TVT-Secur: Minimally Invasive Procedure For Treatment Of Primary Stress Urinary Incontinence. One Year Data From A Multi-Centre Prospective Trial

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Cancer / Oncology
Article Date: 26 Jan 2009 - 2:00 PDT

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UroToday.com - Our study design was a prospective multicenter trial involving four different hospitals. Ninety-five patients with primary urodynamic stress urinary incontinence (SUI) and urethral hypermobility were prospectively selected to receive the TVT-s procedure.

Each centre was allowed to perform the procedure either in the "hammock" or "U" shape approach. Exclusion criteria from the study were: previous anti-incontinence surgery, pelvic organ prolapse requiring treatment, any coexistent pelvic pathology, urethral hypomobility ( Q-tip < 20°) and detrusor overactivity.

The outcome of surgical treatment was estimated both subjectively and objectively. Objective cure was defined as no leakage of urine while coughing during the post-operative stress test. Subjective cure was defined as no urine loss during exertion, and failure as any reported leakage of urine during 'stress'.

The ICI-SF, W-IPSS, PGI-S and PGI-I questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure patient's perception of incontinence severity and improvement.

After enrolment, 55 patients received the procedure with insertion of the tape in the "hammock" shaped position and 40 subjects in the "U" shaped position. There were no differences between these two groups with respect to pre-operative demographic and clinical characteristics, total score in the different questionnaires used, and urodynamic parameters.

The procedures were performed either under general (68%) or local (32%) anaesthesia, and cystoscopy was performed in all the patients who underwent the procedure in the "U" shape approach while only 14 out of 55 patients (25%) in the "hammock" shape group underwent cystoscopy. The intra-operative cough stress test was performed in only 6 patients.

There was excessive bleeding, greater than 500 ml., in 2 patients both receiving the "hammock" shape approach. Four women (4.2%) had voiding difficulty that resolved spontaneously within the first five days from surgery and no one had urinary retention.

The mean follow-up time was 15 + 3 months. Ninety-one patients were available for the analysis. Subjectively 71 (78%) women were cured by the procedure and objectively the cough stress test was negative in 74 (81%) patients. No difference in the success rate was seen between women who underwent the hammock shape approach (79%) and the "U" shape approach (77%) and despite patients having not been randomised to each procedure the two groups were similar in term of age, BMI, MUCP, presence of OAB symptoms,  Q-tip angle at strain, incontinence severity and bother of condition.

The ICI-SF questionnaire symptoms score showed a highly statistical decrease from a mean of 15 + 3.8 before surgery to a mean of 4.4 + 5.7 at the last follow-up visit forwarded (p=0.000), the W-IPSS decreased from 7.7 + 6.6 to 5.1 + 4.6 (p=0.002). Most of the women were satisfied with their post-operative condition with a mean score of 0.8  1.1 at the PGI-I questionnaire (scale 0-6). Postoperative complications included: voiding difficulty in 7 women (8%), recurrent UTI in 9 (10%), de novo urgency incontinence in 9 (10%) and dyspareunia for a defect healing, with vaginal protrusion of the mesh, in two patients. Eight out of 20 failures underwent a new anti-incontinence procedure within the first year of follow-up.

Some concerns may arise regarding the proper tension to apply to the sling. It has been recommended to place the tape close to the urethra with no space allowed in between and to apply a minimal extra tension to the tape because the tape is not elastic. It should be pushed into the tissues rather than pulled through the tissues so it will not get tighter after insertion.

Moreover some surgeons recommend routinely performing an intra-operative cough test for the proper tension of the sling in order to achieve better results on post-operative continence rate, but conflicting data are available in supporting this hypothesis.

Comparing the present results with our own previously published data on TVT and TVT-O, it appears that TVT secur is associated, at the same follow-up time, with a 10% lower success rate.

One can argue that our less satisfying results with the TVT secur system might be due to the initial learning curve, but each surgeon was requested to perform at least 10 procedures before starting the enrolment. Again to avoid the risk of underestimating the effectiveness of the procedure, we performed a sub-analysis where the first 10 cases for each centre were removed. In analysing the remaining 51 patients, figures were similar to those of the whole sample with 40 (78%) and 42 (82%) patients being subjectively and objectively cured.

In conclusion, we believe that TVT or TVT-O remain the reference surgical approaches as far as data from on-going randomised studies with large number of patients become available.

Written by Michele Meschia, MD as part of Beyond the Abstract on UroToday.com

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