Effects of the REMEEX System in Female Patients with Intrinsic Sphincteric Deficiency and Recurrent Urinary Incontinence: 3-Year Outcomes

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1 LUTS (2012) 4, ORIGINAL ARTICLE Effects of the REMEEX System in Female Patients with Intrinsic Sphincteric Deficiency and Recurrent Urinary Incontinence: 3-Year Outcomes Phil H. SONG, Chang H. HYUN, Esther SHIN, and Hee-C. JUNG Department of Urology, College of Medicine, Institute of Biomedical Engineering, Yeungnam University, Daegu, Korea Objectives: To evaluate the long-term outcomes of the REMEEX system (EXternal MEchanical REgulation, Neomedic International, Terrassa, Barcelona, Spain) for the treatment of recurrent urinary incontinence (UI) and intrinsic sphincteric deficiency (ISD). Methods: From August 2006 to September 2007, a total of 30 patients underwent REMEEX system. Patients were categorized into failed UI (Group A, 11 patients) and ISD (Group B, 19 patients). The success rate of patients after surgery was assessed by cure and satisfaction rates postoperatively at follow-up at 1, 12, and 36 months. Clinical, urodynamic, perioperative, and postoperative data of success rates were analyzed. Results: Total cure rates with REMEEX system(group A/Group B) were 100.0/94.7% at 1 month and 90.9/79.0% at 3 years. Satisfaction rates were 100.0/89.5% at 1 month and 81.8/68.4% at 3 years in groups A and B. Two patients (6.7%) experienced wound infections. Of these, one patient was treated using intravenous antibiotics and the other had their varitensor removed. Other minimal postoperative complications were immediately resolved. Conclusion: The REMEEX system may be an effective procedure regardless of previous incontinence surgical interventions and ISD. The correct sling tension is easily achieved during the early postoperative period, and when necessary, is able to convert late failures into cures. The problems of recurrent UI during the follow-up period were also resolved successfully in every case. Key words midurethral sling, urinary incontinence, urologic surgical procedure 1. INTRODUCTION After Petros and Umsten first introduced the integral theory in 1993, the tension-free vaginal tape (TVT) procedure was developed. 1 Thereafter, the midurethral sling procedure was accepted as a standard treatment for stress urinary incontinence (SUI). Long-term follow-up studies have reported that the success rate is approximately 85 90%. 2 4 But complications of midurethral sling procedure have been reported to occur in the presence of a diagnosis of mixed UI, performance of paraurethral surgery, presence of concurrent neurological deficits, and history of radiation therapy. 5 In other words, cure and satisfaction rates have been relatively lower in cases in which there are any factors for intrinsic sphincteric deficiency (ISD). 5 To resolve these problems, a procedure was developed where a sling was placed more proximally to the midurethra or in the neck of urinary bladder unlike previous sling procedures; the REMEEX system (EXternal MEchanical REgulation, Neomedic International, Terrassa, Barcelona, Spain) procedure. 6 This procedure is different from previous types of midurethral sling procedures not only because the tension is exerted to the neck of the urinary bladder and proximal urethra using polypropylene monofilament but also because a device controlling the tension is permanently placed in the lower abdomen. This has been proposed as a surgical modality that can compensate for the demerits of surgery in type III according to the classification of UI by Blaivas and Olsson, 7 that the proximal urethra cannot be further functional. Given the above background, we retrospectively evaluated 3-year outcomes and complications of the REMEEX system procedure in female patients with ISD and recurred UI after previous anti-incontinence surgery. 2. METHODS 2.1. Patients Between August 2006 and September 2007, 34 consecutive female patients with UI underwent REMEEX system procedure by a single operator. Of the 34 patients, 30 (mean ± SD age, 62.4 ± 10.1 years) were followed up for Correspondence: Hee-Chang Jung, MD, PhD, Department of Urology, College of Medicine, Yeungnam University, Daemyung-dong, Nam-gu, Daegu , Korea. Tel: ; Fax: junghc@ynu.ac.kr Received 5 October 2011; revised 18 January 2012; accepted 30 January DOI: /j x

2 Effects of the REMEEX System 121 at least 3 years (mean, 50.7 months; range, 46 59). The remaining four patients were lost to follow-up because they did not respond when contacted by mail and telephone. Of 30 patients, 7 (23.3%) had mixed UI. All patients visited the clinic at 1 month, 1 year, and 3 years after surgery. We divided the patients into two groups: recurred UI after previous anti-incontinence surgery (Group A, 11 patients), and ISD due to neurological factors (Group B, 19 patients). The patients in Group A redeveloped SUI that was about the same as their previous anti-incontinence procedure conditions. At first, anticholinergics medications were applied to distinguish their UI from de novo urge incontinence. However, this UI was different from de novo urge incontinence Preoperative evaluations Preoperative evaluations included medical history, obstetric history, international prostate symptom score (IPSS), physical examination including Q-tip test and stress test, 3-day voiding diary, 1-h pad test, uroflometry, postvoid residual (PVR) urine measurement, and multichannel urodynamic investigation. Urodynamic studies were performed according to International Continence Society standards. 8 An analysis of urodynamic parameters included peak flow rate, maximum cystometric capacity, maximum detrusor pressure, maximum urethral closure pressure (MUCP), and valsalva leak point pressure (VLPP) Procedure The REMEEX system was performed by a single urologist. 9, Surgical methods using REMEEX system (Fig. 1) First, the anterior vaginal wall was incised at the site of urethra bladder anastomosis. Thus, the paraurethral tissue and paracystic tissue were incised at a length of approximately 3 4 cm. In the superior region to the pubic symphysis, a 4-cm incision line was made to the transverse direction. Until the fascia of the rectus abdominis muscle was exposed, the subcutaneous tissue was sufficiently dissected. The threads were placed most closely to the posterior region to the pubis from the lateral side of urethra with the help of a passer handle, and they penetrated into the rectus abdominis muscle. The same maneuver was performed for the contralateral side. The threads passing the inferior abdominal line penetrated into a varitensor from bilateral directions. Then, at a height of approximately 10 cm, they were fixed. Following confirmation of whether a mesh was correctly placed at the site of urethra bladder anastomosis, tension was exerted and the threads were tightened. Following confirmation of a lack of cystic perforation on cystoscopy, the threads passing the lower abdominal area were tightened. Thus, it was examined whether the tension was well exerted. After placing a varitensor on the transverse plane, a manipulator was continuously rotated to a clockwise direction to make sure that it should be Fig. 1 Components of the REMEEX system. A, thread; B, mesh; C, uncoupler (disconnector); D, varitensor; E, manipulator. separated at a gap of approximately two-finger width distance (approximately 3 cm). The anterior vaginal wall and the inferior abdominal area were sutured through general methods Postoperative management of REMEEX system On the following day of surgery, a 16-Fr. foley catheter was removed and self-voiding was attempted accordingly. If urine leakage was persistently present with no respect to the elevation of abdominal pressure, the manipulator was rotated four cycles clockwise direction. This was followed by self-voiding. In patients who could perform self-voiding, the urinary bladder was filled with saline at a volume of approximately ml. This was followed by a stress test. Again, if urine leakage was persistently present, the manipulator was rotated four cycles clockwise. Conversely in patients who could not perform self-voiding and developed urinary retention, the manipulator was rotated at four cycles counter-clockwise. This maneuver was repeated until patients could perform selfvoiding and the amount of residual urine reached a value of less than 100 ml. The manipulator was dissembled from the varitensor with the use of a disconnector. Then, the empty space was sutured using nylon 3-0 silk. Subsequent access to the varitensor is achieved with minimal incision under local anesthesia, locking a sterile manipulator in place to re-adjust the tension up or down when necessary during follow-up Follow-up evaluation All patients were asked to visit the clinic at 1 month, 1 year, and 3 years after surgery, at which time they were evaluated with a careful symptom review, physical examination, uroflowmetry with PVR urine measurement, and postoperative complications associated with the REMEEX system. Questions about satisfaction with the procedure were answered by the patient in the clinic Definition The severity of UI was evaluated based on its definition according to the International Continence Society, 8 and

3 122 Phil Hyun Song et al. TABLE 1. Preoperative clinical characteristics of the patients Group A (n = 11) Group B (n = 19) Variable Mean ± SD (range or %) Mean ± SD (range or %) Mean age (years) 54.9 ± 9.5 (45 73) 66.7 ± 7.8 (56 81) Parity 2.6 ± 1.1(0 4) 4.4 ± 1.7(2 8) Menopause 7 (63.6) 19 (100.0) Mean body mass index (kg/m 2 ) 23.9 ± 3.8 ( ) 24.1 ± 3.5 ( ) Duration of symptoms (years) 3.9 ± 3.3 (1 10) 6.4 ± 6.6 (0.3 24) Follow-up period (months) 50.9 ± 3.9 (46 59) 50.7 ± 3.5 (46 59) Mixed urinary incontinence 1 (9.1) 6 (31.6) Stamey grade I 10 (90.9) 3 (15.8) II 1 (9.1) 3 (15.8) III 0 13 (68.4) IPSS 13.7 ± 7.7 (6 33) 19.2 ± 7.5 (7 31) QoL 3.9 ± 2.0(0 6) 5.1 ± 0.7(4 6) 1-h pad test (g) 33.2 ± 13.8 (10 50) 54.9 ± 70.8 (10 280) Urodynamic parameters Peak urinary flow (ml/s) 22.9 ± 9.0 ( ) 15.8 ± 7.5 ( ) Voided volume (ml) ± 70.3 ( ) ± (62 478) Postvoided residual (ml) 28.9 ± 19.4 (0 55) 33.4 ± 51.6 (0 218) Max. cystometric capacity (ml) ± 65.8 ( ) ± (97 562) Max. detrusor pressure (cmh 2 O) 8.6 ± 3.4 (3 15) 25.1 ± 21.3 (3 87) VLPP (cmh 2 O) 69.8 ± 5.0 (64 79) 41.5 ± 9.0 (27 53) No. detrusor overactivity 1 (9.1) 11 (57.9) Mean operation time (minutes) ± 43.5 (40 200) 90.2 ± 30.5 (60 180) No. anesthesia (%) Spinal 6 (54.5) 17 (89.5) General 5 (45.5) 2 (10.5) Mean hospital stay 7.5 ± 2.4 (4 10) 8.6 ± 3.6 (4-18) Duration of indwelling catheter (days) 1.5 ± 0.5(1 2) 1.5 ± 1.2 (1-6) Group A, recurred urinary incontinence after previous anti-incontinence surgery; Group B, intrinsic sphincteric deficiency. IPSS, international prostate symptom score; QoL, quality of life; VLPP, valsalva leak point pressure. was classified into Grade I (presence of urine leakage due to sudden elevation of severe abdominal pressure in situations such as coughing, running or laughing), Grade II (presence of urine leakage even in the presence of relatively milder elevation of abdominal pressure [i.e. walking or from sitting-to-standing position]) and Grade III (continuously leaked with no respect to increased abdominal pressure). Patients were considered to have ISD identified by a measurement of VLPP < 60 cmh 2 O in the sitting position with a volume of 150 ml in the bladder or a measurement of MUCP < 20 cmh 2 O in the sitting position with a volume of 200 ml in the bladder. 8,11 For the assessment of successful surgical outcomes, according to Stamey grade, 12 cure was defined as complete lack of involuntary urine leakage during stressful activities and a stress cough test. Improvement was defined as a significant reduction of urine leakage, such that it did not require further treatment. All other outcomes were regarded as failure. 3 The degree of subjective satisfaction was graded as very satisfied, satisfied, so-so and unsatisfied. The very satisfied and satisfied were determined to be satisfied postoperative outcomes Statistical analysis Normally distributed variables were compared using Student s t-test. A 5% level of significance was used for all statistical testing and all statistical tests were two-sided. An analysis was performed using Statistical Package for the Social Sciences version 17.0K (SPSS Inc., Chicago, IL, USA). 3. RESULTS Baseline characteristics of the 30 patients are shown in Table 1. In Group A, patients who underwent anti-incontinence surgery comprised six transobturator tape (TOT), three TVT, one innovative replacement of incontinence surgery (IRIS), and one Marshall-Marchetti-Krantz (MMK). In Group B, past surgical history included three cases of other pelvic surgery, such as hysterectomy and uterine prolapse repair, seven cases of spine surgery, and two of brain surgery. Past medical history showed six cases of hypertension, five of diabetes mellitus, four of cerebrovascular accident, one of Parkinson s disease, three of spine fracture, one of herniated lumber disc, and one of major mood disorder (Table 2). At 1 month after surgery, all (cure 84.6%, improvement 15.4%) patients were rated as cured in Group A and 94.7% (cure 81.6%, improvement 13.1%) in Group B. At 3 years after surgery, 90.9% (cure 79.4%, improvement 11.5%) in Group A, and 79.0% (cure 73.2%, improvement 5.8%) in Group B were rated as cured. In terms of subjective satisfaction, at 1 month after surgery, all (very satisfied 45.5%, satisfied 54.5%)

4 Effects of the REMEEX System 123 TABLE 2. Past medical histories of the subjects in each group Group A (N = 11) No. (%) Previous anti-incontinence surgery 11 (100.0) TOT 6 (54.5) TVT 3 (27.3) IRIS 1 (9.1) MMK 1 (9.1) Group B (N = 19) No. (%) Previous other pelvic surgery 3 (15.8) Hysterectomy 2 (10.5) Cystocele repair 1 (5.3) Previous spine surgery 7 (36.8) Previous brain surgery 2 (10.5) Previous medical problem Hypertension 6 (31.6) Diabetes mellitus 5 (26.3) Cerebrovascular accident 4 (21.1) Parkinson s disease 1 (5.3) Spine fracture 3 (15.8) Herniated lumbar disc 1 (5.3) Major mood disorder 1 (5.3) Group A, recurred urinary incontinence after previous anti-incontinence surgery; Group B, intrinsic sphincteric deficiency. TOT, transobturator tape; TVT, tension-free vaginal tape; IRIS, innovative replacement of incontinence surgery; MMK, Marshall-Marchetti-Krantz. patients were rated as satisfied in Group A and 89.5% (very satisfied 42.1%, satisfied 47.4%) in Group B. At 3 years after surgery, 81.8% (very satisfied 36.4%, satisfied 45.4%) in Group A and 68.4% (very satisfied 31.6%, satisfied 36.8%) in Group B were rated as satisfied (Fig. 2). Of 30 patients, 14 (46.7%) benefited from an immediate postoperative readjustment due to continuance of urine leakage (eight patients in Group A, five in Group B) and obstructive voiding symptoms (one patient in Group B). Eight (26.7%) presented with recurrent UI at 3 years follow-up after surgery. Three of these patients refused to be further readjusted reporting enough improvement in their continence, whereas two are on the waiting list for readjustment. Three patients underwent late readjustment under local anesthesia after surgery (10 34 months) (Table 3). Intraoperative complications occurred in five cases (16.7%); bladder perforations in four and urethral injury in one (Table 4). In cases of bladder perforations, a urethral catheter was placed for a maximum period of 6 days. In one case of severe hematuria, transurethral electrocauterization was performed immediately after surgery. As for postoperative complications, there was transient urinary retention, suprapubic discomfort, wound infection, and de novo urgency (Table 4), but all of these symptoms, except wound infection resolved immediately. Two patients (6.7%) experienced wound infections. Of these, one patient was treated using antibiotics medications but the other had their varitensor removed. 4. DISCUSSION TVT procedure, based on the integral theory, 1 has become one of the most popular techniques for the treatment of SUI owing to its ease and effectiveness. Published series with long-term follow-up show good continence rates after TVT procedure ranging from 80 to 90%. 3,13 However, the disadvantage of the midurethral sling procedure, such as the TVT procedure, is that the rate of surgical failure is relatively higher in patients with ISD. 14,15 Given the above background, we conducted the present study to assess the clinical usefulness of the REMEEX system, which has recently been attempted as a novel type of treatment regimen in patients with recurred UI after previous anti-incontinence surgery as well as in patients with ISD. In the present study, the objective cure rate with REMEEX system at 3 years after surgery was 90.9% in Group A and 79.0% in Group B. These results were similar Fig. 2 Objective and subjective success rates of REMEEX system at 1, 12 and 36 months in groups A and B. Group A, recurred urinary incontinence group after previous anti-incontinence surgery; Group B, intrinsic sphincteric deficiency group.

5 124 Phil Hyun Song et al. TABLE 3. Status of eight patients with recurrent urinary incontinence at 3-year follow-up after surgery Patient no. Duration Readjustment Readjustment period after postoperative regulation Objective success after 3 years Subjective success after 3 years 1 3years (+) 34 months Cure Very satisfied 2 3years ( ) ( ) Failure Satisfied 3 1month ( ) ( ) Failure Satisfied 4 3 years Waiting list Waiting list Failure Unsatisfied 5 1year (+) 19 months Cure Satisfied 6 1year ( ) ( ) Failure Satisfied 7 3 years Waiting list Waiting list Failure So-so 8 1year (+) 10 months Cure Very satisfied Duration, duration of recurrence urinary incontinence after postoperative regulation. TABLE 4. Intraoperative and postoperative complications Group A (N = 11) Group B (N = 19) No. (%) No. (%) Intraoperative complications (N = 5) Bladder perforation 3 (27.3) 1 (5.3) Urethral injury 1 (9.1) 0 Postoperative complications at 1-month follow-up (N = 4) De novo urgency 0 1 (5.3) Wound infection 2 (18.2) 0 Acute urinary retention 1 (9.1) 0 Postoperative complications at 1-year follow-up (N = 4) De novo urgency 1 (9.1) 1 (5.3) Suprapubic discomfort 1 (9.1) 1 (5.3) Postoperative complications at 3-year follow-up (N = 2) De novo urgency 0 2 (10.5) Group A, recurred urinary incontinence after previous anti-incontinence surgery; Group B, intrinsic sphincteric deficiency. to those reported in other series about REMEEX system procedure. 9,16 The 3-year follow-up results were possible using late readjustment in three patients to achieve continence. This adjustability of the REMEEX system procedure allowed the patients to regain continence in cases that would have required another surgery if they had been treated with non-adjustable procedures. As previous results of other procedures in patients with recurred UI after surgery, Kocjancic et al. 17 reported a cure rate of 77.6% using ACT (adjustable continent therapy) and Eandi et al. 18 reported a cure rate of 70% using a TVT procedure. Compared with these reports, the efficacy of REMEEX system procedure was relatively higher in our clinical series. In particular, based on the findings that the degree of patient satisfaction was 81.8%, corresponding to a higher value, it is presumed that the REMEEX system procedure is effective for patients with recurred UI after anti-incontinence surgery. In UI due to neurological deficits, Rapp et al. 19 showed a cure rate of 76.3% using suprapubic arc (SPARC). Their finding of increased success in resolution of UI by ISD was similar to that reported in the present study. In recent years, it has also been reported that a retropubic route is more effective for the surgical treatment of patients with ISD as compared with a transobturator route 20. Regarding intraoperative complications in the present study, bladder perforation occurred at a frequency of 27.3 and 5.3% in groups A and B, respectively. These rates were higher than the rates of % seen in previous reports about REMEEX system procedure as well as conventional types of midurethral sling procedure 6,21. This might be not only because the paravaginal tissue underwent fibrotic change due to a mesh used for the previous surgical procedure but also because the other space was penetrated to avoid the previous mesh. Despite the occurrence of bladder perforation, catheter drainage for a short period of time was sufficient for complete bladder healing. When monitoring the postoperative clinical course, similar to Gold et al., 22 there were no significant differences in the cure rate and satisfaction rate between the two groups. There were two cases of wound infection in the present study. One (3.3%) of these patients had their varitensor removed. The removal of a varitensor is required in cases of wound infection, seroma, and hematoma. The patient had a mild skin wound infection and their varitensor was not removed. That case resolved within 1 week with oral antibiotics medication. There was no significant difference from rates of % reported in other series. 23 If a varitensor needed to be removed due to the infections, the residual threads after the varitensor was removed under local anesthesia were tied by exerting the tension whose intensity was not so strong as to cause a urine leakage on an intraoperative stress test. This maneuver was similar to the methods introduced by Iglesias and Espuña. 9 Nevertheless, there was no significant difference in the postoperative clinical course in this study. In the present study, three patients rated that they were satisfied with the REMEEX procedure although their objective surgical outcomes were a failure. We explained the necessity of re-adjustment to regain continence, although the degree of redeveloped SUI was more decreased than the previous REMEEX procedure conditions. However, these patients refused, presumably because they were old (>72 years) and did not feel highly uncomfortable with their current symptoms. However, it is important that we follow them up for a long time.

6 Effects of the REMEEX System 125 In conclusion, the REMEEX system procedure might be an effective surgical treatment modality for female patients with recurred UI after an anti-incontinence surgery as well as those with ISD. The correct sling tension is easily achieved during the early postoperative period, and when necessary, can convert late failures into cures. The problems of recurrent UI during the follow-up period were also resolved successfully in every case. There are associated intraoperative and postoperative complications but correction of these complications is relatively simple and cause practically no morbidity. The absence of adverse events and high subjective and objective postoperative success rates make the REMEEX system procedure a recommendable surgical treatment for female recurred UI after anti-incontinence surgery as well as for ISD. Acknowledgment This research was supported by the Yeungnam University research grants in Disclosure The authors declare no conflict of interest. REFERENCES 1. Petros PE, Ulmsten UI. An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand J Urol Nephrol Suppl 1993; 153: Chêne G, Amblard J, Tardieu AS et al. Long-term results of tension-free vaginal tape (TVT) for the treatment of female urinary stress incontinence. Eur J Obstet Gynecol Reprod Biol 2007; 134: Song PH, Kim YD, Kim HT et al. The 7-year outcome of the tension-free vaginal tape procedure for treating female stress urinary incontinence. BJU Int 2009; 104: Liapis A, Bakas P, Creatsas G. Long-term efficacy of tensionfree vaginal tape in the management of stress urinary incontinence in women: efficacy at 5- and 7-year follow-up. Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: Clemons JL, LaSala CA. 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