Study Population
During routine follow-up visits, we invited 40 Italian-speaking oMtF patients who had undergone GAS and post-operative pelvic non-contrast MRI in our Centre between 2004-2019 to partecipate in this prospective survey study; 20 patients operated with the PNT technique and 20 MtFs who had undergone NCP. The patients who agreed to take part in the study completed an anonymous cognitive questionnaire regarding their demographic, social and medical characteristics (such as current age and age at surgery, partnership status, BMI, diet, alcohol and tobacco consumption, habits and sexual orientation, medical and surgical history, education, job, ethnicity). Ultimately, 18 oMtFs chose not to participate, so the final sample included 22 patients.
Study procedure
Informed written consent was obtained for each participant. The patients were informed that their participation in the present study was anonymous and voluntary and that there would be no disadvantages for them if they decided not to participate. The study was approved by the ethical institutional review board (protocol number N.O. 23/2016).
Sexual Functioning
Sexual functioning was assessed using the Italian versions of the Female Sexual Function Index (FSFI) and the operated Male to Female Sexual Function Index (oMtFSFI) questionnaires. FSFI is one of the few validated questionnaires for which an Italian version is available and it remains the gold standard for screening and one of the most widely used tools.(5) FSFI is a brief, multidimensional, self-reporting questionnaire consisting of 19 items assessing sexual desire, arousal, lubrication, orgasm and sexual satisfaction over the past 4 weeks. All FSFI domains yield a computed maximum subscale score of 6, resulting in an overall maximum score of 36. Higher scores indicate a better level of functioning. An FSFI total score of 26.55 has been found to be the optimal cut-off for differentiating women with and without sexual dysfunction.(6)
oMtFSFI is the first questionnaire to assess sexual function in oMtF patients. It consists of 18 items and assesses 3 domains: Sexual Dissatisfaction, Genital Self Image and Sexual Pain. A preliminary scoring system was developed for each domain as well as for the full scale. An oMtFSFI total score of ≥ 55 was used for diagnostic classification. Any operated MtF patient who scores 55 or more on the total score should be considered at risk for sexual dysfunction.(7)
MRI Measurements
MRI is the best imaging method for studying the pelvis. MRI allows an excellent evaluation of the neoclitoris. The spatulated urethral stump, glans remnant and neurovascular bundle are best evaluated on T2-weighted and gadolinium enhanced T1-weighted images.(8) Variants of the surgical techniques can be identified, such as preservation of the dorsal aspect of the tunica albuginea, isolated or with a small amount of cavernous tissue.(9) For the evaluation of the post-operative changes and presence of postoperative complications, in our Centre patients who had undergone MtF GAS performed a pelvic MRI at 6 weeks after surgery.(10) MR Scans were acquired with 1.5T superconductive equipment in sagittal and axial planes using a multichannel phased array coil for parallel imaging (Intera-Achieva, Philips Healthcare, The Netherlands). TSE T2-weighted images were obtained with 3-4mm thick contiguous sections. When possible, the neovagina and the rectum were distended with gel, or imaging was performed with a vaginal tutor inserted. The patients were instructed to breathe regularly and shallowly to minimize respiratory excursions on the abdominal wall. Respiratory compensation was not necessary, nor use of spasmolytic agents. In the sagittal and in the axial T2-weighted images an excellent depiction of the new female anatomy was obtained. Individual pelvic MRIs were reviewed by two blinded investigators, radiologists with 20 years of experience in pelvic imaging, for the optimal sagittal, coronal and axial images from which the standardized measurements were then obtained. The neoclitoris was identified following the dorsal neurovascular bundle to an ellipsoid mass of variable signal intensity, usually high-to-intermediate. The three axes of the neoclitoris were measured, and the volume was calculated using the ellipsoid formula. The distance between the neoclitoris and the neovagina was also measured. All anatomic measurements were performed using the general electric picture archiving system/centricity system for radiology which has ruler and angle measurement functions scaled to each specific image.
Statistical Analysis
Categorical variables are described by frequencies and percentage while continuous variables by median and interquartile range. The association between the groups of intervention and other categorical variables was evaluated by Chi square-tests or exact Fisher test. The Wilcoxon-Mann Whitney test was used to assess the difference in distribution of the continuous variables across the groups of intervention. P-values <0.05 were considered statistically significant. All analysis was performed using SAS© software, Version 9.4 (SAS Institute Inc., Cary, N.C., USA).