INTRODUCTION: Stress urinary incontinence (SUI) is a condition that affects quality of life. Approximately 50% of incontinent women have SUI. Although conservative management is the first line of treatment, it is expensive and of limited value. The aims of the present study were to evaluate the safety and efficacy of the tension-free vaginal tape (TVT) sling in management of SUI in Indian women and to report 5-year follow-up data.
METHODS: This prospective study was conducted between January 2003 and August 2004. It included 157 patients with genuine SUI, based on a strong clinical history, positive Bonney test, and urine leak on stress during urodynamic study and cysotoscopy. Mean age was 56.3 years; the mean number of births was 2.5. The patients underwent TVT sling procedure under spinal or caudal anesthesia. Periodic follow-up at monthly intervals for the first 6 postoperative months and every 3 months thereafter was done for next 5 years. Any TVT-related complications were recorded and managed accordingly. Objective and subjective measures of surgical success were recorded and analyzed statistically.
RESULTS: Mean operating time was 25 minutes (range, 20-30 minutes). The 157 patients were available for an average of 60 months (range, 58-72 months) of follow-up evaluations. Postoperative urinary tract infections occurred in 13 patients (8.2%). Perioperative complications requiring surgical correction occurred in 10 patients (6.3%) and included urinary retention (n = 5), bladder perforation (n = 3), and urethral perforation (n = 2). Objective cure was defined as the absence of urine leak during a cough test in the lithotomy or upright position. Objective cure, improvement, and failure were recorded in 134 (85.3%), 11 (7%), and 12 (7.6%) patients, respectively. Subjective cure was defined as no reported loss of urine with exercise, coughing, or weight lifting. Subjective cure, improvement, and failure were recorded in 137 (87.3%), 9 (5.7%), and 11 (7%) patients, respectively.
CONCLUSION: TVT is a minimally invasive procedure that is safe and efficacious in the long term for surgical management of genuine SUI. The procedure results in minimal perioperative complications.
KEYWORDS: Tension-free vaginal tape; Stress urinary incontinence; Urodynamics
CORRESPONDENCE: Professor N.K. Mohanty, C â€“ II /124, Motibagh, New Delhi, 110021 ().
CITATION: Urotoday Int J. 2010 Apr;3(2). doi:10.3834/uij.1944-5784.2010.04.02
ABBREVIATIONS AND ACRONYMS: ICCQ, International Consultation on Incontinence Questionnaire; SUI, stress urinary incontinence; TVT, tension-free vaginal tape; UTI, urinary tract infection; VLPP, Valsalva leak point pressure
Involuntary loss of urine due to increased intraabdominal pressure is a condition mainly affecting females. Approximately 50% of all incontinent women have genuine stress urinary incontinence (SUI) . SUI prevalence is highest among women between 25 and 49 years of age (ie, during their reproductive years). In the USA alone, 25 million women have SUI, and this figure is increasing . Although there are many factors contributing to its etiology, increased incidence of pregnancy, child birth, and parity greatly contribute to its development. SUI results in a restricted lifestyle, impacts confidence and self perception, and interferes with the social relationships of the individual [1,2,3,4,5,6].
Initial conservative treatment of SUI with pharmaceutical agents, pelvic floor exercise, and behavioral therapy remains the first line of treatment. However, this treatment is not economical and surgical correction is likely to be required for permanent, effective relief [4,5,6].
Among the many surgical procedures currently practiced, the tension-free vaginal tape (TVT) procedure is the most minimally invasive. It has proven advantages of low morbidity, short operating time, early recovery, and short-term and mid-term efficacy in different series [5,6,7,8,9]. Some randomized controlled studies have shown that the TVT procedure has efficacy similar to the traditional Burch colposuspension [9,10,11,12,13].
Additional studies regarding the long-term efficacy of the TVT procedure are needed. The authors of the present study describe their single center experience using TVT among Indian women presenting with genuine SUI. The purpose of the study was to report the safety and efficacy of the procedure over a period of 5 years.
The participants were 157 females presenting with the complaint of urine leak on stress. The patients were seen between January 2003 and August 2004. The mean (standard deviation) age was 56.3 (11.2) years; the mean number of births was 2.5 (1.2); the mean body mass index (BMI) was 28.7 (2.3). Of the total 157 participants, 123 (78.3%) were menopausal.
Inclusion criteria were based on the results of clinical and laboratory examinations. The examinations included information about the patient's menstrual cycle, obstetric history, sexual habits, profession, and hobbies. Patients completed the International Consultation on Incontinence Questionnaire (ICCQ) . A per-vaginal examination, the Bonney test, and evaluations of urine culture/sensitivity and fasting blood sugar were also performed. Patients also had abdominal ultrasonography, urodynamic evaluation, and cystoscopy under local anesthesia.
Patients were included in the study if they had a strong clinical history, positive Bonney test, and urine leak on stress during urodynamic study and cysotoscopy. Patients were excluded from the study if they had: (1) pelvic organ prolapse; (2) urinary tract infection (UTI); (3) diabetes mellitus; (4) other associated bladder pathologies commonly seen in urge incontinence (eg, vesical calculus, carcinoma in situ, cystitis, malignancy of urinary bladder, trabeculation of urinary bladder without obstruction, neurological hyperreflexic bladder); (5) detrusor overactivity during the filling phase on urodynamic study.
Patients were asked to perform a Valsalva procedure to demonstrate urine leak during the cystometry filling phase. The Valsalva leak point pressure (VLPP) was recorded.
Informed consent was obtained from all patients before undergoing the TVT procedure. Surgery was conducted on an outpatient basis. Regional spinal or caudal anesthesia was used and surgery was performed under strict aseptic methods. The standard technique for TVT with a polypropylene sling (Ethicon Inc, Somerville, NJ, USA) was used. Cystoscopy was performed to ensure no bladder perforation. In case of bladder perforation, the tape was retrieved and reloaded. The procedure was then repeated with caution. The tape ends were then brought out through the abdominal incision. A curved artery forcep was placed between the vaginal tape and midurethra to prevent tension on the tape. Application of traction on the tape was only to be considered when VLPP was < 60 cmH2O; otherwise, there should not be any tension on the tape around the midurethra. Once the tape was positioned at the midurethra, the curved artery forcep was removed. The bladder was filled with normal saline, and the patient was asked to cough to ensure that there was no leakage of urine and that continence was achieved without overcorrection. A 16F Foley indwelling catheter was then placed in the bladder and kept for 24 hours.
Patients were discharged on the same day, with antibiotic coverage for 4 consecutive days. Patients were advised not to indulge in heavy exercise or work and to avoid sexual activities for the next 12 weeks.
Periodic follow-up at monthly intervals for the first 6 postoperative months and every 3 months thereafter was done for the next 5 years. Follow-up included clinical examination, urine for routine microscopy and culture sensitivity, ultrasound examination of the abdomen for measuring postvoid residual (PVR) volume, and the ICCQ. Any TVT-related complication was recorded and managed accordingly.
Objective cure was defined as the absence of urine leak during a cough test in the lithotomy or upright position. Objective improvement was defined as postsurgical urine loss that was < 50% of the presurgical urine loss. Subjective cure was defined as no reported loss of urine with exercise, coughing, or weight lifting. Subjective improvement was defined as a perceived significant reduction in the leaking episodes, expressed by patient satisfaction. The data were recorded and analyzed using a chi-square test for categorical variables, Wilcoxon rank-sum test for nonparametric variables, and the t test for continuous variables.
Table 1 shows the preoperative VLPP that was calculated during urodynamic assessment for all patients. The majority of patients (63.1%) had VLPP > 90 cmH20.
Mean operating time was 25 minutes (range, 20-30 minutes). The 157 patients were available for an average of 60 months (range, 58-72 months) of follow-up evaluations.
Perioperative complications are listed in Table 2. UTI was the most common postoperative complication, seen in 13 patients (8.2%). These patients were treated with appropriate antibiotics. Ten patients (6.3%) had perioperative complications that required surgical correction. Urethral perforation was seen in 2 patients. The urethral perforation was detected intraoperatively and corrected by urethral closure over an indwelling Foley catheter that was kept in place for 2 weeks postoperatively. Three patients had bladder perforation, detected intraoperatively during cystoscopy. They were kept on an indwelling catheter for 1 week postoperatively, following tape retrieval and reintroduction under cystoscopy guidance. Urine retention was recorded in 5 patients in the postoperative period at 30 days, 28 days, 35 days, 40 days, and 32 days, respectively. After doing a local examination and cystoscopy, treatment for these patients consisted of incising the tape per-vaginally in the midline to release tension. There were no late complications .
Table 3 shows the results of the objective and subjective outcome measures at the final evaluation. No worsening of symptoms was recorded in any of the patients. Objective cure, improvement, and failure were recorded in 134 (85.3%), 11 (7%), and 12 (7.6%) patients, respectively. Subjective cure, improvement, and failure were recorded in 137 (87.26%), 9 (5.7%), and 11 (7%) patients, respectively. Differences in objective and subjective ratings were not statistically significant (P = .44).
The TVT procedure was introduced as a treatment modality for the surgical management of female SUI in 1995 . This procedure was based on midurethra theory. This theory proposed that injury arising from surgery, delivery, aging, or hormonal deficiency causes weakening or damage of pubourethral ligaments. This damage impairs midurethral function and anterior wall support and causes stress incontinence . The TVT procedure supplements the diminished midurethral mechanism and produces the ingrowth of new host tissues after implantation. The new host tissues further supplement the support provided by this procedure [16,17,18].
The TVT surgery provides all of the advantages of a minimally invasive procedure including a short operating time, low incidence of perioperative complications, short catheterization period, early recovery, high long-term patient satisfaction, and high-short and long-term success rates[5,6,7,8,9,19,20]. The TVT procedure has shown results similar to traditional Burch colposuspension in many randomized trials [9-13].
The TVT procedure uses a synthetic polypropylene monofilament mesh. The technique for tape introduction in the present study was similar to that of Wang and Lo . VLPP is a key indicator of successful repair. If VLPP > 60 cmH2O, no traction on the tape should be applied. If the VLPP < 60 cmH2O, mild traction on the tape will ensure no postoperative leak on stress .
In the present study, the objective cure, improvement, and failure were 134 (85.3%), 11 (7%), and 12 (7.6%) patients, respectively. The objective outcomes were not statistically different from subjective assessments. These results are comparable to other published series [5,6,7,8,9,19,20].
In the present study, 10 out of 157 patients (6.3%) had perioperative complications requiring surgical correction. UTI was reported in 8.2% of patients. These complication rates are similar to those reported in previously published series [5,6,7,8,9,19,20,23].
Two urethral perforations occurred during the study. These may be attributed to the application of tension on the tape in early cases where the patient VLPP was < 60 cmH2O. All 5 patients who developed postoperative retention of urine had preoperative VLPP < 60 cmH2O. Mild to moderate traction /tension was applied on the tape during the surgical procedure, and the surgeon may have overcompensated. In these 5 patients, the tape was cut in the midline to release tension. It was not possible to remove the tape in the postoperative period because of fibrosis. All 5 patients had subsequent urine leak on stress that was corrected by open surgery (Burch colposuspension procedure).
The present study confirms the 5-year efficacy of the TVT procedure for surgical management of stress urinary incontinence in Indian women. However, additional trials with larger numbers of patients are needed to validate these findings and to evaluate efficacy of the TVT procedure at 10 and 20 years.
The present study indicates that TVT is a minimally invasive procedure that is safe and efficacious in the long term for surgical management of genuine SUI. The procedure results in minimal perioperative complications.
Conflict of Interest: none declared
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