Creating a gold standard surgical device: scientific discoveries leading to TVT and beyond: Ulf Ulmsten Memorial Lecture 2014.

INTRODUCTION AND HYPOTHESIS: The discovery of tension-free vaginal tape (TVT) began in 1986 with two unrelated observations: pressure applied unilaterally at the midurethra controlled urine loss on coughing; implanted Teflon tape caused a collagenous tissue reaction. METHODS AND RESULTS: In 1987, Mersilene tape was implanted retropubically in 13 large dogs, with the aim of creating an artificial collagenous pubourethral neoligament. Extensive testing showed that the operation was safe and effective. In 1988-1989, human testing was carried out (n = 30). Mersilene tape cured 100 % of stress and mixed incontinence with a sling in situ; however, there was simultaneous recurrence of the two symptoms in 50 % on sling removal. X-rays showed no elevation of the bladder neck. In 1990-1993, collaboration with Ulf Ulmsten took place: a permanently implanted tape was required. Polypropylene was the ideal material. In 2003, the neoligament principle was applied as an adjustable "micro" sling to the arcus tendineus fasciae pelvis (ATFP), cardinal, uterosacral ligaments, and perineal body for cure of cystocele, rectocele, and apical prolapse. It was found that symptoms such as urgency, nocturia, chronic pelvic pain, obstructive defecation syndrome (ODS), and fecal incontinence were frequently cured or improved. CONCLUSIONS: The lecture concluded with advice to younger members. Without new paradigms, there are no randomized controlled trials, no meta-analyses, Cochrane. Indeed, no progress. Be open to new concepts. Read Kuhn's "The Structure of Scientific Revolutions" to understand the discovery process. Examine the relationship among symptoms, ATFP, cardinal, uterosacral ligaments, and the perineal body. This is the next paradigm. Don't disregard anomalies. Pursue them. They are the pathway to discovery. Innovation is born from challenge, not conformity. Persist, even when meeting resistance. Resistance is a sign that your discovery is important.

Etiopathogenesis, diagnostics and history of surgical treatment of stress urinary incontinence.

Urinary incontinence represents involuntary urine leakage into the urethra. This pathological condition represents a major medical, social and hygienic problem. The paper presents risk factors for development of the disorder, as well as diagnostic methods applied in evaluation of the female patients. Chronological review of diverse surgical techniques used in treatment of stress urinary incontinence reported in the published scientific papers is also presented. Review of the literature data was also performed. Sling procedures with application of suburethral loops have been used since the beginning of the last century in treatment of this disorder. Surgical treatment of stress urinary incontinence is applied when conservative treatment fails to give any effects according to strictly defined indications. During the last 100 years, surgical techniques have undergone different improvements and the results have also been significantly improved.

Edward McGuire's influence in the field of stress urinary incontinence and bladder storage symptoms.

AIMS: Dr. Edward McGuire's academic career spans four decades. His impact in our field of female urology and urodynamics is reflected by the many residents and fellows he has trained that are now academic leaders in our subspecialty. For this festschrift, my goals are to: (1) review the history of the surgical approaches to alleviate stress urinary incontinence (SUI) (2) discuss recent research in SUI and bladder storage symptoms and the influence of Dr. McGuire in these areas and (3) propose a paradigm shift in the understanding of the function of the bladder urothelium from providing barrier function to providing afferent input that affects bladder storage function. METHODS: A literature review of the publications related to SUI and bladder storage symptoms was performed. Using Thompson Reuters ISI Web of Knowledge, the two most cited papers by Dr. McGuire are discussed. RESULTS: Dr. McGuire's two most cited publications are related to valsalva leak point pressure (VLPP) and the utility of the American Urologic Association Symptom Index (AUASI). These two instruments, one objective and one subjective, address two canonical areas in our subspecialty: 1. role of urethral function in continence and 2. pathophysiology of lower urinary tract symptoms. These two areas continue today to be fertile areas for research and creativity. Recent investigations have proposed that bladder urothelium may play a role in bladder afferent function; thus mediating bladder storage. CONCLUSIONS: Dr. McGuire helped establish the scientific foundation for our subspecialty. His influence remains pertinent today as it ever has.

[Vicissitudes of a humble inventor]. / Vicisitudes de un sencillo inventor.

Mechanized procedure for the treatment of female stress urinary incontinence. Retropubic fixation of the vagina with a stapler specifically designed, using the pubis' symphysis as the site for anchoring. We intend to demonstrate the physiopathologic rationale to achieve continence by anchoring the urethra. In our elementary conditions for research and development we could not design the suitable procedure, although the idea was presented to international companies. We summarize the development of the instrument until it was operative, filming one operation which was presented to the Hispanic-American Congress in Madrid 1992. The instrument was patented in the Spanish Office of Patents and Trademarks in July 1992 with the category of invention patent because there were no previous mechanized procedures for vaginal fixation.

Vicisitudes de un sencillo inventor / Vicissitudes of a humble inventor

Procedimiento mecanizado para el tratamiento de la Incontinencia Urinaria de Esfuerzo en la mujer. Fijación retropúbica de la vagina con una grapa disparada con grapadora diseñada con la forma apropiada, que utiliza la sínfisis del pubis como lugar de anclaje. Se pretende demostrar la razón fisiopatológica para devolver la continencia, por medio del anclaje de la uretra. En nuestras condiciones elementales de investigación y desarrollo no se pudo llegar a diseñar el procedimiento idóneo, aunque se presentó la idea mecanizada a Empresas de ámbito internacional. Se relata resumidamente el desarrollo del instrumento hasta conseguir hacerlo operativo, filmándose una intervención que se presentó al Congreso Hispanoamericano que se realizó en Madrid en 1992. El instrumento se patentó en la Oficina Española de Patentes y Marcas en julio de 1992 con categoría de Patente de Invención, al no existir antecedentes de procedimientos mecanizados para la fijación de la uretra a través de la vagina (AU)

Mechanized procedure for the treatment of female stress urinary incontinence. Retropubic fixation of the vagina with a stapler specifically designed, using the pubis’ symphysis as the site for anchoring. We intend to demonstrate the physiopathologic rationale to achieve continence by anchoring the urethra. In our elementary conditions for research and development we could not design the suitable procedure, although the idea was presented to international companies. We summarize the development of the instrument until it was operative, filming one operation which was presented to the Hispanic-American Congress in Madrid 1992. The instrument was patented in the Spanish Office of Patents and Trademarks in July 1992 with the category of invention patent because there were no previous mechanized procedures for vaginal fixation (AU)

¿Son iguales todos los sistemas empleados para corregir la incontinencia urinaria mediante mallas libres de tensión? / The devices used to correct the urinary incontinence by tension-free meshes. Are all them equals?

Desde el año 1996 en que Ulmsten describe la técnica del TVT (Tension-free vaginal tape) para la corrección de la Incontinencia Urinaria de Esfuerzo (IUE), han sido numerosas las variantes descritas y los dispositivos existentes en el mercado que tratan de reproducir la técnica original. Sin embargo, los resultados no van a depender exclusivamente de la técnica quirúrgica sino también de otros dos factores fundamentales que son: 1. Características y tipo de malla utilizada. 2. Sistema y vía de implantación de la misma. Las características de la malla empleada posiblemente sean tan importantes o más que la propia técnica quirúrgica. No es posible extrapolar los datos relativos al TVT para otros dispositivos. Sería necesario realizar estudios randomizados en los que se comparen las diferentes técnicas para poder hacer afirmaciones semejantes. La vía de implantación tiene también una gran importancia en los resultados obtenidos. En el presente trabajo se hace una revisión de las características de las mallas y sus propiedades así como de las diferentes vías de abordaje y colocación de las mismas. Se analiza también la influencia decada uno de estos factores sobre los resultados quirúrgicos. Finalmente se repasan los principales dispositivos existentes en el mercado, las propiedades de la malla y del sistema de implantación de cada uno de ellos

Since 1996, when Ulmsten described the TVT procedure (Tension-free Vaginal Tape) for correction of women urinary stress incontinence, a large number of different devices have been manufactured with that purpose. Results depend not only of the surgical procedure but also of two principal factors: 1. Characteristics and properties of the mesh. 2. System and way for the implantation. Properties of the mesh used are probably as important as surgical technique. It’s not possible to assume that results achieved with the TVT device will be similar with other meshes. Further randomized studies will be necessary to make these affirmations. In this paper we analyse properties of the mesh, characteristics of the implantation system and the influence of those factors in the surgical results. Finally, we describe some of the devices available and the mesh characteristics of each one

Uretrocervicopexia laparoscópica: seguimiento a largo plazo / Laparoscopic urethrocervicopexy: the long term follow-up

La Incontinencia Urinaria de Esfuerzo (IUE) es una condición en la mujer que causa un fuerte impactosocial, psicológico y familiar. Existía consenso entre los urólogos que las técnicas abdominales con materialno absorbible eran las de mayor éxito. Hacia 1993, la uretrocervicopexia laparoscópica (UL) se hizopopular en centros dedicados a la introducción de la laparoscopía en urología.Se realiza estudio prospectivo entre agosto de 1995 y agosto del 2003. Se realizaron 61 UL, en dos centroshospitalarios, por el mismo equipo quirúrgico. Se incluyeron en esta revisión solamente las 52 pacientesbeneficiarias de FUSAT, de las cuales todas permanecen en control, según protocolo. Todas las pacientescompletaron, al menos, 24 meses de control. A todas las pacientes se les realizó historia clínica, examenfísico, cistoscopía, QT Test, Prueba de Marshall y urodinamia cuando se sospechó incontinencia tipo 1 ó2. La técnica era transperitoneal y la suspensión se efectuaba con malla prolene, fijada a la fasciaperivaginal y ligamento iliopectíneo, con clips de titanio. Las pacientes se evaluaban al mes, 6 meses, alaño y luego cada año, efectuándose uroflujometría, medición de residuo post miccional y encuesta desatisfacción.La tasa de éxito fue de 88,9 porciento al primer año, pero cae drásticamente, hasta llegar a 28,9 porciento a los 9 años. El seguimiento promedio fue de 60,7 meses (26-101). Tiempo operatorio promedio 40 minutos (30-65). Lascomplicaciones perioperatorias fueron 2 perforaciones vesicales mínimas, 2 infecciones urinarias simples,una retención urinaria. Las complicaciones tardías fueron una paciente con un clip de titaniointravesical y 4 pacientes con migración de la malla de prolene dentro de la vejiga.La laparoscopía en urología presenta una serie de ventajas, pero su aplicación exacta debe ser revisadaa largo plazo. Nuestro servicio ha abandonado su aplicación en incontinencia, reservándola para otrasindicaciones.

The treatment of urinary incontinence in 1814.

A selection from a little-known medical treatise of the early 19th century is presented which describes the condition of urinary stress incontinence and its treatment by means of pessaries, mechanical occlusive devices and electrical stimulation therapy. The author provides a foreshadowing of therapies that would come into more common use 150 years later.

Sensibilidade de dados da história clínica na detecçäo da incontinência urinária de esforço do tipo esfincteriana / Sensitivity of clinical history data in detection of sphincteric stress urinary incontinence

Foram avaliadas 78 mulheres portadoras de incontinência urinária de esforço, para identificar dados da história clínica (esforçco físico e número de absorventes vaginais em 24 horas), que pudessem predizer casos de incontinência urinária esfincteriana. Submetemos todas as pacientes ao estudo urodinâmico completo para a determinaçäo da pressäo de perda sob manobra de Valsalva. A distribuiçäo dos tipos de incontinência foi a seguinte: 22 classificadas como incontinência urinária tipo I, 26 tipo II e 30 tipo III. Do total de pacientes 45 pacientes, 45 mulheres (57,6 porcento) foram submetidas previamente a cirurgias, e entre essas 17 (37,7 porcento) apresentavam incontinência urinária esfincteriana. A associaçäo de incontinência urinária tipo III e cirurgia prévia mostrou-se näo significativa estatisticamente. O uso de 2 ou mais absorventes em 24 horas foi estatisticamente significativo para as pacientes com incontinência esfincteriana. Nossos resultados demonstram que mulheres com perdas aos pequenos esforços e uso de 2 ou mais absorventes vaginais apresentam alta probabilidade de lesäo esfincteriana (p<0,05). Entretanto, o estudo urodinâmico é o único exame comprovativo do diagnóstico de incontinência urinária esfincteriana