Transobturator tape: over 10 years follow-up

Natale F1, Illiano E2, La Penna C3, Zucchi A4, Costantini E2

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 243
Female Stress Urinary Incontinence
Scientific Podium Short Oral Session 12
Wednesday 29th August 2018
17:07 - 17:15
Hall B
Stress Urinary Incontinence Surgery Prospective Study Quality of Life (QoL)
1. Urogynecology Unit, Department of Gynecology, San Carlo di Nancy Hospital, Rome, Italy, 2. Andrology and Urogynecology Clinic Santa Maria Terni Hospital, University of Perugia,Perugia, Italy, 3. Section of Gynecology and Obstetrics, Department of Surgery, “Tor Vergata” University, Rome, Italy, 4. Department of Surgical and Biomedical Sciences, Urology and Andrology Clinic, University of Perugia, Perugia, Italy
Presenter
E

Ester Illiano

Links

Abstract

Hypothesis / aims of study
The growth of the elderly population in western countries highlights the importance of studying the long-term outcomes of the various treatments of chronic conditions, including urinary incontinence. 
The aim of this study is to assess the outcomes in incontinent patients who underwent TOT with a 10-year minimum follow-up.
Study design, materials and methods
This is a single-center prospective study on women who underwent TOT for stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence. 
Pre-operatively, all patients underwent a standardised pre-op urogynaecological work-up including: urogynecological history; pelvic examination using the POP-Q classification; standardised cough stress test (CST) performed in the standing position at a bladder volume of 300 mL or at maximum cystometric capacity if it was less than 300mL; conventional urodynamic study (according to ICS criteria). Urinary symptoms were evaluated using a structured questionnaire and the standardised questionnaire UDI-6. In particular, the voiding phase was evaluated in the structured questionnaire in terms of yes-no questions on hesitancy, slow-stream, intermittency, straining to void, and feeling of incomplete emptying (as defined by ICS ), and in UDI-6 question 5, which gives 4 degrees of difficulty in voiding. SUI was defined according to ICS standardisation and classified according to the Ingelmann-Sundberg scale. The King’s Health Questionnaire (KHQ) was used to evaluate Quality of Life (QoL). 
TOT surgery was performed according to the technique described by Delorm.
In September-October 2017 all patients who had undergone TOT before 2007 were recalled for follow-up. They completed the same pre-op questionnaires used in the pre-op evaluation. The subjective cure rate was evaluated using the Patient Global Impression of Improvement (PGI-I): success was defined as ‘very much better’ or ‘much better’ on the PGI-I scale. 
The primary outcome was the SUI cure rate. Secondary outcomes included improvement in QoL, effect on the other urinary symptoms and late adverse events. Institutional Review Board Committees approved this study; participants gave informed consent. 
For statistical analysis we used the McNemar chi-square test for continuous non-parametric variables, the  Fisher’s exact test for categorical variables and the t-test for continuous parametric variables. We considered p<0.05 to be statistically significant.
Results
From January 2003 to December 2007, 136 consecutive patients underwent TOT. Thirteen patients were lost to follow-up, so we report data on 123 patients. Of these 32 (26.1%) had SUI grade 1 according to the Ingelmann-Sundberg scale, 67 (57.5%) had SUI grade 2 and 24 (19.5%) had SUI grade 3.
Mean age was 58.3+9.94; median parity was 2; mean BMI 27.22+2.76; 87 patients (70.2%) were menopausal.
At a mean follow-up of 145 months (121-181 months), 77 patients (62.6%) were subjectively cured for SUI. Of the 46 failed patients 31 (25.2%) had SUI grade 1, 9 (7.3%) had SUI grade 2, and 6 (4.9%) had SUI grade 3.  Only 10 of the failed patoents underwent further SUI surgery: 8 underwent TVT and 2 underwent bulking agent therapy.
Urgency reduced statistically significantly (from 67.5% to 38.3%, p<0.005), as did urgency urinary incontinence (from 56.9% to 31.7%, p<0.005). De novo urgency occurred in 7.3% of cases.
Voiding symptoms increased from 8.9% to 18.7% (p=0.37). De novo voiding symptoms appeared in 14.6% of patients.
All domains of the KHQ except general health and sleep saw statistically significant improvements.
We had 5 cases of partial mesh extrusion, requiring tape revision; none became incontinent.
Interpretation of results
Our study demonstrates that TOT can be considered safe and effective with good long-term outcomes. At a follow-up of ten or more years, also if cure rates are lower than in shorter-term studies, however, at 62.6%, they may still be considered satisfactory. It is difficult to ascertain if this decline, 10 years or more after surgery, is due to long-term treatment failure or to general factors like age or another pathology.
Concluding message
In our study TOT procedure appeared to be an effective minimally invasive procedure for SUI with low rate of complication and satisfactory long-term outcome.
Figure 1
References
  1. Kelleher CJ, Cardozo LD, Khullar V., A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997
  2. Artibani W, Pesce F, Prezioso D., Italian validation of the urogenital distress inventory and its application in LUTS patients. Eur Urol. 2006.
  3. Delorme E. Transobturator urethral suspension: mini-invasive procedure in thetreatment of stress urinary incontinence in women. Prog Urol. 2001; 11:1306-13.
Disclosures
Funding No discosures Clinical Trial Yes Registration Number Ceas Umbria RCT No Subjects Human Ethics Committee Ceas Umbria Helsinki Yes Informed Consent Yes
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