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doi:10.1111/j.1447-0756.2008.00947.x

J. Obstet. Gynaecol. Res. Vol. 35, No. 2: 346353, April 2009

Tissue Fixation System (TFS) to repair uterovaginal prolapse with uterine preservation: A preliminary report on perioperative complications and safetyHiromi Inoue, Yuki Sekiguchi, Yutaka Kohata, Yuka Satono, Kenji Hishikawa, Toyoko Tominaga and Mika OobayashiDivision of the Urogynecological Center, Department of Obstetrics and Gynecology, Shonan Kamakura General Hospital, Kanagawa, Japan

AbstractObjectives: To assess the effectiveness, perioperative safety and invasiveness of the Tissue Fixation System (TFS) sling operation when used for repair of uterovaginal prolapse with uterine preservation. Methods: Operations using the TFS anchor system were performed on 25 women aged between 44 and 84 years (average 65) for grade 3 or 4 uterine prolapse with or without urinary incontinence. Details of the procedures were as follows: midurethral sling (n = 2); posterior sling of the uterosacral ligaments (n = 25); U-sling for lateral/central anterior vaginal wall defects (n = 24). The defect of the perineal body and rectovaginal fascia were repaired in all cases. Results: All patients were followed up for a minimum of 3 months. The mean standard deviation of the operating time and loss of blood were 94.2 ( 19.3) minutes and 98.1 ( 129.6) mL, respectively. Twelve patients (48%) were discharged on the same day of surgery and 13 patients (52%) on the following day, with a return to normal activities within 17 days. There were no intra- or postoperative complications. At the 3-month follow up, cure rates of symptoms due to pelvic laxity were: urinary frequency 85.7% (n = 14); nocturia 66.6% (n = 12); urgency 93.3% (n = 15); and dragging pain 100% (n = 6). There was one recurrent uterovaginal prolapse and one recurrent cystocele. Conclusion: The TFS procedure delivers satisfactory results for uterine prolapse repair with uterine preservation. The procedure is useful because of the short duration of the operation, the short term of recovery, its safety prole and minimal invasiveness. There is a signicant improvement in the quality of life, especially for older women. However, long-term results are currently unknown. Key words: Tissue Fixation System, uterine preservation, uterine prolapse.

IntroductionThe population of elderly women is increasing in Japan, and as a consequence, many elderly patients have come to suffer from pelvic oor laxity and

uterovaginal prolapse. Pelvic laxity is not a lifethreatening condition, although performing surgery for this condition is not without its complications. Ostergard (2002)1 stated that it was not ethical to impose a life-threatening operation on a patient for a

Received: December 26 2007. Accepted: June 24 2008. Reprint request to: Dr Hiromi Inoue, Division of the Urogynecological Center, Department of Obstetrics and Gynecology, Shonan Kamakura General Hospital, 1202-1 Yamazaki Kamakura, Kanagawa 247-8533, Japan. Email: [email protected] Brief Summary: The Tissue Fixation System (TFS) for repair of uterine prolapse with uterine preservation is safe and effective with very few perioperative complications. Abbreviations: Tissue Fixation System (TFS), posterior intravaginal slingplasty (PIVS). Declaration: The authors have received no nancial incentives and have no nancial interest in the TFS.

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TFS for repair of uterine prolapse with uterine preservation

condition which is not life-threatening. He also stated that there should be zero tolerance for such operations. A perioperative complication rate of up to 46% has been reported in patients undergoing reconstructive pelvic surgery using traditional surgical techniques.2 These techniques are often painful, require many days of catheterization, and hospitalization, all of which may predispose the patient to thrombosis, embolism and other serious complications. Effective and minimally invasive operations with a rapid return to normal activities are therefore required to satisfy safety and quality of life issues. Another concern is preservation of the uterus. Hysterectomy is widely performed concomitantly at the time of prolapse repair surgery whenever the uterus is signicantly prolapsed. There is no clear evidence supporting the role of hysterectomy in improving surgical outcome.3 Hysterectomy necessitates division of the descending branch of the uterine artery, a key blood supply for the vaginal apex and uterosacral ligaments, and may itself be associated with a vault prolapse incidence of 11.6% in such patients.4 In 1997, a minimally invasive procedure was introduced by Petros,5 the infracoccygeal sacropexy, better known as the posterior intravaginal slingplasty (PIVS). The PIVS operation has built-in efcacy, safety, and simplicity and also preserves the uterus, but it requires thorough anatomical knowledge and technical skill. However, almost one in ve patients having a PIVS subsequently developed a cystocele, probably caused by a diversion of pelvic forces onto an already subclinically damaged anterior vaginal wall. Unfortunately, it is not possible for a PIVS procedure to repair a damaged anterior vaginal wall. In 2005, a new minimally invasive universal system, the Tissue Fixation System (TFS) was reported. This was applied entirely via the vagina, and was able to repair all the damaged ligaments and fascia of the pelvic oor.69 The TFS tape can be tightened to precisely restore the correct tension, essential if normal function is also to be restored.9 Our perspective of the pelvic oor support is akin to that in a suspension bridge (Fig. 1).9 The TFS mimics a suspension bridge by reinforcing damaged ligaments and fascia (Fig. 2). It also applies a new bioengineering principle, where the tape acts as a ceiling joist, and the vagina as the plasterboard,8 so that a large mesh is not required. We were attracted to this new method because of its safety, minimally invasive technique, its vaginal application, its ability to repair a cystocele, and if required, the perineal body.

Figure 1 Structure: The suspension bridge analogy. The suspension bridge analogy illustrates how the pelvic structures are interdependent. In a suspension bridge, strength is maintained through tension of suspensory steel wires (arrows). Weakening of any one part of the structure may disturb the equilibrium, strength and function of the whole. Relating the analogy to Figure 1, form (i.e. shape and strength) is achieved because the vagina and bladder are suspended from the bony pelvis by ligaments, pubourethral ligaments (PUL), uterosacral ligaments (USL), arcus tendineus fascia pelvis (ATFP) and fascia (F). The structural dimension develops when these are stretched by muscle forces (arrows). Reproduced with the permission of Professor PE Petros. PS, pubic symphysis; S, sacrum.

The principal aim of this study was to assess the perioperative safety, effectiveness, and minimal invasiveness of the TFS for repair of uterine prolapse leaving the uterus in situ.

Methods and MaterialsWe prospectively studied 25 women aged 44 to 84 years (average age 65), in our institution. The mean (range) body mass index and parity were 24.1 (19.7 37.4) and 2.4 (04), respectively (Table 1). In this operation, the TFS applicator (TFS Manufacturing, Adelaide, Australia) was used. This instrument has two polypropylene plastic anchors attached to an adjustable non-stretch multilament polypropylene mesh tape. The posterior TFS sling (uterosacral ligaments [USL]sling) operation was originally performed as reported by Petros and Richardson.6 A 2.5 cm transverse incision was made 2 cm below the cervix. The uterosacral ligaments or their remnants were identied and grasped with Allis forceps. If an enterocele was present, it was dissected clear of the fascia and reduced. Mayo scissors angled at 30 degrees created a 45-cm long space between the ligamentous remnants and the vaginal mucosa just below the insertion point of utero-


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Midurethral-sling Urethra Vagina U-sling Uterus

CervixRectum USL-sling

Sacrum

Figure 2 Polypropylene tapes T (Midurethral-sling, U-sling and uterosacral ligamentssling) may be used to reinforce the two main suspensory ligaments, pubourethral ligament and uterosacral ligament, and to reinforce a pubovesical cervical fascia.

Table 1 Demographics Study population characteristic Age Body mass index Parity Mean (range) 65 (4484) 24.1 (19.737.4) 2.4 (04)

sacral ligaments, just sufcient to accommodate the TFS delivery instrument (Fig. 3). At the required depth, the instrument was triggered, and the anchor delivered (Fig. 4). The instrument was removed, and 1020 s elapsed so as to allow for restoration of the tissues. The anchor was then set by pulling on the tape. The same procedure was repeated on the opposite side. Maintaining the instrument in position to support the anchor base, the tape was tightened along the instrument axis, and inspected for adequate tightening (Fig. 5). Finally, the free end of the tape was cut 1 cm from the anchor (Fig. 6). The TFS U-sling was also performed for cystoceles as reported by Petros et al.8 The vagina was dissected off the bladder wall and the fascial remnants over the cystocele were approximated with interrupted 00 Polysorb sutures (Tyco Health Care, USA). A tunnel was created with Mayo scissors between the bladder fascia and the

anterior vaginal mucosa medial to the obturator fossa, until the muscle behind the obturator fossa was reached. The applicator was then placed into the tunnel and the anchor displaced adjacent to the muscle and tugged to x it. This was repeated on the contralateral side and the tape tightened just sufciently to reduce fascial laxity. All patients underwent USL-sling procedures, and 24 patients also had U-sling repairs. In ve patients with severely stretched perineal bodies, the TFS was used to reinforce these structures. The rectum was separated from the laterally displaced perineal body, under continuous tension. As the rectal wall was invariably thin, a nger was kept inside the rectum per anum during this procedure in order to ensure that perforation did not occur. The laterally displaced perineal body was identied, and grasped with Allis forceps. Using dissecting scissors, a 34 cm deep tunnel was created inside the perineal body below the forceps. The applicator was placed inside the dissected space and triggered to deploy the anchor. This was then repeated to the contralateral edge. The tape was tightened until resistance was felt, and then trimmed accordingly. Two patients with stress incontinence were also treated with a mid-urethral sling.7

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TFS applicator

TFS Tape

Cervix

Figure 3 The posterior Tissue Fixation System (TFS) sling (uterosacral ligamentssling) operation. The TFS delivery instrument is put in a 46-cm long space between the ligamentous remnants and the vaginal mucosa just below the insertion point of uterosacral ligaments.

Ligamentous remnants (Uterosacral ligament)

Rectovaginal fascia and perineal body repairs were carried out in all patients without any tissue excision. The fascial defects of any rectocele were repaired directly, and trimmed remaining tape was placed over the repaired defect to create additional brosis. Informed consent was obtained from all patients who took part in this study. This study was approved by the Ethics Committee of our institution.

ResultsAll patients had grade 3 or 4 uterine prolapse according to the Pelvic Organ Prolapse Quantication (POPQ) standard scoring system. The mean standard deviation operating time and blood loss were 94.2 19 min and 98.1 129.6 mL, respectively. Twelve patients (48%) were discharged on the same day after surgery and the remaining patients (52%) on the next day, returning to normal activities within a week of surgery (Table 2). There were no intra- or post-

operative complications. Urinary symptoms after 3 months of operation were: urinary frequency 85.7% (n = 14), nocturia 66.6% (n = 12), urgency 93.3% (n = 15), and dragging pain 100% (n = 6) (Table 3). Two patients with stress incontinence who were treated with mid-urethral sling repair, had complete resolution of symptoms. One patient had a tape erosion one month after operation which was treated as an outpatient procedure. There was one recurrence of uterovaginal prolapse and one recurrent cystocele. There were no new symptoms (urinary urgency etc). The learning curve for performing the procedure was abrupt (Fig. 7).

DiscussionThe uterosacral ligaments are a principle support structure for the uterus.10 Attached to these structures is the rectovaginal fascia (Denonvilliers fascia) which borders laterally on the rectal pillars, and is fused


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TFS Tape

Cervix

Anchor

Ligamentous remnants

Figure 4 At the required depth, the instrument is triggered, and the anchor delivered. TFS, Tissue Fixation System.

distally to the perineal body and proximally to the cervical ring and levator plate muscles.10 These structures function interactively as a supportive subsystem.11 Where there are normal fascial attachments between the organs and the tensioning muscles, it is possible to stretch the upper part of the vagina and uterus downwards and backwards. Damaged connective tissues inactivate this mechanism, predisposing to uterine prolapse, cystocele, rectocele, and vault prolapse.11 The discussion of uterine preservation at prolapse surgery goes back at least to 1934, when Bonney12 stated that the uterus plays a passive role in uterovaginal prolapse. The pericervical fascia or the cervix is the cornerstone of pelvic reconstruction.1315 Hysterectomy may predispose not only to vaginal prolapse, but also to severe urinary incontinence later in the patients life.16 In any case, there is no clear evidence supporting the role of hysterectomy in improving surgical outcome.3 What is the most preferable surgical procedure, when patients request uterine preservation at the time of prolapse surgery?

The American College of Obstetrics and Gynecology (ACOG) practice bulletin in 2007 recommended two surgical options (1. abdominal or laparoscopical sacral xation, and 2. vaginal sacrospinous xation of the uterus or the vaginal apex) to women wishing uterine preservation at the time of prolapse surgery.17 However, these repair techniques are not physiological. The former creates an indirect attachment of the uterus or upper vagina to the sacral promontory, and the latter to the ischial spines. Complications of these procedures include hemorrhage, hematoma, wound infection, small-bowel obstruction, incisional hernia, and mesh erosion.1821 The laparoscopic approach has been used for hysteropexy, but data are limited.21,22 There is also a protracted learning curve.23 In 1997, PIVS as a minimally invasive procedure was introduced.5 In our experience, this procedure has had better safety, and is simpler than previous procedures, with equivalent or better results, and at the same time also preserves the uterus. The PIVS operation requires thorough anatomical knowledge and technical skill.

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Cervix

Cervix

Figure 6 The free end of the tape is cut 1 cm from the anchor and the vaginal mucosa is closed. Figure 5 Maintaining the position of the instrument to support the anchor base, the tape is tightened along the instrument axis, and inspected for adequate tightening. Table 2 Perioperative data Mean (range) Operation time (min) Estimated blood loss (mL) Postoperative hospital stay(day) Return to usual life(day) 94.9 (72145) 98.1 (5400) 0.52 (01) 1.5 (17)

However, the exact method for reconstruction of the uterosacral ligaments may not be so important. Diwan24 reported that laparoscopic uterosacral ligament uterine suspension is an effective treatment for women with uterovaginal prolapse, even for those who also desire uterine preservation. Other practitioners5,25,26 have used PIVS and more recently, the TFS procedure.6 In the aged population with a higher risk generating sometimes major perioperative complications, a serious question is which is the safest and most effective operation? The posterior TFS sling (USL-sling) operation is a much simpler operation than the PIVS, and it is more anatomical, because it directly reapproximates

and reinforces the uterosacral ligaments, elevates the vaginal apex, and also closes an enterocele, if present. The PIVS actually pulls the apex downwards, creating a neoligamentous attachment between apex and levator muscles. It cannot approximate the uterosacral ligaments. The short term outcome for prolapse repair is equivalent to those reported previously for posterior sling surgery.6 The TFS sling operation is also available for the repair of rectovaginal fascia (level 2), and perineal body (level


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Table 3 Cure rates of complaints 3 months after surgery Variable (no/25) Pelvic organ prolapse Urinary urgency (15/25) Urinary frequency (14/25) Nocturia (12/25) Dragging pain (6/25) B/A 24/25 14/15 12/14 8/12 6/6 Cure rate (%) 96 93.3 85.7 66.6 100

B/A: No of Cures/No of patients with specic symptoms.

(Time:minute, EBL:ml)500 400 300 200 100 0 1 11 21 operating time(min) blood loss(ml)

antero-posterior elasticity is largely maintained and the risk of erosion, stula, or organ adherence is decreased because of the smaller area of mesh, and the suspensory action of the anchors.9 Tightening lax ligaments and fascia are essential for restoration of normal function to reduce troublesome symptoms.28 Cure rate of symptoms (Table 3) is comparable to that achieved with the PIVS operation.25,26,29 Unfortunately, the TFS application is currently not widely available in Japan and is presently only used in three institutions throughout the country. A better understanding of the procedure and its benets will hopefully lead to increased application in the future.

ConclusionOur initial results indicate that the TFS sling operation fulls Ostergards ethical criteria for pelvic surgery. The TFS has a short operating time, a short recovery time, and it is safe. It is able to repair any fascial defect of pelvic organs according to the normal anatomy. Long-term results, and randomized control trials compared to more traditional prolapse operations are required.

(25cases)

Figure 7 Learning curve of TFSL: Amount of blood loss and operating time, after experiencing just ve cases, the estimated blood loss (EBL) and time of operation were minimized.

Acknowledgments3), respectively. These options are not available with the PIVS, sacrospinous colpopexy, or abdominal sacrocolpopexy. A cystocele may recur, or occur de novo following repair of a uterine prolapse, even though a repair of a cystocele can be performed at the time of the repair. Recently, many surgeons prefer to leave the mesh tension-free, especially if it is a large mesh. Possible complications of large mesh repair include surfacing or erosion of the mesh, stula, and adherence of one viscus to another.9 In a study by Milani et al.,27 32 patients for repair of the anterior wall and 31 patients for repair of the posterior wall were treated with mesh (prolene), and the success rate was anatomically 94%. However, 20% among the anterior wall repair group and 63% among the posterior wall repair group had dyspareunia, and 13% and 6.5% had erosion of the mesh, respectively. For repair of the prolapsed anterior vaginal wall, the TFS polypropylene mesh tape (0.8 cm wide) is anchored laterally by the TFS and tightened sufciently to support the overlying bladder, just like joists of a ceiling reinforcing a plasterboard (Fig. 2). The advantage of this method is that unlike large sheets of mesh, We wish to thank Dr Joel Branch for the English correction and Professor PE Petros for advice with regard to this manuscript.

References1. Ostergard DR. Editorial. The epochs and ethics of incontinence surgery: Is the direction forward or backwards? Int Urogynecol J Pelvic Floor Dysfunct 2002; 13: 13. 2. Lambrou N, Butler J, Thompson J, Cundiff G, Chou B, Monts F. Prevalence of perioperative complications among women undergoing reconstructive pelvic surgery. Am J Obstet Gynecol 2000; 183: 13551360. 3. Neuman M, Lavy Y. Conservation of the prolapsed uterus is a valid option: Medium term results of a prospective comparative study with the posterior intravaginal slingplasty operation. Int Urogynecol J Pelvic Floor Dysfunct 2007; 18: 889893. 4. Marchionni M, Bracco G, Checcucci V et al. Incidence of vaginal vault prolapse. Thirteen years of experience. J Reprod Med 1999; 44: 679684. 5. Petros PE. Vault prolapse II: Restoration of dynamic vaginal supports by the infracoccygeal sacropexy, an axial day-case vaginal procedure. Int Urogynecol J Pelvic Floor Dysfunct 2001; 12: 296303. 6. Petros PE, Richardson PA. Tissue Fixation System posterior sling for repair of uterine/vault prolapse: A preliminary report. Aust N Z J Obstet Gynaecol 2005; 45: 376379.

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7. Petros PE, Richardson PA. The midurethral TFS sling: A micro-method for cure of stress incontinence preliminary report. Aust N Z J Obstet Gynaecol 2005; 45: 372375. 8. Petros PE, Richardson PA, Goeschen K, Abendstein B. The Tissue Fixation System (TFS) provides a new structural method for cystocele repair a preliminary report. Aust N Z J Obstet Gynaecol 2006; 46: 474478. 9. Petros PE. Surgery. In: Petros PE (ed.). The Female Pelvic Floor: Function, Dysfunction and Management, According to the Integral Theory, 2nd edn, Chapter 4. Heidelberg: Springer, 2006; 83167. 10. Nichols DH, Randall CL. Massive eversion of the vagina. In: Nichols Randall CL (ed.). Vaginal Surgery, 3rd edn. Baltimore, MD: Williams Wilkins, 1989; 328357. 11. Petros PE. Vault prolapse I: Dynamic supports of vaginal. Int Urogynecol J Pelvic Floor Dysfunct 2001; 12: 292295. 12. Bonney V. The principles that should underline all operations for prolapse. J Obstet Gynaecol Br Emp 1934; 41: 669683. 13. Ross JW. Apical vault repair, the cornerstone of pelvic vault reconstruction. Int Urogynecol J Pelvic Floor Dysfunct 1997; 8: 146152. 14. Petros PE. Inuence of hysterectomy on pelvic-oor dysfunction. Lancet 2000; 356: 1275. 15. Petros PE. The Female Pelvic Floor, Function, Dysfunction, and Management, according to the Integral Theory, Chapter 4. Heidelberg: Springer, 2004; 123. 16. Brown JS, Sawaya G, Thorn DH, Grady D. Hysterectomy and urinary incontinence: A systematic review. Lancet 2000; 356: 535539. 17. ACOG. ACOG Practice Bulletine Number 79, Pelvic Organ Prolapse. Obstet Gynecol 2007; 109: 461473. 18. Maher CF, Cary MP, Slack MC, Murray CJ, Milligan M, Schluter P. Uterine preservation or hysterectomy at sacrospinous colpopexy for uterovaginal prolapse? Int Urogynecol Pelvic Floor Dysfunct 2001; 12: 381384; discussion 384385. 19. Barranger E, Fritel X, Pigne A. Abdominal sacrohysteropexy in young women with uterovaginal prolapse: long-term follow-up. Am J Obstet Gynecol 2003; 189: 12451250.

20. Costantiti E, Mearini L, Bini V, Zucchi A, Mearini E, Porena M. Uterus preservation in surgical correction of urogenital prolapse. Eur Urol 2005; 48: 642649. 21. Van Brummen HJ, van de Pol G, Aalders CI, Heintz AP, van der Vaart CH. Sacrospinous hysteropexy compared to vaginal hysterectomy as primary surgical treatment for a descensus uteri: Effects on urinary symptoms. Int Urogynecol J Pelvic Floor Dysfunct 2003; 14: 350355; discussion 355. 22. Lin LL, Ho MH, Haessler AL et al. A review of laparoscopic uterine suspension procedure for uterine preservation. Curr Opin Obstet Gynecol 2005; 17: 541546. 23. Ross JW, Predton M. Laparoscopic sacrocolpopexy for severe vaginal vault prolapse: Five-year outcome. J Minim Invasive Gynecol 2005; 12: 221226. 24. Daiwan A. Laparoscopic uterosacral ligament uterine suspension compared with vaginal hysterectomy with vaginal vault suspension for uterovaginal prolapse. Int Urogynecol J Pelvic Floor Dysfunct 2006; 17: 7983. 25. Farnsworth BN. Posterior intravaginal slingplasty (infracoccygeal sacropexy) for severe posthysterectomy vaginal vault prolapse: A preliminary report on efcacy and safety. Int Urogynecol J Pelvic Floor Dysfunct 2002; 13: 48. 26. Neuman M, Lavy Y. Posterior intra-vaginal slingplasty for the treatment of vaginal apex prolapse: Medium-term results of 140 operations with a novel procedure. Eur J Obstet Gynecol Reprod Biol (in press). 27. Milani R, Salvatore S, Soligo M, Pifarotti P, Meschia M, Cortese M. Functional and anatomical outcome of anterior and posterior vaginal prolapse repair with prolene mesh. Br J Obstet Gynaecol 2005; 112: 107111. 28. Petros P, Ulmusten U. An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand J Urol Nephrol Suppl 1993; 153: 1 93. 29. Petros PE. New ambulatory surgical methods using an anatomical classication of urinary dysfunction improve stress, urge, and abnormal emptying. Int Urogynecol J Pelvic Floor Dysfunct 1997; 8: 270278.


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