The Bioceptive SCR is a device that can replace the standard single-tooth tenaculum to place traction on the cervix. This study was basically a feasibility trial conducted on the device for the IUD placement.
The process was divided into the three-stage feasibility process which began with Stage 1, where the device was tested on in-vitro and ex-vivo samples. After stage one in the second stage, 10 women received their IUD using the device. In the third, a feasibility trial, we randomly assigned 25 consenting women to receive their IUD using either the Bioceptive SCR or the standard single-tooth tenaculum. The results obtained were the pain score after attaching the SCR or tenaculum. Wilcoxon rank-sum tests compared pain scores between devices.
Pain scores with the SCR were lower than controls with the single-tooth tenaculum. Reported patient satisfaction with the SCR device was 80% in Stage 2% and 90% in Stage 3.
The study concluded through its findings that Bioceptive SCR has potential as an atraumatic alternative to standard cervical retractor devices for gynecological procedures. These findings can guide point estimates for future clinical studies.