Hypothesis / aims of study
Recurrent urinary incontinence, after one or more surgical treatment attempts, is an underreported and undertreated burden to women. The disappointment and the possible burden of the side effects of prior treatments add up to the reduced physical but more profound even psychological well-being of the patient and results in a reduced participation in terms of work and other social activities(1) . Despite several types of therapies, 18% of the patients still remain incontinent (2). For these ‘therapy resistant patients’, more invasive and technically demanding surgical options are available such as implantation with an artificial urinary sphincter (AUS).
Aim of study: The evaluation in terms of functional outcome with device and treatment survival of an AUS in women with complicated and recurrent urinary stress incontinence after 4 months to 9 years of follow-up.
Study design, materials and methods
All female patients who underwent AMS-800 sphincter prosthesis implantation for recurrent stress urinary incontinence after at least one surgical treatment or primary implantation for neurological reasons between November 2011 and January 2021 (to ensure a minimum 4-months follow-up) were retrospectively included in the study. All patients were treated in the same urological referral center by the same urologist.
Surgical procedure: Implantation of the AUS in female patients using an open surgical procedure. When previously scheduled or considered necessary during the procedure, a 2-stage procedure was performed with an omentum plasty wrap around the bladder neck during a preparatory procedure. When necessary due to erosion or wrong placement, eroded bulking agents, tapes, slings, meshes or suspension stitches were removed in a separate earlier procedure with often a concomitant reconstruction using an omentum wrap or Martius flap.
All baseline patient characteristics and perioperative outcomes were collected from patient history, referral letters, anesthesia reports and operation reports. Functional outcomes were registered at the latest follow-up consultation. The study group was subdivided in non-complex patients after 2 or less previous pelvic surgical procedures and complex patients with 3 or more of these procedures or a history of extrophy or pelvic radiotherapy.
Results
Overall, thirty-four patients, median age 59.5 years (IQR 28.0-86.0) underwent surgical implantation of an AUS and were included. 88.2% of the study population underwent at least one surgical procedure for stress urinary incontinence before the implantation of the sphincter.
10 patients (29.4%) underwent at least one preparatory surgical procedure to enable implantation. 5 of these patients (50.0%) received an omentum plasty wrap and 5 (50.0%) received a Martius flap during the preparatory surgical procedure.
Survival rates of the initial AUS device were 80.6%, 77.1%, 57.2% and 32.7% and of the AUS treatment (including revisions) 87.0%, 87.0%, 76.7% and 76.7% , at 1, 2 ,5 and 9.5 years of follow-up, respectively (see figure 1). In 7 women (20.6%) the AUS had been explanted. One of these women received a new AUS after 9 months recovery.
The 11 non-complex patients versus 23 complex patients showed a primary sphincter survival of 72.7% vs 56.6%, overall sphincter survival 90.9% vs 78.3%, explantation 9.1% vs 26.1%.
At the last follow-up evaluation, 11 patients (33.3%) were completely continent. 14 (42.4%) patients needed max 1 pad per day. Of these patients, 8 patients (24.2%) had urgency incontinence complaints. In 1 patient (3.0%) the incontinence was unchanged after the surgery. 1 patient (3.0%) developed voiding dysfunction and needed clean intermittent catheterization. In one case the AUS had to be deactivated due to dementia and the inability to operate the pump.
When comparing the non-complex to the complex patients, complete continence was gained in 45.5% vs 27.3% and continence with max 1 pad use in 45.5% vs 40.9%.
Interpretation of results
In this group of 34 women with mainly complex recurrent stress urinary incontinence after 2 to up to 10 previous pelvic surgical interventions, an AUS was placed using an open surgical procedure. 10 of these women needed a preparatory procedure with an omentum plasty bladderneck wrap or a Martius flap reconstruction. After 5 years the survival rate of the primary sphincter was 57, 2 percent, which is lower than in series in a less challenging population. (3). The survival of the treatment however was 76,7 % including revisions. Functional outcome at a median follow-up of 28 months shows a continence rate allowing for max 1 pad a day in 75,7% of the patients comparable to other open and robotic series (4)
Implantation in the more complex treatment group due to previous surgeries or treatment with radiotherapy in the same area caused less favorable functional outcomes. However even in this complex study population, continence rates, allowing for max 1 pad a day, were still 68.2%.