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  • Title: Creation of a novel inflatable vaginal stent for McIndoe vaginoplasty.
    Author: Romanski PA, Bortoletto P, Pfeifer SM.
    Journal: Fertil Steril; 2021 Mar; 115(3):804-806. PubMed ID: 33272624.
    Abstract:
    OBJECTIVE: To describe how to create an inflatable vaginal stent for use in McIndoe vaginoplasty that can be constructed using standard operating room supplies. DESIGN: Step-by-step video instructions that demonstrate how to construct and use an inflatable vaginal stent. (This video article was exempt from institutional review board approval.) SETTING: Academic hospital. PATIENT(S): A woman presenting with vaginal agenesis requiring a McIndoe vaginoplasty for the creation of a neovagina. INTERVENTION(S): A novel inflatable vaginal stent compliant with operating room procedures that is radio-opaque, functional, and can be used for patients with or without a functional uterus. The device is modeled after the effective inflatable vaginal stent that was previously commercially available but is no longer produced. Although a vaginal stent may be created in the operating room by placing surgical sponges inside a sterilized condom, many operating rooms have restrictions on equipment that can be brought into the operating room and special criteria for how to sterilize this equipment, and there are also restrictions against leaving non-radio-opaque objects "inside" the patient. The novel inflatable vaginal stent we have developed has multiple advantages compared with a rigid dilator: it is deflatable, so it does not cause trauma or interrupt the delicate tissue graft during insertion, removal, or repositioning; it is firm enough to conform and circumferentially press the tissue graft against the dissected vaginal space but is soft enough to decrease the risk of pressure necrosis or damage to the urethra; and it has a drainage port to prevent the buildup of a fluid pocket that could interfere with graft adherence. Our stent incorporates all these unique properties and can be easily constructed using sterile operating room supplies. The construction of this device requires a silicone Foley catheter, sterile foam sponges from a vaginal prep kit, a sterile radio-opaque sponge, a sterile vaginal ultrasound probe cover, a long Kelly, a 60-cc catheter tip syringe, a ruler, scissors, 0-vicryl suture, and sterile gloves. MAIN OUTCOME MEASURE(S): Effectiveness of a self-made inflatable vaginal stent using standard operating room supplies that meets operating room protocol standards. RESULT(S): A standard dose of prophylactic antibiotics should be administered preoperatively to prevent surgical site infection. After placement of the tissue graft in the dissected neovagina cavity, the vaginal stent is placed and slowly inflated to circumferentially apply the tissue graft against the dissected vaginal space. The stent remains in place for 7 days and then should be removed in the operating room to allow for an examination under anesthesia, which provides the ideal setting to best evaluate the initial graft adherence. After careful inspection of the neovagina and tissue graft, a standard silicone vaginal mold is placed to maintain vaginal patency and prevent stricture of the tissue graft. The silicone mold should remain in place continuously until complete graft adherence occurs (approximately 4 to 6 weeks), and then it can be worn nightly until the patient is regularly sexually active. If at any point the patient discontinues nightly use of the silicone mold before regular sexual activity, vaginal stricture and a decrease in vaginal caliber will occur. CONCLUSION(S): Our novel inflatable vaginal stent is useful to surgeons performing a McIndoe vaginoplasty for vaginal agenesis with or without a uterus. It is compliant with operating room protocols and restrictions, as it is constructed from operating room supplies and is radio-opaque. Moreover, it is adjustable in size and effective in applying circumferential pressure for graft adherence. When used for segmental vaginal agenesis, the Foley catheter may be advanced through the cervix, then the balloon can be inflated, to stabilize the position of the stent during the first week postoperatively. The main limitation of this device is that it must be constructed by the surgeon, but the advantage of self-constructing the stent is that the size and shape can be tailored to conform to each individual patient. We prefer this inflatable vaginal stent to a rigid vaginal dilator in the first week of tissue healing to allow for easy insertion and removal of the stent without disrupting the tissue graft, to help prevent tissue necrosis, and to provide a fluid drainage port during graft adherence. We recommend this device as an ideal option for surgeons to consider when performing a McIndoe vaginoplasty.
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