Hypothesis / aims of study
Following FDA warming for the treatment of IUS are used alternative techniques such as bulking agents (BU),sometimes even in I-line. Indications for performing bulking agent are still not entirely clear.The guidelines do not identify to which population it is applicable.Currently, bulking agent is identified as a procedure to be offered as an alternative to sling implantation, either first- or second-line.The indications currently are the same.It might be useful to understand then which procedure women prefer to undergo after careful consunselling.The aim of our study is to evaluate, in women with naïve IUS, after careful counselling, the treatment preference between sling implantation and BU (Bulkamid®) infiltration;and what characteristics the two groups have
Study design, materials and methods
It is a prospective study conducted from July 2021 to July 2022.Women with naïve IUS for surgical treatment regardless of the degree of urethral hypermobility were included; women with POP, previous anti incontinence surgery, with neurological diseases were excluded. Preoperative evaluation includes medical history, objective examination, dynamic urologic ultrasonography, urodynamic examination,according to ICS criteria .Follow-up visits are performed at 1 month,3,6,12 months after surgery and annually , with the same preoperative evaluations except for urodynamic examination which is performed at 6 months after surgery.Stress urinary incontinence was defined according to ICS standardization and classified
according to the Ingelmann-Sundberg scale.Urinary symptoms were evaluated using the standardized questionnaire UDI6.TOT surgery was performed by an expert surgeon using the out-in transobturator technique originally described by Delorm.Objective cure for SUI was defined as the absence of urine leakage during the stress test. Subjective cure was defined by a “no answer” to question 3 of the UDI-6 questionnaire.The study was approved by the Ethics Committee of our institution. All patients signed informed
At the time of diagnosis,careful counselling was conducted by providing the patient with the
following information:
• "The BU involves the infiltration by cystoscopy of a volumizing agent at the level of the continence muscle; whilesling implantation involves the placement of a prosthesis at the urethral level by vaginal access."
•”At our hospital the hospitalization is one day for both procedures."
•"The BU, unlike the sling, allows you to resume daily activity from the next day."
•"Long-term outcomes are better with sling than with BU."
• "In case of failure BU can be repeated and does not compromise subsequent sling implantation, while more complicated is the treatment of persistence/recurrence after sling"
• "BU has urinary retention as a complication; while a sling can result in extrusions/exposures ,urinary retention, UTI, dyspareunia" The patient was left free to choose between the two types of treatment
Results
80 patients with mean age 50±7.07 years were included. Most women choose to perform BU (61.3% vs 38.8%,p<0.0001) and compared to those who choose sling are older (52.5±6.8 vs 48.3±6.7,p=0.009), and have no help at home living alone (30 % vs 12.5%,p=0.001), and may have comorbidities (35.5% vs 18.3%, p=0.02) .Most women who choose BU were nurse and colf (Graph1). These women have justified their choice with the type of work, physically tiring and with the fact that they cannot be absent for so long. While women who choose slingwere housewives or unemployed (Graph1)
Interpretation of results
Our results showed that after careful counselling, patients choose the treatment that best meets their current needs in these moment.Women who do not have family help during convalescence, or who do heavy work and cannot get away from the workplace for a long time,or who have family problems (children, elderly to be cured, disabled....)prefer an alternative to sling.They prefer a procedure that allows them to return as quickly as possible to daily life.Sometimes the social, family needs of the patients for the patient himself are worth more than the probable clinical results.They accept a compromise:to be not completely dry and not forever, however, they can continue everyday life from the very beginning.In addition, for young women, avoiding early implantation of a sling, aware of the results but also the complications is a valid reason to prefer bulking agent