The comparative outcome between TVTO and Altis® (Coloplast) in the Management of Urinary Stress Incontinence.

Al Ramsi E1, Fadda M2, Elredy M2, Alharmi F3, Alkaabi S3, Alguzi N3, Alabadla S3, Alawadi R3

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 438
Open Discussion ePosters
Scientific Open Discussion Session 102
Wednesday 23rd October 2024
13:00 - 13:05 (ePoster Station 4)
Exhibition Hall
Surgery Stress Urinary Incontinence Female
1. NMC royal women hospital, 2. Sheikh shakbout medical city, 3. Cornich hospital
Presenter
Links

Poster

Abstract

Hypothesis / aims of study
Stress urinary incontinence, prevalent in 13% to 46% of young women and peaking during menopausal ages, significantly impacts quality of life across various domains including sexuality, physical well-being, emotional, and social aspects (1,2). However, effective management options exist to improve patients' quality of life, with management strategies tailored based on symptom severity. Procedures like Transvaginal Tension-Free Vaginal Tape-Obturator (TVT-O) and Mini-sling have demonstrated efficacy both in the short and long term. This study aims to compare TVT-O and Altis® (Coloplast) procedures to identify an approach with high effectiveness and patient satisfaction, while also assessing the prevalence of short and long-term complications. Additionally, the study investigates the relationship between various factors such as age, body mass index (BMI), menopausal status, parity, vaginal delivery and chronic disease with the aforementioned outcomes.
Study design, materials and methods
This is a retrospective study, conducted at a specialized urogynecology department between  February 2020 to 2024. The study included patients who underwent surgery for stress incontinence, either the Transvaginal Tension-Free Vaginal Tape-Obturator (TVT-O) procedure or the single-incision sling system Altis® (Coloplast). Patients who did not attend follow-up appointments after surgery were excluded from the study. Electronic health records of selected patients were reviewed to collect relevant data, including demographic details such as age, body mass index (BMI), menopausal status, parity, chronic illnesses, past surgeries, type of incontinence, complications, and follow-up information. The study was approved by the Institutional Review Boards, and adherence to good clinical practice guidelines was ensured throughout the study period.
Results
The study involved 184 female respondents aged above 20 years, with the majority (37%) falling in the 40-50 age range, followed by 50-60-year-olds at 26.6%. The sample primarily comprised obese individuals (53.3%), with the majority being Arab (96.2%) and non-smokers (96.7%). Pre-menopausal, menopausal, peri-menopausal, and menopausal hysterectomy subjects accounted for 37.5%, 36.4%, 19%, and 7.1%, respectively.
 Parity distribution exhibited variability among the study participants, with 10.8% reporting nulliparity, 8.7% reporting parity of 2, 9.8% reporting parity of 3, 12.5% reporting parity of 4, 16.8% reporting parity of 5, and a significant proportion (49.5%) reporting parity of more than 6. Vaginal delivery rates followed a similar pattern, with 9.4% having delivered 2 children, 10.5% having delivered 3 children, 14.4% having delivered 4 children, 15.5% having delivered 5 children, and a substantial 44.2% having delivered more than 6 children.
The prevalent chronic diseases observed within the study sample included asthma (15.2%), constipation (25%), hypertension (23.4%), and diabetes (28.8%). A notable portion of participants (29.3%) did not report any chronic diseases, while hypothyroidism (6%) and hyperlipidemia (3.3%) were reported at lower frequencies. Other chronic conditions collectively accounted for less than 3% of the study population.
Regarding surgical history, 17.9% of the sample reported no prior surgeries, while 13.6% had undergone non-pelvic surgeries. Incontinence types among the participants predominantly included pure stress incontinence (75%) and mixed urinary incontinence with predominant stress component (25%). 

In terms of surgical procedures, 66.8% underwent TVTO while 33.2% underwent Altis surgery. Complications within 72 hours were reported by 4.89% of respondents, with UTI (10  %),  dysuria (10%), leg and back pain ( 50%), and numbness ( 20%) being the main issues. Long-term complications were reported by 11.41% of subjects, mainly comprising DENOVO urgency (52.38 %) ,  DENOVO voiding dysfunction ( 23.81 %) and defective healing ( 23.81 %).
  The study further sought to compare Altis® (Coloplast) and TVTO. The findings revealed that only 2.7% of respondents expressed dissatisfaction with Altis, while 4.3% reported dissatisfaction with TVTO. Statistical analysis indicated that the levels of patient dissatisfaction with both TVTO and Altis methods were not statistically significant, with p-values of 0.077 and 0.150, respectively, which exceeded the threshold of 0.05.
 Regarding short-term complications within 72 hours post-intervention, the incidence rates were 2.7% for the Altis group and 6.5% for the TVTO group. Despite the differences in rates, the association between the two interventions and short-term complication rates within 72 hours was not statistically significant.
Regarding long-term complications, the Altis group exhibited a rate of 29.5%, whereas the TVTO group had a rate of 21.1%. However, statistical analysis revealed that these differences were not significant, with p-values of 0.795 and 0.481, respectively. Both intervention groups experienced minimal incidence of complications, and there was considerable overlap in the distribution of complications between the groups.
Furthermore, the association between the interventions and long-term complications was not statistically significant, with p-values of 0.270 and 0.143, respectively. Although complications within 72 hours and long-term complications were more prevalent among respondents aged 40-50 years, these differences were not statistically significant across all age groups.

High BMI was associated with increased complications, while menopause status significantly influenced both short-term and long-term complications. Non-Arabs were more susceptible to short-term complications, while Arabic ethnicity was associated with both short-term and long-term complications. Smoking did not significantly influence complication rates.
Interpretation of results
The comparative analysis between TVTO and Altis® (Coloplast) procedures did not reveal any statistically significant differences in outcomes. The evaluated variables and individual characteristics did not significantly predict the superiority of either intervention.

This study identified BMI, menopause status, and chronic diseases as risk factors for stress urinary incontinence (SUI). Obesity and overweight were recognized as significant risk factors due to their association with increased intra-abdominal and intravesical pressure, impacting urethral function. Research suggests a strong correlation between SUI and obesity, with prevalence notably higher in women with a BMI exceeding 40 kg/m² and those with metabolic syndrome. (3)
Furthermore, the study findings indicate comparable outcomes in terms of quality of life and objective evaluations between TVTO and mini-sling (Altis) surgical approaches for women with SUI. Previous research supports the equivalency of TVTO and mini-sling (Altis) techniques in surgically managing SUI, with no discernible disparity in symptom alleviation and quality of life enhancement between the two methods(2). Respondents undergoing both interventions reported achieving continence, satisfaction, and resolution of SUI symptoms.
Concluding message
TVTO is the most commonly performed surgical procedure in the general population. Urine tract infections, sling infections or rejection, urge urine incontinence, peri-vesical or para-vaginal hemorrhage/hematomas, and urinary urgency are among the few problems that may arise with this treatment. On the other hand, Mini-sling is a novel, minimally invasive approach with a general population efficacy comparable to TVTO and no intraoperative problems. Following surgery, both groups' overall positive stress test results were cured, with no discernible differences. Because both techniques had minimal postoperative problems, they thus constitute a viable option for treating stress urinary incontinence.
References
  1. Oliveira, L. M. D., Dias, M. M., Martins, S. B., Haddad, J. M., Girão, M. J. B. C., & Castro, R. D. A. (2018). Surgical treatment for stress urinary incontinence in women: a systematic review and meta-analysis. Revista Brasileira de Ginecologia e Obstetrícia, 40, 477-490.
  2. Schiavi, M. C., Carletti, V., Yacoub, V., Cardella, G., Luffarelli, P., Valensise, H. C. C., & Zullo, M. A. (2023). Evaluation of the efficacy and safety of single-incision sling vs TVT-O in obese patients with stress urinary incontinence: Quality of life and sexual function analysis. Taiwanese Journal of Obstetrics and Gynecology, 62(1), 89-93.
  3. Ströher, R. L. M., Sartori, M. G. F., Takano, C. C., de Araújo, M. P., & Girão, M. J. B. C. (2020). Metabolic syndrome in women with and without stress urinary incontinence. International Urogynecology Journal, 31, 173-179.
Disclosures
Funding None Clinical Trial No Subjects Human Ethics Committee Ssmc Helsinki Yes Informed Consent Yes
05/04/2025 10:33:38