Publication

ClearSpec IRB clinical study published in the International Journal of Gynecology and Obstetrics

ClearSpec is scientifically proven by an IRB randomized clinical study to improve visualization for every exam. The study “Sheathed versus standard speculum for visualization of the cervix” by David A. Hill has been published in the May 2014 of the prestigious International Journal of Gynecology and Obstetrics.

clinical study published in the International Journal of Gynecology and Obstetrics

Abstract


Objective

To determine whether modifying a plastic speculum with a flexible sheath would improve visualization and decrease pain during vaginal examination.

Methods

We conducted a prospective randomized controlled trial of 136 women undergoing vaginal speculum examination at an outpatient obstetrics and gynecology faculty practice. Patients underwent examination via a standardized technique with either a medium-sized plastic speculum (standard) or an identical speculum modified with a flexible polypropylene sheath (sheathed). Investigators recorded the percentage of the cervix visualized. After speculum insertion, patients recorded pain using a 10-cm visual analog scale.

Results

There were no substantial demographic differences between the standard (n = 67) and the sheathed (n = 68) groups. Investigators were able to visualize a significantly greater percentage of the cervix using the sheathed speculum compared with the standard speculum (95.1% ± 8.2% vs 78.2% ± 18.4%; P < 0.001), representing a 21.6% improvement in visualization, and were able to visualize the entire cervix in 42 (61.8%) patients when using the sheathed speculum compared with 11 (16.4%) patients undergoing standard speculum examination (P < 0.001). Patients undergoing examination with the sheathed speculum reported a nonsignificant decrease in pain scores (1.0 vs 1.2; P = 0.087).

Conclusion

A sheathed speculum significantly improves visualization of the cervix, without compromising patient comfort.

Click here to download the full article

Contact Us

Address: 123 NW 13th Street, Ste 307
Boca Raton, FL 33432

Phone: 561.395.7767
Email: sales@clearspecmedical.com


clearspec image logo for footer