New customizable mold created for vaginoplasty postoperative period

May 13, 2023

Experts from Mayo Clinic Urogynecology and Radiology anatomic modeling, along with colleagues from three other institutions, have created a 3D-printed, anatomically customizable vaginal mold to be used postoperatively following vaginoplasty. Obstetrics & Gynecology published these findings in August 2022.

With the positive outcome of the case published in this journal plus ever-widening 3D printing availability, the study authors believe customized, 3D-printed vaginal molds hold promise for individualized vaginal agenesis treatment.

Vaginal agenesis — also called mullerian agenesis, mullerian aplasia or Mayer-Rokitansky-Kuster-Hauser syndrome — is a rare, congenital condition. It often comes to light when a young woman of menstrual age, 15 to 20 years old, is not menstruating and seeks medical assistance. In these cases, the patient's uterus and vagina are absent or a uterine muscle remnant exists yet is nonfunctional. Occasionally, the uterus has formed, but the vagina has not. Patients diagnosed with this condition present with a normal female karyotype with normal breasts, pubic hair and external genitalia. Some patients experience kidney or skeletal issues.

The road to the new 3D-printed, customizable vaginal mold

The need for a customizable vaginal mold arose when a petite patient presented to John B. Gebhart, M.D., chair of Mayo Clinic Urogynecology in Rochester, Minnesota. He specializes in repairing vaginal agenesis. This patient's diagnosis was pubic symphysis nonfusion with abnormally shallow pelvis from pubic bone to sacrum. She had undergone previous failed vaginoplasty.

In this patient's surgery at Mayo Clinic, Dr. Gebhart dissected the neovaginal space between the bladder and the rectum, lining the interior with a skin graft, which he compares to wallpapering. He inserted a temporary sponge mold with a tampon-like shape to maintain the created space. However, the mold was too large for the patient's anatomy.

"Not everyone's going to retain that well," he says. "If a mold sticks out, it tends to come out."

Dr. Gebhart had to get creative. Aware of the work of Jonathan M. Morris, M.D., a Mayo Clinic radiologist specializing in anatomic modeling, Dr. Gebhart pursued assistance from Dr. Morris to create a stent to fit the patient. He asked Dr. Morris to create 2 to 4 smaller vaginal molds to provide alternatives, to ensure a precise fit during surgery. It worked.

"Without a mold that fit in the newly created vagina, the vagina would have lost depth, width and function," says Dr. Gebhart. "We need options so our patients can wear a functional mold 24/7 while the skin heals post-surgically for six-plus months."

Dr. Gebhart and team recommend a 3D-printed custom temporary vaginal mold, especially because there are so few commercially available mold options. After 7 to 10 days, the urogynecologist removes this temporary mold and inserts a permanent plastic one.

Another challenge for Drs. Gebhart and Morris was an ideal material for the permanent mold. They needed a substance appropriate for bodily implantation with a feature like dentures: removability for cleaning twice daily or antibiotic cream application. Evaluating this possibility caused Dr. Gebhart to start considering the potential use of dental resin for the mold.

"The 3D lab group was surprised at my request, but it ended up working out," says Dr. Gebhart.

Vaginal agenesis treatment

Surgery is one of two major vaginal agenesis therapies. First line therapy is self-dilation in which the patient applies repetitive pressure with a dilator, gradually creating a vaginal cavity.

Surgery — often the McIndoe procedure and less often the laparoscopic Vecchietti or Davydov vaginoplasty — is used for patients who may be uncomfortable with self-dilation or when self-dilation doesn't produce the desired results. Dr. Gebhart imagines a student sharing a college dorm room with a roommate, for instance. This situation may not be conducive to self-dilation. Sometimes patients prefer surgery for more immediate effect.

Self-dilation is advantageous because it engages the patient in therapy, which Dr. Gebhart considers positive. The disadvantage is it requires the patient's compliance for at least six months of tissue stretching. Self-dilation is also less invasive than surgery, and the neovagina rarely shrinks after this method. However, if a patient forgoes dilation partway through the process, the vagina could return to ground zero. Dr. Gebhart says there is nothing wrong with quitting for a time and then resuming, however, if needed.

He indicates most young women are diagnosed by OB-GYN or primary care professionals who then refer to him for treatment.

Goals for patients with vaginal agenesis

Dr. Gebhart says most patients he sees desire a fully formed vagina for sexual function purposes.

"This requires sufficient depth," he says. "A shot glass size is not going to function well."

While a neovagina can be constructed, some functions cannot be restored currently.

Often patients with vaginal agenesis are infertile and cannot get pregnant, says Dr. Gebhart. However, he says some women with this condition could procreate by egg harvest requiring assisted reproductive technology.

Patients lacking a functional uterus, however, require a uterine surrogate. Dr. Gebhart says a couple of his patients have undergone this process, with eggs harvested abdominally or transvaginally through the neovagina.

After patients heal from surgery or regular dilator use, they maintain their new vaginal canals through intercourse and a dilator. Patients become accustomed to the permanent mold over time.

"Initially, it's difficult to wear a mold because nothing's gone in that space before," Dr. Gebhart says. "That's why I spend time with them in the hospital after surgery to demonstrate removal and insertion, and I have them do it."

More than just a physical issue

Dr. Gebhart also mentions the nature of missing a fully formed uterus or vagina goes far beyond physical reparation. For a teen with the condition, being different from peers is emotionally trying, Dr. Gebhart says.

"I try to reassure them they are normal young women and have done nothing wrong," says Dr. Gebhart." I explain that embryologically, the vaginal tissue simply did not fully form. I emphasize this doesn't define them and they're going to be OK."

When patients come to see him, Dr. Gebhart clarifies their diagnoses while empathizing with them and offering treatment options.

"We have to help these patients with their emotional state and sometimes shock,” says Dr. Gebhart. "It's not as straightforward as repairing a knee. Often there is much more emotion involved because of what it represents. This is as intimate as it gets for a young woman."

Dr. Gebhart indicates he typically bonds significantly with patients with vaginal agenesis while guiding them through an emotional and physical process. He notes they often stay in touch with him.

Outcomes of vaginal formation

Dr. Gebhart is pleased that thus far, each patient he has treated for vaginal agenesis has adjusted to the mold and successfully had sexual relations.

"In a past study, we saw after treatment that these patients not only could have sex but also an orgasm," he says.

The study also found that vaginal dryness impacts these patients, as less natural lubrication exists with vaginal creation, and requires lubrication.

Vaginal agenesis therapy referral

Dr. Gebhart encourages physicians to refer patients with vaginal agenesis due to its rarity. Mayo Clinic in Minnesota has one of the broadest experiences with treatment. He currently treats most vaginal agenesis at the medical center and has performed over 60 McIndoe vaginoplasties in 20 years.

"Just the uniqueness of this condition produces referrals," he says, indicating most OB-GYN surgeons and even urogynecologists do not perform vaginoplasty. "I would not suggest dabbling in this particular space and doing one every year or two."

Dr. Gebhart says he has learned a lot by caring for patients with vaginal agenesis and performing vaginoplasties over the years.

"It involves caring for the whole patient and assisting with psychological acceptance of the condition and themselves," he says. "It also involves providing patients with the reassurance they need."

For more information

Kisby CK, et al. Three-dimensional-printed vaginal molds for use after McIndoe neovagina creation. Obstetrics & Gynecology. 2022;140:311.

Refer a patient to Mayo Clinic.