Tension‐free vaginal tape procedure without preoperative urodynamic examination: Long‐term outcome

Objectives: To evaluate the long‐term outcome of the tension‐free vaginal tape procedure. Methods: A total of 191 patients were operated on with tension‐free vaginal tape between January 1998 and May 2000. Of these, 127 (66%) had stress urinary incontinence, 64 (34%) had mixed urinary incontinence and 39 (20%) had recurrent incontinence. A total of 34 (18%) patients had had concomitant surgery. The diagnosis of incontinence was based on a history of leakage during stress and physical examination with a supine stress test in all patients. Tension‐free vaginal tape was carried out under local (82%) or spinal (18%) anesthesia. After a mean of 10.5 years follow up, the assessment included a gynecological examination and a supine stress test. Subjective outcome was evaluated with Urinary Incontinence Severity Score, Detrusor Instability Score, visual analog scale, European quality of life‐five dimensions, European quality of life – visual analog scale and short versions of Incontinence Impact Questionnaire‐7 and Urogenital Distress Inventory‐6. Objective cure was defined as a negative stress test and an absence of reoperation for incontinence during the follow up. Results: A total of 138 (72%) of 191 patients were evaluated. Patients with minimally invasive surgery before operation had significantly higher scores in Urinary Incontinence Severity Score, Detrusor Instability Score, Incontinence Impact Questionnaire‐7 and Urogenital Distress Inventory‐6 at follow up than the patients with stress urinary incontinence (P < 0.01). Recurrent incontinence and concomitant surgery did not affect the long‐term outcome. Three patients (2.3%) had late‐onset adverse events. The objective and subjective cure rates were 90% and 78%, respectively. Conclusions: The tension‐free vaginal tape procedure is effective and safe even after 10 years. The objective cure rate is high, but the subjective outcome is significantly lower in mixed urinary incontinence patients compared with patients with pure stress urinary incontinence. Recurrent stress urinary incontinence does not affect the outcome, and tape‐related problems are rare.     

Short‐term assessment of a tension‐free vaginal tape for treating female stress urinary incontinence

OBJECTIVE

To evaluate the short‐term surgical complications and results of a tension‐free vaginal tape (TVT) system (TVT‐Secur^TM, Gynecare, Ethicon, Somerville, NJ, USA) in the treatment of female stress urinary incontinence (SUI).

PATIENTS AND METHODS

TVT‐Secur was applied to 107 women with SUI through a vaginal incision and left abutting the urethra. Postoperative pain, complications, de novo lower urinary tract symptoms, incontinence cure rate and the King’s Health Questionnaire (KHQ) score were evaluated.

RESULTS

The operative duration was 12 min; the mean pain score was 2.3 and only one patient had transient voiding difficulties. After a mean follow‐up of 15 months, 71% of the patients were dry and 14% improved. The KHQ scores decreased significantly for most subscores. Urgency appeared de novo in six patients (5.6%), and vaginal erosion required one TVT‐Secur explantation.

CONCLUSION

This study shows that TVT‐Secur is a simple and safe treatment for female SUI, but before recommending this sling as a first choice for treating SUI, TVT‐Secur must pass the test of time and comparative studies with conventional slings.     

Tension‐free vaginal tape retropubic sling for recurrent stress urinary incontinence after Burch colposuspension failure

Objectives: To verify the efficacy and to clarify the mechanism of the tension‐free vaginal tape retropubic sling for recurrent stress urinary incontinence after Burch colposuspension failure. Methods: A total of 24 women having tension‐free vaginal tape retropubic sling placement for recurrent stress urinary incontinence after a previous failed Burch urethropexy were enrolled in the present study. Median follow up was 57 months (range 12–96). Pre‐ and postoperative urethral mobility and urodynamics were evaluated. Results: Preoperatively, all 24 patients had intrinsic sphincter deficiency and 14 had urethral hypermobility. Postoperatively, 15 patients were completely dry and two had a leakage of urine less than 5 g/h. The overall success rate was 70.8%. There was a significant postoperative increase of maximum urethral closure pressure (P < 0.001), and a decrease of average flow rate (P = 0.001) and urethral hypermobility (P < 0.001). When comparing successful with failure cases, only elevated maximum urethral closure pressure (P = 0.002) was significantly different. Multivariate logistic regression showed the change of maximum urethral closure pressure (P = 0.011) was the only independent parameter significantly correlated with the outcome of sling placement. Conclusions: Recurrent stress urinary incontinence with intrinsic sphincter deficiency after Burch colposuspension might be well treated with the tension‐free vaginal tape retropubic sling by effectively elevating the maximum urethral closure pressure.     

The 7‐year outcome of the tension‐free vaginal tape procedure for treating female stress urinary incontinence

OBJECTIVE

To evaluate the long‐term results and predictive risk factors for efficacy after the tension‐free vaginal tape (TVT) procedure for treating female stress urinary incontinence (SUI).

PATIENTS AND METHODS

Inall, 306 women (mean age 50.7 years, sd 8.7) who had a TVT procedure for SUI were selected and followed ≥7 years (mean 92.3 months, range 84–110) after surgery. We analysed the long‐term results, the variables predictive of cure rates, and patient satisfaction.

RESULTS

The overall 7‐year cure rate was 84.6%, with a satisfaction rate of 69.3%. The cure rates were lower in patients with high‐grade SUI (50% in grade III, 82.8% in grade II and 90.7% in grade I; P < 0.001). On multivariate analysis, there were no independent risk factors related to cure rate, and urgency was the only factor independently associated with patient satisfaction (P = 0.008; odds ratio 2.47). Seventy‐one patients (23.2%) had complications at the 1‐month follow‐up after surgery, but only eight (2.6%) had complications at the 7‐year follow‐up, including mesh exposure in six and de novo urgency in two.

CONCLUSION

The absence of long‐term adverse events associated with the TVT procedure, and high subjective and objective 7‐year success rates with no independent predictive factors affecting the long‐term cure rate, make the TVT procedure a recommendable surgical treatment for female SUI.     

Impact of tension‐free vaginal tape procedure on dysfunctional voiding in women with stress urinary incontinence

Objectives: To determine the prevalence of dysfunctional voiding (DV) in female stress urinary incontinence (SUI) and its modification after tension‐free vaginal tape (TVT) procedure. Methods: Three hundred and sixty women with SUI were enrolled and underwent urodynamics from 2002 to 2008. DV was determined when non‐neurogenic detrusor‐sphincter dyssynergia occurred during voluntary voiding. It was further quantitatively analyzed using the tense/loose value, a parameter derived from external anal sphincter electromyogram. The distribution of other urodynamic variables was also evaluated. One hundred and fifty patients underwent the TVT procedure and forty of them were studied with urodynamics after surgery during follow up. Results: Overall, DV was diagnosed in ninety‐nine patients, with a prevalence of 27.5%. The functional profile length in SUI women with DV was significantly shorter than that in SUI women without DV (3.13 ± 0.76 vs 3.32 ± 0.65, P = 0.017). After the TVT procedure, the recovery of SUI between cases with and without DV showed no significant difference. The rate of DV state change after the surgery, namely from with to without DV or from without to with DV, significantly differed between the female patients with and without DV (66.7% vs 3.6%, P < 0.05) during follow up. The DV improved after the surgery in SUI women with DV. Conclusions: DV might represent a coexistent finding in women with SUI. The main difference of women with SUI and DV, as compared with those without DV, is a shortened functional profile length. In such cases, TVT procedure can improve DV along with the treatment of SUI.     

Long‐term outcome of tension‐free vaginal tape for treating stress incontinence in women with neuropathic bladders

Study Type – Therapy (case series)
Level of Evidence 4

OBJECTIVE

To evaluate the long‐term safety and efficacy of the tension‐free vaginal tape (TVT) for the treatment of stress urinary incontinence (SUI) in women with neuropathic bladder dysfunction.

PATIENTS AND METHODS

Twelve women (mean age 53.3 years, range 41–80) with neuropathic bladder dysfunction and SUI confirmed by video‐cystometrography (VCMG) were treated with a TVT in one institution by an expert neuro‐urologist between November 1997 and December 2000. The patient’s notes, clinical annual follow‐up and VCMG after the procedure, and the incontinence impact questionnaire (IIQ) forms (Urinary Distress Inventory, and IIQ‐7) were assessed during the long‐term clinical follow‐up for SUI, in addition to a health‐related quality of life assessment. The cure of SUI was defined as no loss of urine on physical exercise, confirmed VCMG after the procedure, and by clinical assessment.

RESULTS

The mean (range) follow‐up was 10 (8.5–12) years. Nine patients were using clean intermittent self‐catheterization before the insertion of TVT and continued to do so afterward. At 10 years of follow‐up, one patient had died (with failed TVT initially), and two were lost to follow‐up at 5 years after surgery, but up to 5 years they did not complain of UI and VCMG did not show SUI. The remaining seven of the nine patients were completely dry, and two improved and were satisfied with using one or two pads/day. Two patients showed neurogenic detrusor overactivity confirmed on VCMG, with no evidence of SUI. One patient needed a transient urethral catheter for urinary retention after surgery, one had a bladder injury that required leaving the catheter for 5 days, but no urethral erosions were reported during the follow‐up.

CONCLUSIONS

In women with neuropathic bladder dysfunction secondary to a variety of spinal cord pathologies, and who have SUI necessitating a definitive intervention, insertion of TVT should be considered a desirable treatment, with very good long‐term outcomes.     

Mid‐urethral synthetic slings in the treatment of urodynamic female stress urinary incontinence without concomitant pelvic prolapse repair: 4‐year health‐related quality of life outcomes

Study Type – Therapy (outcomes research)
Level of Evidence 2c

OBJECTIVE

To report 4‐year health‐related quality of life (HRQL) outcome data after retropubic mid‐urethral synthetic sling (MUS) surgery without concomitant prolapse repair for treating female stress urinary incontinence (SUI) in a single institution.

PATIENTS AND METHODS

The data were prospectively collected, which yielded 21 consecutive patients with a mean (range) age of 67.6 (41–81) years who underwent retropubic MUS with ≥4 years follow‐up. Before surgery, all patients underwent history, examination, pad usage, and multichannel fluoroscopic urodynamics according to International Continence Society standards. In all, 19 patients had urethral hypermobility with an abdominal leak‐point pressure (ALPP) of >90 cmH₂0 and two had intrinsic sphincter deficiency with an ALPP of <60 cmH₂0. The MUS were all placed under no tension. All patients were cystoscoped with both 30 and 70° lens at the end of the procedure with a fully distended bladder to exclude bladder or urethral injury. The validated Kings Health Questionnaire (KHQ) was used both before and after surgery to assess HRQL measures. All patients were assessed at 3 months, and then at least three times thereafter.

RESULTS

The paired Student’s t‐test was used on the mean KHQ scores before and after MUS surgery (4 years follow‐up). There were statistically significant improvements in all nine domains on the KHQ between preoperative and 3 months after MUS surgery (P < 0.01), with the most significant being in ‘General Health Perceptions’, ‘Incontinence Impact’, ‘Physical Limitations’, and ‘Role Limitations’. Improvement in HRQL persisted up to 4 years in all domains. Bladder perforation occurred in two patients with uneventful resolution. Two patients required very short‐term catheterization (<5 days). In the present series, there was no sling revision, division, infection or erosion. No patients developed de novo urgency or urge UI after MUS surgery. The pad‐free rate in the present series was 85.7%.

CONCLUSION

In our institution, HRQL improvement at 3 months after retropubic MUS surgery predicts persistence of improvement at 4 years. This is useful clinically in counselling our patients for treatment efficacy. Tension‐free placement is associated with minimal risk of postoperative retention or de novo overactive bladder. Although patient numbers are modest, these data contribute to the scarce longer term (≥4 years) HRQL data on the MUS, which is a safe and durable procedure with a minimal complication profile.