Ajust single incision transobturator sling procedure for stress urinary incontinence: Results after 1-year follow-up

Department of Urology, Groupe Hospitalo-Universitaire EST, Assistance Publique-Hôpitaux de Paris, University Paris VI, Tenon Hospital, Paris, France.
International Urogynecology Journal (Impact Factor: 1.96). 05/2012; 23(9):1265-70. DOI: 10.1007/s00192-012-1740-0
Source: PubMed


Data on the Ajust, a new single-incision sling procedure for female stress urinary incontinence (SUI) management, remain scarce and limited to a 1-year follow-up. Our goal was to assess the efficacy of this procedure after a 1-year follow-up.
This prospective evaluation involved 95 consecutive patients implanted with Ajust at a single centre. All patients had SUI on urodynamics due to urethral hypermobility, 33 % had preoperative overactive bladder (OAB) symptoms and none had detrusor overactivity. Ninety-two patients were treated on an outpatient basis, and 3 patients had general anaesthesia. Postoperative assessment was conducted at 1, 6, 12 months, and yearly thereafter. The main outcome measure was pad usage. Secondary parameters were self-reported SUI episodes, OAB symptoms, data of clinical examination, satisfaction using the Patient Global Impression of Improvement (PGI-I) scale, postoperative pain, and adverse events.
After a mean follow-up of 21 ± 6 months (12-32), 76 out of 95 patients used no pads or one dry security pad, showing a success rate of 80 %. Seventy-nine out of 95 patients had no more SUI-related leakage. Only 6 patients experienced late recurrence of SUI after 6 months' follow-up. Perioperative complications included 1 case of vaginal hematoma, 1 case of acute urinary retention, 2 cases of urinary tract infection, all managed conservatively. Half of the patients had no pain after day 1, free of medications. Late complications were vaginal erosion in 1 case, and pain during exertion in 2 cases.
The Ajust single incision transobturator sling is a safe and effective procedure, with durable results after 1 year.

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    • ". Cornu et al. observed de novo OAB symptoms in 10 patients (10.5% of the sample) [20]. It is worth noting that this rate is comparable with that given for retropubic and transobturator tape implantation. "
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    ABSTRACT: Objective: The primary outcome of this study was to evaluate the subjective and objective outcomes of an adjustable Single Incision Sling (Ajust™ C.R. Bard Inc., New Providence, NJ, USA) for the treatment of SUI, with a 2-year follow-up. The secondary outcome was to evaluate the safety of this procedure and the impact of this mini-sling on the filling and voiding phases of the bladder. Study design: In our prospective multicenter study we included 95 females with a clinical symptomatic and urodynamic diagnosis of primary SUI, and unsuccessful previous conservative treatment. Cure rate was evaluated objectively, using a standardized cough stress test and subjectively using the patient global impression of improvement. The King's Health questionnaire was used to evaluate quality of life (QoL). Urgency was evaluated using the patient perception of intensity of urgency scale. Complications were assessed intra-, peri- and post-operatively. All patients underwent urodynamic studies pre-operatively and at 6 months. The McNemar chi-square test was used to compare categorical variables, the paired t-test for continuous parametric variables, and the Fisher exact test for continuous non-parametric variables. A logistic regression model and odds ratios (with 95 percent confidence intervals) were used to assess the independent prognostic value of four variables for the outcome (age, parity, body mass index and menopausal status). Results: 92 Patients completed the 2-year follow-up. The objective cure rate was 83.7% and the subjective cure rate was 81.5%. De novo urgency was present in 9 patients (9.8%) and was associated with de novo urge incontinence in 6 patients (6.5%). Only 1 patient with de novo urge incontinence showed de novo detrusor overactivity. Regarding QoL, the King's Health Questionnaire indicated a statistically significant improvement in all domains except sleep. We observed no intraoperative complications. Post-operatively 1 patient referred pain in the right leg, 3 patients had mesh extrusions, 1 patient had recurrent urinary tract infections. Post-operative urodynamics showed a statistically significant increase of detrusor pressure at maximum flow and a reduction of maximum flow rate. No patients were obstructed according to the Blaivas and Groutz nomogram.
    European Journal of Obstetrics & Gynecology and Reproductive Biology 08/2014; 182C:48-52. DOI:10.1016/j.ejogrb.2014.08.011 · 1.70 Impact Factor
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    ABSTRACT: Introduction: The mid-urethral sling has become the mainstay in the surgical management of stress urinary incontinence. Early meta-analyses suggested that the obturator approach (TOT) may be preferable in women with a high body mass index (BMI), concomitant voiding difficulties (VD), mixed urinary incontinence (MUI), or previous retropubic surgery. However, this approach is associated with increased and prolonged de novo groin pain. The AJUST® single-incision sling (SIS) was developed as an alternative to the retropubic and obturator slings and has been shown to be an effective treatment for urodynamic stress incontinence (USI) in the short term. We aim to assess if the AJUST® SIS would be an effective alternative to the TOT in a cohort of patients who have urodynamic stress incontinence (USI) with concomitant detrusor overactivity (DO), VD, high BMI, or those with previous retropubic surgery. Methods: Women with USI and either concomitant DO, VD, previous failed retropubic surgery, or a BMI > 35 underwent treatment with the AJUST® SIS. Women were asked to complete the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) and an Urgency Perception Scale (UPS) preoperatively and then at 6 weeks, 6 months, 12 months, and 24 months postoperatively along with the PGI-I form. The numerical rating scale (NRS) was used to score pain 3 hours postoperatively and prior to discharge. Changes in ICIQ-UI-SF and UPS scores were measured. Results: Twenty-five women were recruited. The mean age was 58 years. Of these, 28% had USI and 72% had mixed incontinence. There were no major perioperative complications. Mean postoperative pain scores were low with no de novo groin pain. All women had satisfactory postoperative voiding and a negative cough stress test at 6 weeks of follow-up. At the 2-year follow-up, 89% had still improved. Conclusion: The AJUST® SIS appears to have promising medium-term efficacy in this challenging cohort of women. The long-term results are awaited.
    01/2013; 06(03). DOI:10.3834/uij.1944-5784.2013.06.10
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    ABSTRACT: Purpose: We analyzed the correlation between pad use, as determined by objective pad count, and the severity of urinary incontinence, as measured by pad weight. Materials and methods: We performed a retrospective study of consecutive incontinent patients who wore pads on a daily basis and were instructed to complete a 24-hour pad test. They were told to use the usual pads, change them as usual and place each in a separate plastic bag the day before the scheduled appointment. All pads were weighed and total urine loss was calculated by subtracting dry pad weight from wet pad weight, assuming that a 1 gm weight increase was equivalent to 1 ml of urine loss. The number of pads was correlated to pad weight using the Spearman rank correlation coefficient due to the nonparametric nature of the data. Results: The 116 patients included 51 men 39 to 89 years old (mean age 66) and 65 women 27 to 95 years old (mean age 72). When comparing the number of pads used to the gm of urine lost, the Spearman ρ was 0.26 (p=0.005) in the total cohort, and 0.40 and 0.26 (each p<0.05) in males and females, respectively. Conclusions: There was little correlation between the number of pads used and the severity of urinary incontinence (r=0.26). These data suggest that pad count should not be used as an objective measure of incontinence severity. Instead, pad weight on a 24-hour pad test should be used.
    The Journal of urology 05/2013; 190(5). DOI:10.1016/j.juro.2013.05.055 · 4.47 Impact Factor
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