Kelly-Keenedy Plication Versus Tension Free Vaginal Tape-Obturator (TVT-O) for the Treatment of Stress Urinary Incontinence: A Randomized Trial

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1 Med. J. Cairo Univ., Vol. 77, No. 2, September: , Kelly-Keenedy Plication Versus Tension Free Vaginal Tape-Obturator () for the Treatment of Stress Urinary Incontinence: A Randomized Trial HAMDY AZAB, M.D.; HATEM I. ABD EL-MOATY, M.D.; SHERIF NEGM, M.D.; AHMAD MAGDI, M.D. and MARYAM MAHMOOD, M.D. The Department of Obstetrics & Gynecology, Faculty of Medicine, Cairo University. Abstract Objective: To compare the objective and subjective cure rates of suburethral plication versus in women with SUI. Methods: This is a randomized comparative trial done at a university hospital. Patients recruited were chosen to have urodynamic evidence of genuine SUI. They were randomized to have either suburethral plication or. Patients were assessed preoperatively and postoperatively at 6 weeks, 6 months, and 12 months intervals. Objective cure rate was evaluated by the cough stress test. Subjective cure rates were evaluated by completing the short forms of an Arabic translation of the Urogenital Distress Inventory (UDI6) and the Incontinence Impact Questionnaire (IIQ7) preoperatively and postoperatively. The secondary outcomes that were evaluated were intraoperative and postoperative complications, voiding dysfunction, and urge symptoms. Results: One hundred ten patients were enrolled for surgery. 8 patients withdrew because of refusal or desire to delay surgery. 102 patients were randomized, 51 allocated for suburethral placation and 51 allocated for procedure. Finally, 50 patients received suburethral plication and 49 patients received procedure, 3 patients were excluded because of medical reasons. 91 patients completed 12 months follow-up; 43 in the suburethral plication group and 48 in the group. There was no significant difference between the two groups regarding type of anesthesia, incidence of blood loss >250 ml, bladder perforation, vaginal perforation, UTI, wound infection, hematoma formation, PVR urine >100 ml, and de novo urge symptoms. plication had significantly shorter operating time compared with (28.4±2.3 Vs 29.9± 1.7, p<0.05). No cases in the sub urethral group suffered from groin pain compared with 5 cases in the group (p<0.05). The objective cure rate defined as a negative cough stress test at 12 months follow-up was similar in both groups. There was no significant difference between the 2 groups regarding the preoperative UDI6 and IIQ7 scores. There was significant improvement in the two scores in both groups postoperatively. Conclusion: After 12 months follow-up, the suburethral plication and the procedure are equally effective in terms of objective and subjective cure rates. There were no significant clinical complications regarding either procedure. Key Words: Kelly-Kennedy plication Anterior colporrhaphy plication SUI. Introduction THE midurethral sling has become the standard treatment of stress urinary incontinence (SUI). The tension free vaginal tape (TVT), introduced in 1996, was the first to be widely used. Numerous studies have demonstrated its efficacy [1,2]. In spite of its proven efficacy and relative safety, some authors have expressed concerns regarding possible complications resulting from the blind retro pubic passage. Bladder perforations, bowel injuries and vascular injuries have been reported [1,2,3]. To avoid these complications, de Laval [4] developed an inside out transobturator tape technique (TVT- O). The transobturator techniques are thought to avoid these complications and proved to be equally effective to the original TVT [5,6]. plication, or Kelly-Kennedy plication, is accomplished through an anterior vaginal incision: a series of plicating mattress sutures of either permanent or delayed-absorbable material is surgically placed beneath the urethrovaginal junction, and any fascial defect that may exist below the urethra and bladder is included. This surgical approach has been reported to have more than a 90% patient-reported success rate, with literature reports of success ranging from 31-69% with a one- to five-year follow-up. Other longterm (4-year results) studies suggested a mean cure rate of 61% (47%-72%). For many years this was the preferred method of treatment. However, since the development of sling and retro pubic urethropexy procedures, this method is not as frequently performed [7,8]. The aim of this study is to compare the subjective and objective success rates of suburethral 139

2 140 Kelly-Keenedy Plication Vs Tension Free Vaginal Tape-Obturator plication versus the as well as the complication related to each procedure. We are proposing that suburethral plication with meticulous surgical technique may keep its place among surgical choices for management of SUI. Materials and Methods This study was carried out during the period from November 2007 to July 2009 at the department of obstetrics and gynecology, Kasr El-Ini hospital, Cairo University. 110 women with a complaint of SUI participated in the study. Local institute approval was taken before starting the study. Informed consents were taken from participating patients. Subjects were included if they demonstrated urodynamic evidence of SUI and desired surgical correction. Patients who required surgery for anterior vaginal wall prolapse were also included. Subjects were excluded if they have clinical or urodynamic evidence of detrusor instability, current urinary tract infection (UTI), post void residual (PVR) urine volume of more than 100 ml, congenital or neurogenic bladder disorder, had previous surgical correction of SUI, or any contraindication to anesthesia and surgery. All patients had careful history taking, general examination, and local examination including a cough stress test, urine analysis, and urodynamic study including simple uro-flowmetry and filling cystometry. The short forms of an Arabic translation of the Urogenital Distress Inventory (UDI6) and the Incontinence Impact Questionnaire (IIQ7) were used preoperatively and postoperatively for subjective assessment of success rate. Women were randomized using sealed envelopes containing the assumed mode of management. Envelopes were picked by the patient and opened by the responsible surgeon on the day of surgery. All women received prophylactic antibiotic just before the surgery. The type of anesthesia, whether general or spinal, was chosen according to the patient and surgeon preference. The technique used for suburethral plication started with injection of sterile saline around the area of bladder neck to facilitate dissection. A midline incision was made in the vaginal mucosa about 1 cm from the external urethral meatus. The incision was extended for 4-5 cm or more if there is associated cystocele. The vaginal mucosa was carefully separated from underlying fascia using combined sharp and blunt dissection. The vaginal mucosa was dissected laterally to reach the pubic bones. Care must be taken to be in the proper plane to preserve as much as possible of endopelvic fascia. The site of bladder neck was marked by inserting a Foley's catheter in the bladder, inflating the balloon with 10 cc saline and withdrawing the catheter gently. The areas of urethrovesical junction, proximal and miduretha were further dissected with the catheter in place. Three pairs of Allis clamps were applied about cm lateral to the previously mentioned areas holding as much as possible of vesico-vaginal fascia. Three to five number 1 silk vertical mattress sutures were used to approximate the tissues held by Allis clamps creating a buttress of fascia supporting the urethrovaginal junction, proximal, and mid urethra. Further rows of simple plicating sutures were used over the entire area using vicryl (00) sutures incorporating the lateral fascia into the midline. The vaginal mucosa was then closed with simple interrupted sutures. The procedure was done according to the following technique. The patient was placed in dorsal lithotomy position with the hips hyper extended. A Foley's catheter was inserted to empty the bladder. The skin exit points were marked by tracing a horizontal line at the level of the urethral meatus and a second line parallel and 2 cm above the first. The exit points were located on this line 2 cm lateral to the folds of thighs mm incisions were made at these points. A vaginal incision was made for 1 cm starting 1 cm from the urethral meatus. Curved scissors were used for blunt dissection at an angle of 45 from midline. The dissection was continued until the junction between the body of pubic bone and the inferior pubic ramus. When this junction is reached the obturator membrane was perforated. The wing guide provided in the kit (gynecare, Ehticon, Johnson & Johnson Co., Smoerville, NJ) was then inserted into the dissected track until a loss of resistance is felt with passage through the obturator membrane. The helical passer was then inserted into the track following the channel of the wing guide. The passer was pushed inwards until passing though the membrane. Once in position the guide was removed. The handle of the helical passer was rotated towards the midline so that the point of the passer exits through the previously made skin incision. The tip of the passer was grasped with a clamp while the passer was removed by a reverse rotation of the handle. The plastic tubes were pulled completely until the tape appears. The same process was repeated on the opposite side. The tape was positioned behind the midurethra without twist or tension. It was adjusted by using the cough test if the patient is conscious or by stretching it allowing a scissor or a clamp to be inserted between it and the urethra

3 Hamdy Azab, et al. 141 if the patient was under general anesthesia. When the tape was in position the plastic sheaths were removed. The vagina was then closed using interrupted sutures. Associated cystoceles were repaired according to the standard technique of anterior colporrhaphy [9]. For either procedure the catheter was removed after 12 hours. After catheter removal post void residual urine was assessed by ultrasonography. Postoperatively, women were assessed at 6 weeks, 6 months and 12 months. The primary outcome was the objective cure rate assessed after 1 year with the cough stress test and the subjective cure rate as assessed by the preoperative and postoperative UDI6 and IIQ7 questionnaires. The secondary outcomes that were evaluated were intraoperative and postoperative complications, voiding dysfunction, and urge symptoms. Data were expressed as mean, median, and standard deviation (SD). Independent samples were compared using the student t test. Paired samples were compared using the paired sample t test. The chi square test and Fisher exact test were used for categorical data. p<0.05 was considered to indicate statistical significance. Statistical analysis was done using the MedCalc computer program. Results One hundred ten patients were enrolled for surgery. 8 patients withdrew because of refusal or desire to delay surgery. 102 patients were randomized using sealed envelopes, 51 allocated for suburethral plication and 51 allocated for procedure. Finally, 50 patients received suburethal plication and 49 patients received procedure, 3 patients were excluded because of medical reasons. 91 patients completed 12 months followup; 43 in the suburethral plication group and 48 in the group. Fig. (1) shows the flow chart of participating patients. The basic characteristics, demographic data and preoperative clinical parameters of all patients are presented in Table (1). There were no significant differences between the two groups. Type of anesthesia, operation time, intraoperative and postoperative complications are shown in Table (2). There was no significant difference between the two groups regarding type of anesthesia, incidence of blood loss >250 ml, bladder perforation, vaginal perforation, UTI, wound in- fection, hematoma formation, PVR urine >100 ml, and de novo urge symptoms. plication had significantly shorter operating time compared with (28.4±2.3 Vs 29.9± 1.7, p<0.05). No cases in the suburethral group suffered from groin pain compared with 5 cases in the group (p<0.05). All cases suffering from groin pain reported marked improvement in the 6 th month follow-up visit. There was one case of wound hematoma in the suburethral plication arm which was managed by release of 3 vaginal sutures and evacuation followed by antibiotic cover and observation. The objective cure rate defined as a negative stress test at 12 months follow-up was similar in both groups. This is shown in Table (3). There was no significant difference between the 2 groups regarding the preoperative UDI6 and IIQ7 scores. There was significant improvement in the two scores in both groups postoperatively. This is shown in Table (4). Fig. (2) shows the improvement in IIQ7 score postoperatively in the sub urethral plication group. Table (1): Patient demographics. plication (n=50) (n=49) p value Age (y, mean±sd) 43.35± ±9.44 NS Parity (median, range) 3 (1-7) 4 (0-9) NS BMI (mean±sd) ± ±4.21 NS Postmenopausal NS Hysterectomy 3 2 NS Cystocele 10 8 NS Duration of symptoms (y, mean±sd) 5.4± ±7.2 NS NS= Non significant. SD= Standard deviation. Table (2): Operative characteristics and complications. plication (n=50) (n=49) p value Anesthesia: General NS Spinal Operation Time (min, mean ± SD) 28.4± ± 1.7 p<0.05 Blood loss >250 ml 0 0 NS Bladder perforation 0 0 NS Vaginal perforation 0 1 NS Groin Pain 0 5 p<0.05 UTI 6 4 NS Wound Infection 1 0 NS Hematoma 1 0 NS PVR > 100 ml: After 24 hours 10 7 NS After 6 weeks 3 2 NS De novo urge symptoms 2 2 NS

4 142 Kelly-Keenedy Plication Vs Tension Free Vaginal Tape-Obturator Table (3): Objective cure rate after 12 months. IIQ7 score Assessed for eligibility (n=110) Allocated to (n=51) Received (n=49) Did not receive (n=2) Reasons: high blood pressure (n=1), tachyarrhythmia (n=1) Follow-up at 12 months (n=48) Lost to follow-up (n=1) Analyzed (n=48) Completed cough stress test (n=43) Completed questionnaires (n=43) plication (n=43) Negative cough 37 (86%) stress test Positive cough 6 (14%) stress test Enrollment Randomized (n=102) Preoperative Allocation Follow-up Analysis (n=48) Excluded (n=8) Refused to participate (n=3) Social reasons (n=5) Allocated to Plication (n=51) Received Plication (n=50) Did not receive Plication (n=1) Reasons: high blood pressure (n=1) Follow-up at 12 months (n=43) lost to follow-up (n=5) Refused follow-up because of being asymptomatic (n=2) Analyzed (n=43) Completed cough stress test (n=43) Completed questionnaires (n=43) Postoperative p value 44 (91.7%) NS 4 (8.3%) Fig. (1): Flow chart of participating patients. Fig. (2): IIQ7 for the suburethral plication group. Table (4): Subjective assessment using the UDI6 and IIQ7 forms. plication (n=43) Preoperative UDI6 12.2±2.09 IIQ7 16.8±3.25 Postoperative 3.93± ±2.19 Preoperative 12.5± ±3.18 (n=48) Postoperative 3.94± ± 1.75 p+ Within group analysis using paired t test. p# In between group analysis using independent sample t test. Data are expressed as mean ±SD. Discussion p+ p# value value p<0.001 NS p<0.001 NS Over 200 procedures designed to cure urinary incontinence have been described in the medical literature, denoting that no single procedure is ideal [10]. In 1993, Ulmsten and Petros proposed the Integral Theory, postulating that stress and urge are defective flow symptoms that may arise from laxity in the vagina or its supporting ligaments. Using this theory and the hammock hypothesis previously proposed by DeLancey and Richardson [11], Ulmsten et al. postulated that re-creation of the pubourethral ligament and support of the suburethral vagina are essential in treating SUI. This finding led to development of the original tension-free urethropexy. Retropubic midurethral slings were introduced in Their wide applicability and technical simplicity have led to their widespread use, and they have become the preferred surgical treatment of stress incontinence by most surgeons [12]. The TVT sling is placed at the mid urethra. The rationale behind transvaginal tape is that a tissue reaction to the polypropylene mesh tape produces a controlled longitudinal deposition of collagen along the length of the tape, forming a collagen scar that simulates the urethral support mechanism of the pubourethral ligaments. This scar secures proper fixation of the mid urethra to the pubic bone and simultaneously reinforces the suburethral vaginal hammock and its connection to the pubococcygeus muscles [13]. Anterior repair with plication of the fascia lying between the vaginal mucosa, urethra and bladder base has been used for decades for the treatment of stress incontinence and prolapse of the anterior vaginal wall. It is a low morbidity procedure with a relatively low risk of complications, short period of hospitalization and quick recovery. Unfortunately the long-term success for the treatment of stress incontinence is low, with objective cure rates at 1 year approximately 65-70% which drop to 37% at 5 years. A few surgeons may have higher success

5 Hamdy Azab, et al. 143 rates with anterior repair when care is taken to take deep bites of tissue in the fascia incorporating the area described as the pubourethral ligament located superior and lateral to the urethra [14]. In this study we tried to compare the effectiveness of suburethral plication versus one of the midurethral minimally invasive sling operations; the. We used a meticulous surgical technique in performing suburethral plication with proper dissection preserving the vesicovaginal fascia as possible. We took generous bites of fascia on either side of the bladder neck, proximal, and miduretha. These bites were approximated in midline to form a buttress using silk sutures to hold in place for a long time. This was followed by a layer of fascia plicated using vicryl sutures starting as lateral as possible. We are suggesting that this 2 layer repair will finally provide a hammock formed of fibrous and scar tissue that will maintain a support more or less similar to what obtained by tension free tapes. After 1 year, our objective cure rate for the suburethral plication was 86% which was not significantly different from that obtained by the (91.7%). The higher success rate in both groups compared to other studies [15] could be due to the younger age of our patients and the exclusion of patients with mixed SUI. Both procedures showed significant postoperative improvement of the UDI6 and IIQ7 questionnaires. The operation time for suburethral plication was significantly shorter compared with the TVT- O. There was no significant difference between the two procedures regarding the postoperative complications except for higher incidence of groin pain in the group. However, all cases reported resolving of pain within 6 months. The main problem with this study is the limited follow-up for 12 months only. However, based on our promising data we are opening the door for longer studies. Further trials in the same field should test if suburethral plication should be restricted for patients without intrinsic sphincter deficiency or it can be used for such patients. It appears, according to our findings, that suburethral plication is comparable to regarding the success rate and side effects profile, however, this needs to be verified by long term follow-up studies. We are suggesting that this procedure should be saved from the medical museum and kept among the surgical armamentarium of stress incontinence operations. It appears that suburethral plication would be suitable for patients suffering from SUI and cystocele. Moreover, in developing countries with low income resources the operation could be among the choices of relatively young patients suffering from distressing symptoms who have not made final decision regarding future child birth. References 1- WARD K.L. and HILTON P.: A prospective multicenter randomized trial of tension free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am. J. Obstet. Gynecol., 190: , MESCHIA M., PIFAROTTI P., BERNASCONI F., et al.: Tension free vaginal tape: analysis of outcomes and complications in 404 stress incontinent women. Int. Urogynecol. J. Pelvic Floor Dysfunct, 12 Suppl: S24-7, KARRAM M.M., SEGAL J.L., VASSALLO B.J. and KLEEMAN S.D.: Complications and untoward effects of tension free vaginal tape procedure. Obstet. Gynecol., 101: , DE LAVAL J.: Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur. Urol., 44: , LAURIKAINEN E., VALPAS A., KIVELÄ A., KALLI- OLA T., RINNE K., TAKALA T. and NILSSON C.G.: Retro pubic compared with transobturator tape in treatment of urinary incontinence. A randomized controlled trial. Obstet. Gynecol., 109: 4-11, BARBER M.D., KLEEMAN S., KARRAM M.M., PA- RAISO M.F., WALTERS M.D., VASAVADA S. and ELLERKMANN M.: Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet. Gynecol., 111 (3): , NAGER C.W. and KANE A.R.: Operative Management of Urinary Incontinence. In: Gibbs RS, Karlan BY, Haney AF, Nygaard IE, editors. Danforth s Obstetrics and Gynecology. 10th ed. Philadelphia, PA: Lippincott Williams & Wilkins, Ch. 52, ROBERT M. and FARREL S.: Choice of surgery for stress urinary incontinence. J. Obstet. Gynaecol. Can., 27 (10): , DENG D.Y., RUTMAN M.P., RODRIGUEZ L.V. and RAZ S.: Anterior Compartment. In: Zimmern PE, Norton PA, Haab F, Chapple CCR, editors. Vaginal Surgery for Incontinence and Prolapse. Springer-Verlag London Limited, Ch 11, WALL L.L.: Urinary stress incontinence. In: Rock JA, Thompson JD, editors. TeLinde s operative gynecology. 8th ed. Philadelphia: Lippincott-Raven, p , DeLANCEY J.O.L. and RICHARDSON A.C.: Anatomy of genital support. Clin. Obstet. Gynecol., 175: , JHA S., ARUNKALAIVANAN A.S. and DAVIS J.: Surgical management of stress urinary incontinence: a questionnaire based survey. Eur. Urol., 47: , 2005.

6 144 Kelly-Keenedy Plication Vs Tension Free Vaginal Tape-Obturator 13- GHONIEM G.M. and KHATER U.M.: Sling/Tension- Free Vaginal Tape. In: Davila GW, Ghoniem, Wexner SD, editors. Pelvic Floor Dysfunction A Multidisciplinary Approach. Springer-Verlag London Limited, Ch.6, JABS C.F.I., DRUTZ H.P. and CURRIE I.: Surgical approaches to female stress urinary incontinence. In: Drutz HP, Herschorn S, Diamant NE, editors. Female Pelvic Medicine and Reconstructive Pelvic Surgery. Springer-Verlag London, Ch. 6, ROUMEGUERE T., QUACKELS T., BOLLENS R., degroote A., ZLOTTA A., BOSSCHE M.V. and SCHULMAN C.: Trans-obturator vaginal tape (TOT) for female stress incontinence: one year follow-up in 120 patients. Eur. Urol., (48) 5: 805-9, 2005.