A three-year follow up of tension free vaginal tape for surgical treatment of female stress urinary incontinence

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1 British Journal of Obstetrics and Gynaecology April 1999, VO~ 106, pp A threeyear follow up of tension free vaginal tape for surgical treatment of female stress urinary incontinence Ulf Ulmsten Professor, Per Johnson Associate Professor, Masoumeh Rezapour Associate Professor Department of Obstetrics and Gynaecology, Uppsala University Hospital, Uppsala, Sweden Objective To study the long term results of tensionfree vaginal tape, a new ambulatory surgical procedure for treatment of female stress urinary incontinence. Study design A prospective open study using a standardised protocol for pre and postoperative evaluation. Participants Fifty consecutive women participated in the study. All suffered from genuine stress incontinence. The mean age was 57 years (SD ll), 42 women (84%) were multiparous, 8 (16%) nulliparous. Surgical method Tensionfree vaginal tape implies the implantation of a prolene tape around midurethra via a minimal vaginal incision. The procedure is carried out under local anaesthesia, allowing the surgeon to check intraoperatively that continence has been obtained. Results All the women except one could be operated on an ambulatory basis under local anaesthesia. Mean operation time was 29 minutes (range 1647). Ninety percent of the women were able to micturate spontaneously within 24 hours with insignificant residual volumes. In another 10% of the women an indwelling catheter had to be used temporarily. There was no need for long term postoperative catheterisation (> 14 days). Postoperative evaluation was carried out after 2 to 6, 12,24 and 36 months. According to the protocol, 86% of the women were completely cured and another 11% were significantly improved. No signs of deterioration of the results over time were observed. No defect in healing or rejection of the tape occurred. Conclusion We consider the tensionfree vaginal tape operation to be a safe and effective surgical procedure for the treatment of female urinary stress incontinence. The technique can be considered as an ambulatory procedure performed under local anaesthesia, allowing the majority of the women to be discharged from the clinic the same day or the day after the procedure. INTRODUCTION We have previously reported the preliminary results of a new ambulatory surgical technique now called tensionfree vaginal tape for the treatment of female urinary stress incontinence'. It is based on a series of experimental investigations on the urethral closure mechanisms in women2. The preliminary results were encouraging, showing a cure rate of more than 85%. The present investigation was aimed to study the long term results (i.e. the outcomes three years after surgery). It was designed as a prospective open study of the standardised tensionfree tape technique using a special protocol for the evaluation of the outcomes. Since the tensionfree vaginal tape operation was originally described as an ambulatory surgical procedure Correspondence: Dr U. Ulmsten, Department of Obstetrics and Gynaecology, Uppsala University Hospital, SE Uppsala, Sweden. performed under local anaesthesia, the proof of this statement was also examined in the present study. The study was approved by the local ethics committee, and all women gave informed consent. METHODS A special protocol was devised for the pre and postoperative evaluation according to the following criteria: 1. A thorough history was taken of the duration and the severity of the stress incontinence. 2. A stress provocation test was performed in the supine and standing positions with a comfortably filled bladder (250 ml bladder volume recorded by ultrasound). 3. A 24 to 48 hour padtest was carried out3. 4. A quality of life evaluation was ~ndertaken~.~. 5. Urodynamic evaluation with urethrocystometry and urethral profile measurement were performed6. 6. The postoperative evaluation also included exam 0 RCOG 1999 British Journal of Obstetrics and Gynaecology 345

2 ~ ~~~~ 346 u. ULMSTEN ET AL ination of the casenotes with regard to operation time, intra and postoperative complications, voiding problems, signs of urinary infection, bleeding, defective healing and other complications. Participants Fifty consecutive women participated in the study. Their mean age was 57 years (SD 11). Fortytwo women (84%) were multiparous, and 8 (16%) nulliparous. Women with urge incontinence and prolapse were excluded. All postmenopausal women were taking systemic or local oestrogen therapy. In all the women the duration of symptoms was more than three years. The mean severity of the symptoms was grade II (range IIII), according to the IngelmanSundberg scale7, meaning that the women leaked urine daily on coughing, sneezing and running. The characteristics of the women are given in Table 1. All operations were primary procedures, and they were carried out irrespective of a low or high resting urethral pressure. Ten women in the present study also participated in a short term Scandinavian multicentre study'. The preoperative urodynamic data are given in Table 2. Surgical procedure As described previously' the main aims of the tensionfree vaginal tape operation are to reinforce 'functional' pubourethral ligaments, thereby securing proper fixation of the midurethra to the pubic bone and simultaneously reinforcing the suburethral vaginal hammock and its connection to the pubococcygeus muscles'2. Briefly the procedure is performed as follows: The operation is carried out under local anaesthesia using 0.25% prilocaine with adrenaline. In general 60 ml of this solution is injected abdominally in the skin above the symphysis, and along the back of the pubic bone. Another 40 ml is injected intravaginally. Two minimal (1 cm) incisions, 5 cm apart, are made in the abdominal skin just above the superior rim of the pubic bone. A sagittal incision 1.5 cm long is made in the suburethral vaginal wall starting 1 cm from the external urethral meatus. After minimal bilateral paraurethral dissections of the vaginal wall a special prolene tape (Ethicon Inc., Sommerville, New Jersey, USA) covered by a plastic sheath is introduced using a two component needle instrument (MedScand Medical, Malmo, Sweden) (Fig. 1). The tip of this needle first perforates the urogenital diaphragm, and withm the retropubic space the needle tip just internal to the pubic bone is brought up to the abdominal incision (Fig. 2). The procedure is then repeated on the other side. The tape therefore is placed in a Uformed shape around the midurethra (Fig. 3), where the highpressure part of the organ is located, and, from functional aspects, the main insertion of the pubourethral ligaments and pubococcygeus muscles are arranged'.2.6,y. After cystoscopy to make sure that the bladder is undamaged, the tape is adjusted without tension under the urethra. During this adjustment the woman is asked to cough to confirm that she has become continent by the procedure. The plastic sheath covering the prolene tape is removed and, due to the strong friction between the special prolene tape and the narrow tissue canals created by the procedure, no fixation of the tape is necessary and should not be carried out. The vaginal and abdominal incisions are then closed, after cutting the abdominal ends of the tape in the subcutaneous tissue without any fixation. In case of a loose suburethral vaginal wall, excessive tissue is excised before closure of the vaginal incision. One advantage of this procedure is that the surgeon can make sure that continence (i.e. no urinary leakage on coughmg) has been obtained during the operation, without elevation of the urethra, thereby avoiding postoperative urinary retention. By the same token, the operation is individualised, since the adjustment of the tape is carried out according to each Table 1. Patients characteristics. Values are given as mean (SD). Parity Leakage per 24 h (g) No. of micturitions per 24 h No. of Age Operation time women (years) Multiparous Nulliparous heoperative Postoperative Preoperative Postoperative (fin) (11) (74) 9 (2) 7.2 (1.7) 5.8 (2.5) 29 (10) Table 2. Reoperative urodynamic variables. Values are given as mean (SD). Maximum urethral Urethral closure pressure Volume at first desire (ml) pressure at rest (cm H20) Urethral length (mm) at stress (cm H20) Residual urine (ml) 169 (71) 57.5 (18) 31 (4) I 0 in all women 19 (21)

3 VAGINAL TAPE TO TREAT URINARY INCONTINENCE 347 Fig. 1. Tensionfree vaginal tape instrument. The instrument consists of two needles to which a prolene tape covered by a plastic sheath is connected. Each needle can be mounted to a handle for insertion of the tape. When the needle tip has reached the abdominal incision the needle is disconnected from the handle. A cathether guide introduced into the Foley catheter facilitates identification of the urethra and bladder neck. Simultaneously this catheter guide enables the bladder neck to be moved sideways, in turn avoiding injury to the bladder neck at insertion of the needle. Fig. 2. Schematic illustration of insertion of the needle. Directly after the needle tip has perforated the urogenital diaphragm and entered the cavum Retzii, it is brought up to the abdominal incision in close contact with the back of the pubic bone.

4 348 U. ULMSTEN ET AL. Fig. 3. The final placement of the prolene tape. Observe that the tape is loosely located around the midurethra. woman s requirements. This is why the procedure should be performed under local anaesthesia. After the operation the bladder is emptied and no catheter is inserted. The outcome of the treatment was evaluated and measured after 2 to 6, 12,24 and 36 months according to the following criteria. Completely cured No stress incontinence as tested by padtests (10 g/24 h), no incontinence on stress provocation test, and a quality of life evaluation implying a more than 90% satisfaction on behalf of the patient, as indicated on a visual analogue scale (see below). In addition, the women should not have any voiding problems (i.e. no urinary retention or a residual urine volume > 100 ml). Catheterisation after the operation for more than 24 hours was specifically noted. Signacantly improved No incontinence on stress provocation test and quality of life evaluation indicating more than 75% satisfaction but less than 90%. There should be no postoperative urinary retention or urge incontinence. Failures All the women, even if improved, who did not meet the above criteria. Quality of life evaluation During this study, we evaluated various quality of life measurements4. By doing so we found that the essential information from these quality of life evaluation forms can be summarised on a visual analogue scale, provided thorough discussion has been undertaken with the woman concerning her incontinence problems. Postoperatively, the woman indicates on the scale the percentage of improvement that she has recognised by the surgical procedure. An improvement of 90%100% indicates that, from the woman s point of view, she is completely cured, while an improvement between 75% and 90% indicates a significant improvement5. RESULTS Three experienced urogynaecological surgeons performed all the operations. All the women could be operated upon on an ambulatory basis (i.e. they could be discharged within 24 hours of the procedure). However, some older women with long distances to travel were, for social reasons, allowed to stay for an extra day. All but one of the women could be operated on under local anaesthesia; one very obese woman (body mass index > 35) was operated on under low spinal anaesthesia. The mean operation time was 29 minutes (range 1647), including time for local anaesthetics to take effect.

5 VAGINAL TAPE TO TREAT URINARY INCONTINENCE 349 Fortythree of the 50 women (86%) were completely cured, according to our criteria. Six women (12%) were significantly improved, while in one the operation failed. There were no significant intra or postoperative complications: no severe bleeding (> 300 ml), urinary retention (> 100 ml), recurrent urinary infection, defective healing, or rejection of the tape. The majority of the women were discharged the morning after the surgical procedure. Fortyfive of the women (90%) were able to micturate on the afternoon of the surgical procedure. In two women repeated catheterisation had to be performed for two and three days. In another three women an indwelling catheter had to be used for 7, 10 and 12 days respectively. No further catheterisation was then needed. The need for postoperative analgesia was minimal and comparable to that used after curettage (i.e. rectal suppositories of paracetamol). When the results of the pre and postoperative urodynamic recordings were compared, no significant changes were found, except for the urethral closure pressures at stress, which were negative before, but positive after, the operation in the cured women. The women underwent follow up examinations after 2 to 6, 12,24 and 36 months. As seen from Fig. 4 there were no changes in the postoperative outcome over time v Months 43 L 2436 Fig. 4. Outcome of the 50 operated women over time. As can be seen there was no declination of the results during the threeyear follow up period. 0 = cured; = improved; 1 = failure. DISCUSSION The results of this first long term follow up study are comparable with those reported after short term follow up of the tensionfree vaginal tape operation, 3. The success rate was high (go%), and was accomplished with no significant complications, especially no long term urinary retention. Since nearly all the women were operated on under local anaesthesia and were discharged the day after surgery, it is justifiable to consider the tensionfree tape technique as an ambulatory surgical procedure for stress urinary incontinence. The reason why so few intraand postoperative complications occurred, despite the fact that the tensionfree vaginal tape might be considered as a slinglike procedure, is due to the tape being loosely placed around the midurethra without elevation. This minimises postoperative voiding problems, as reported previously. In addition, the minimal dissection and trauma involved in the operation may explain the minimal postoperative pain compared with conventional operations for stress urinary in~ontinence ~. Most encouraging is the finding that there was no defective healing or rejection of the tape. This is in contrast to the reports of other sling procedures using other techniques and materials, where, apart from voiding problems, a significant number of sling protrusions and defective healing has been observed. In a previous study where we used a different sling technique and other materials, we observed rejection of the tape in 10% of the cases16. There are a large number of surgical procedures for the treatment of female stress incontinence. Few of these operations have been evaluated objectively in prospective long term follow up studies. Examination of over 1500 papers dealing with the surgical treatment of stress urinary incontinence reveals that in fewer than 100 has the outcome been evaluated objecti~elyl~.~ ~~*. Hence it has been proposed that better, and more standardised, protocols must be used in order to compare different surgical procedures for stress incontinencei5. The protocol used in the present study meets the criteria which have to be met in such an evaluationi5. Since the implanted tape does not absorb with time it may be justifiable to assume that the results are permanent. This notion is supported by the results from another study using a similar surgical technique which demonstrated the deposition of collagen in paraurethral connective tissue around the tape more than two years after the Operation. Our results agree with other reports using the same In all these studies the complete cure rate with tensionfree vaginal tape was reported to be about 85%, with another 6%8% of women considerably improved. The close agreement between the results of these different investigations indicates that

6 350 U. ULMSTEN ET AL the tensionfree vaginal tape operation is a highly standardised technique and easy to learn. Tensionfree vaginal tape is an individualised technique, since during the operation, with the woman awake, the surgeon can adjust the tape so that continence is obtained without overcorrection. Thus postoperative voiding problems are minirnised, as we found in our study. The results of our study agree with those of a recently completed multicentre study of the tensionfree vaginal tape operation in Scandinavia'. In this multicentre study there were very few complications, in particular no longlasting postoperative urinary retention and no rejection of the tape or defective healing. CONCLUSION We conclude that the tensionfree vaginal tape operation is a safe and effective surgical technique for the treatment of female urinary stress incontinence. The results seem to persist over time. The technique is an ambulatory surgical procedure performed under local anaesthesia with short operation times. In our opinion, it deserves to be included as a recognised operation for the surgical treatment of urinary stress incontinence. The final place of the tensionfree vaginal tape operation has to be interpreted in prospective randomised clinical trials where the procedure is compared with presently existing methods, such as the Burch colposuspension. Such studies are in progress. References 1 Ulmsten U, Henriksson L, Johnson P. Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J 1996; 7: Petros P. Ulmsten U. An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand J Urn1 Nephroll993; (Suppl 153): Victor A, Larsson G. Asbrink AS. A simple patientadministered test for objective quantitation of the symptom of urinary incontinence. Scad J Urol Nephroll987; 21: Khullar V, Salvatore S. Cardozo LD, Yip A, Kelleher CJ. The importance of urinary symptom and urodynamic parameters in quality of life assessment. Neurourol Urodyn 1995; 14: Nflrgaard JP, van Goo1 JD, HjalmL K. Djurhuus JD, Hellstrom AL. Standardization and definitions in lower urinary tract dysfunction in children. BrJ Urol 1998; 81 (Suppl3) Ulmsten U, Asmussen M. Lindstrom K. A new technique for sirnultaneous urethrocystometry and measurement of the urethral pressure profile. Urn1 Inr 1977; 32: IngelmanSundberg A. Ulmsten U. Surgical treatment of female urinary stress incontinence. Contr Gynec Obster 1983; 10: Ulmsten U. Falconer C, Johnson Pet al. A Multicentre study of TVT (tension free vaginal tape) for surgical treatment of stress urinary incontinence. Int Urogynecol J 1998; 9: Westby M, Asmussen M, Ulmsten U. Location of maximum intraurethral pressure related to urogenital diaphragm in the female studied by simultaneous urethrocystometry and voiding urethrocystography. Am J Ohster Gynecoll982; 144: Nilsson CG. IVSITlrTA new surgical procedure for treatment of female stress urinary incontinence. Finish and Scandinavian experiences. Nordic Urogynecological Association Meeting; February ; Oslo, Norway. Acta Obstet Gynecol Scad 1998; 77 (Suppl 168): Wang AC, Lo TS. TensionFree Vaginal Tape. A minimally invasive solution to stress urinary incontinence in women. J ReprodMed 1998; 43: Villet R, Fitremann C. SaletLizee D, Collard D, Zafiropulo M. Un nouveau proccd6 de traitement de l'incontinence urinaire d'effort (IUE): soutknement sousuv5tral de prolene sous anesthksie locale. Progris en Urologie 1998; 8: Ulmsten U. Hilton P, Ferrari A. Fischer W. Jacquetin B. Tensionfree vaginal tape procedure. A microinvasive surgical technique for GSI. 22nd Annual Meeting of the International Urogynecological Association; July 30August ; Amsterdam, The Netherlands. Int Urogynecol J 1997; 8: S Black N. Griffiths J, Pope C, Bowling A, Abel P. Impact of surgery for stress incontinence on morbidity: cohort study. BMJ 1997; 315: US Department of Health and Human Services. Urinary Incontinence in Adults: Acute and Chronic Management. Clinical Practice Guideline 1996; 2: Ulmsten U. Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephroll995; 29: Jarvis G. Surgery for genuine stress incontinence. Br J Obsret Gynaecoll994; 101: Black NA, Downs SH. The effectiveness of surgery for stress incontinence in women: a systematic review. Br J Urol 1996; 78: Falconer C, EkmanOrdeberg G, Malmstmm A, Ulmsten U. Clinical outcome and changes in connective tissue metabolism after intravaginal slingplasty in stress incontinent women. Int Urogynecol J 1996; 7: Received 8 June 1998 Returned for revision 21 October 1998 Accepted 30 November 1998