Vaginal Dilators: Issues and Answers.

INTRODUCTION: Vaginal dilators are often prescribed to facilitate an adaptive brain-body connection to decrease anxiety and pain that can be experienced in anticipation of sexual intercourse among populations of women with sexual pain syndromes. Postmenopausal women, cancer survivors, and women with a wide variety of pelvic floor disorders who experience genito-pelvic pain/penetration disorder (GPPPD) are often advised to incorporate vaginal dilators into their pelvic floor rehabilitation program and treatment regimens to enable penetrative intercourse with less pain. However, little is known about the behaviors of dilator users, what treatment protocols are most effective, how patients are currently using their dilators, and how effective are clinicians in helping their patients achieve success with their dilation therapy. METHODS: A recent PubMed literature search was performed using the key words vaginal dilator, vaginal dilator therapy, sexual quality of life, vaginal stenosis, vaginal dilation, vaginismus. A total of 29 English articles were reviewed and summarized. Articles were excluded for the following reasons: not in English and unrelated to dilator therapy. MAIN OUTCOME MEASURE: This article will summarize the current research on vaginal dilators and discuss needs for future research to maximize patients' compliance and success with this treatment. Much of the summary data regarding user behavior will come from the early survey data with Milli, a novel, patient-controlled electronic dilator that slowly expands 1 mm at a time from its smallest diameter, 15 mm to a maximum diameter of 40 mm. Milli is currently being used by more than 1,000 women, and 3-month follow-up data were recorded on 335 of those patients. RESULTS: Dilators exist in multiple forms (plastic, latex, and medical grade material), may come individually or in sets, and many have special features such as vibration or the ability to be heated or cooled before use. Little is known about patients' use of dilators and the Milli's 3-month survey serves as an insight to patient dilator behavior. The most common medical goals for patients undergoing dilation treatment were return to penetrative intercourse and pain reduction during coitus. Patients were dilated on average 2.72 days/week; 56.8% of patients had suffered from sexual pain for 2 or more years and 36.3% had previously used static dilators. More than 70% of Milli users purchased Milli and are using Milli without the direct guidance of a clinician. The most common emotions patients used to describe their treatment were not only "anxious," "frustrated," but also "empowered" and "optimistic." The most common dilatory session duration was 6-10 minutes, mostly in the evening/bedtime (68.3%), located in the bedroom (96.8%). Adjunctive treatment included the following: vaginal moisturizers, local estrogen products, coital lubricants, and genital pelvic floor physical therapy. During the dilation sessions, women most often watched TV/videos, practiced mindfulness, or listened to soothing music. Factors that showed trends toward improved patient outcomes were length of dilation treatment (greater than 3 months) and use of meditation and soothing music. Factors not associated with improvement trends were as follows: when/where patients dilated and patient demographics including age, race, or religious preferences. CONCLUSION: Patients who purchase dilators have often suffered with their condition for a long time and had difficulty finding a competent health-care clinician well versed in sexual pain syndromes that can help them. When patients did find a clinician, there were no clinically proven standardized protocols or formalized guidelines to give to patients about how to best use their dilators. Larger long-term interventions investigating a standardized dilation protocol are planned in future studies to better elucidate the effective and optimal dilation treatment plans. Liu M, Juravic M, Mazza G, et al. Vaginal Dilators: Issues and Answers. Sex Med Rev 2021;9:212-220.

Novel epicardial off-pump device for mitral regurgitation: acute evaluation.

OBJECTIVE: This study evaluates the ability of a novel epicardial annuloplasty device Mitral Touch (MAQUET Cardiovascular LLC, San Jose, CA, USA) to reduce functional mitral regurgitation (MR) in a rapid ventricular pacing-induced dilated cardiomyopathy model in dogs. METHODS: A median sternotomy was performed in 13 dogs after MR induction by rapid ventricular pacing (230 beats/min for an average of 35.6 + or - 12.8 days). Two-dimensional epicardial echocardiographic and haemodynamic measurements were performed to evaluate the baseline MR grade, the septal-lateral (S-L) dimension of the mitral annulus, mitral valve (MV) geometry and left ventricular function. The Mitral Touch was implanted by sliding the anterior arm onto the floor of the transverse sinus and positioning the posterior arm just apical to the atrioventricular groove on the left ventricular posterolateral wall. The 24-mm-long device was implanted in eight dogs, the 27-mm-long device in four and the 30-mm standard length device in one. MR grade, S-L dimension and haemodynamics data acquisition were immediately rechecked after device implantation. RESULTS: All implantations, which took only approximately 30s to deploy, were performed on beating hearts without cardiopulmonary bypass. In one early case, after extended manipulation with undersized devices, an atrial laceration was created and bleeding occurred. Design changes were made to eliminate this complication. The MR grade was significantly (p=0.003) reduced from 3.1 + or - 1.1 at baseline to 1.4 + or - 0.8 after device implantation. The S-L dimension at end of systole was also significantly (p=0.001) reduced from 2.7 + or - 0.4 cm at baseline to 2.3 + or - 0.3 cm after device implantation (% reduction: 15.1 + or - 10.6%). The mitral valve coaptation length was significantly (p=0.0001) increased from 0.36 + or - 0.11 cm to 0.50 + or - 0.08 cm, and the mitral valve tethering area was significantly (p=0.0003) decreased from 1.36 + or - 0.38 cm(2) to 0.81 + or - 0.29 cm(2) after Mitral Touch implantation. CONCLUSIONS: This new epicardial device was effective in significantly reducing MR and S-L dimensions acutely on the beating heart without requiring the use of cardiopulmonary bypass. Further studies are necessary to confirm the long-term maintenance of MR and S-L reductions.

Acute feasibility study of a novel device for the treatment of mitral regurgitation in a normal canine model.

OBJECTIVE: : The purpose of this study was to evaluate the implantability of a novel epicardial mitral annuloplasty device and its ability to reduce the septal-lateral (S-L) dimension of the mitral annulus. METHODS: : The devices were implanted on the beating heart in 2 healthy dogs (the 24-mm long device in dog A and the 27-mm and 24-mm standard devices in dog B) by sliding the anterior arm onto the floor of the transverse sinus and positioning the posterior arm just apical to the atrioventricular groove on the left ventricular posterolateral wall. The devices were secured with titanium helical tacks driven through the device into the ventricular wall. Two-dimensional epicardial echocardiograms were performed before and after device implantation to evaluate the degree of mitral regurgitation (MR) and the S-L dimension. RESULTS: : Device implantation was uneventful, taking only ∼30 seconds to deploy. MR (1+) in both dogs at baseline was reduced to zero after implant. The reductions in S-L dimension in systole for the 24-mm device were 7.5% in dog A and 30.5% in dog B. For the 27-mm device in dog B, S-L reduction in systole was 29.9%. The leaflet coaptation length was increased in both cases. CONCLUSIONS: : The new device was effective in reducing S-L dimension and 1+ MR without requiring the use of cardiopulmonary bypass. We are currently evaluating this device for the treatment of MR in a rapid-pacing canine heart failure model.