RESUMO
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.
Assuntos
Slings Suburetrais , Incontinência Urinária por Estresse/cirurgia , Adulto , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Qualidade de Vida , Reoperação , Resultado do TratamentoRESUMO
OBJECTIVE: To evaluate the reliability and responsiveness (internal and external) of the Portuguese version of the ICIQ-SF. We assessed the responsiveness of the ICIQ-SF after surgical procedures for the treatment of stress urinary incontinence. MATERIALS AND METHODS: Prospective open label study in 2 tertiary referral centers. Sixty-one patients of both genders (54 female and 7 male) were enrolled. Patients were treated using surgical procedures, mostly with synthetic sling (82%). Patients were assessed before surgery and at least 1 month postoperatively using the ICIQ-SF in its translated and validated Portuguese version. Patients also underwent pre-operative urodynamic tests, Stamey incontinence grading and pad usage assessments. After surgery, patients underwent stress tests, Stamey incontinence grading and pad usage assessments. RESULTS: The mean age was 57.2 (+/- 11.6) years and the mean duration of follow-up was 7.2 months (+/- 4.5). Objective parameters such as urodynamic tests (by means of VLPP) and pad usage had significant correlation with changes in post-treatment scores on the ICIQ-SF (p = 0.0062 and p < 0.0001 respectively). The responsiveness expressed in terms of standardized effect sizes (SES) and standardized response means (SRM) was large for both questionnaires (p < 0.0001). CONCLUSION: The results showed high responsiveness (large effect sizes I and II) for the Portuguese version of the ICIQ-SF, indicating that this instrument is suitable for measuring outcomes in clinical trials for Brazilian patients with stress urinary incontinence.
Assuntos
Inquéritos e Questionários/normas , Tradução , Incontinência Urinária por Estresse/cirurgia , Adulto , Idoso , Brasil , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Período Pós-Operatório , Estudos Prospectivos , Reprodutibilidade dos TestesRESUMO
OBJECTIVE: To evaluate the concurrent validity, internal consistency and responsiveness of King's Health Questionnaire (KHQ) in patients who underwent sling procedures for the treatment of stress urinary incontinence. MATERIALS AND METHODS: We performed a prospective open label multicenter study in 4 tertiary referral centers. Sixty-eight female patients were enrolled with urodynamically diagnosed urinary stress incontinence. Patients were treated using surgical procedures, mostly (73%) with the synthetic sling procedure, which has been considered one of the gold standard methods for the treatment of urinary incontinence. The patients were assessed before and after one month of postoperative follow up, using the KHQ in its validated Portuguese version. Patients also underwent preoperative urodynamic test, Stamey incontinence grading, pad usage and the assessment of number of pads used per day. After surgery, patients underwent stress test, Stamey incontinence grading pad usage and the assessment of number of pads used per day. RESULTS: The concurrent validity showed good correlations in some domains of KHQ to clinical parameters. The internal consistency was higher after treatment compared to preoperative values. Objective parameters, such as pad usage and the assessment of number of pads used per day, had significant correlation with changes in post-treatment scores on KHQ. The responsiveness expressed in terms of standardized effect size (SES) and standardized response mean (SRM) was large. CONCLUSION: The results showed moderate concurrent validity, strong internal consistency and high responsiveness for KHQ, indicating that it is suitable for measuring outcomes in clinical trials among female patients with stress urinary incontinence.
Assuntos
Indicadores Básicos de Saúde , Inquéritos e Questionários , Incontinência Urinária por Estresse/cirurgia , Feminino , Humanos , Período Pós-Operatório , Estudos Prospectivos , Próteses e Implantes , Qualidade de Vida , Reprodutibilidade dos TestesRESUMO
OBJECTIVE: To evaluate the reliability and responsiveness (internal and external) of the Portuguese version of the ICIQ-SF. We assessed the responsiveness of the ICIQ-SF after surgical procedures for the treatment of stress urinary incontinence. MATERIALS AND METHODS: Prospective open label study in 2 tertiary referral centers. Sixty-one patients of both genders (54 female and 7 male) were enrolled. Patients were treated using surgical procedures, mostly with synthetic sling (82 percent). Patients were assessed before surgery and at least 1 month postoperatively using the ICIQ-SF in its translated and validated Portuguese version. Patients also underwent pre-operative urodynamic tests, Stamey incontinence grading and pad usage assessments. After surgery, patients underwent stress tests, Stamey incontinence grading and pad usage assessments. RESULTS: The mean age was 57.2 (± 11.6) years and the mean duration of follow-up was 7.2 months (± 4.5). Objective parameters such as urodynamic tests (by means of VLPP) and pad usage had significant correlation with changes in post-treatment scores on the ICIQ-SF (p = 0.0062 and p < 0.0001 respectively). The responsiveness expressed in terms of standardized effect sizes (SES) and standardized response means (SRM) was large for both questionnaires (p < 0.0001). CONCLUSION: The results showed high responsiveness (large effect sizes I and II) for the Portuguese version of the ICIQ-SF, indicating that this instrument is suitable for measuring outcomes in clinical trials for Brazilian patients with stress urinary incontinence.
Assuntos
Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários/normas , Tradução , Incontinência Urinária por Estresse/cirurgia , Brasil , Seguimentos , Período Pós-Operatório , Estudos Prospectivos , Reprodutibilidade dos TestesRESUMO
OBJECTIVE: To evaluate the concurrent validity, internal consistency and responsiveness of King's Health Questionnaire (KHQ) in patients who underwent sling procedures for the treatment of stress urinary incontinence. MATERIALS AND METHODS: We performed a prospective open label multicenter study in 4 tertiary referral centers. Sixty-eight female patients were enrolled with urodynamically diagnosed urinary stress incontinence. Patients were treated using surgical procedures, mostly (73 percent) with the synthetic sling procedure, which has been considered one of the gold standard methods for the treatment of urinary incontinence. The patients were assessed before and after one month of postoperative follow up, using the KHQ in its validated Portuguese version. Patients also underwent preoperative urodynamic test, Stamey incontinence grading, pad usage and the assessment of number of pads used per day. After surgery, patients underwent stress test, Stamey incontinence grading pad usage and the assessment of number of pads used per day. RESULTS: The concurrent validity showed good correlations in some domains of KHQ to clinical parameters. The internal consistency was higher after treatment compared to preoperative values. Objective parameters, such as pad usage and the assessment of number of pads used per day, had significant correlation with changes in post-treatment scores on KHQ. The responsiveness expressed in terms of standardized effect size (SES) and standardized response mean (SRM) was large. CONCLUSION: The results showed moderate concurrent validity, strong internal consistency and high responsiveness for KHQ, indicating that it is suitable for measuring outcomes in clinical trials among female patients with stress urinary incontinence.