Objective
The current study aimed to evaluate objective and subjective results 10 years after the tension-free vaginal tape procedure.
Study Design
Two hundred ten patients who underwent a tension-free vaginal tape procedure at the 2 participating units between 1999 and 2001 were invited for follow-up. Evaluation at 10 years included history, clinical examination, cystoscopy, urodynamics, a cough stress test, and the Incontinence Outcome Questionnaire.
Results
Interview data were available for 67%; full clinical investigation was performed in 56% of patients. At 10 years, the clinical stress test was negative in 84%, slightly positive in 8.5%, and strongly positive in 4.3%. Subjectively, 57% of patients considered themselves “cured,” 23% “improved,” 6.4% “unchanged,” and 11% “worse.” Eleven of 141 (7.8%) had been reoperated in the interim. The rate of de novo urgency was 20%. Obesity seemed to be a risk factor for failure.
Conclusion
These data indicate satisfactory objective and subjective cure rates 10 years after tension-free vaginal tape procedure placement.
Stress urinary incontinence (SUI) affects 25 to 35% of women at all ages, with a peak prevalence between 45 and 49 years of age. Up to half of women with SUI also have symptoms of overactive bladder (mixed incontinence). Treatment of SUI usually starts with lifestyle interventions and pelvic floor training and frequently progresses to surgery. The concept of placing a tape of alloplastic material under the midurethra was first described by Ulmsten et al in 1996. This concept was brought to market as the tension-free vaginal tape (TVT) procedure in Europe in 1997. The features of the TVT concept include reduced invasiveness with shorter recovery time compared with the previous standard, colposuspension.
In many areas in Europe the TVT procedure quickly displaced colposuspension, even though randomized trials had not been completed and long-term results, and possible sequelae, were unclear. In particular, long-term outcomes after placement of alloplastic material close to the vagina, urethra, and bladder was, and remains, a concern.
The current study aimed to evaluate objective and subjective outcomes 10 years after TVT placement in patients operated at 2 centers that were early adopters of the procedure. We also evaluated late complications, such as mesh erosions and reoperations, and prevalence of overactive bladder (OAB) symptoms.
Materials and Methods
A total of 210 patients who underwent a TVT procedure at the 2 participating units between 1999 and 2001 were invited for follow-up. All patients had undergone a standard retropubic TVT procedure as per the original description. All had clinically and urodynamically verified stress incontinence. Preoperative clinical and urodynamic assessment included a relevant history, cystometry, midurethral closure pressure, and a cough stress test.
Evaluation at 10 years included history and clinical examination, assessment of residual urine, urodynamics (cystometry, midurethral closure pressure), a cough stress test, cystoscopy, interview with questions on pad use, and the self-administered Incontinence Outcome Questionnaire (I-Quol-D). The cough stress test was classified in negative, slightly positive (dropwise leakage), and strongly positive (more than dropwise leakage) subjectively by the examiner. Patients not available for physical examination were asked to complete the I-Quol-D (sent per mail); in addition, we performed a telephone interview for overall and disease-specific history.
All patients were included in the Austrian TVT registry. The study protocol was approved by the Ethics Committee of the Medical University of Graz.
Results
A total of 210 patients underwent TVT placement between 1999 and 2001 at the 2 hospitals. The mean age at surgery was 60 years (range, 35–89 years). The mean duration of follow-up was 115.7 months (range, 100–140). Twenty-six patients died in the interim, unrelated to the TVT procedure; 10 were too ill or frail for follow-up. Among the remaining study population of 174 patients, 16 could not be reached and 17 patients declined follow-up. One hundred forty-one of 210 patients were available for follow-up (67%). Subjective data were available from all 141 patients; a complete workup was performed in 117 patients (117/210 patients, 56%) ( Figure ) .
Demographic data, previous surgery, and concomitant procedures of the 141 patients followed up are listed in Table 1 . Sixty patients (43%) had previous gynecologic surgery, including 14 previous antiincontinence procedures (4 Burch colposuspensions, 9 needle suspensions, 1 periurethral bulking) and 30 (21%) pelvic organ prolapse repairs. Fifty-one patients (36%) underwent concomitant procedures with TVT.
| Demographic | Mean | Range | Median |
|---|---|---|---|
| Age, y | 58.5 | 35–85 | 59 |
| Parity | 2.54 | 0–8 | 3 |
| BMI | 28.2 | 19.4–40.8 | 28.6 |
| Previous surgery (of patients available for follow-up), n (%) | |||
| Hysterectomy only | 19 (13.5) | ||
| Hysterectomy + Burch colposuspension | 4 (2.8) | ||
| Hysterectomy + needle suspension | 2 (1.4) | ||
| Hysterectomy + needle suspension + colporrhaphy | 6 (4.3) | ||
| Needle suspension | 1 (0.7) | ||
| Periurethral bulking agent injection | 1 (0.7) | ||
| Radical hysterectomy + radiation therapy | 2 (1.4) | ||
| Staging procedure (ovarian cancer) | 1 (0.7) | ||
| Total | 36 (25.5) | ||
| Concomitant surgeries (of patients available for follow-up), n (%) | |||
| Vaginal hysterectomy | 11 (7.8) | ||
| Vaginal hysterectomy + colporrhaphy | 34 (24.1) | ||
| Colporrhaphy | 4 (2.8) | ||
| Vaginal sacrospinous ligament fixation | 2 (1.4) | ||
| Total | 51 (36.2) |
At 10 years, 11 of 141 patients (7.8%) had been reoperated for incontinence or reasons related to the TVT procedure: 4 patients underwent further antiincontinence procedures. Six procedures were performed to relieve voiding obstruction including 1 urethrotomy (120 months after surgery), followed by urethral mesh erosion. In 1 patient transurethral removal of bladder stones (30 and 42 months after TVT) and resection of mesh eroded into the bladder per laparotomy (50 months after TVT) was necessary ( Table 2 ).
| Variable | Months after TVT |
|---|---|
| Urethral dilatation under general anesthesia | <1 |
| Cutting of tape, paravaginal repair | 13 |
| Repeat TVT (n = 2) | 14, 58 |
| Vaginal augmentation/colposuspension/vesicovaginal fistula repair (patient after radical hysterectomy and radiation therapy) | 25/50/58 |
| Cutting of tape (n = 2) | 26, 61 |
| Transurethral removal of bladder stones (twice)/resection of intravesical tape | 30/42/50 |
| Periurethral bulking agent/repeat TVT | 70/83 |
| Urethrotomy | 104 |
| Urethrotomy, for intraurethral mesh | 120 |
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