Easier insertions eyed for IUD procedures
Easier insertions eyed for IUD procedures
Many women might consider use of the intrauterine device (IUD) for contraception, but some might shy away from choosing the method due to fear of pain during insertion. In large contraceptive efficacy trials, pain at insertion was recorded from clinicians' subjective assessment of patients; some level of pain was registered in 13% to 24% of insertions.1,2
Providers might underestimate patient pain levels. In a recent secondary analysis of a randomized placebo-controlled trial of 200 women that looked intracervical lidocaine gel as an analgesic during IUD insertion, data indicates a wide expanse between providers' and patients' perceptions. On a 100-point visual analog scale, patients' mean perceived pain score was 63.8, registering moderate pain, while the providers' assessment of their patients' pain level was recorded at a mean of 35.3, registering as mild pain.3
What can cause pain during the insertion procedure? Components might include applying the tenaculum to the cervix to stabilize the uterus and provide traction for straightening the cervical canal, passing the uterine sound, inserting the IUD in the inserter tube through the cervix, and irritating the endometrial cavity with the device.4
Who might be more susceptible to pain at insertion? A 2006 study identified nulliparity, age greater than 30 years, lengthier time since last pregnancy or last menses, and not currently breastfeeding as predictors of pain during such procedures.5
Research has eyed use of non-steroidal anti-inflammatory medication, lidocaine gel, and misoprostol to reduce pain during procedures. A 2010 review identified no ideal medication. Data from a just-published study indicates self-administered misoprostol before IUD insertion does not ease IUD insertion or reduce patient-perceived pain in nulliparous women.6
According to Contraceptive Technology, many clinicians provide ibuprofen or naproxen prior to device placement. Use of these medications, however, has not been shown to decrease pain during or after placement.7
New inserter in focus
Bioceptive, a New Orleans-based company, is researching and developing a new approach to the insertion procedure for IUDs. The Bioceptive Inserter has been developed as a comprehensive, standalone device that can perform the procedure with no additional instruments other than a vaginal speculum, says Benjamin Cappiello, Bioceptive's chief scientific officer. Cervical tenaculum, os finder, uterine sound, and suture scissors will not be needed, as the functions of all such instruments will be accomplished by the Bioceptive Inserter, says Cappiello.
The Bioceptive Inserter replaces the piercing and clamping of the cervical tenaculum with a gentler, suction-based cervical attachment feature, states Cappiello. The inserter incorporates a force-limiting mechanism that serves two important functions, Cappiello observes. First, it ensures that no perforations occur, as the device cannot physically push the IUD hard enough to perforate the myometrium of the uterus. Second, the mechanism allows the provider to ensure ideal placement of the IUD against the fundal wall in any uterus from 6-13 cm in endometrial cavity depth, he states. The inserter incorporates an automatic string cutter to cut IUD strings 3 cm from the external cervical os simultaneously with the placement of the IUD at the fundus, eliminating another step and instrument from the procedure, states Cappiello.
For providers inserting an IUD with the Bioceptive Inserter, all they need to know is two steps: "one, attach the Bioceptive Inserter to the cervix by creating suction via pulling a lever, and two, squeeze the deployment handle six times," says Cappiello. "That's all."
The device is in early research stage, says Cappiello. The latest generation of the prototype has been completed. Cadaver testing is underway, as well as ex vivo tissue testing, he states. The company plans to submit applications for regulatory clearances with U.S. and European drug regulatory agencies by the end of 2012, says Cappiello.
The product has the potential to be "game-changing" for healthcare providers and the women they serve, particularly in under-served areas in the United States and globally, says Tamara Kreinin, program director for the Los Altos, CA-based David and Lucile Packard Foundation's Population and Reproductive Health Program and Bioceptive investor. It will increase the reach of IUDs to rural areas of the United States and developing countries where providers are scarce, she states.
References
- Farr G, Amatya R. Contraceptive efficacy of the copper T380A and the multiload Cu250 IUD in three developing countries. Adv Contracept 1994; 10:137-149.
- Farr G, Amatya R. Contraceptive efficacy of the copper T 380A and copper T 200 intrauterine devices: results from a comparative clinical trial in six developing countries. Contraception 1994;49:231-243.
- Maguire K, Morrell K, Davis A. Accuracy of providers' assessment of pain during IUD insertion. Presented at the 60th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. San Diego; May 2012.
- Allen RH, Bartz D, Grimes DA, et al. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev 2009; (3):CD007373.
- Hubacher D, Reyes V, Lillo S, et al. Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen. Am J Obstet Gynecol 2006;195:1,272-1,277.
- Swenson C, Turok DK, Ward K, et al. Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol 2012; 120(2 Pt 1):341-347.
- Dean G, Schwarz EB. Intrauterine contraceptives (IUCs). In: Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive Technology: 20th revised edition. New York: Ardent Media; 2011.
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