Patient-controlled expanding dilator for dyspareunia

Updated September 17, 2020 to reflect the updated Milli website

Compared to conventional available vaginal dilators, the patient-controlled Milli (Materna Medical) was found uniformly superior and most women reported that the device was easy to clean, comfortable, aesthetically pleasing and improved their sexual confidence, according to a survey-based study.

Milli, which is electronically operated, mostly targets women with dyspareunia. The device increases by 1 mm at a time. Patients can also slowly increase progress at their own pace toward specific goals. 

“Because Milli is the first and only patient-controlled dilatory device, it helps promote and improve compliance,” said principal investigator Michael Krychman, MD, MPH, executive director of the Southern California Center for Sexual Health and Survivorship Medicine Inc. in Newport Beach.

“There is currently poor compliance with dilators,” Dr. Krychman told Contemporary OB/GYN. Among the reasons contributing to this poor compliance are the possibility that dilators may recondition the brain-body reconnection for anticipatory anxiety, burdensome regimes, excessive time commitments and worries about stepwise abrupt transitioning between dilator sizes.

Milli, on the other hand, rectifies many of these challenges, according to Dr. Krychman. The initial pilot study indicated more gradual and rapid vaginal health recovery, with less apprehension or anxiety.

The study, which appears in Obstetrics & Gynecology, comprised the 57 patients who purchased Milli during the initial soft launch and completed a baseline and a 3-month follow-up anonymous survey.

Overall, 77% of study patients were diagnosed with dyspareunia and 33% of patients had suffered more than 5 years before seeking care. Additionally, 25% of patients had not been sexually active for at least 5 years.

 “We anticipated that women would prefer to do dilators in the morning when there was less time, stress and other intervening factors, yet some prefer to do their dilators in the evening,” Dr. Krychman says.

Most study patients used Milli three times a week, with half of the women spending between 5 and 15 minutes using the dilator per session, the vast majority (90%) in the setting of a bedroom, and 44% of patients used the device before bedtime.

Moreover, 43% of patients used the dilator before intercourse, yet 64% did their accompanying relaxation exercise alone.

There were no reported serious adverse events or device complications. 

“Vaginal spasm and/or avoidant sexual behavior due to pain and concerns about sexual pain often require dilator use,” Dr. Krychman said. “But we are unaware of what treatment paradigms work best with patients. This study gives us some insight to what exactly is going on in the field and where we can improve.”

Future studies are planned about frequency of dilator use and the duration of each session. “We want to develop the optional treatment paradigm for safe, effective and quick return to sexual function,” Dr. Krychman said. “Other dilator data will be forthcoming.”

According to Imperial College Healthcare in London, women suffering from superficial dyspareunia or vaginismus can benefit from using vaginal dilators, which are plastic tubes specifically designed for use to create a vagina and that come in various sizes. Dilator therapy, coupled with some relaxation exercises, can be extremely successful in treating superficial dyspareunia. Stretching the vagina to accommodate a medium to large dilator facilitates intercourse, which also dilates the vagina. 

A lubricating gel is used with dilator therapy but patients may still have some discomfort or slight vaginal bleeding during the first few days of treatment. That is normal because vaginal skin is being stretched. They need to be shown how to insert a dilator at the correct angle to avoid any minor tears or weakening of the vaginal wall. Length of treatment typically ranges from a few weeks to a few months, depending on symptom severity.

Disclosures:

Dr. Krychman is a medical consultant to Materna Medical.