Malla suburetral retropúbica (TVT): experiencia clínica y análisis de datos en el Hospital El Carmen de Maipú / Retropubic suburethral mesh (TVT): clinical experience and data analysis at the Hospital El Carmen de Maipú

La incontinencia urinaria de esfuerzo es la pérdida involuntaria de orina durante una maniobra de esfuerzo físico, ejercicio, estornudo o tos. Afecta aproximadamente al 15% de las mujeres de 30-60 años y su prevalencia es del 30-41%. Aunque existen terapias conservadoras para su manejo, muchas pacientes terminarán necesitando cirugía para su resolución. Las mallas suburetrales son alternativas para el manejo quirúrgico, existiendo dos vías de instalación, la transobturadora (TOT o TVT-O) y la retropúbica (del inglés tension-free vaginal tape o TVT), siendo esta última la que presenta mejores resultados y menos complicaciones posoperatorias. Objetivo: evaluar la tasa de efectividad y las complicaciones de la TVT en la Unidad de Piso Pélvico Femenino del Hospital El Carmen de Maipú entre los años 2015 y 2020. Materiales y Métodos: Se obtuvieron 715 registros de pacientes que fueron sometidas a TVT y se logró contactar telefónicamente con el 60,69% de ellas. Resultados: Los resultados muestran una tasa de efectividad del 94,8% y una tasa de complicaciones del 2,3%. Conclusión: Este estudio aporta evidencia local de los resultados posoperatorios en la IOE en pacientes que requirieron la instalación de una malla suburetal retropúbica, demostrando ser una cirugía altamente efectiva y segura.

Stress urinary incontinence is the involuntary loss of urine during physical exertion, exercise, sneezing, or coughing. It affects approximately 15% of women aged 30-60, with a prevalence of 30-41%. Although there are conservative therapies for its management, many patients will eventually require surgery for resolution. Suburethral sling are considered for surgical management, and there are two installation alternatives, transobturator (TOT or TVT-O) and retropubic (tension-free vaginal tape or TVT), with the latter presenting better results and fewer postoperative complications. Objetive: to evaluate effectiveness rate and complications of the TVT in the Female Pelvic Floor Unit of Hospital El Carmen de Maipú between 2015 and 2020. Materials and Methods: A total of 715 patient records were obtained for those who underwent TVT, and 60.69% of them were successfully contacted by telephone. Results: The results show an effectiveness rate of 94.8% and a complication rate of 2.3%. Conclusion: This study provides local evidence for the results of stress urinary incontinence that required the placement of a retropubic suburethral sling, proving to be a highly effective and safe surgery.

Impact of COVID-19 on surgical procedures for stress urinary incontinence in the Brazilian public health system.

INTRODUCTION AND HYPOTHESIS: The objective was to characterize the impact of the COVID-19 pandemic on the surgical treatment of female stress urinary incontinence (FSUI) in Brazil. METHODS: This study was conducted with population-based data from the Brazilian public health system database. We obtained data on the number of surgical procedures for FSUI in 2019 (before the coronavirus disease [COVID-19] pandemic), 2020, and 2021 (during the pandemic) in each of the 27 Brazilian states. We included official Brazilian Institute of Geography and Statistics (IBGE) data on the population, Human Development Index (HDI), and annual per capita income of each state. RESULTS: A total of 6,718 surgical procedures for FSUI were performed in the Brazilian public health system in 2019. The number of procedures was reduced by 56.2% in 2020, and an additional reduction of 7.2% was seen in 2021. The distribution of procedures by state showed important differences, ranging from 4.4 procedures/1,000,000 inhabitants in Paraíba and Sergipe to 67.6 procedures/1,000,000 inhabitants in Paraná (p<0.01) in 2019. The number of surgical procedures was higher in states with a higher HDI (p=0.0001) and per capita income (p=0.042). The decrease in the number of surgical procedures affected the whole country and its rate did not correlate with HDI (p=0.289) or per capita income (p=0.598). CONCLUSION: The impact of the COVID-19 pandemic on the surgical treatment of FSUI in Brazil was significant in 2020 and persisted in 2021. Access to surgical treatment of FSUI varied according to geographic region, HDI, and per capita income, even before COVID-19.

Preliminary report of post-Ophira mini sling implantation voiding pattern: What to learn from pressure-flow studies?

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 12 months 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 (p < 0.0001) and ICIQ-OAB from 8 to 4 (p = 0.0001). 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 4.9 mL/s (95% CI: 0.62-10.8; p = 0.035), and the mean detrusor pressure at maximum flow increased to 11.4 cmH2O (95% CI: 4-18; p = 0.0078). 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.

Medium-term safety outcomes in patients undergoing tension free vaginal tape obturator for stress urinary incontinence in Murcia, Spain. Historical cohort / Resultados de seguridad a mediano plazo en pacientes intervenidas con el cabestrillo suburetral transobturador dentro-fuera para incontinencia urinaria de esfuerzo en Murcia, España. Cohorte histórica

OBJECTIVE: Describe the medium-term safety of the tension free vaginal tape obturator (TVT-O) procedure in terms of complications, cure and changes in quality of life (QoL) after the surgery. MATERIALS AND METHODS: Descriptive historical cohort that included women over 18 years of age who underwent TVT-O due to objectively proven stress urinary incontinence, urethral hypermobility or mixed urinary incontinence in which the stress component predominated, confirmed on urodynamic testing between July 2013-April 2017, in a reference hospital located in the city of Murcia Spain. Women with previous anti-incontinence surgery, concomitant vaginal surgery and planning pregnancy were excluded. Follow-up was determined for each patient based on the time elapsed between surgery and the time when the research protocol was applied. Complications were stratified according to the modified Clavien-Dindo classification; also we evaluated subjective cure rate, quality of life using the ICIQ-SF score, before and after surgery. RESULTS: The mean age was 52.6 (SD± 10.5) years and 80.1% of patients were at least overweight. The incidence of complications at 12 months was: 8.3% (12/144). We did not detect complications after this period in the followed patients at 24, 36 and 48 months. The subjective cure determined at 12, 24, 36 and 48 months was 62.5% (90/144), 59.09% (55/88), 50.81% (31/61) and 50% (7/14), respectively. There was a significant improvement in quality of life, as determined by the ICQ-SF mean score before and after surgery (13.76[6,34] vs 3.84[5.76]; p<0.05). CONCLUSIONS: The TVT-O surgery is a safe therapy associated with a low complication incidence at 12 months, an acceptable subjective cure rate in stress urinary incontinence, and quality-of-life improvement. Classifications of complications related to the insertion of the prosthesis and of those inherent to surgery, such as urinary tract infection, are required.

Objetivo: describir la seguridad a mediano plazo del procedimiento con el cabestrillo suburetral transobturador dentro-fuera (en inglés: tension free vaginal tape obturator TVT-O) en términos de: complicaciones, cura y cambios en la calidad de vida después de la cirugía. Materiales y métodos: cohorte histórica descriptiva que incluye mujeres mayores de 18 años intervenidas de TVT-O por incontinencia urinaria de esfuerzo (IUE) objetivamente comprobada, hipermovilidad uretral o incontinencia urinaria mixta en la que predominó el componente de esfuerzo, confirmada en prueba urodinámica entre julio del 2013 y abril del 2017 en un hospital de referencia ubicado en la ciudad de Murcia, España. Se excluyeron mujeres con cirugía previa de incontinencia, cirugía vaginal concomitante y planificación del embarazo. El seguimiento se determinó para cada paciente por el tiempo transcurrido desde la cirugía hasta el momento en que se aplicó el protocolo de investigación. Las complicaciones se estratificaron según la clasificación de Dindo-Clavien modificada, además, se evaluaron la tasa de curación subjetiva y la calidad de vida mediante el International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) antes y después de la cirugía. Resultados: la edad media de las pacientes fue de 52,59 (DE±10,46) años, el 80,1 % tenía al menos sobrepeso. La incidencia de complicaciones en los primeros 12 meses fue del 8,3%. No detectamos complicaciones después de este periodo en las pacientes seguidas a 24, 36 y 48 meses. La curación subjetiva determinada a los 12, 24, 36 y 48 meses fue del 62,5% (90/144), 59,09% (55/88), 50,81% (31/61) y 50% (7/14), respectivamente. Hubo una mejoría significativa en la calidad de vida, en términos de puntuación media ICQ-SF antes y después de la cirugía (13,76 [6,34] vs 3,84 [5,76]; p < 0,05). Conclusiones: el TVT-O es una terapia segura, con baja tasa de complicaciones a los 12 meses, aceptable tasa de curación subjetiva de la IUE y una mejora en la calidad de vida. Se necesitan clasificaciones de complicaciones relacionadas con la inserción de la prótesis y que incluyan complicaciones inherentes a la cirugía, como la infección del tracto urinario.

Medium-term safety outcomes in patients undergoing tension free vaginal tape obturator for stress urinary incontinence in Murcia, Spain. Historical cohort / Resultados de seguridad a mediano plazo en pacientes intervenidas con el cabestrillo suburetral transobturador dentro-fuera para incontinencia urinaria de esfuerzo en Murcia, España. Cohorte histórica

ABSTRACT Objective: Describe the medium-term safety of the tension free vaginal tape obturator (TVT-O) procedure in terms of complications, cure and changes in quality of life (QoL) after the surgery. Materials and methods: Descriptive historical cohort that included women over 18 years of age who underwent TVT-O due to objectively proven stress urinary incontinence, urethral hypermobility or mixed urinary incontinence in which the stress component predominated, confirmed on urodynamic testing between July 2013-April 2017, in a reference hospital located in the city of Murcia Spain. Women with previous anti-incontinence surgery, concomitant vaginal surgery and planning pregnancy were excluded. Follow-up was determined for each patient based on the time elapsed between surgery and the time when the research protocol was applied. Complications were stratified according to the modified Clavien-Dindo classification; also we evaluated subjective cure rate, quality of life using the ICIQ-SF score, before and after surgery. Results: The mean age was 52.6 (SD± 10.5) years and 80.1% of patients were at least overweight. The incidence of complications at 12 months was: 8.3% (12/144). We did not detect complications after this period in the followed patients at 24, 36 and 48 months. The subjective cure determined at 12, 24, 36 and 48 months was 62.5% (90/144), 59.09% (55/88), 50.81% (31/61) and 50% (7/14), respectively. There was a significant improvement in quality of life, as determined by the ICQ-SF mean score before and after surgery (13.76[6,34] vs 3.84[5.76]; p<0.05). Conclusions: The TVT-O surgery is a safe therapy associated with a low complication incidence at 12 months, an acceptable subjective cure rate in stress urinary incontinence, and quality-of-life improvement. Classifications of complications related to the insertion of the prosthesis and of those inherent to surgery, such as urinary tract infection, are required.

RESUMEN Objetivo: describir la seguridad a mediano plazo del procedimiento con el cabestrillo suburetral transobturador dentro-fuera (en inglés: tension free vaginal tape obturator TVT-O) en términos de: complicaciones, cura y cambios en la calidad de vida después de la cirugía. Materiales y métodos: cohorte histórica descriptiva que incluye mujeres mayores de 18 años intervenidas de TVT-O por incontinencia urinaria de esfuerzo (IUE) objetivamente comprobada, hipermovilidad uretral o incontinencia urinaria mixta en la que predominó el componente de esfuerzo, confirmada en prueba urodinámica entre julio del 2013 y abril del 2017 en un hospital de referencia ubicado en la ciudad de Murcia, España. Se excluyeron mujeres con cirugía previa de incontinencia, cirugía vaginal concomitante y planificación del embarazo. El seguimiento se determinó para cada paciente por el tiempo transcurrido desde la cirugía hasta el momento en que se aplicó el protocolo de investigación. Las complicaciones se estratificaron según la clasificación de Dindo-Clavien modificada, además, se evaluaron la tasa de curación subjetiva y la calidad de vida mediante el International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) antes y después de la cirugía. Resultados: la edad media de las pacientes fue de 52,59 (DE±10,46) años, el 80,1 % tenía al menos sobrepeso. La incidencia de complicaciones en los primeros 12 meses fue del 8,3%. No detectamos complicaciones después de este periodo en las pacientes seguidas a 24, 36 y 48 meses. La curación subjetiva determinada a los 12, 24, 36 y 48 meses fue del 62,5% (90/144), 59,09% (55/88), 50,81% (31/61) y 50% (7/14), respectivamente. Hubo una mejoría significativa en la calidad de vida, en términos de puntuación media ICQ-SF antes y después de la cirugía (13,76 [6,34] vs 3,84 [5,76]; p < 0,05). Conclusiones: el TVT-O es una terapia segura, con baja tasa de complicaciones a los 12 meses, aceptable tasa de curación subjetiva de la IUE y una mejora en la calidad de vida. Se necesitan clasificaciones de complicaciones relacionadas con la inserción de la prótesis y que incluyan complicaciones inherentes a la cirugía, como la infección del tracto urinario.

Embolization in patient with hypovolemic shock after transobturator sling procedure / Embolização após sling transobturatório em paciente com choque hipovolêmico

Abstract The placement of a suburethral sling is standard treatment for stress urinary incontinence. The transobturator technique (TOT) emerged as an alternative to minimize the risks of the blind insertion of needles, leading to a lower rate of perforation complications compared with the retropubic approach. We present a case of injury to a branch of the left obturator artery following the placement of a urethral sling using TOT, followed by intense bleeding and hemodynamic instability, which was treated with embolization.

Resumo Sling de uretra média é o tratamento padrão para a incontinência urinária de esforço. A abordagem transobturatória (TOT) surgiu como alternativa para minimizar os riscos da inserção às cegas das agulhas com taxa de complicações perfurativas menores quando comparadas à abordagem retropúbica. Apresentamos um caso de lesão em ramo da artéria obturatória esquerda após sling TOT que evoluiu com sangramento intenso e instabilidade hemodinâmica, sendo tratado com embolização.

Controvérsias com o emprego de malhas no tratamento de problemas do assoalho pélvico / Controversies about the use of mesh in the management of pelvic floor problems

La utilización de las mallas en el tratamiento del prolapso de los órganos pélvicos es una excelente alternativa principalmente en el tratamiento de los prolapsos apicales (uterino / cúpula vaginal), a través de una sacrocolpopexia por vía abdominal, así como en los prolapsos anteriores, por vía vaginal. Para el prolapso de la pared vaginal posterior no existe evidencia del beneficio de las mallas para la corrección del problema. Los factores más importantes para el éxito quirúrgico y minimizar las complicaciones asociadas a las mallas son fundamentalmente la selección adecuada de las pacientes y que el cirujano deba tener un adecuado entrenamiento en cirugías del piso pélvico.

Use of mesh for the treatment of pelvic organ prolapse is an excellent alternative especially in the treatment of the apical prolapse (uterine / vaginal vault) through an abdominal sacrocolpopexia; also in the anterior wall prolapse treated per vagina. There is no evidence to support use of mesh to correct posterior vaginal wall prolapse. Most important factors for favorable surgical outcome and to reduce mesh-associated complications are adequate selection of patients and a surgeon adequately trained for pelvic floor surgery.

Deficiencia intrínseca esfinteriana: qué papel juega la hipermotilidad en su manejo? / Intrinsic sphincter dysfunction: what is the role of urethral hypermobility in management?

Objetivo: reflexionar sobre la importancia del diagnóstico de la hipermotilidad uretral en el manejo quirúrgico de la disfunción intrínseca del esfínter uretral y la evaluación que se ha hecho de la hipermotilidad en los estudios que evalúan las diferentes técnicas para su corrección.Conclusión: son pocos los estudios en pacientes con diagnóstico de deficiencia esfinteriana intrínseca que han evaluado la tasa de curación y porcentaje de complicaciones posoperatorias en pacientes llevadas cirugía con cabestrillos TVT y TOT teniendo en cuenta la presencia o no de hipermotilidad uretral.

Objective: To reflect on the importance of diagnosing urethral hypermobility in the surgical management of intrinsic urethral sphincter dysfunction, and on the assessment of hypermobility carried out in the studies that have evaluated the different techniques used for addressing the problem.Conclusion: Only a few studies in patients diagnosed with intrinsic sphincter dysfunction have evaluated cure rates and percentage of post-operative complications in patients taken to surgery with TVT and TOT slings, taking into account the presence or absence of urethral hypermobility.

Primary fixation of mini slings: a comparative biomechanical study in vivo

INTRODUCTION AND OBJECTIVES: The mini sling concept for stress urinary incontinence is an anatomical approach that involves placing a midurethral low-tension tape anchored to the obturator internus muscles bilaterally. They overcome the blind passage of long needles and all the related complications. There are many different devices available and because these are outpatient procedures, primary fixation plays an important role in the outcome. The objective is to evaluate the primary fixation of the various devices of attachment of the commercially available mini-slings through biomechanical tests. MATERIALS AND METHODS: A total of 45 Wistar rats were divided in 3 groups of 15 rats each. They underwent 5 subcutaneous implantation of different mini slings and one polipropilene mesh (control), as follows: TVT-Secur® (Gynecare, USA), Type 1 polypropylene mesh (control); Ophira Mini Sling System® (Promedon, Argentina), Tissue Fixation System® (TFS PTY, Australia), Zipper Sling® and "T device" (Prosurg, USA). The abdominal wall was removed on bloc at different times after implant for biomechanical evaluation, which consisted in application of unidirectional force to the extremity of the fixation system or mesh, until it was completely removed from the tissue using a tension meter (Nexygen 3.0 Universal Testing Machine - LLOYD Instruments). The force was measured in Newtons (N). RESULTS: There was significant difference in the resistance to extraction among the different fixation systems. At 7 days the Ophira Mini Sling System® presented the best fixation and "T dispositive" the worst. CONCLUSION: Ophira mini sling System® presented the best primary fixation at 7º, 14º and 30º days. The impact of this feature in the clinical setting needs to be verified.

Single institution experience with the transobturator sling suspension system AdVance® in the treatment of male urinary incontinence: mid-term results

PURPOSE: To evaluate the clinical outcome after placement of AdVance® sling in men with stress urinary incontinence after prostate surgery. MATERIALS AND METHODS: Incontinence was assessed on basis of number of pad usage. Patients' satisfaction was evaluated using a non-validated patient questionnaire at 12 months post-operatively. RESULTS: Incontinence cure rate (no pad usage) was 61.5 percent (16/26) and improvement (1-2 pads per day) was seen in 26.9 percent (7/26). No improvement was observed in 11.5 percent (3/26) of patients. A total of 87.5 percent (21/24) of patients were very satisfied with the operation 22 months after surgery. Success rate in patients with prior radiation therapy (20 percent cure; 40 percent improvement) was significantly worse. CONCLUSIONS: Placement of the AdVance® sling represents an effective and safe treatment option for patients with post prostate surgery incontinence. Patients that underwent radiotherapy after prostate surgery had lower success rate.

Comparison of the outcomes of the sling technique using a commercial and hand-made polypropylene sling

PURPOSE: To compare the outcomes and costs of stress urinary incontinence (SUI) surgery using a hand-made sling (Marlex®) versus a commerciallyavailable suburethral polypropylene sling (Advantage®). MATERIALS AND METHODS: Thirty-nine women with SUI due to bladder neck hypermobility and/or sphincter incompetence diagnosed by clinical examination and urodynamic studies were divided into two groups: group 1 (n = 19) consisted of patients from an academic center (Department of Urology, University Hospital of Federal University of Maranhao, and group 2 (n = 20) patients from private practice. The hand-made polypropylene suburethral sling was used in group 1 and the commercial sling in group 2. The patients were evaluated 30, 60 and 90 days after surgery. RESULTS: The mean duration of surgery was 43 min. in group 1 and 51 min. in group 2. No postoperative voiding difficulties were observed in group 1 (100 percent), as well as, in 94.7 percent of patients of group 2. A bladder catheter was not required in any of the patients of the two groups at the end of the study. The level of satisfaction was 100 percent in group 1, whereas, one patient of group 2 considered the surgery to be unsuccessful. Urodynamic studies showed low amplitude uninhibited contraction in 11.1 percent of patients of group 1 and 10.5 percent of group 2. No complications were observed in either group. CONCLUSION: The hand-made polypropylene mesh (Marlex®) can be used for sling procedures, saving costs and yielding results similar to that obtained with commercial sling systems.

The Miniarc® sling system in the treatment of female stress urinary incontinence

AIMS: To assess the technical feasibility of a new mini-invasive sling procedure (MiniArc®) and present short-term results in the treatment of female urinary incontinence. MATERIAL AND METHODS: A total of 97 women with mixed or stress urinary incontinence (SUI) were treated by placement of the new single-incision sling. Pelvic organ prolapse was graded using the POP-Q system (pelvic organ prolapse quantification system). Preoperative workup included urodynamic evaluation, cough stress test and introital ultrasound. Postoperatively, introital ultrasound was performed to determine residual urine and check tape position. Quality of life was measured using King's Health Questionnaire. A voiding diary and pad count served to verify the patients' subjective complaints. RESULTS: The MiniArc® single-incision sling procedure was the initial intervention in 37 (38.2 percent) patients and the second intervention in 60 (61.7 percent) patients with recurrent incontinence. The cough stress test was negative in 79 (83.1 percent) women 6 weeks after the sling procedure and in 74 (77.8 percent) at 12 months. De novo urge occurred in 32 (36.8 percent) women. Quality of life was significantly improved at 12-month follow-up in 65 (69.1 percent) patients (p < 0.001). The number of pads decreased significantly from 2.2 to 0.6 (p < 0.001) after the procedure. One patient developed an hematoma and bladder perforation occurred in another. CONCLUSIONS: Our short-term clinical results suggest that the MiniArc® is a safe and effective minimally invasive sling procedure for treating female SUI. Randomized comparative controlled trials and long-term results are still required to define the role of the new sling system in comparison to established mid-urethral tape techniques for treating incontinence.

Outcomes following mid-urethral sling placement in patients with intrinsic sphincteric deficiency: comparison of Sparc and Monarc slings

Purpose: The treatment of patients with intrinsic sphincteric deficiency (ISD) remains difficult. It is theorized that differing vectors of support provided by retropubic versus transobturator mid-urethral sling routes may affect outcomes. We sought to compare outcomes of patients undergoing SPARC versus MONARC sling types in patients with Valsalva leak point pressures (VLPPs) below 60 cm H2O. Materials and Methods: A retrospective review of female patients with stress urinary incontinence undergoing SPARC™ (n = 97) or MONARC™ (n = 39) placement following urodynamic diagnosis of ISD was performed, with minimum 12-month follow-up required. Outcomes were assessed using a questionnaire comprising validated incontinence questionnaires (UDI-6, IIQ-7) and additional items addressing satisfaction. Results: Success rates of 76 percent and 77 percent were observed in the SPARC (mean follow-up 36 months) and MONARC (mean follow-up 32 months) cohorts, respectively (p > 0.05). Superior UDI scores were demonstrated in the MONARC cohort (3.8 vs. 5.3, p = 0.04)), in contrast to similar IIQ scores across both groups (3.7 vs. 3.1, p > 0.05). A deterioration in success rates was seen in both cohorts with more extended follow-up and with lower VLPPs. However, this finding was limited by low patient numbers in these cohorts. A complication rate of 7 percent and 3 percent was noted in SPARC and MONARC cohorts (p > 0.05). Conclusions: We observed no significant differences in subjective outcomes when comparing patients undergoing SPARC versus MONARC sling placement in the treatment of SUI with VLPP < 60 cm H2O. A deterioration in continence rates was seen with extended follow-up. These data may be affected by low patient numbers and related study power, in particular with more extended follow-up.

Mini-invasive collagen sling in the treatment of urinary incontinence due to sphincteric incompetence

OBJECTIVE: To assess the technical feasibility of mini-invasive sling procedure and present preliminary results in the treatment of urinary incontinence due to sphincteric insufficiency. MATERIALS AND METHODS: Thirteen patients (6 males, 7 females, 8 with myelomeningocele, 1 with tethered spinal cord, 3 with bladder exstrophy, 1 with epispadias) underwent sling procedure with porcine dermis acellular collagen matrix (PelvilaceTM, Bard medical, UK). The median age was 15.5 (range 8.9-27.5) years. A suprapubic catheter was inserted for the measurement of leak point pressure during the operation. In females vaginal and in males perineal incision was used for sling insertion. The sling was introduced under cystoscopic control. The sling was not fixed with sutures. The outcomes were reviewed at 1, 6 and 12 month after the operation. RESULTS: The median leak point pressure increased from 21.5 (range 5-25) cm H2O to 85 (range 70-100) cm H2O. At 1 month 8 and at 6 months 3 out of 13 patients were dry. At 12 months, none out of 11 patients was completely dry. However, at 12 months some improvement in incontinence was detected in 9 out of 11 patients. Two patients had primary failures. One patient got sling erosion to urethra after a tightening attempt. In one patient detrusor overactivity increased after the sling procedure. CONCLUSIONS: PelvilaceTM sling is safe and easy to introduce in both males and females if pelvic floor anatomy is normal. Although immediate results were promising in neuropathic incontinence, the results seem to deteriorate to unacceptable low level already during the first year. In exstrophy patients the results are generally poor.