Female urology: What method will you select?

Abstract

When I was a resident, my leader taught me that the gold standard for patients with stress incontinence is the Marshall–Marchetti–Krantz (MMK) procedure. But a few years later, urologists who could perform advanced techniques showed me needle suspension as the best method at a urological meeting. Fortunately my boss gave me a chance for a hand-to-hand lesson of the stamay procedure by the specialist. Since then, I have been selecting this procedure for a few years. Without doubt, this needle suspension was the gold standard at that time. But now most urologists do not select this technique because of bad results. After I had mastered the technique of tension-free vaginal tape (TVT), I could see the smiling faces of patients after the operation. At that time I believed that TVT would be the gold standard for this condition. But the present status is what you know. Recently most specialists, including myself, believe that using ‘mesh’ is the best operation for patients with pelvic organ prolapse. Is this tendency good for the patients in the long run? No one can predict the results of this procedure more than ten years from now. God knows what procedure will be the gold standard in the future. Assistant Professor Yasuyuki Suzuki md phdDepartment of Urology, Jikei University School of Medicine, Tokyo, JapanEmail: [email protected] Transobturator tape (TOT), which was introduced by Delorme1 in 2001 after the introduction of tension-free vaginal tape (TVT) by Ulmsten in 1996, is also a minimally invasive midurethral sling procedure for stress urinary incontinence (SUI). Although TVT has become one of the most popular continence operations worldwide because of its efficacy, safety, and the low recurrence rate, major complications such as bowel injury and vascular injury have been reported.2 Since those complications can be fatal, TOT has been developed to prevent them. A systematic search of the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience Database (MAUDE), which monitors voluntary reporting of complications of the use of devices in midurethral slings, revealed 33 cases of bowel injury (4.7%), six of them fatal, among 700 major complications following the use of TVT. It also revealed 32 cases of vascular injury, two of them fatal.2 When major complications were defined as bladder perforation, urethral perforation, nerve injury, and sepsis, in addition to bowel injury and vascular injury, they accounted for 20% of the complications of midurethral slings in the MAUDE database. However, according to published reports, major complications of midurethral slings accounted for 5.2% of all complications, and there were no reports of fatalities. In other words, reports of complications have not been made compulsory, and since they are the result of self reports, the complications we were able to learn about from the published reports seem to be the tip of the iceberg in terms of the actual numbers that have occurred. TVT is passed retropubically in a blind manner, whereas TOT is passed via a lateral approach through the obturator foramen on each side to support the midurethra, and because it does not pass through the retropubic space, there is no bowel injury, and there is also very little likelihood of vascular injury or massive bleeding. Since bowel injury cannot always be avoided, with punctures occurring even when great care is taken, the surgeon is subjected to considerable mental stress. Especially in patients with a history of abdominal surgery in whom intestinal adhesions are predicted and in extremely obese patients TOT can be considered the procedure of first choice. The most frequent intraoperative complication of TVT is bladder injury, and the rate is said to be approximately 5%. Because it seldom occurs in TOT,3 intraoperative cystoscopy is unnecessary, and the operation time is definitely shorter. With TOT, on the other hand, vaginal erosion is observed as a postoperative complication in approximately 3% of cases, and it occurs much more frequently than after TVT.3 However, the authors think that vaginal erosion is attributable to accidental punctures of the vaginal wall during surgery, and they think that its incidence can be reduced by strict use of a finger guide when making needle punctures and confirming the lateral sulcus of the vaginal wall during the operation. Another complication, unique to the TOT approach, is postoperative leg pain. It is hypothesized that the etiology of the pain is either subclinical hematoma or transient neuropathic injury. The leg pain responds to anti-inflammatory medication and resolves within a few days of the operation. In addition, voiding dysfunction occurs as a postoperative complication of TVT in 3–8% of cases, and there is no significant difference from Burch colposuspension. Postoperative de novo urgency also occurs in 5–15%, and can be said to occur at almost the same rate as after other sling operations. The development of voiding dysfunction and de novo urgency greatly diminishes patients' degree of satisfaction even when postoperative continence has been achieved, but there are several reports that their incidence is lower after TOT than after TVT.3 The difference appears to be associated with the fact that in TOT the tape lies more horizontally than in TVT, and if voiding difficulty tends not to occur after TOT because the tension exerted during abdominal pressure stress is weaker than afterTVT, there is concern that the results would be poorer. Actually, there is a report that in subjects with a maximum urethral closure pressure (MUCP) of 42 cm or less H2OTOT is nearly six times more likely to fail at 3 months after surgery than TVT,4 and a report that in subjects with a valsalva leak point pressure of 60 cm or less H2O TOT is 12 times more likely to fail,5 and the total cure rate is lower for some intrinsic sphincter deficiency (ISD)-dominant cases. However, it is unknown whether applying TVT to cases of TOT failure would succeed. Thus, if it is a question of achieving the original advantage of being minimally invasive surgery, the first choice is TOT, and we think that it is all right to consider what to do in regard to ISD patients with very low abdominal leak point pressure and/or MUCP.6 Finally, 11-year long-term results of TVT have been reported, but there are still no reports of the long-term results of TOT. However, the short-term results of TOT are said to be about the same as forTVT,3 and similar results were obtained in the prospective multicenter study conducted by the authors.6 We think that it can be assumed that TOT operations carried out with the same concept and the same tape will be followed by a low recurrence rate over time, the same as after TVT operations, and that the long-term results will be a continuation of the short-term results. Hikaru Tomoe mdDepartment of Urology, Tokyo Women's Medical University Medical Center East Tokyo, Japan[email protected] During the past 100 years a variety of surgical procedures have been invented and reported for stress urinary incontinence (SUI). However, the majority of them were abandoned because of poor surgical outcomes and/or severe complications. The tension free vaginal tape (TVT) sling procedure has become a widely accepted surgical treatment for SUI. This bottom-up approach was first described by Ulmsten with the use of TVT made of monofilament macroporous polypropyleme mesh. Since 1995 there have been over 1 400 000 TVT sling procedures carried out world wide.7 The cure rate of between 80% and 95% has been described, with recognized complications including bladder, bowel and major vessel injury as well as postoperative voiding difficulties, de novo urgency and urge incontinence. The Australian national register reported bladder injury in 2.7% in a series of 2795 cases.8 Major vascular and bowel injuries were reported at rates of 0.07 and 0.04%, respectively. The high success rates and low morbidity rates of the TVT procedures have revolutionized the treatment of stress urinary incontinence. In 2001 Delorme described a new method of inserting the tape that passes through the obturator foramen, thus theoretically avoiding some of the complications such as bladder injury.9 Like the TVT, this method is a minimally invasive midurethral sling using a synthetic tape, but is placed using a transobturator approach rather than a retropubic one. The transobturator approach has been advocated because it avoids retropubic passage and, at least in theory, should reduce the risk of bladder, bowel and iliac vessel injury. The transobturator tapes can be inserted from the skin into the vagina (outside-in technique: TOT) or from the vagina out onto the skin over the obturator foramen (tension free vaginal tape inside-out technique: TVTO). In a systemic review and meta-analysis of effectiveness and complications of TOT and/or TVTO in a comparison with TVT published recently,10 11 randomized controlled trials involving 1261 women with SUI were included. Five trials compared TVTO with TVT and six compared TOT with TVT. In each of these trials, no significant difference was found in the subjective continence rates. When compared with TVT, short-term subjective cure of SUI was slightly worse in the TVTO group and equivalent in the TOT group though neither was statistically significant at 2–12 months (odds ratio [OR] 0.85). Bladder injury (OR 0.12) and voiding difficulty (OR 0.55) were less in transobturator tapes. The vaginal injuries/extrusions of the tape were reported to be doubled in the obturator groups (OR 2.08). On subgroup analysis, the extrusion was seen more in the TOT group and less in the TVTO group when compared with TVT. Pain in the groin/thigh was, as expected, significantly higher in obturator tapes especially in TOT compared with TVT (OR 8.28). De-novo frequency and urgency symptoms were equivalent. In a retrospective study in which 241 women underwent procedures with transobturator tapes, four urinary tract injuries were reported (1%), which consisted of two ureteral injuries and two bladder injuries. The transobturator tapes had been believed to have extremely rare complications of bladder injury and ureteral injury; however, these assumptions were false.11 The jury is still out on whether transobturator tapes are better than the TVT procedure. To help resolve the issue of medium-term to longterm effectiveness and complications, clinicians may initiate good quality and adequately powered trials with long-term follow up or participate in ongoing robustly designed multi-center trials. The main issues are sample size and trial methodology. Until sufficient randomized controlled trials with long-term follow up could demonstrate that transobturator tapes are truly equivalent to or superior to TVT, the TVT sling procedure should remain the most reliable method of treatment for SUI. Hideo Ozawa md phdKawasaki Medical School, Kawasaki Hospital Okayama, Japan[email protected] The Marshall-Marchetti-Krantz procedure (MMK) and Burch colposuspension (Burch), reported in 1949 and 1961, respectively, are open retropubic suspension procedures for treating stress urinary incontinence (SUI). These procedures improve SUI by using the vaginal wall to restore the neck of the urinary bladder and proximal urethra to their anatomical positions. However, the tension-free vaginal tape (TVT) and transobturator tape (TOT) sling procedures are now used to treat SUI because of their low invasiveness. These procedures replace the sling operation (including the Stamey procedure) reported by Ulmsten et al. Treating SUI with open retropubic suspension alone is used in few cases. Open retropubic suspension is used when an abdominal surgery is simultaneously carried out and the vaginal capacity is small due to a past medical history and the outcome of transvaginal surgery would be unsatisfactory, (e.g. hysterectomy and surgery for small intestinal prolapse). Open retropubic suspension is indicated for urethral overactivityassociated SUI, but not for intrinsic sphincter disorder (ISD)-associated urinary incontinence. Overactive bladder (OAB) symptoms and descent of the pelvic organs may induce detrusor muscle overactivity. Differentiating the cause of detrusor overactivity is difficult in many cases. OAB may be improved by returning the urinary bladder and urethra to their anatomically correct positions. Using the MMK or Burch procedure alone to correct severe urinary bladder prolapse is difficult. Therefore, these procedures are not indicated for SUI with severe OAB symptoms (i.e. mixed-type urinary incontinence). The short- and long-term outcomes for urinary incontinence treated by the MMK and Burch procedures are favorable. In a meta-analysis reported by Jarvis et al.,12 the MMK procedure achieved subjective continence in 88.2% of patients in a 1- to 72-month follow-up period and objective continence in 89.6% of patients in a 3- to 12-month follow-up period. The Burch procedure achieved subjective continence in 91% of patients in a 3- to 72-month follow-up period and objective continence in 84% of patients in a 1- to 60-month follow-up period. Long-term follow-up shows that urinary incontinence worsens with both the MMK and Burch procedures, and the aggravation rate is greater in patients treated with the MMK procedure. In regards to the MMK, Clemens et al.13 noted that subjective cure or improvement in SUI and urge urinary incontinence occurred in only 41% of patients who had been followed-up for a mean period of 17 years. In regard to the Burch procedure, Alcalay and colleagues14 noted a subjective and objective SUI cure rate of 69% with a mean follow-up period of 13.8 years. Characteristic complications of retropubic suspension include dysuria (due to overcorrection of the urethrovesical angle), de novo urgency, and vaginal prolapse. The incidence of dysuria persisting for 4 weeks or longer following the MMK or Burch procedure is 4% to 22%.15 Postoperative vaginal prolapse is problematic and, in many cases, treated with the Burch procedure. In the Burch procedure, the posterior vaginal wall becomes weakened because of the strengthening of the lateral wall, which readily causes an enterocele.16 Open suspension of the neck of the urinary bladder is currently not the first choice of surgery for SUI. However, this procedure may be necessary in some cases. Surgeons should fully understand not only the procedure, but also when the procedure is indicated for treating SUI. Akihide Hirayama mdDepartment of Urology Nara Medical University Kashihara, Nara, Japan[email protected] Although the suburethral sling has become the so-called ‘gold standard’ for the treatment of stress urinary incontinence (SUI), there are various ways to put a back-board support below the mid-point of the urethra. However, we are still uncertain about the ideal form of the procedure. It has to be emphasized that inserting a suburethral sling with a delivery instrument is a blind procedure and has potential intraoperative risks. The small bowel in the prevesical cavity, the bladder, the external iliac vessels and the obturator nerves and vessels all lie within 2 cm of the track taken by the instrument.17 The tissue fixation system (TFS) is a new universal ‘minisling’ tool introduced by Petros. This system uses a small, soft tissue anchor to fix an 8-mm polypropylene tape into the subpubic tissues. Through a small (about 2-cm) vaginal incision on the mid-urethra, the dissection is carried down just below the pubic bone and the anchor is inserted into the perineal membrane with a special inserting device. The sling is adjusted for tension using a one-way non-slip tightening mechanism at the base of the soft tissue anchoring device. After the insertion of the tape, the vaginal hammock and the external urethral ligament are tightened with sutures as well. We have performed anterior TFS in 18 urodynamically proven SUI patients between 45 and 76 years of age so far since April 2008. In 10 of the 18 cases, concomitant pelvic organ prolapse (POP) repairs were also carried out with TFS. Eight cases without POP underwent only anterior TFS under local anesthesia on an outpatient basis. Mean operating time for anterior TFS was 21.3 min (15–39) and blood loss was the minimum in all cases. Cure rate (subjectively dry and no urine leakage on stress test) at 3 months was 100% (18/18; mean follow-up period, 4.2 months). Sekiguchi18 reported that they performed anterior TFS on 37 genuine stress urinary incontinence patients (15 with intrinsic sphincter deficiency). All patients were discharged within 8 h. Three patients were discharged with an indwelling catheter but passed urine at 48 h. Review at 6 months showed 91% cure rate. The three failed cases responded to a repeat TFS. It is obvious that the potential intraoperative risks seen in retropubic or transobturator suburethral sling procedures can be avoided in anterior TFS. Additional prospective studies are required to verify these preliminary findings in longer periods and to compare the impact of anterior TFS with that of other anti-incontinence surgeries. Yasukuni Yoshimura mdDepartemnt of Urology, Yotsuya Medical Cube, Tokyo, JapanEmail: [email protected] Pelvic organ prolapse (POP) affects a large proportion of women. An American woman has an estimated 11.1% lifetime risk of undergoing a single operation for POP and stress urinary continence.19 However, conventional POP surgery is often exposed to failure. Recent publications showed that the new surgical technique with synthetic mesh seems promising. One of the most popular POP reconstructive procedures is the tension-free vaginal mesh (TVM) technique, which was originally developed by a French group of gynecologists.20 The TVM technique is a minimally invasive surgery of total pelvic reconstruction through a vaginal approach using a non-absorbable soft prolene mesh. The objective of the mesh is to replace the damaged visceral fascia and to restore cohesion between the visceral and parietal fascia like the hammock connected to the arcus tendineus fascia pelvis. The mesh arms are stabilized through the obturator membrane and the sacrospinous ligament with a tension-free technique. The TVM technique is useful in any patients a surgeon feels would require POP repair. Patients with high-risk factors for failure such as a severe degree of POP and patients with previous surgical failure are the clearest indication. The contraindication is women with plans for pregnancy, as soft prolene mesh does not stretch significantly.A past history of vaginal radiation and an immune-compromised host can be a relative contraindication. Several clinical data validate the safety and efficacy of the TVM technique. A retrospective multicenter study for 106 stage-III or -VI patients demonstrated a more than 95% success rate 3 months after the surgery.20 Mesh extrusion was seen in five patients (4.7%) and two of them required surgical management.20 Another multicenter case study for 89 POP patients also showed a 6.7% failure rate with a mean follow up of 5 months.21 A prospective multicenter study demonstrated that serious complications occurred in 4.4% of patients (n = 11). Most of them (10 of 11 cases) were visceral injury (bladder [5], rectum [3] urethra [1]) that could be repaired at the time of surgey.22 The most common postoperative complication is mesh extrusion. The erosion extrusion rate ranged from 1 to 10% and occurred in the midline and at the cranial end of the scar. Mesh extrusion is seen more commonly after hysterectomy, indicating that reduced vascularity is one of the key issues. The original mesh used in prolapse repair was associated with an unacceptably high rate of infection and rejection. These problems are now rare with the use of a type I macroporous monofilament polypropylene mesh. This mesh seems to be the best material available at present for use in POP surgery. Further changes in other characteristics of the mesh, such as mesh stiffness or mesh coating, may also decrease the current low rate of mesh extrusion. In conclusion, recent publications suggest that surgical repair with synthetic meshes are promising for the treatment of POP and meshrelated complications are manageable. However, few studies show a sufficient level of evidence. Long-term controlled studies will have to confirm the effectiveness and safety of mesh surgery. Masayoshi Nomura md phd, Hiroshi Kusanishi md phd and Yukiko Shimizu md phdUrogynecology Center, Department of Obstetrics and Gynecology Kameda Medical Center Kamogawa, Chiba, Japan[email protected] Pelvic organ prolapse (POP) impairs the activities of daily living and affects quality of life for elderly women. It has been thought that pathogenesis of POP is a pelvic floor herniation caused by anatomical defects of the supportive mechanism of the pelvic organs such as bladder, urethra, uterus, rectum, anus and perineal body located around the vagina. Surgical treatments are principally indicated for severe POP. Therefore, urogynecologists should precisely evaluate physioanatomical defects of pelvic organ support and reconstruct the defective parts to recover the functions of the pelvic floor organs, including urination, defecation and sexuality. The apical part of the vagina and uterine cervix are suspended to sacrum by the complex of uterosacral ligaments and cardinal ligaments connected to the uterine cervical ring (Level 1).23 The upper two thirds of the vagina, sandwiched by the pubocervical fascia (PCF) anteriorly and the rectovaginal fascia (RVF) posteriorly, is attached to the arcus tendinous fascia pelvis (ATFP) located at the pelvic side wall. These two sheets of PCF and RVF support the bladder and rectum like a hammock (Level 2). The lower one third of the vagina, urethra, perineal body and anus are supported by fusion to the perineal membrane and levator ani muscles (Level 3). It is rational that pelvic floor reconstructive operation is carried out to restore anatomical defects of these three levels in a site-specific manner (Table 1). As standard operations for Level 1 defect (uterine prolapse, high cystocele, enterocele), vaginal hysterectomy with reinforcement of vaginal apex and closure of culde-sac is preferred. The modified McCall culdeplasty (fixation of vaginal apex to bilateral uterosacral ligaments), the sacrospinous ligament fixation and iliococcygeous fascial fixation (Inmon's technique) have been proved to be effective in evidence-based medicine. For Level 2 defects (cystocele, urethral hypermobility, rectocele), anterior colporrhaphy with Kelly's suture (plication of PCF) is carried out. Although anterior colporrhaphy is suitable for the midline defect on PCF (distention type cytocele), anterior vaginal wall plication for lateral defect of PCF (displacement type cystocele) results to worsen stress urinary incontinence due to a hypermobile urethra and narrowing down the vaginal width. In order to restore lateral support of the vaginal wall, paravaginal repair suturing the vaginal side wall to the detached ATFP is selected. Since Level 3 defects lose the support of the urethra and lower vagina, suburethral fascial plication (Nichols method) is effective to the hypermobile urethra. For a low rectocele and perineal laceration, posterior colporrhaphy and perineorrhaphy are useful to reattach the perineal body to RVF. Furthermore, for the uterine prolapse with cervical elongation, the Manchester operation (Donald-Fothergill method), in which the uterine cervix is amputated and the uterosacral ligaments are reattached to the neocervix is also useful for women desiring uterine preservation. Vaginal obliterative operations such as LeFort partial colpocleisis and colpectomy are also considerable and very effective procedures in elderly POP patients or patients with high risk medical complications. Since Level 1 supportive abnormality is present in most POP patients, it is important for surgeons to give adequate support for the vaginal apex to reinforce suspension. Vaginal total hysterectomy is an effective procedure because the loss of support of the uterine cervix gives rise to cervical elongation and consequently the uterus is dropped into the vagina. In the uterosacral ligament and cardinal ligament complex, the proximal part, with enough strength to suspend Level 1 usually remains, while the distal part of the uterosacral ligament and cardinal ligament complex are often damaged and attenuated in POP patients. In these cases we must search for an unrelaxed strong ligament and reattach it to the vaginal apical part, so that it is possible to restore the anatomical location of the vaginal apex and prevent vaginal canal shortening and recurrence of POP. The original McCall suture was reported as culdeplasty for enterocele in 1957 and has since been improved as the modified McCall procedure by Nichols to be a sophisticated reconstructive technique that is useful in the recovery of both axis and depth of the vaginal canal.24 A vaginal apex can be deepened by fixing the posterior fornix at a high position of the uterosacral ligament and Level 1 support is strengthened by suturing with plural monofilament polydioxanone stitches. The modified McCall culdeplasty not only restores an enterocele but also prevents future enlargement of cul-de-sac because it is closed at a high position. This procedure is indicated in all cases in which the strength of Level 1 supports are affected and lost. There are sporadic problems of ureteral obstruction during suturing. The issue may be quickly resolved by cystoscopy after ligation of McCall suture with administration of indigo carmine. Vaginal hysterectomy followed by this procedure is a simple and safe operation, and should be considered as a primary operation for POP. The support of the vaginal apex is further anatomically reinforced by attaching multiple positions of the pelvic floor. The Iliococcygeous fascia attachment technique corrects vaginal vault prolapse and enterocele by attaching the lateral angle of the vaginal cuffs to the fascia overlying the iliococcygei in patients who had inadequate uterosacral ligaments. We reported the excellent results of bilateral attachment of the vaginal cuff to iliococcygeous fascia concomitantly with the modified McCall culdeplasty.25 The durability of the combined procedures was superior to that of the modified McCall culdeplasty alone. We reported that the recurrence rate of vaginal hysterectomy with the fixation of the vaginal apex to proper positions on the pelvic floor was 8.3%, which seems likely to be low. Recently, tension-free vaginal mesh operation (TVM) to restore POP comprehensively was introduced from France and TVM cases have rapidly been increasing in Japan. As for the total mesh procedure, it can be easily simplified and unified, and the high durability has been clarified by a long history of operations for inguinal hernia. However, the recurrence rate of TVM is also around 3–10%, and postoperative complications such as mesh erosion, bladder and rectal injuries and infection occurred in no small measure. The Food and Drug Administration (FDA) in the US has given alerts since 2007.26 TVM will be able to decrease the recurrence rate of POP in comparison with non-mesh operations, but hysterectomy can prevent future gynecological malignancy and hormone replacement therapy will be safely introduced for POP patients. It is important that the aim of POP surgery is to restore entire functions of the pelvic organs. Urogynecologists should determine medical interventions through precise physical findings, age, and patients' lifestyle.We must build up enough data on various pelvic reconstructive surgeries now and carefully follow the long-term outcomes of POP patients. Masayasu Koyama md phd and Hungwu Chien mdWomen's Pelvic Surgery Center, Kitano Hospital The Tazuke Kofukai Medical Research Institute Osaka, Japan[email protected]