Study design, materials and methods
It was a prospective study conducted between April 2022 and May 2023, with clinical and urodynamics assessment, as well the implantation procedure of the AUS performed by one experienced single urologist, in 15 patients with severe UIPP. The UIPP was categorized through the male stress incontinence grading scale (MSIGS), number of PADs per day and 24 hours PAD test. We have selected patients with MSIGS grade 3 and 4 plus PAD test > 400g/24h. Urodynamic was performed following the International Continence Society guidelines. Follow up was performed at 3 months using the patient global improvement (PGI) questionnaires, in order to evaluate success after surgery. The study was approved by the local ethics committee. T-student test or Mann-Whitney was used to compare the outcomes and correlation analyses (Pearson and Spearman) were performed according to the data distribution.
Results
The mean age was 70.1 ± 5.44 (mean + standard deviation) years. Eleven percent had a previous incontinence surgery, 55% underwent to radiotherapy and 33% had urethra stenosis, previously. At the baseline, number of PADs per day and 24-hour PAD test was 4 ± 1.07 units and 413 ± 125g respectively. Urodynamically, the mean abdominal leak point pressure (ALPP) was 80.5 ± 31.6 cmH2O, and filling volume into the bladder of 165 ± 113 ml. Patients underwent radiotherapy had lower ALPP values before the procedure (p=0.03, [IC 20.1-83.9]).
After device implantation, the PGI improvement was high (median 90%). The median PRB volume was 20.5 ml (IQR 18 – 21.3). There was no correlation between satisfaction of the subject after surgery and any parameter assessed previously [ALPP (p=0.665), 24-hour PAD test (p=0.917) or number of PADs per day (p=0.295)]. Despite of lower ALPP in patients with radiotherapy history, we did not find a strong correlation between this feature and the final volume of adjustment (p=0.656). This was the first study according to our research in which the pre-operative, surgery and post-operative were performed by the same surgeon. The sample size is a limitation, and a larger number of patients is needed to corroborate or refute this hypothesis.
Interpretation of results
This was the first study according to our research in which the pre-operative, surgery and post-operative were performed by the same surgeon. The sample size is a limitation, and a larger number of patients is needed to corroborate or refute this hypothesis.