READJUSTABLE MIDURETHRAL SLING FOR SEVERE STRESS URINARY INCONTINENCE IN WOMEN WITH HYPOMOBILE URETHRA

Escura Sancho S1, Ros Cerro C1, Anglès Acedo S1, Larroya Solà M1, Bataller Sánchez E1, Amat Tardiu L2, Sánchez Ruiz E1, Espuña Pons M1

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 224
On Demand Female Stress Urinary Incontinence (SUI)
Scientific Open Discussion Session 18
On-Demand
Stress Urinary Incontinence Surgery Grafts: Synthetic Urgency Urinary Incontinence
1. Hospital Clínic de Barcelona, 2. Hospital Sant Joan de Déu d'Esplugues de Llobregat
Presenter
Links

Abstract

Hypothesis / aims of study
In women with recurrent stress urinary incontinence (rSUI) after a failed mid-urethral sling (MUS) or other surgery, there is no consensus about the surgical procedure of choice. When urethral hypermobility persists, another MUS or a colposuspension are the most common procedures. However, when the previous surgery caused periurethral fibrosis restricting the urethral mobility, we should consider other treatments such as bulking agents, autologous fascial sling, artificial sphincter or adjustable slings.   
Remeex® re-adjustable sling (Mechanical External Regulation; Neomedic International) is a closed system which allows the regulation of the sling tension the days after the placement or at any time during the follow-up. In our urogynecology unit, this re-adjustable sling is an option for a selected group of women with severe SUI and hypomobile urethra, often associated to an intrinsic sphincter deficiency (ISD) and/or hypoactive detrusor during voiding. The selection of these complex group of patients is based on the clinical evaluation in combination with urodynamics and pelvic floor ultrasound.
The aim of this study is to evaluate the results of Remeex® system in a group of women with a severe SUI and hypomobile urethra.
Study design, materials and methods
We included patients who underwent Remeex® surgery between July 2012 and February 2020 from two different university hospitals. All women presented urodynamic SUI and a sonographic hypomobile urethra, which was considered when the distance shift between the bladder neck at rest and during straining were <5 mm (1). Patients affected with any pelvic organ prolapse and those who missed follow-up visits were not included in this study. The study was approved by the Hospital Institutional Ethics Committee and informed consent was obtained from all patients.
Demographic characteristics, gynecological history and previous anti-incontinence surgeries were recorded. For the evaluation of the symptoms of urinary incontinence (UI) we used the Incontinence Questionnaire-Short Form (ICIQ-UI-SF) with scores ranging from 0 to 21 points. We classified the severity of the UI in the following intervals according to the ICIQ-UI-SF: slight (1-5), moderate (6-12), severe (13-18), and very severe (19-21) (2). Patient satisfaction after surgery was assessed by Patient Global Impression of Improvement scale (PGI-I). In all women a 3-day bladder diary, a 24 hour-pad weight test, a pelvic physical examination and an International Continence Society (ICS) Uniform Cough Stress Test (ICS-UCST) were performed. All patients had a urodynamic evaluation including: Uroflowmetry, Post Void Residual (PVR), Cystometry, Pressure-flow study and Urethral Pressure Profile (UPP). ISD was defined as a maximal urethral closure pressure (MUCP) of 20 cmH2O or less. Urethral mobility was assessed by pelvic floor transperineal ultrasound (2D-TPUS), in the mid-sagittal plane. 
Statistical analysis was performed with the SPSS software package (version 19.0, SPSS Inc., Chicago, IL, USA). Values from quantitative parameters were expressed as mean and standard deviation (SD), and values from qualitative parameters as number and frequency. Comparison between variables was performed using the unpaired and paired Student’s t-test, Fisher, Cohen`s Kappa and Wilcoxon test. Results were considered statistically significant with p<0.005 (two-sided).
Results
A total of 90 patients with severe SUI, who underwent Remeex® surgery were included with a median follow-up of 4.9 ± 2.7 years. The mean score of the ICIQ-UI-SF was 18.1 ± 2.6 points and the mean 24 hour-pad weight test was 273.6 ± 320 grams. Only 22.7% of the patients complained of pure SUI symptoms and 77.3% of the patients complained of concomitant urgency incontinence according to the dimension of symptoms of ICIQ-UI-SF. Sixty-six (59.4%) of the 90 patients had a previous anti-incontinence surgery, being MUS 44.1% of those. Twenty-four women without previous anti- incontinence surgery, with urethral mobility <5 mm measured by 2D-TPUS, were also treated with this readjustable sling. The reasons for the hypomobile urethra in these patients were the periurethral fibrosis due to a previous anterior colporrhaphy in twenty cases and pelvic radiotherapy in four cases. All patients had a urodynamic SUI, 26% of them had an associated detrusor overactivity (DO) and/or hypoaccomodation and 14% voiding dysfunction due to a hypoactive detrusor. ISD was observed in 47% of the 90 patients. 
Major surgical complications occurred in 18 patients (20%), reported as bladder perforation during sling placement, surgical wound infection and tape exposures to the vagina. Minor complications occurred in 18 patients (20%), reported as postoperative urinary retention, urinary tract infections and postoperative pain. 
Subjective success measured by answering the PGI-I as (Very much better/Much better/A little better) was 70% (63 patients). There was a mean decrease of ICIQ-UI-SF score after surgery of 9,4 ± 7.0 points. A decrease of the severity of de IU according to ICIQ-UI-SF score was observed in 69 patients (76.7%) (Figure 1). Additionally, a mean reduction of 109.6 ± 291.4 grams in the post-surgical 24 hour-pad weight test was observed. Urodynamics one-year after surgery (performed in 59 patients) revealed cure of the urodynamic SUI (negative stress test at maximum cystometric capacity) in 15 (25.4%) of the 59 patients. A persistency or de novo DO was observed in 19 (32.2%) of the 59 patients.
When we compared women with post-surgical decreased severity of de UI with those without UI severity changes, we found lower mean BMI (28.2 ± 4 kg/m2 vs. 30.5 ± 4.6 kg/m2, p = 0.028) and 24 hour-pad weight (188.0 ± 244.6 g vs. 385.1 ± 366.6 g, p = 0.027) in the first group.
Interpretation of results
Surgical treatment of women with severe SUI and an hypomobile urethra due to a periurethral fibrosis, is a challenge. In these complex group of women, the preoperative assessment with a combination of clinical evaluation, 24 hour-pad weight test, urodynamics and pelvic floor ultrasound, allow us to select patients who are not candidates for MUS. In these cases, the election of the type of surgery is based in the resources available, the experience of the surgeons and the preferences of the patient. 
In this group of complex SUI patients, operated with a readjustable sling procedure (Remeex®), we observed a statistically and clinically significant decrease in ICIQ-IU-SF score after surgery in more than three-quarters and a subjective success rate of 70%.
Concluding message
In our sample of patients with severe SUI, all with sonographic hypomobile urethra and nearly half with ISD, the surgical treatment with a readjustable sling (Remeex®), shows a limited objective cure of urodynamic SUI. However, the objective improvement of the UI severity scores are acceptable and the subjective success rate was good considering the severity and complexity of their SUI.
Figure 1 Figure 1. Comparison of ICIQ-UI-SF score of women underwent Remeex® surgery, before and after the procedure, sorted by severity.
References
  1. Wlazlak E, Viereck V, Kociszewski J, Kuszka A, Rautenberg O, Walser C, Surkont G, Gamper M, Fehr MK. Role of intrinsic sphincter deficiency with and without urethral hypomobility on the outcome of tape insertion. Neurourol Urodyn. 2017 Sep;36(7):1910-1916. doi: 10.1002/nau.23211. Epub 2017 Jan 31. PMID: 28139863.
  2. Klovning A, Avery K, Sandvik H, Hunskaar S. Comparison of two questionnaires for assessing the severity of urinary incontinence: The ICIQ-UI SF versus the incontinence severity index. Neurourol Urodyn. 2009;28(5):411-5. doi: 10.1002/nau.20674. PMID: 19214996.
Disclosures
Funding No funding. Clinical Trial No Subjects Human Ethics Committee COMITÉ DE ÉTICA DE LA INVESTIGACIÓN CON MEDICAMENTOS Helsinki Yes Informed Consent Yes
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