ADJUSTABLE TRANSOBTURATOR MALE SYSTEM (ATOMS®) TO TREAT MALE STRESS URINARY INCONTINENCE AFTER PROSTATE SURGERY: OUR INITIAL EXPERIENCE.

Rodríguez Rodríguez A1, García Larrosa A1, Costa Planells M1, Abascal Junquera J1, Fumadó Ciutat L1, Munarriz Polo C1, Sanromà Salvà A1, Polaina Barroso L1, Cámara Moreno C1, Rodríguez Malatesta R1, Vicens Morton A1, Delgado Ortega G1, Francés Comalat A1, Cecchini Rosell L1

Research Type

Clinical

Abstract Category

Male Stress Urinary Incontinence (Post Prostatectomy Incontinence)

Abstract 303
E-Poster 2
Scientific Open Discussion ePoster Session 18
Thursday 5th September 2019
13:15 - 13:20 (ePoster Station 2)
Exhibition Hall
Male Stress Urinary Incontinence Grafts: Synthetic Prospective Study
1.Parc de Salut Mar, Hospital del Mar. Urology Department. Barcelona. Spain.
Presenter
A

Alfredo Rodríguez Rodríguez

Links

Abstract

Hypothesis / aims of study
Stress urinary incontinence (SUI) is one of de sequelae with the greatest negative impact on the quality of life of the patient after prostate surgery.  In radical prostatectomy its incidence ranges from 6% to 69% and seems to depend mainly on surgical experience. In addition, at least 2% of patients undergoing surgeries for benign prostatic hyperplasia (BPH) can also develop SUI. Classically the gold standard treatment after failure of conservative therapy for male SUI has been the artificial urinary sphincter (AUS), despite its high rate of complications and explantations.

Adjustable transobturator male system (ATOMS®, Agency for Medical Innovations GmbH, Feldkirch, Austria) is a device that allows the bulbar urethra to be compressed only on one side. It is composed of a central silicone cushion connected to a port and a two-arm mesh that is anchored to the cushion through a transobturator passage on both sides of the pubis. The compression of the urethra is performed ventrally and can be progressively adjusted postoperatively by filling or emptying the cushion with a simple injection of sterile saline solution into the port. The device can be easily adjusted postoperatively in the office. ATOMS® was developed in 2008 (1) and the third-generation device with pre-attached silicone-covered scrotal port (SSP) was introduced in 2014. In a recent meta-analysis treatment with ATOMS® resulted in a mean 67% (95% CI 0.61–0.72) dryness rate and 90% (95% CI 0.86–0.94) improvement after adjustment was considered complete (2).
 
The objective of this study was to assess the effectiveness and safety of the Adjustable Transobturator Male System (ATOMS®) to treat male stress urinary incontinence after prostate surgery at our institution.
Study design, materials and methods
In an open prospective study we analyzed 17 consecutive patients with a mean age of 71.65 ± 4.83 years, with persistent stress urinary incontinence secondary to prostatic surgery (13 laparoscopic radical prostatectomy, 2 transurethral resection of the prostate and 2 holmium laser enucleation of prostate) and operated with pre-attached scrotal port ATOMS®. Four patients (23.5%) were treated with prior adjuvant radiation and 4 patients (23.5%) received previous surgical treatment for SUI with transobturator AdVance® sling. The mean postoperative follow-up was 34 weeks. Clinical efficacy was defined as use of no pad or one safety pad per day (PPD) after device adjustment. We evaluated the effectiveness of the device after the necessary adjustments, compared to the baseline using 24h pad-test, 24h pad count, International Consultation on Incontinence Impact Questionnaire-Short Form (ICIQ-SF), Incontinence Impact Questionnaire-7 (IIQ-7) and Patient Global Impression of Improvement (PGI-I) questionnaire. Complications derived from the technique were registered according to Clavien-Dindo classification.
Surgical technique (3): In a lithotomy position after bladder catheterization with Foley 14Fr catheter, a longitudinal perineal incision is made, the Colles fascia is dissected, and the bulbospongiosus muscle is exposed without dissecting the urethra. The ischiorectal fossa and ischiocavernosus muscles are then dissected on both sides. The obturator membrane is pierced with the tunneling needle through the obturator foramen with a rotating movement sliding down the inferior branch of the pubis. The tunneling needle is recovered with the help of the index finger in the ipsilateral ischiorectal fossa. The same procedure is performed on the contralateral side. Once both arms are passed, it is very important to give enough tension to prevent their future migration. After removing the protective plastics from the arms, both arms are sutured to the central pad with four prolene stitches. The filling of the port is done with 10mL of PS, which is introduced and extracted to purge the air inside the pad. Once this maneuver is done, 10mL of PS are injected again until the pressure is adjusted, usually returning 1–2mL, thus filling the system with 8–9mL. Finally, a subdartos scrotal passage is made to introduce the scrotal port that is easily accessible by puncture from the outside. The hemostasis is checked and the perineal wound is closed by planes without leaving drainage. Patients are discharged the following day without bladder catheter. The postoperative adjustment is performed if necessary on an outpatient basis after 3–4 weeks.
Results
Treatment with ATOMS® resulted in 94.11% (16/17) improvement rate (no pads or one safety pad) and in a 52.94% (9/17) complete dryness rate (no pad) after adjustments. Only 1 patient (5.88%) with severe SUI and previous radiation therapy perceived not significant improvement of his incontinence. The baseline 24h pad-test was 374.1 ± 202.96 ml and 24h pad count 2.71 ± 0.92. After adjustments the 24h pad-test and pad count was 28.11 ± 93.16 ml and 0.71 ± 0.98 respectively (p< 0.001). We observed a significant reduction in the ICIQ-SF (16.53 ± 1.91 vs 4.24 ± 3.75) and in the IIQ-7 (79.69 ± 10.68 % vs. 18.08 ± 18.44%) scores (p< 0.001) (Figure 1). The mean filling of the cushion in the operating room was 8.41 ± 0.8 ml and after the adjustments was 12.64 ± 5.88 ml. The mean number of adjustments was 1.64 ± 1.71. The global perception of improvement perceived by the patient was very satisfactory (PGI-I 1.47± 0.6). Only grade 1 complications (Clavien-Dindo) were reported in 6 cases (35.2%). In one case (5.8%) urinary retention occurred after catheter removal and it was solved removing 2 ml from the cushion. Any infection occurred and explant rate was 0%.
Interpretation of results
According to the current results, the ATOMS® system for the treatment of male SUI after prostate surgery appears to be an efficacious and safe procedure, with high objective and subjective effectiveness and low rate of complications in the short and medium term. To confirm these results a larger number of patients with a longer follow-up are necessary.
Concluding message
In our initial experience, the third generation of ATOMS® device with pre-attached silicone-covered scrotal port is an effective and safe system for the treatment of male urinary stress incontinence after prostate surgery even in patients with previous surgery for incontinence.
Figure 1
References
  1. Bauer W, Brössner C. Adjustable transobturator male system (ATOMS) for the treatment of post- prostatectomy urinary incontinence: the surgical technique. Pelviperineology. 2011;30:10–8.
  2. Esquinas C, Angulo JC. Effectiveness of Adjustable Transobturator Male System (ATOMS) to Treat Male Stress Incontinence: A Systematic Review and Meta-Analysis. Adv Ther. 2019 Feb;36(2):426-441. doi: 10.1007/s12325-018-0852-4. Epub 2018 Dec 17. PubMed PMID: 30560525.
  3. Esquinas C, Arance I, Pamplona J, Moraga A, Dorado JF, Angulo JC. Treatment of stress urinary incontinence after prostatectomy with the adjustable transobturator male system (ATOMS®) with preattached scrotal port. Actas Urol Esp. 2018;42:473–82.
Disclosures
Funding none Clinical Trial No Subjects Human Ethics Committee Comitè Ètic d'Investigació Clínica del Parc de Salut Mar Helsinki Yes Informed Consent Yes