Outpatient Mid Urethral Tissue Fixation System Sling for Urodynamic Stress Urinary Incontinence: 1-Year Results

Outpatient Mid Urethral Tissue Fixation System Sling for Urodynamic Stress Urinary Incontinence: 1-Year Results Yuki Sekiguchi,* Manami Kinjyo, Hiromi Inoue, Hisaei Sakata and Yoshinobu Kubota From the Yokohama Motomachi Women’s Clinic LUNA (YS, MK) and Department of Urology, Yokohama City University Graduate School of Medicine (YK), Yokohama, Urogynaecology Center, Shonan Kamakura General Hospital (HI), Kamakura and Graduate School of Business, Nihon University (HS), Tokyo, Japan

Abbreviations and Acronyms ISD ⫽ intrinsic sphincter deficiency SUI ⫽ stress urinary incontinence TFS ⫽ tissue fixation system Submitted for publication April 6, 2009. Study received Medical Corporation Leading Girls Ethics Committee approval. * Correspondence: Yokohama Motomachi Women’s Clinic LUNA, 3-115 Hyakudan-kan, Motomach, Nakaku, Yokohama 231-0861, Japan.

Purpose: We tested the feasibility of using the tissue fixation system to create a mid urethral sling for urodynamic stress urinary incontinence at a freestanding outpatient facility. The tissue fixation system is a new mini sling device with a 1-way tightening system. Materials and Methods: We performed 44 mid urethral tissue fixation system sling operations between December 2006 and March 2008 at Yokohama Motomachi Women’s Clinic LUNA. All patients had urodynamic stress urinary incontinence, as proven by preoperative urodynamics. Results: Mean ⫾ SD patient age was 58.2 ⫾ 11.9 years. Surgery was done on an outpatient basis using local anesthesia. Postoperative pain was minimal. All patients were discharged home the same day. Mean operative time, including local anesthesia administration, was 24.5 ⫾ 7.7 minutes (median 25, range 15 to 50). Mean blood loss was 17.7 ⫾ 21.7 ml (median 5, range 3 to 98). Five patients who could not pass urine within 8 hours were discharged home with an indwelling Foley catheter but they passed urine normally within 48 hours. The cure rate at 12 months was 90.9% (40 of 44 cases). Of the patients 15 (34.4%) had intrinsic sphincter deficiency. Three of the 4 failed cases were cured by another tissue fixation system mid urethral sling inserted at 6 months. There was no de novo urgency or urge urinary incontinence at 12 months. Conclusions: Results show that the tissue fixation system mid urethral sling operation is a simple, safe, effective procedure that may be done without difficulty at a freestanding clinic on an outpatient basis. Key Words: urethra; urinary incontinence, stress; suburethral slings; outpatients; Japan

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THE TVT™ is an effective operation for SUI that may be done in more complicated cases, such as intrinsic sphincter deficiency other than in primary cases.1 TVT creates a neopuburethal ligament that anchors the 3 muscle forces activating urethrovesical closure, including pubococcygeus muscles, longitudinal muscle of the anus and levator plate.1 However, in addition to a significant 0.2%

to 1% postoperative urinary retention rate, TVT carries a 3% to 4% risk of bladder, urethral or intestinal perforation, and a 1% to 2.5% risk of major vessel and nerve injury, and hematoma in the retropubic space.2 TFS is a next generation mini sling device that is applied entirely from the vagina (fig. 1). Thus, it does not require suprapubic or perineal skin perforation.3 Like TVT, TFS works by

0022-5347/09/1826-2810/0 THE JOURNAL OF UROLOGY® Copyright © 2009 by AMERICAN UROLOGICAL ASSOCIATION

Vol. 182, 2810-2813, December 2009 Printed in U.S.A. DOI:10.1016/j.juro.2009.08.045

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Operative Data

Figure 1. TFS consists of 2 anchors (An) joined by a polypropylene mesh tape (T) passing through 1-way trapdoor at each base, which allows tightening. Anchor holder fits on saddle (S) on top of TFS applicator (Ap). Anchor is released into tissue by activating TFS applicator button (B). Remover (R) slides up shaft to remove saddle.

creating a foreign body collagenous tissue reaction that reinforces weakened pelvic ligaments.4 It has been successfully used as a mid urethral sling. The anchors are positioned immediately behind the urogenital diaphragm in the fascia and below the pubococcygeus muscles. We report 1-year data on mid urethral TFS sling operations for urodynamic SUI done entirely on an outpatient basis.

MATERIALS AND METHODS We performed 44 mid urethral TFS sling operations between December 2006 and March 2008 at Yokohama Motomachi Women’s Clinic LUNA. All patients had urodynamic SUI, as proven by preoperative urodynamics. All patients had a positive cough stress test and post-void residual urine was less than 10 ml. We evaluated patients 12 months postoperatively. Mean ⫾ SD age was 58.2 ⫾ 11.9 years and all patients were Japanese. Average body mass index was 23.57 ⫾ 12.03 kg/m2. The menopause rate was 61.4%. Patients underwent no previous urogynecological surgery and none had pelvic organ prolapse. This study was approved by the Medical Corporation Leading Girls Ethics Committee in 2006 and patients provided written informed consent.

Preoperative Data The mean 24-hour pad test result was 108 ⫾ 259 ml. Mean abdominal leak point pressure was 81.5 ⫾ 34.1 cm water and mean maximum urethral closure pressure was 33.1 ⫾ 15.7 cm water. There was no detrusor overactivity on urodynamics. We defined ISD as abdominal leak point pressure less than 65 cm water or maximum urethral closure pressure less than 20 cm water. According to this definition 15 of the 44 patients (34.1%) were diagnosed with ISD.

Patients were given 25 mg hydroxyzine hydrochloride and 0.5 mg atropine sulfate intramuscularly, and 50 mg diclofenac sodium first preoperatively. Surgery was done by 2 surgeons using local anesthesia, including 10 ml 1% xylocaine, 40 ml physiological saline and 10 U vasopressin. Patients also received 2.5 mg midazolam divided. Local anesthesia was injected at surgical sites, including the anterior vaginal wall, the periurethral spaces and below the pubic symphysis, and the tissues behind the perineal membranes (urogenital diaphragm). All operations were done on an outpatient basis. Average operative time, including local anesthesia, was 24.5 ⫾ 7.7 minutes (median 25, range 15 to 50). Average blood loss was 17.7 ⫾ 21.7 ml (median 5, range 3 to 98). Surgery was performed as described previously.3 The mid urethal TFS sling operation is identical to the first part of a midline tension-free tape operation. A full-thickness midline incision was made in the vagina from just below the urethral meatus to the mid urethra. The vagina was dissected off the urethra with dissecting scissors to the inferior surface of the pubic symphysis to the urogenital diaphragm. Dissection was carried a few mm beyond the urogenital diaphragm. The space created was just sufficient for applicator passage. The applicator was placed in the dissected space and triggered to release the TFS anchor. The tape was pulled with a short, sharp movement to set the anchor prongs into the tissues. Adequate anchor gripping was tested by pulling the free end of the tape. The procedure was repeated on the contralateral side. The tape was tensioned until it was firmly against but not indenting the urethra and the free end was cut. An 18 gauge Foley catheter was used to distend the urethra and prevent excessive tension. The needle was placed in the external ligament, fascial layer of the vaginal hammock, into the contralateral external ligament, and tightened. No cystoscopy was needed because the anchor was inserted into the under surface of the pelvic muscles, always well below the space of Retzius. The vaginal hammock fascia and the external ligamentous attachment of the external urethral meatus were then tightened. A 2-zero Dexon™ suture was placed immediately lateral to the ligamentous attachment of the external meatus on the right side, then into the smooth muscle layer on the inside of the vagina on each side and then into the lateral attachment of the meatus on the left side, much as in a Kelly suture. The suture was tightened so that the fascia covered the tape (fig. 2). Patients received 180 mg loxoprofen sodium for pain relief for 3 days and 1 gm of the third-generation antibiotic sulperazone divided once during surgery to prevent urinary tract infection. They also received 300 mg cefcapene pivoxil hydrochloride orally for 3 days postoperatively.

RESULTS Mean operative time was 24.5 ⫾ 7.7 minutes, mean estimated blood loss was 17.7 ⫾ 21.7 ml and mean clinic stay time was 5.56 ⫾ 1.06 hours. Patients were discharged home after the first urination or 8 hours postoperatively. Recovery nurses asked pa-

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TISSUE FIXATION SYSTEM FOR URODYNAMIC STRESS URINARY INCONTINENCE

DISCUSSION

Figure 2. Hammock and external ligament suture for hammock tightening. Purse-string suture (S) is inserted in turn into each external urethral ligaments (EUL) and fascial layer (f) of vagina (V) on each side and tightened to eliminate laxity and cover suburethral tape. U, urethra.

tients about pain upon discharge and all patients answered that postoperative pain was minimal. There were no significant complications. In 13 patients judged by the surgeon to bleed more than 20 to 30 ml a gauze tampon was inserted in the vagina until the first void after surgery. Five patients who could not void spontaneously within 8 hours of surgery were discharged home with a special indwelling catheter with an attached DIB cap (Dib International, Osaka, Japan). The cap is a magnetic plug that allows the patient to urinate and dispenses with a urine bag. All 5 patients voided without difficulty within 2 days. Success was defined as no patient report of leakage during coughing, a negative cough stress test with a full bladder and 24-hour pad test results less than 3 gm with 3 gm considered average loss from normal vaginal discharge. All patients were followed at least 1 year (mean 16.1 ⫾ 3.5 months). Success was noted in 40 of 44 cases (90.9%). In 4 of the 44 cases (9.1%) treatment failed. Average total International Consultation on Incontinence Questionnaire-Short Form score in successful cases changed from 12 ⫾ 4.2 to 1.2 ⫾ 2.0 points. In the 4 failed cases we hypothesized that the tape was loose. In patients in whom treatment failed average 24hour pad test results were 82 ⫾ 79 cc 6 months postoperatively. We reoperated in 3 of the 4 patients using another TFS mid urethral sling at 6 months and all 3 patients were continent after reoperation. Nine patients had occasional urge incontinences postoperatively but these symptoms disappeared entirely by 12 months. Patients did not require anticholinergics. The only treatment was self-administered pelvic floor exercises. There was no de novo urgency or urge urinary incontinence at 12 months. We noted 1 tape erosion in the 44 cases. Although this patient retained continence at 1-year followup, the eroded tape was cut.

The 21st century has brought a change in demographics. Large numbers of people in developing countries have rapidly growing incomes, live longer and seek to improve quality of life while those in advanced countries would like to work even into advanced age. A consequence of this trend is an increasing demand for effective management for incontinence since continence is a major component of quality of life and a major determinant of the ability to work effectively. The keys to successful treatment for incontinence revolve around providing safe, effective, minimally invasive treatment at an appropriate cost. The end point of such a solution is a corrective operation using local anesthesia on an outpatient basis. The Yokohama Motomachi Women’s Clinic LUNA is a conventional freestanding clinic with a small outpatient surgical facility and no overnight facilities. There is an arrangement with neighboring hospitals for patient transfer in case of emergency but this was not required in any of our patients with the mid urethal TFS. Surgery was done at the clinic safely, effectively and inexpensively. Our 90.9% success rate is the same as the TVT success rate of 87% to 91%.2 Our polypropylene sling is a mixture of micropore and macropore material with large 70 to 200 ␮ spaces. Histology has shown penetration of macrophages and vascular tissue.5,6 There was only 1 erosion in our 44 cases. Also, the TFS tape was changed to nonstretch, type 1, totally macropore tape from 2009 and thereafter. From our perspective the important points of day surgery for incontinence are safety, surgical efficacy, minimal postoperative pain and no postoperative voiding difficulty. For safety the surgical technique for stress incontinence surgery must be such that it is virtually impossible to injure the bladder, intestine or major blood vessels.2 We agree with others that there should be zero tolerance for such complications.7,8 Anesthesia should be light and bleeding should be minimal. For efficacy sling material such as the tape must be correctly positioned at the mid urethra, and the hammock and external urethral ligaments must also be repaired, as previously advised.6 Avoiding skin perforation and minimizing tissue trauma also minimize postoperative pain. These problems are almost completely resolved by the mid urethral TFS operation. We performed this operation successfully at a detached outpatient surgical clinic. The only requirement not completely met was postoperative voiding difficulty. It is possible that the 5 patients discharged home with a Foley catheter may have voided spontaneously if they had remained overnight. This problem may be minimized by using nonstretch tape9 and intraoperative urethral splinting with an 18 gauge Foley catheter.3

TISSUE FIXATION SYSTEM FOR URODYNAMIC STRESS URINARY INCONTINENCE

We await longer term ISD results in the 15 patients with that condition. Petros and Richardson described results at 3 years in 10 patients with ISD who received a mid urethral TFS.3 This report of minimal deterioration in 35 patients at 3 years encourages us to believe that our group of 15 patients with ISD will achieve the same long-term results as those who received a TVT. The first 2 failed TFS cases occurred in the first 5 cases. Thus, the learning curve of the mid urethral TFS operation at our institution was about 5 cases. The other 2 failed cases occurred at about 20 cases after the learning period. Failure in 4 cases was caused by loose tape, resulting in anchor slippage from the urogenital diaphragm. Perhaps some patients have a weak urogenital diaphragm. Because subsequent TFS surgery was successful, we attribute the failure to surgical error.

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The TFS was reported in 2005 by Petros and Richardson as the first mini sling.10 The main difference from other mini slings11,12 is the 4 pronged anchor, its mode of action, which is like a grappling hook, and the 1-way tensioning system. This has the unique quality of restoring laterally displaced ligaments and fascia to the correct anatomical position. Our hammock suture supports ligament reconstruction (fig. 2).8 It is considered to have a supportive but not a major role in the continence mechanism. Histology studies in rats revealed that the anchor is entirely covered with collagenous tissue within 2 weeks of implantation.10 This prevents any anchor movement or exposure. In conclusion, results indicate that the TFS mid urethral sling operation is simple, safe and effective procedure that may be done without difficulty at a freestanding clinic on an outpatient basis.

REFERENCES 1. Ulmsten U, Henriksson L, Johnson P et al: An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996; 7: 81. 2. Atherton MJ and Stanton SL: The tension-free vaginal tape reviewed: an evidence-based review from inception to current status. Int J Obstet Gynaecol 2005; 112: 534.

5. Papadimitriou J and Petros PEP: Histological studies of monofilament and multifilament polypropylene mesh implants demonstrate equivalent penetration of macrophages between fibrils. Hernia 2005; 9: 75. 6. Petros PE: The Female Pelvic Floor Function, Dysfunction and Management According to the Integral Theory. Heidelberg: Springer Medizin Verlag 2006; chapt 4, pp 83–167.

3. Petros PE and Richardson PA: Midurethral tissue fixation system (TFS) sling for cure of stress incontinence—3 year results. Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 869.

7. Lose G and Ostergard DR: Medical technology assessment and surgery for stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1999; 10: 351.

4. Papadimitriou JM and Petros PEP: Biocompatible properties of surgical mesh using an animal model. Aust N Z J Obstet Gynaecol 2006; 46: 368.

8. Ostergard DR: The epochs and ethics of incontinence surgery: is the direction forward or backwards? Int Urogynecol J Pelvic Floor Dysfunct 2002; 13: 1.

9. Rechberger, T Rzezniczuk K, Skorupski P et al: A randomized comparison between monofilament and multifilament tapes for stress incontinence surgery. Int Urogynecol J Pelvic Floor Dysfunct 2003; 14: 432. 10. Petros PEP and Richardson PA: The midurethral TFS sling—a ‘micro-method’ for cure of stress incontinence—preliminary report. Aust N Z J Obstet Gynaecol 2005; 45: 372. 11. Martan A, Masata J and Svabík K: TVT SECUR System–tension-free support of the urethra in women suffering from stress urinary incontinence—technique and initial experience. Ceska Gynekol 2007; 72: 42. 12. Debodinance P and Delporte P: MiniArc: preliminary prospective study on 72 cases. J Gynecol Obstet Biol Reprod (Paris) 2009; 38: 144.