Study design, materials and methods
A retrospective case note review was conducted. All cases undergoing surgery 18 months before July 2018 and 18 months after were recorded. Information on baseline demographics, surgery undertaken, post-operative complications and requirement for further surgery were collected using Excel. All surgical procedures during the time periods were included. Patients whom this was not their primary surgery for SUI were also included.
Results
Thirty operations were conducted in each 18-month period. Patient demographics including age, type of incontinence and conservative treatments were matched (table 1).
In the pre-ban group 29 patients underwent urodynamics, this failed to demonstrate SUI in six cases. In the post-ban group 27 patients had urodynamics, SUI was not demonstrated in eight cases. Seven patients in the pre-ban group had already undergone a surgical procedure for SUI and eight in the post ban group, these ranged from intra-urethral bulking agent, tension-free vaginal tape (TVT) and colposuspension.
In the pre-ban group 12 patients underwent TVT, 16 had intra-urethral bulking agent, one patient had an autologous sling and one colposuspension. Post ban 29 patients underwent intra-urethral bulking agent and one patient had an artificial urinary sphincter (AUS).
Minimal surgical complications occurred. Pre-ban, two TVT patients had an intra-operative bladder perforation of which re-positioning was performed and they had no further complications. There were no other intra-operative complications with other procedures. 30 day complications included two TVT patients who were treated for UTI and one intra-urethral bulking patient had urinary retention in the pre-ban group. In the post ban group, the patient with whom the AUS placed had an intra-operative urethral perforation, she had no other post-operative complications. 30 day complications in the post-ban group receiving intra-urethral bulking agent identified four patients who went into retention and one patient had a myocardial infarction, which was not found to be related to the surgery. One patient in the pre-ban group was lost to follow up and one did not attend follow up compared to two patients lost to follow up in the post-ban group.
Success in achieving dryness was higher in the pre-ban group; 47% (14/30) patients were dry and happy with the outcome compared to only 27% (8/30) patients in the post ban group. Of the patients that remained incontinent in the pre-ban group five were still happy with the outcome, two of these patients had undergone a TVT and three intra-urethral injections. In the post-ban group 57% (17/30) patients were unsatisfied with the outcome and requested further treatment. A number of patients who were not satisfied with the response after initial surgery in both groups are awaiting or have undergone further procedures (table 2).
Interpretation of results
Since the pause on synthetic tape insertion in July 2018 we have performed the same number of SUI surgeries. Immediate and 30 day complications were minimal in both groups. During the follow up of patients who had a TVT none had a mesh erosion. Post ban more patients opted for the minimally invasive option of intra-urethral injections however a higher number of patients were unsatisfied with the results, and are awaiting decision on more invasive surgical options. 30 day complications in the intra-urethral bulking agent patients was higher when compared to TVTs.