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Creating a gold standard surgical device: scientific discoveries leading to TVT and beyond

Ulf Ulmsten Memorial Lecture 2014

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Abstract

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.

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Conflicts of interest

P. Petros is the co-inventor of TVT. There are no other conflicts of interest.

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Correspondence to Peter Petros.

Glossary

Anomalies

Occur with internal logical inconsistencies or especially when experimental findings cannot be explained by the existing paradigm.

Crisis

Crises occur when the dominant paradigm fails to solve problems or when the bases or predictions of the paradigm are invalidated.

Incommensurability

Scientific paradigms preceding and succeeding a paradigm shift are so different that their theories are not able to be judged by the same standards. Nor is the change gradual. “Like a gestalt switch, it must occur all at once, or not at all” [1]. Furthermore, the paradigm shift does not merely involve the revision or transformation of an individual theory, it changes the way in which terminology is defined, how the scientists in that field view their subject, and, perhaps most significantly, what questions are regarded as valid, and what rules are used to determine the truth of a particular theory. Examples: the urodynamic paradigm uses pressure readings to guide whether surgery is performed or not. The integral theory paradigm views prolapse and pelvic symptoms as being mainly secondary to ligament laxity, all being surgically repairable.

Normal science

Is when the paradigm is applied to solve puzzles within the context of the dominant paradigm. Examples are the ICS urodynamic paradigm and the integral theory paradigm

Paradigm

Is a conceptual framework that ultimately leads to a widespread consensus on the appropriate choice of methods, terminology, and on the kinds of experiment that are likely to contribute to increased insights.

Scientific revolutions

A totally different paradigm emerges that seeks to explain the phase in which the underlying assumptions of the field are re-examined and a new paradigm is established.

Surgical principle of TVT artificial neoligament

Using a tape implanted precisely in the anatomical position of a ligament (e.g., pubourethral ligament) to restore its structural function.

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Petros, P. Creating a gold standard surgical device: scientific discoveries leading to TVT and beyond. Int Urogynecol J 26, 471–476 (2015). https://doi.org/10.1007/s00192-015-2639-3

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  • DOI: https://doi.org/10.1007/s00192-015-2639-3

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