Veda-scope: More comfortable than the bivalve speculum and cytologically equivalent

The aim of the present study was to confirm that the Veda-scope is equivalent to the bivalve speculum in the collection of endocervical cells, as confirmation of adequate cervical sampling for Pap smear testing. The study also aimed to assess the comfort level of the Veda-scope compared to the traditional bivalve speculum and the patient preference of the Veda-scope compared to the bivalve speculum.

Multicentre, randomised, controlled crossover, cytologist blinded study.

The total number of subjects enrolled in the study were 250. The number of evaluable subjects were 210.

In primary efficacy analysis, no significant difference was seen between the presence or absence of endocervical cells in the smears using either the Veda-scope or the bivalve speculum. There was a high concordance level between the diagnosis assigned to each specimen of a paired sample, the diagnosis agreeing in 97.6% cases. The primary reason given by many women for avoidance of regular Pap smear examinations is the discomfort or pain experienced with sample collection with the bivalve speculum. In the present study, 92% of subjects indicated a preference for the Veda-scope for Pap smear collection, while only 8.4% preferred the bivalve speculum. Subject preference was also assessed with respect to how the subject rated the comfort level of her previous Pap smear. In subjects who rated their previous Pap smear as very comfortable or comfortable, 86% expressed a preference for the Veda-scope. This rose to 93% in subjects who rated their previous Pap smear as only tolerable.

The results of the present study show that Pap smear collections with the Veda-scope are of equal quality to those collected with the bivalve speculum, with an equivalent diagnostic outcome. A very strong preference for the Veda-scope was shown by the women enrolled in the present study based on the comfort levels experienced with the two devices.