E. M., Erickson, D. B., Bregg, K. J. and Nitti, V. W.: The Raz bladder neck suspension: results in 206 patients. J. Urol., 148. 845, 1992.