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.
- intrauterine devices
- cervical retractor
- iud insertion
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Contributors All authors made significant contributions to the research endeavor and manuscript, in accordance with the ICJME criteria for authorship.
Funding This study was funded by Bioceptive, Inc., the company developing the suction cervical retractor. Bioceptive employees were involved in the study design and manuscript writing but were not involved in data collection or analysis. Use of REDCap provided by Eunice Kennedy Shriver National Institute of Child Health and Development grant (8UL1TR000105 (formerly UL1RR025764) NCATS/NIH). Support from the Eunice Kennedy Shriver National Institute of Child Health & Human Development and the Office of Research on Women’s Health of the National Institute of Health is provided under award number K12HD085852 for JNS, K12HD085816 for LMG, and K24HD087436 for DKT.
Competing interests DKT received speaking honoraria from Allergan and Medicines360, served as a consultant for Bioceptive, and served on advisory boards for Actavis, Bayer, Pharmanest and Teva. LMG served on an advisory board for Evofem Biosciences. BC is a biomedical engineer for Bioceptive, Inc. The Department of Obstetrics and Gynecology, University of Utah, receives contraceptive research funding from Bayer, Bioceptive, Medicines360, Merck, Teva and Contramed. The other authors have no conflicts of interest to disclose.
Patient consent Obtained.
Ethics approval University of Utah IRB.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Interested parties may contact the lead author for a copy of a de-identified dataset should they be interested.
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