Single incision mini sling for the treatment of urodynamic stress incontinence: Surgical outcomes and preoperative predictors of failure

Abstract

Objective

To evaluate the surgical outcomes and predictors of failure of Single Incision Mini Sling (Ophira) in women with urodynamic stress incontinence.

Materials and methods

Records of 115 women underwent anti-incontinence procedure using Ophira Mini Sling from June 2019 to September 2020 reviewed. Subjective evaluation was assessed using validated IIQ-7, UDI-6, POPDI-6 and PISQ-12 questionnaires. Multichannel urodynamics, 1-h pad test and 72-h voiding diary was performed as objective evaluation. Primary outcome was the objective cure rate of negative urine leak on provocative filling cystometry and 1-h pad test weight <2 g, and subjective cure rate was negative response to question 3 of UDI-6. Secondary outcome was to identify risk factors associated with failure for Ophira.

Results

Total of 108 women were evaluated. The objective cure rate was 91.7% with subjective cure rate of 86.1%. Comparison of clinical outcome shows significant improvement of USI post-operatively (p < 0.001) and reflected in 1-h pad test (p < 0.001). Improvement in all subjective evaluation parameters is seen except for POPDI-6. Failure of Ophira correlate significantly in women age >66 years, presence of asthma, pre-operative Intrinsic Sphincter Deficiency (ISD), and Maximum Urethral Closure Pressure (MUCP) value < 40 cmH20.

Conclusion

Ophira Single Incision Mini Sling is safe and effective treatment option for USI, showing high objective and subjective cure rates with low incidence of complications. Non-modifiable risks of age ≥66 years, asthma status, pre-operative intrinsic sphincteric deficiency and low maximal urethral closure pressure were the factors of failure for Ophira.