Introduction: The Bioceptive suction cervical retractor (SCR) is a novel device that can replace the standard single-tooth tenaculum to place traction on the cervix. A feasibility trial was conducted on the device for intrauterine device (IUD) placement.
Methods: Our three-stage feasibility process began with Stage 1, where the device was tested on in-vitro and ex-vivo samples. In Stage 2, 10 women received their IUD using the device. In Stage 3, a feasibility trial, we randomly assigned 25 consenting women to receive their IUD using either the Bioceptive SCR or the standard single-tooth tenaculum. In Stages 2 and 3, we collected pain scores using an electronically adapted 100-point visual analogue scale (VAS) at eight timepoints during and after the insertion procedure, as well as satisfaction and acceptability measures. The primary outcome was the pain score after attaching the SCR or tenaculum (VAS 3). Wilcoxon rank sum tests compared pain scores between devices.
Results: In Stage 2, pain scores with the SCR were lower than historical controls with the single-tooth tenaculum. In Stage 3, the median VAS 3 pain scores were 31 and 57 for the intervention and control groups, respectively. The differences in pain scores were not statistically significant but the trend was to lower pain scores with the intervention. Reported patient satisfaction with the SCR device was 80% in Stage 2% and 90% in Stage 3.
Conclusions: The Bioceptive SCR has potential as an atraumatic alternative to standard cervical retractor devices for gynaecological procedures. These findings can guide point estimates for future clinical studies.
Trial registration: NCT02283463.
Keywords: bioceptive; cervical retractor; intrauterine devices; iud insertion; pain.
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