Clinical and quality-of-life outcomes in women treated by the TVT-O procedure
Objectives To objectively assess the success rate at 6 months after tension-free vaginal tape obturator (TVT-O) procedure. To assess subjective success rates, complications, patient satisfaction, and quality of life (QOL).
Design A prospective observational study.
Setting A tertiary referral urogynaecology practice.
Population A cohort of 100 consecutive women who underwent the TVT-O procedure between March and October 2004.
Methods The TVT-O technique was performed as described. Three standardised QOL questionnaires were completed preoperatively at 6 months and 12 months. At 6 months, a urogenital history, visual analogue scale score (VAS) for patient satisfaction, uroflow, and urinary stress test were performed. After 12 months, a urogenital history and patient satisfaction verbal analogue score (VeAS) were obtained by telephone interview.
Main outcome measure Objective success rate of the TVT-O procedure was measured by negative stress test. Secondary outcomes were subjective success rates at 6 and 12 months, pre- and postoperative comparison of urodynamic parameters, complications, postoperative symptomatology, QOL analysis, and patient satisfaction.
Results Mean follow up was 18.5 months. Objective success rate was 95%. Subjective success rates were 92 and 84% at 6 and 12 months. Complications included recurrent urinary tract infection (six), voiding difficulty (two), persistent groin discomfort (three), haematoma (one), wound infection (one), vaginal tape erosion (one), and urethral irritation (one). Prevalence of de novo urge incontinence was 4.1 and 4.8% at 6 and 12 months. QOL analysis showed significant improvements in QOL scores postoperatively. Visual and verbal analogue scores indicated high patient satisfaction (VAS, VeAS ≥ 80%) in 77 and 67% at 6 and 12 months.
Conclusion The TVT-O is a safe and effective treatment for female stress urinary incontinence.
The tension-free vaginal tape obturator (TVT-O) (Ethicon, Somerville, NJ, USA) is a transobturator suburethral synthetic sling used in the treatment of female stress urinary incontinence. The transobturator approach is believed to avoid bowel injuries and reduces the risk of bladder and major vascular injuries.1 It also eliminates the need for routine cystoscopic examination during insertion.1 The primary aim of this study was to prospectively assess the objective success rate (as shown by a negative urinary stress test 6 months following surgery) of the TVT-O procedure. Secondary outcomes assessed were the subjective success rates of the TVT-O procedure 6 and 12 months following surgery, and the safety and efficacy of this device focusing on complications, patient satisfaction with surgery, and impact on patients’ quality of life (QOL).
A prospective analysis was made of 100 consecutive women undergoing the TVT-O procedure. Consent for the procedure and this study was obtained from all the participants. Formal ethics committee approval was not required for this study as it was categorised as a clinical audit.
All the women underwent preoperative urodynamic testing, which confirmed urodynamic stress incontinence in all of them. Forty-one women (41%) had isolated symptoms of stress urinary incontinence, 59 (59%) had mixed urinary symptoms, but only 15 (15%) showed detrusor overactivity on urodynamic testing. Urodynamic testing included measures of urinary flow rate, postvoiding residual volumes, and multichannel cystometry, which included provocative maneuvers to show incontinence.
The TVT-O procedures were performed in accordance with the technique described by de Leval,1 where a paraurethral dissection plane is made from a suburethral incision to the obturator foramen. The obturator membrane is punctured, an introducer is passed along the passage made, and the spiral trocar of the TVT-O device is guided along the introducer through the obturator membrane before being rotated out through the groin incisions (made at a plane 2 cm above the urethral meatus at a point 2 cm lateral to the labial crural folds). Once the trocar is pulled through and the correct tension has been achieved, the plastic cover over the tape is removed. An instrument between the tape and the urethra ensures that the mesh remains tension free. Lateral vaginal fornices are checked for breaches in the vaginal epithelium at the conclusion of the procedure to avoid paraurethral vaginal mesh erosion. All the procedures were performed under a general anaesthesia with additional local anaesthetic infiltration in the paraurethral dissection plane and at the groin exit sites.
Participants were evaluated at 6 months postoperatively when a urogenital history and examination, a visual analogue scales (VAS) for patient satisfaction (pertaining to the TVT-O procedure only), a uroflow study, a postvoiding residual volume, and a urinary stress test were performed. They were advised to present with a comfortably full bladder for their urinary stress test. This test involved a series of provocative maneuvers such as coughing in an erect and supine position to show the presence of stress urinary incontinence. A negative stress test was the objective measure of success used in this study.
Patients completed three standardised QOL questionnaires preoperatively at 6 months and 12 months postoperatively. These were the Short Urogenital Distress Inventory (SUDI), the Short Incontinence Impact Questionnaire (SIIQ), and the European Quality of Life Questionnaire (EuroQol). The SUDI and SIIQ questionnaires were scored out of 100, where high scores reflected greater distress and impact of urinary symptoms on patients’ QOL, while low scores reflected minimal distress or impact on patients’ QOL. The EuroQol questionnaire was scored out of 1, with higher scores being indicative of better general QOL.
After 12 months, a further urogenital history and verbal analogue score (VeAS) for patient satisfaction (pertaining to the TVT-O procedure only) were obtained by telephone interview. Participants were specifically asked if they had any urinary leakage due to stress incontinence, leakage due to urge incontinence, any voiding difficulty, or other urinary symptoms such as frequency, urgency, nocturia, or dysuria. They were also asked if they required further surgery since the 6-month review, or suffered from any persistent or new problems related to their surgery since the 6-month review.
The primary outcome measure was the objective success rate of the TVT-O procedure, as shown by a negative urinary stress test 6 months following surgery. Secondary outcome measures included subjective success rates of the TVT-O procedure 6 and 12 months following surgery, pre- and postoperative comparison of urodynamic parameters, operative complications, postoperative symptomatology, QOL analysis, and patient satisfaction.
Statistical analysis was performed using SSPS 11 for windows (SSPS Inc., Chicago, IL, USA). Tests for significance were conducted using the t test for normally distributed continuous variables and Wilcoxon signed-ranks test for nonparametric analyses of QOL scores. Statistical analyses pertaining to subjective success rates and prevalence of urge urinary incontinence were undertaken using Fisher’s exact test.
Mean duration of follow up was 18.45 months (SD 2.34). Ten women were lost to follow up at 6 months and 18 at 12 months. The mean age was 55.5 years (SD 9.43) and median parity was 3 (range 0–11). Fifty-five women (55%) were menopausal, and 19 (19%) were taking hormone replacement therapy. All of the above had urodynamic stress incontinence. Fifty-nine women (59%) had concomitant urge incontinence symptoms, and only 15 (15%) showed detrusor overactivity on preoperative urodynamics. Preoperative urodynamics also showed a low maximal urethral closure pressure (MUCP < 20 cm H20) in five women (5%).
Forty-six women (46%) had prior urogenital surgery: anterior vaginal repair (25), posterior vaginal repair (25), vaginal hysterectomy (12), abdominal hysterectomy (19), colpopexy (six), laparoscopic paravaginal repair (three), open paravaginal repair (one), cystodistension (one), urethral dilatation (one), and urethrolysis in a woman with a previous sling procedure. Fifteen women (15%) had previous incontinence surgery: Burch colposuspension (ten), sling procedure (four), and Macroplastique™ (Uroplasty, Minneapolis, MN, USA) injection (one).
Concomitant surgery was performed in 49 women (49%). These procedures included: anterior vaginal repair (31), posterior vaginal repair (42), vaginal hysterectomy (11), hysteropexy/colpopexy (39), anal sphincteroplasty (four), hysteroscopy and curettage (two), vaginoplasty (one), cystodistension (one), and haemorrhoidectomy (one).
Success rates are detailed in Table 1. These were calculated as a percentage of the 90 women who returned for follow up at 6 months, and a percentage of the 82 women who followed up at 12 months. The objective success rate was 95%, and the subjective success rates (asymptomatic of stress incontinence) were 92 and 84% at 6 and 12 months. The decline in subjective success rate between 6 and 12 months was not statistically significant (P= 0.13). There was also a statistically significant reduction in the prevalence of urge urinary incontinence from 59% preoperatively to 28% (P < 0.001) at 6 months and 35% (P < 0.001) at 12 months postoperatively. The difference in the prevalence of urge urinary incontinence between 6 and 12 months was not statistically significant (P= 0.36). The prevalence of de novo urge urinary incontinence was relatively stable at 4.1% at 6 months and 4.8% at 12 months. There were no significant differences between preoperative and postoperative uroflow parameters or postvoiding residual volumes, and there was no correlation between individual preoperative MUCP and postoperative outcomes (Table 1).
Table 1. Comparison of pre- and postoperative outcomes
|Number of women||100||90||82|| |
|De novo UUI (%)|| ||4||4.8|| |
|Maximum flow rate (ml/second)||26.8 (SD 15.6)||24.4 (SD 13.2)|| ||0.49|
|Residual volume (ml)||30.8 (SD 35.1)||29.05 (SD 38.9)|| ||0.40|
|SUDI score||45.51 (SD 21.6)||14.77 (SD 18.5)||12.03 (SD 15.9)||<0.001|
|SIIQ score||51.74 (SD 24.1)||12.83 (SD 23.4)||9.33 (SD 16.8)||<0.001|
|EuroQol score||0.96 (SD 0.05)||0.98 (SD 0.04)||0.99 (SD 0.02)||0.01|
|High satisfaction (%)|| ||77||67|| |
|Subjective cure (%)|| ||92||84||0.13|
|Objective cure (%)|| ||95|| |
Complications are shown in Table 2. The most prevalent complication or complaint within the first 6 months postoperatively was groin pain or discomfort (22 women, 24.4%). This figure was markedly reduced by the 12-month review, where only three women (3.7%) continued to have persistent groin pain. Culture-proven urinary tract infections (UTIs) occurred frequently in the first 6 months (14 women, 15.5%). Two of these individuals (2.2%) continued to have recurrent UTIs in the first 6 months, and by 12 months, six women (7.3%) had reported recurrent UTIs.
Table 2. Operative and postoperative complications
|Voiding difficulty||0 (0)||2 (2.4)|
|UTI||14 (15.5)||6 (7.3)|
|Recurrent UTIs||2 (2.2)||6 (7.3)|
|Wound infection||1 (1.1)||—|
|Groin discomfort||22 (24.4)||3 (3.7)|
|Paraurethral vaginal tape erosion||1 (1.1)||—|
|Urethral irritation||1 (1.1)||—|
There were also two women (2.4%) with voiding difficulty, which developed between the 6- and 12-month postoperative review. One woman was complicated by recurrent UTIs and required intermittent self-catheterisation, while the other was managed with double/triple voiding techniques. There were no women with injury to bladder, vessels or other viscera. There were three women with recurrent vaginal prolapse (3.3%) and three with dypareunia (3.3%), all after concomitant vaginal surgery.
Twelve operations were required subsequent to the initial procedure, but only five of these procedures were related to the TVT-O. In the first 6 months, three women (3.3%) required further anti-incontinence procedures. These included: TVT (one woman, 1.1%), Burch colposuspension (one woman, 1.1%), and intraurethral Macroplastique™ injection (one woman, 1.1%). One woman (1.1%) required excision of a paraurethral vaginal mesh erosion from the TVT-O, and one woman (1.2%) required excision of paraurethral and left inner thigh segments of TVT-O tape and superficial urethrolysis at the left inner thigh for persistent groin pain. The remaining seven operations were vaginoplasties (three women, 3.3%), excision of vaginal mesh (three women, 3.3%), and a laparoscopic sacrocolpopexy (one woman, 1.2%).
QOL analysis showed a significant improvement in mean SUDI, SIIQ, and EuroQol scores at both 6- and 12-month follow up (Table 1). Subjects also reported an improved general state of health compared with the previous 12 months in 62.4% at 6 months and 59% at 12 months. This was determined by subjects’ response to the last question of the Euroqol questionnaire: ‘Compared with my general level of health over the past 12 months, my health state today is better/much the same/worse’. In addition, visual analogue scores (VAS) at 6 months and VeAS at 12 months indicated high patient satisfaction (VAS, VeAS ≥ 80%) in 77% of women at 6 months and 67% at 12 months.
This study indicates that the TVT-O procedure is a safe and effective treatment for female stress urinary incontinence. Our objective success rate of 95% at 6 months and subjective success rates of 92 and 84% at 6 and 12 months were comparable with those reported for the retropubic TVT (81–96%) and Burch colposuspension (80–95%).2–10,11 Studies investigating the TVT-O and other transobturator tapes have also achieved similar success rates in the order of 80–90% at 1 year.12–14 To date, there have not been any comparative studies between the TVT-O and other traditional techniques such as the retropubic TVT or the Burch colposuspension. Further comparative studies of this nature would be needed before any definitive conclusions can be drawn about the relative safety and efficacy of this technique.
The prevalence of urge incontinence was significantly reduced from 59% preoperatively to 28% at 6 months and 35% at 12 months. Similar findings have also been reported with the retropubic TVT and Burch colposuspension.2,5,9 While 15 of the 59 women with urge urinary incontinence in our study were treated with anticholinergic medication, all the above were still symptomatic of urge urinary incontinence at 12 months. Thus, the reduction in the prevalence of urge incontinence was not a result of concomitant anticholinergic therapy. Similarly, concomitant anterior vaginal repair was performed on 19 women symptomatic of urge urinary incontinence. Of those, only 11 had a resolution of their symptoms of urge urinary incontinence. It is therefore reasonable to conclude that any concomitant prolapse surgery performed did not have any significant effect on the reduction of postoperative prevalence of urge urinary incontinence.
The prevalence of de novo urge incontinence in our series (4.8%) was also similar to the rates reported with the retropubic TVT (5.8–15%) and Burch colposuspension (5–27%).2,5,7,15–20
Other complication rates associated with the TVT-O procedure compared favourably with the retropubic TVT and Burch colposuspension. Notably, the prevalence of postoperative voiding difficulty (2.4%) was lower than the 4–22.6% reported with the retropubic TVT and 6–20% with Burch colposuspension.1,2,6,7,10,15–18,20–26 There was no significant difference between preoperative and postoperative urinary flow parameters or postvoiding residual volumes in our study and no correlation between the preoperative MUCP and clinical outcome.
While bladder injury is the most common intraoperative complication reported with the retropubic TVT, occurring in 3.8–9.7% of women, there were no such injuries in our series.2,3, 6,7,14–17,20,22,26 The rate of bladder injury for the Burch colposuspension is in the order of 2%.2,23 There were no women with vascular or other visceral injuries in our study. These results are consistent with other studies of transobturator sling procedures.1,12,13,27
The most prevalent complication or complaint in this series was groin pain in the first 6 months. While 24.4% of women (22) experienced groin discomfort within the first 6 postoperative months, only 3.6% of them (three) had persistent groin pain, which had not resolved by the 12-month review. This complication has not attracted much attention in the published literature. While Duckett and Jain published a series involving groin pain following retropubic TVT,28 there have been no published data about the prevalence or suggested management of this complication with the TVT-O. One such subject in our series underwent surgical removal of vaginal and inner thigh segments of the TVT-O after local anaesthesia and steroid injections failed to improve her symptoms. The subject has already reported an improvement (but not complete resolution) of her symptoms early in the postoperative course.
The incidence of UTIs in the first 6 postoperative months in this series was 15.5% (14 women). This was comparable with the reported UTI rates for the retropubic TVT (4–22%) and the Burch colposuspension (8–32%).2,10,14,15,22,23,29 The prevalence of recurrent UTIs in our series (7.3%, six women) was similar to that reported for the retropubic TVT (10.9%) in one study.18 One women (1.1%) with urethral irritation reported in our series at the 6-month review spontaneously resolved by the 12-month review.
There were no women with intraoperative haemorrhage in our series and only one woman (1.1%) had superficial wound haematoma. This compares with a pelvic haematoma rate of 0.6–1.9% for the retropubic TVT and 0.8–2% for the Burch colposuspension, and a ‘significant’ intraoperative blood loss in 0.9–5.4% with the retropubic TVT and 3–8.1% with the Burch colposuspension.6,14–16,18,22–24 There was also one woman (1.1%) with superficial wound infection in our series compared with 0.4–2% reported for the TVT and 5–7% for the Burch colposuspension.2,15,16,22–24 Similarly, our 1.1% rate of paraurethral vaginal mesh erosion from the TVT-O is comparable with the 0.4–4.1% quoted in other series for the retropubic TVT.2,14–16,18,20
The woman with the paraurethral vaginal mesh erosion in our series is also one of the three subjects who required further anti-incontinence surgery. The vaginal tape erosion was treated by surgical excision of the exposed TVT-O mesh, mobilisation of the surrounding vaginal epithelia, and closure of the defect. Given other studies have reported a 33–50% incontinence rate following tape division and a 30% requirement for further anti-incontinence surgery, it was not unexpected that this woman developed incontinence and required a transurethral Macroplastique™ injection following the tape excision.18,30 The other two anti-incontinence surgeries performed were a retropubic TVT and a laparoscopic Burch colposuspension. These were performed for persisting stress urinary incontinence. All three additional anti-incontinence procedures were successful at the 6- and 12-month review.
Of the three women (3.3%) who reported recurrence of vaginal prolapse, all had undergone a concomitant vaginal repair at the time of the TVT-O procedure. One very mild case resolved with conservative management, one woman required a laparoscopic sacrocolpopexy, and the remaining woman with vaginal prolapse was unresolved by the 12-month review. It is unlikely that these findings related to the TVT-O procedure.
Similarly, of the three women (3.3%) who reported dyspareunia, all had undergone concomitant vaginal repairs at the time of the TVT-O procedure, and it is most likely that these symptoms related to the vaginal repairs rather than the TVT-O. All the three women subsequently underwent vaginoplasties, which adequately treated two of the three women. The remaining woman still reported dyspareunia at the 12-month review.
Comparisons of the preoperative and postoperative QOL questionnaires showed a significant improvement in QOL both at 6 and 12 months postoperatively. This was reflected in the high levels of patient satisfaction (VAS, VeAS ≥ 80%) achieved at 6 (77%) and 12 months (67%).
Our results indicate that the TVT-O procedure is a safe and effective treatment for female stress urinary incontinence. The short and medium-term objective and subjective success rates appear comparable with the traditional Burch colposuspension and the retropubic TVT procedure. There appears to be a reduction in the prevalence of voiding difficulty when compared with the reported rates for the Burch colposuspension and the retropubic TVT procedure. The overall complication rate was low, patient satisfaction was high, and QOL was improved after treatment. The TVT-O appears to have performed favourably as a safe and effective alternative to the other traditional treatments for female stress urinary incontinence.