The aim was to perform a medium-term follow-up analysis of outcomes for four surgical procedures used for treatment of urodynamic stress incontinence (USI). The hypothesis was that the autologous fascial sling (AFS) is the best curative procedure1. The primary objective was a subjective report of no leakage recorded on question 11a of the International-Consultation-on-Incontinence-Questionnaire - female lower urinary tract symptoms (ICIQ-FLUTS). Secondary objectives were to assess patient satisfaction and complications between the four surgical groups.

A prospective observational study was performed as part of clinical care in our specialist multi-disciplinary tertiary centre between 2012 and 2020 of adult female patients who had surgery for USI and had completed a baseline ICIQ-FLUTS. All participants included in the analysis provided a written informed consent and local institutional board ethical approval was granted. Exclusion criteria included patients who did not respond, patients who responded but did not consent to inclusion in the study, and deceased patients.

A postal invitation pack was sent out to participate in the study, and a reminder was sent one month after the first invite. Patients were given three questionnaires to complete: ICIQ-FLUTS, ICIQ-vaginal symptoms (VS), and ICIQ-satisfaction (S). 

Statistical analysis: Patient groups and treatment arms were formed depending on the surgery received. A power calculation was not required as all participants who met the inclusion criteria in the study period were invited to participate. Fisher's exact test was used to evaluate complications between the groups. Kruskal-Wallis test was used to evaluate satisfaction between the groups. The Chi-Square Test of Homogeneity was performed to evaluate sampling error. To assess which surgery had the best result, an indicator was built as an observable quantitative expression that allows a description of the results through the evolution of the variables measured in the questionnaire, specifically in terms of efficacy, satisfaction, global improvement and pain. For this, each item was assigned a proportional percentage (25% in this case), which was distributed among the questions that each item contained. Then, this weight was multiplied by the proportion of patients who expressed a satisfactory response, depending on the context of each question. Each score obtained per procedure was added, obtaining a global score for each surgery ranging from 0 to 1.

There were 853 USI procedures performed in the study period. 777 invitations were sent, once duplicates and deceased participants were excluded. Of the 404 (52%) participants who returned completed questionnaires, only 395 were included in the final analysis: 9 transobturator tape (TOT) responders were excluded as their numbers were too small for statistical analysis. Four groups were established for analysis: 226 retropubic mid-urethral tape tapes (TVT), 84 colposuspension, 51 Urethral bulking and 34 autologous fascial slings (AFS). The median follow-up was 5.9 years (range 1 to 10.1 years, SD +/- 2.5 years).

In terms of cure i.e. no SUI on ICIQ-FLUTS question 11a, TVT was significantly superior to colposuspension and urethral bulking (p<0.001). There was no difference between TVT and AFS in efficacy, with 63.8% TVT and 62.1% AFS reporting no SUI (p = 0.999).  In terms of success on the ICIQ-S question 1, the TVT group were most satisfied with the outcome of their surgery. Satisfaction: 79.7% TVT, 69.1% colposuspension, 56% urethral bulking and 74.19% AFS. This did not reach statistical significance [except for TVT versus urethral bulking (p<0.001)]. On the patient global impression, ICIQ-S question 2, the urethral bulking group were least satisfied with the outcomes of their procedure: 75.9% TVT, 69.1% colposuspension, 45.8% urethral bulking and 87.1% AFS. Statistical significance was not reached [except for TVT and AFS versus urethral bulking (p<0.001)] (Table 1).

In terms of complications, the AFS group had the lowest reported rate of complications, question 12 ICIQ-S: 65.7% TVT, 67.1% colposuspension, 71.74% Urethral bulking and 22.6% AFS (p<0.001). Pain (question 11a ICIQ-S) was the most reported complication in all the groups, and there was no statistical difference between the groups although the AFS had the least pain. In terms of vaginal pain (question 2a ICIQ-VS), the TVT group scored the highest in reporting no vaginal pain, though this was not statistically significant between the groups: (p=0.553). This response was mirrored in the bladder pain question 4a ICIQ-FLUTS, where the TVT group once again scored highest in reporting no bladder pain: (p=0.35) (Table 2). In terms of sexual activity question 10 on ICIQ-VS, 7% of the TVT group reported not having a sex life because of their vaginal symptoms. This was statistically significant across the groups: 6.9% TVT, 17.9% colposuspension, 12.8% urethral bulking and 16.7% AFS (p=0.041). Urinary urgency was the most reported storage symptom in all the groups: 55.6% TVT, 60.2% colposuspension, 86.3% urethral bulking and 56.3% AFS (p < 0.001). Intermittent stream question 8a ICIQ-FLUTS was the most reported symptom of voiding dysfunction for all the groups. There was no difference between the groups: 37.7% TVT, 36.3% colposuspension, 38.8% Urethral bulking and 50% AFS (p=0.591). 
TVT sub-analysis: When asked if they would recommend the surgery to friends or family question 5 ICIQ-S, 152/226 answered yes, 38/226 answered no and 36/226 were undecided. Qualitative assessment of the comments on complications provided by 32 of the TVT participants to ICIQ-S question 12 revealed three themes: 1) voiding dysfunction (12/32),2) recurrent urinary tract infections (9/32), and 3) tape erosion or pain requiring further surgery (6/32). 

Overall, when all patients reported outcome measures (PROMs) were evaluated, the TVT procedure was reported to be the best procedure in terms of satisfaction and complication, with a total score of 0.682. This was closely followed by the AFS procedure at 0.678, then colposuspension 0.575, and finally urethral bulking 0.441.

This study suggests that the AFS and TVT procedures are the best procedures for the surgical management of USI. Although there is a high percentage of patients who report severe pain, this can be attributed to pain at other body sites, because there is limited reporting of pain at the vagina and bladder, which anatomically are the sites most likely to be affected by the procedures. Additional research into the reporting of generalised body pain following mid-urethral tape insertion is required to further appraise the narrative of severe pain completely.

In the medium-term, AFS and TVT are the most efficacious procedures for the cure of USI and have the highest patient reported satisfaction and global impression of improvement. However, the AFS avoids mesh related complications. Pain was the most reported complication following surgery for USI, however, there was no difference between the groups in terms of vaginal or bladder pain. Careful patient counselling of outcomes is required as well as long-term data at 10 and 20 years.

Nambiar AK, Arlandis S, Bø K, Cobussen-Boekhorst H, Costantini E, de Heide M et al. European association of Urology guidelines on the diagnosis and management of female non-neurogenic lower urinary tract symptoms: part 1: diagnostics, overactive bladder, stress urinary incontinence and mixed urinary incontinence. Eur Urol 2022 Jul;82(1):49-59.