Safety and clinical efficacy of retropubic tension-free vaginal tape versus anti-incontinence pessary for treating women with stress urinary incontinence

Abstract

Background: Anti-Incontinence pessary use has long been reserved for patients with significant comorbidities, incontinence during pregnancy, elderly population or patients refusing surgery. The pessary utilization rate is lowest in Africa. The Tension-Free Vaginal Tape (TVT) was first approved by the FDA in 1998 then underwent systematic review in 2009-2011 to establish safety and efficacy, FDA is still approving the use of TVT for stress urinary incontinence, however, permanent vaginal mesh use for pelvic organ prolapse has been banned by FDA. The rising complication rates with TVT might result in imposed restriction of its use, can the pessary provide alternative solution.

Methods: 2 phase parallel group non-randomized clinical trial design was used, phase 1 was the baseline assessment followed by phase 2 which was the clinical design, 80 patients received intervention A (Retropubic Tension-Free Vaginal Tape), while the other group received intervention B (Anti-Incontinence Pessary). Prospective cohort was, however, due to COVID-19 implication on the operative time and urogynecology clinic, retrospective cohort was used to complete the sample size. Interrupted time series analysis approach was used to assess the outcomes at 6 weeks, 6 months and one year using a urogynecology questionnaire derived from UDI-6 and IIQ-7.

Results: UDI-6 showed a statistically significant difference between both groups at baseline with TVT mean 41.66+ 11.86 compared to pessary group 34.37+12.04 (p=0.008), another statistically significant difference was seen at the 1-year mark; however, the difference was not significant from clinical perspective, TVT mean was 16.87+12.34 compared to 22.69+10.83 for pessary group (p=0.028). The IIQ-7 showed a statistically significant difference between both groups at baseline with TVT mean 201.58+63.34 compared to 122.47+14.01 for pessary group (p=0.00), however, this significant difference did not exist at the 1- year mark period with the TVT mean 60.89+58.83 when compared to 75.99+75.78 for the pessary group (p=0.323).

Conclusion: TVT has a higher success rate according to UDI-6, however, the IIQ-7 shows no difference at 1-year period suggesting Anti-Incontinence pessary can be used as an alternative to TVT with comparable result in the general quality of life.