Ex-vivo forces associated with intrauterine device placement and perforation: a biomechanical evaluation of hysterectomy specimens.

BACKGROUND: This biomechanical analysis of hysterectomy specimens assesses the forces associated with intrauterine device placement. These include compressive forces required to cause uterine perforation with two commonly available commercial intrauterine device placement instruments and a metal uterine sound. METHODS: We obtained hysterectomy specimens at a single academic center. All specimens resulted from excision for benign conditions in premenopausal women by any operative method. Within one hour of excision, we stabilized uterine specimens in an apparatus specifically designed for this analysis. A single, experienced clinician performed all experimental maneuvers and measured forces with a Wagner FDIX-25 force gauge. The investigator applied traction on a tenaculum to approximate force used during an intrauterine device placement. The maximum compressive force to the uterine fundus was determined by using manufacturers' placement instruments for two commercially available products and a metal sound. RESULTS: Sixteen individuals provided hysterectomy specimens. No complete perforations occurred while using loaded intrauterine devices; in a single observation the LNG IUS entered the myometrium. The plastic intrauterine device placement rod bowed in all attempts and did not perforate the uterine serosa at the fundus. A metal uterine sound created a complete perforation in all specimens (p < .001). The lowest mean maximum force generated occurred with the levonorgestrel intrauterine system placement instrument 12.3 N (SD ± 3.8 N), followed by the copper T380A intrauterine device placement instrument 14.1 N (SD ± 4.0 N), and highest for the metal sound 17.9 N (SD ± 7.6 N) (p < 0.01). CONCLUSIONS: In this ex-vivo model, metal uterine sounds caused complete perforation and intrauterine device placement instruments did not. This study received Institutional Review Board (IRB0059096) approval.

Use of a novel suction cervical retractor for intrauterine device insertion: a pilot feasibility trial.

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.