Ajust single incision transobturator sling procedure for stress urinary incontinence: Results after 1-year follow-up
ABSTRACT 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) . It is worth noting that this rate is comparable with that given for retropubic and transobturator tape implantation. "
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: 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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ABSTRACT: To assess the efficacy and complications of inside-out transobturator tension-free vaginal tape (TVT-O) in comparison with a single incision sling procedure (Ajust) for the treatment of urodynamic stress urinary incontinence. Prospective closely matched controlled study. In total, 171 patients were included in the study: 86 women underwent the TVT-O procedure, while in other 85 cases the Ajust procedure was performed. Subjective and objective cure, improvement and failure rates, mean operative time, hospital stay and incidence of complications were assessed. There was no statistically significant difference between the two groups for age, body mass index, parity, menopausal status and severity of prolapse. No major intraoperative complications occurred. There was no significant difference in the mean operative time and the duration of hospital stay between the two groups. The mean follow-up time of the study was 22.3 months (range 12-36 months). For the TVT-O group the objective cure rate was 86%, the improvement rate was 5.9% and the failure rate was 8.1%, while the subjective cure rate was 82.6%. For the Ajust group the objective cure rate was 84.7%, the improvement rate was 4.7%, 10.6% of patients showed no change in their symptoms and the subjective cure rate was 81.2%. The Ajust sling procedure presents success rates, at 22 months' mean follow up, comparable to the TVT-O method. Both techniques seem to be safe and effective for the treatment of urodynamic stress urinary incontinence.European journal of obstetrics, gynecology, and reproductive biology 08/2013; 170(2). DOI:10.1016/j.ejogrb.2013.07.041 · 1.70 Impact Factor