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BACKGROUND: The study is amined to correlate the voiding pattern after successful mini sling Ophira implantation with postoperative symptoms and satisfaction, in addition to identifying obstructions. MATERIALS AND METHODS: From 2012 to 2015 in a single institution, all consecutive patients who had stress urinary incontinence treated by using the mini sling Ophira had a pre- and 12âmonths postoperative urodynamic test. The International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) and the International Consultation on Incontinence Questionnaire - Overactive Bladder (ICIQ-OAB) translated into Portuguese, were given. Patients were objectively considered cured when presenting no urinary incontinence at the Valsalva test and subjectively cured when the ICIQ-UI-SF was zero. RESULTS: Questionnaire scores were obtained from 29 patients and urodynamic data from 20 patients. Mini sling Ophira implantation resulted in a significant improvement of urinary symptoms evidenced by a significant mean reduction in ICIQ-UI-SF from 16 to 5 (pâ<â0.0001) and ICIQ-OAB from 8 to 4 (pâ=â0.0001). The subjective and objective cure rates were 55% and 45%, respectively. The urodynamic changes were not related to success even when adjusted for age, hormonal status, or anterior pelvic organ prolapse. The mean maximum flow decreased to 4.9âmL/s (95% CI: 0.62-10.8; pâ=â0.035), and the mean detrusor pressure at maximum flow increased to 11.4âcmH2O (95% CI: 4-18; pâ=â0.0078). CONCLUSIONS: Mini sling Ophira implantation decreased maximum urinary flow and increased the detrusor pressure at the maximum urinary flow and these urodynamic changes were not related to success.
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INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) is the involuntary loss of urine on effort and is a condition that negatively interferes with various aspects of a woman's life. This study aimed to demonstrate the non-inferiority of the less invasive single-incision mini-sling (SIMS) method in objective and subjective cures in relation to tension-free transobturator tape (TOT) in two analyses, per protocol and intention to treat, and secondarily to evaluate complications and quality of life. METHODS: This study was a randomized controlled trial (RCT). Participants in this study included 105 women with a clinical diagnosis of stress predominant urinary incontinence and urodynamic results demonstrating SUI and absence of detrusor overactivity. Patients were evaluated pre- and postoperatively through anamnesis, physical examination, urinalysis, urine culture and susceptibility testing, simplified pad test, the Urinary Incontinence-Specific Quality of Life Instrument (I-QOL) and Urogenital Distress Inventory Short Form (UDI-6). RESULTS: Regarding the objective cure, SIMS was non-inferior to TOT (p < 0.05). However, the same was not found for the subjective cure (p > 0.05). There were no differences in the complication rates (p > 0.05). However, in the TOT group, bladder perforation (2.4%), tape exposure (2.4%) and urinary retention occurred, lasting > 7 days (2.4%). In both groups, there was improvement in quality of life after surgery, without significant differences (p > 0.05). CONCLUSIONS: The non-inferiority of SIMS in relation to TOT was only demonstrated in the objective cure. There were no significant differences between groups regarding complications and quality of life.
Assuntos
Slings Suburetrais , Incontinência Urinária por Estresse , Incontinência Urinária , Feminino , Humanos , Qualidade de Vida , Slings Suburetrais/efeitos adversos , Resultado do Tratamento , Incontinência Urinária por Estresse/cirurgia , Procedimentos Cirúrgicos UrológicosRESUMO
PURPOSE: To evaluate mini-sling long-term results and correlate them to failure predictors. Many studies show comparable results among different single-incision slings developed as an attempt to reduce complications while keeping good results, but there is a lack of evidence about mini-slings outcomes in the long term. METHODS: This prospective, single-center study evaluated 40 patients for long-term outcomes after mini-sling placement. Objective cure was defined as leakage of less than 1 g in 1-hour pad-test and no leakage at Valsalva maneuver. An objective improvement was defined as leakage of a maximum 50% of the preoperative test. Subjective continence was considered as a zero score at International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). Patients were also evaluated for comorbidities and previous surgeries. RESULTS: The mean age was 56 (±9.3) years, the mean ICIQ-SF score was 16 (±2.98) before surgery and 3.5 (± 5) at last follow-up, showing sustained improvement in the long term, mean 100 (84-109) months follow-up. The objective results show 67.5% of success, 17.5% of improvement, and 15% of failure. Age and parity were not related to outcomes (p = 0.33), but previous surgeries increase failure rate with 5.66 OR (p = 0.04). Success, improvement, and failure rates were 85, 10, and 5% for treatment-naive patients versus 50, 25, and 25% for patients with previous surgeries, respectively. CONCLUSION: Mini-sling Ophira shows good long-term results with low complications rates in patients without previous anti-incontinence surgery. Randomized trials are necessary to compare mini-slings results to other mid-urethral slings in recurred stress urinary incontinence.
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Slings Suburetrais/efeitos adversos , Incontinência Urinária por Estresse/cirurgia , Incontinência Urinária/etiologia , Incontinência Urinária/cirurgia , Adulto , Idoso , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Inquéritos e Questionários , Resultado do Tratamento , Manobra de ValsalvaRESUMO
BACKGROUND: The role of single-incision mini-slings (SIMS) in stress urinary incontinence (SUI) management is still not elucidated. OBJECTIVE: To compare efficacy and safety of SIMS and transobturator sling (TOT) for SUI after 36-month follow-up. METHODS: A randomized controlled clinical trial involving 130 women with SUI that had either SIMS or TOT. Primary outcomes: objective cure defined as negative cough stress and pad tests, and subjective cure reported as satisfaction and no desire for additional treatment. SECONDARY OUTCOMES: quality-of-life by IQOL and UDI-6 questionnaires, complications and reoperation rates. Student's t, χ2 , Fisher's exact, and Mann-Whitney tests, ANOVA and P < 0.05 as cut-off point were used for statistics. RESULTS: A total of 82 patients (n:41 each arm) completed 36-month follow-up. Objective cure was lower in the SIMS compared to TOT groups by both per protocol (68.3% and 90.2%, respectively, P = 0.027) and intention-to-treat analysis considering missing data as failures (40.6% and 60.7%, respectively, P = 0.035), while similar in both groups (81.2% and 93.4%, respectively) considering missing data as successes. Subjective cure rates were similar for both groups. TOT group presented better outcome regarding the avoidance and limiting behavior domain of IQOL (P = 0.021), and UDI-6 scores (P = 0.026). Seven out of 69 (10.1%) women in the SIMS group compared with two out of 61 (3.3%) in the TOT group (P = 0.172) had repeat surgery due to recurrent SUI at year follow up. CONCLUSION: TOT was associated to higher objective cure rate than SIMS for SUI treatment although satisfaction rate was similar for both groups 3 years postoperative.
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Slings Suburetrais , Incontinência Urinária por Estresse/cirurgia , Adulto , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Qualidade de Vida , Reoperação , Resultado do TratamentoRESUMO
INTRODUCTION AND HYPOTHESIS: Currently, a sling implant is the standard treatment for stress urinary incontinence in women. To be effective, they require an adequate anchoring system. The aim of this study is compare biomechanical features of fixation systems of two mini slings models available on the market (Ophira™ and Mini Arc™) through a tensile test. MATERIALS AND METHODS: Anchoring devices of each sling were surgically implanted in abdominal wall of 15 rats divided into three groups of five animals which were arranged according to the date of post implant euthanasia on 7, 14 and 30 days. Abdominal walls of rats were extracted on bloc containing the anchoring system and were submitted to a tensile strength test to measure the maximum load and elongation until device avulsion from the tissue. The results were compared using Student test t and a 5% cut off was considered significant. RESULTS: The Ophira™ mini sling fixation system demanded a greater maximum load and developed a longer stretch for avulsion from the implanted site at all moments evaluated (p value less than 0.05). CONCLUSION: There were significant differences in fixation patterns of the anchoring systems, which were exclusively related to their designs. The Ophira™ mini sling fixation device provided better fixation to the abdominal wall of rats compared to the Mini Arc™ device, even in the late post implant period.
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Slings Suburetrais , Âncoras de Sutura , Animais , Fenômenos Biomecânicos , Feminino , Desenho de Prótese , Ratos , Ratos Wistar , Resistência à TraçãoRESUMO
PURPOSE: The aim of this study was to critically review the Arc-to-Arc mini-sling (Palma's technique) a less invasive mid-urethral sling using bovine pericardium as the sling material. MATERIALS AND METHODS: The Arc-to-Arc mini-sling, using bovine pericardium, was the first published report of a mini-sling, in 1999. The technique was identical to the "tension-free tape" operation, midline incision and dissection of the urethra. The ATFP (white line) was identified by blunt dissection, and the mini-sling was sutured to the tendinous arc on both sides with 2 polypropylene 00 sutures. RESULTS: The initial results were encouraging, with 9/10 patients cured at the 6 weeks post-operative visit. However, infection and extrusion of the mini-sling resulted in sling extrusion and removal, with 5 patients remaining cured at 12 months. CONCLUSION: The Arc-to-Arc mini-sling was a good concept, but failed because of the poor technology available at that time. Further research using new materials and better technology has led to new and safer alternatives for the management of stress urinary incontinence.