Surgical and functional outcomes of penoscrotal vaginoplasty in AMAB transgender patients: a comprehensive analysis of patient satisfaction and postoperative findings

INTRODUCTION

Gender dysphoria (GD) refers to the discomfort or distress experienced by individuals whose gender identity differs from their assigned sex at birth^[1]. This condition can cause significant psychological suffering. The true prevalence of GD remains uncertain, mainly due to variation in study methodologies and diagnostic definitions^[1,2]. Only a minority of individuals with GD seek professional care - one Dutch study estimated that about 10% pursue medical support, with even fewer reaching specialized centers^[3]. Once diagnosed, transgender women (assigned male at birth, AMAB) typically begin a multidisciplinary psycho-endocrinological pathway to align physical traits with gender identity, which may include psychological support, hormone therapy, and gender-affirming surgery (GAS), such as breast augmentation or genital reconstruction^[4].

The gold standard for GAS in AMAB individuals is vaginoplasty, a procedure designed to create a neovagina that closely resembles a natal vagina in both appearance and function, using the existing urogenital tissue^[5,6]. Over time, numerous surgical techniques have been developed to improve both aesthetic and functional outcomes while minimizing complication rates. Generally, GAS has shown high patient satisfaction and improved quality of life. Vaginoplasty, which typically involves the inversion of penile skin, remains the gold standard procedure^[7-11].

Although vaginoplasty has been carried out for many years, there are relatively few studies that rigorously evaluate its aesthetic, functional, and long-term outcomes, particularly regarding patient satisfaction^[12,13].

This study aims to assess the surgical and functional outcomes of transgender women who received vaginoplasty at an Italian referral center.

METHODS

Surgical technique

All patients received penoscrotal vaginoplasty carried out by two consultant urologists with specific training in andrology surgery and genital reconstructive surgery.

All patients received standard antibiotic prophylaxis with 2 g of intravenous cefazolin at induction, followed by a repeat dose after 4 h of surgery. At that time, a single dose of intravenous amikacin (1 g) was also administered. Thromboembolic prophylaxis was performed using low-molecular-weight heparin (LMWH), typically initiated on postoperative day 2 or 3, depending on individual bleeding risk. This approach reflects the generally low thromboembolic risk profile of our patient population, who were predominantly young and otherwise healthy.

The vaginoplasty included penectomy, bilateral orchiectomy, vulvoplasty, and creation of the vaginal canal, aiming to achieve an aesthetically pleasing and functional genital complex. The surgical procedure was carried out under general anesthesia with the patient in the lithotomy position, with legs placed on calf stirrups to provide adequate exposure of the perineum and external genitalia.

The first phase of the procedure was the demolitive phase, involving bilateral orchiectomy and penectomy. During this phase, tissues and anatomical structures necessary for the subsequent reconstructive phase were preserved. A perineoscrotal skin flap was elevated, and the penile shaft skin was preserved. [Figure 1].

Figure 1. Perineoscrotal flap and penile skin flap.

A urethral mucosal flap was also preserved to create the neovulvar vestibule, along with retraction of the urethral meatus and meatoplasty. The preputial skin flap (if available), the neurovascular bundle attached to the dorsal portion of the tunica albuginea, and the dorsocentral portion of the glans (reconfigured according to Preecha’s technique) were preserved for the construction of the clitoral complex, clitoral hood, and labia minora. [Figure 2].

Figure 2. Neoclitoris configuration.

Once the neovaginal cavity was created (between the rectal wall and the urethroprostatic plane, following Denonvilliers’ fascia), it was lined with appropriately approximated and sutured perineoscrotal and penile skin flaps. In cases of limited skin availability, a full-thickness skin graft harvested from excess scrotal skin was applied to ensure maximum neovaginal depth. After lining the vaginal cavity, the neovulvar vestibule (including the clitoral complex/labia minora, urethral meatus, and vaginal introitus) was completed, and the labia majora were created and sutured. (Figure 3 - for more details about the surgical technique, see Supplementary Figures 1-3)

Figure 3. Final appearance.

RESULTS

DISCUSSION

Genital GAS is a key step in the transition process for many AMAB individuals^[4,19]. It has been associated with reduced GD, greater body satisfaction, improved social integration, and enhanced quality of life^[10,20-23]. However, current evidence is limited by small sample sizes, retrospective designs, heterogeneous outcomes, and inconsistent terminology^[24-26]. These issues hinder comparisons between techniques and the development of standardized guidelines. Moreover, most studies rely on tools designed for cisgender populations, which may not adequately reflect the experiences of transgender individuals.

Our study aimed to provide an objective and reproducible evaluation of both surgical and functional outcomes following penoscrotal vaginoplasty using validated tools during the follow-up. Regarding surgical outcomes, our combined penoscrotal flap technique, with the optional use of a full-thickness skin graft in cases of limited tissue availability, achieved a median neovaginal depth of 14 cm (IQR 12-14).

This finding is in complete agreement with the existing literature, where the mean neovaginal depth has been reported to range from 10 to 13.5 cm^[27,28].

Similarly, in the series by Buncamper et al, no significant differences were observed in postoperative depth between patients who underwent vaginoplasty with or without a skin graft. In both groups, the median recorded depth was 13.8 cm. Furthermore, during follow-up, the authors reported a comparable degree of neovaginal cavity reduction after at least one year, estimated at approximately 2.1-2.5 cm^[6].

Supporting the significance of achieving sufficient depth for postoperative satisfaction, Karim et al. postulated that a neovaginal depth of at least 10 cm is necessary for functional penetrative sexual intercourse^[5].

Regarding surgical complications, previous literature reports variable rates ranging from 33% to 47%^[29]. The majority of these are classified as minor and do not require surgical revision. Rectovaginal fistula rates are reported to be around 1%-2%^[12,27-29], while urethral complications occur in approximately 1%-6% of cases^{[12,27,30-32]}. Neovaginal stenosis has been documented in 2%-10% of patients undergoing surgery^{[2,12,27,31,33]}.

In our series, the incidence of major complications was comparable to previously published studies. Notably, we observed a higher rate of meatal stenosis (~15%), which was more frequent during the earlier phase of our surgical experience. This suggests that improvements in ureteral stump management and neomeatus configuration over time - reflecting the surgical learning curve - contributed to reduced complications in later cases. Similarly, the retrospective study by Raigosa et al. reported a 15% complication rate in 60 patients undergoing vaginoplasty with penile and scrotal skin flaps, with most issues related to the urethra or introitus^[34]. This is consistent with our findings and reinforces the viability of the penoscrotal approach when performed in experienced centers.

Surgical revision for urethral complications in some series can reach up to 20%^[29]. Our data align with previously published data. However, the majority of revision procedures (approximately 43%) were performed for aesthetic reasons. In our current series, aesthetic revision requests were not detailed, but they only involved 4 patients out of 47 (8.5%). Recent prospective data from Mañero et al. highlight the importance of systematically evaluating not only surgical outcomes, but also functional, aesthetic, and sensory complications following transfeminine vaginoplasty. In their 2022 study, over 60% of patients experienced at least one postoperative issue, including sexual dysfunction and altered genital sensitivity, despite high overall satisfaction rates^[35]. In our cohort, a proportion of patients reported some degree of sexual dysfunction at 12 months, most commonly related to reduced genital sensitivity or mild discomfort during penetration. While these findings underscore the need for long-term follow-up and targeted postoperative counseling, it is important to interpret them within a broader context. Although these scores were actually higher than those reported in a sample of Italian cisgender female undergraduates in a 2018 study^[36], it should be noted that comparisons across populations must be interpreted with caution. Furthermore, Mañero et al., in another manuscript, emphasized the demand for aesthetic revision surgery in transfeminine patients, reporting a revision rate of 22.9%, primarily for labia minora asymmetry, clitoral hood irregularities, and introitus contour^[37]. Differences in patient expectations, surgical technique, follow-up duration, and even legal or cultural factors may help explain this discrepancy.

The overall revision rate in our series, combining both aesthetic and complication-related revisions, was 27.6%, which is similar to previously published global revision rates around 27%^[2].

Finally, a notable difference from other series is the absence of neovaginal prolapse in our cohort. While previous studies have reported this complication in approximately 2% of cases^[12,38,39], those data primarily derive from penile inversion techniques rather than penoscrotal flaps. Additionally, unlike historical approaches, modern penoscrotal flap techniques no longer involve fixation to the prostatic capsule, which was a common practice in the past.

Regarding the response rate to functional questionnaires during follow-up, we achieved a response rate of 63.8%. Similar studies addressing functional outcomes reported comparable response rates, which highlights the challenges of following these patients over time and obtaining large sample sizes. This difficulty arises because patients are often unreachable or non-compliant in completing the questionnaires during the long-term postoperative period. Monstrey et al. reported similar challenges in contacting women after surgery, as they could not be located^[40]. Reasons for not wanting to participate included “research fatigue” or “to be done with being seen as a patient” and desire to move beyond the surgical aspect and return to everyday life. However, it is possible that this has introduced a bias in the results^[29].

As supported by other series, the overall results from the different questionnaires confirm that GAS leads to high success rates, patient satisfaction, and an overall improvement in quality of life^[10,41,42].

Specifically, the oMtFSFI questionnaire, which was designed to assess sexual function in transgender women, offers a more tailored evaluation of postoperative outcomes compared to generic tools designed for cisgender populations. The progressive improvement in oMtFSFI scores observed over time suggests a clear trend toward functional recovery and enhanced sexual well-being following vaginoplasty.

At 3 months, only 33.3% of patients achieved scores classified as normal, while a considerable proportion still fell into the mild-to-moderate, borderline, or even critical ranges. This likely reflects the early postoperative challenges, including ongoing healing, tissue adaptation, and psychological adjustments. However, by 6 months, the percentage of patients in the normal range increased to 50%, with a corresponding decline in those reporting critical dysfunction. At 12 months, the trend was even more pronounced, with 63.3% of patients reaching normal function and no cases in the borderline or critical categories.

The steady increase in normal scores, coupled with the significant reduction in severe dysfunction, suggests that sexual function continues to improve well beyond the immediate postoperative period. These findings highlight the importance of long-term follow-up and postoperative support, as patients may require time to adapt physically and psychologically to their new anatomy. The persistence of mild-to-moderate dysfunction in a subset of patients (36.7% at 12 months) indicates that, while most individuals achieve satisfactory outcomes, some may require additional interventions to optimize function Additionally, while the oMtFSFI provides a more appropriate assessment tool for transgender women, further research is needed to refine its scoring thresholds and ensure that it accurately captures the nuances of sexual health in this population. Indeed, functional outcomes using this specific validated tool are not frequently reported in the literature.

It is debatable whether a questionnaire designed for cisgender women can reliably assess female genital self-image or sexual function in the AMAB transgender population. In our study, we used two additional questionnaires to better investigate sexual function and genital self-image in our patients, as no other tools specifically designed for AMAB patients are currently available.

Regarding the FSFI questionnaire, there are inherent limitations when applied to transgender women, particularly concerning the established cutoff for sexual dysfunction (score of 26.55). Given the anatomical and physiological differences in neovaginal function, as well as potential disparities in sensory perception and lubrication, the direct application of this threshold to our cohort may not be entirely appropriate. In our cohort, 22 patients (73.3%) reported being sexually active at 12 months. Among them, the median FSFI score at 12 months postoperatively was 24.8 (IQR: 22.2-27.1), slightly higher than the overall cohort median score of 22.2 (IQR 20-25.7). Comparable outcomes are reported in the literature (e.g., FSFI score of 16.9 and 23.7 in the series by Buncamper et al. and 26.67 in the series by Monteiro et al.^[2,6,29]). This supports the notion that sexual activity is associated with better FSFI scores and may help explain differences across studies.

Additionally, no significant differences in FSFI scores were observed between patients who underwent vaginal cavity expansion using a skin graft. Furthermore, the FSFI score appeared only marginally related to the functionality of the neovagina and was not correlated with the grade given for overall satisfaction (P = 0.13)^[6].

These low scores may be explained by the fact that the FSFI is not specifically designed for transgender patients and does not adequately assess the unique aspects of sexual functionality in individuals with reconstructed genitalia. It is worth noting that the domain of the questionnaire assessing satisfaction consistently had the highest scores at all follow-up time points (at 3, 6, and 12 months). Similarly, in the literature, the most difficult domain in the FSFI appears to be lubrication. Since the neovagina does not contain mucous tissue and, therefore, cannot produce fluids, lubrication issues are an expected limitation of this surgery^[6,29]. Despite this limitation, the progressive improvement observed across all FSFI domains over time suggests a significant enhancement in sexual function postoperatively, potentially nearing normative values established for cisgender women, indicating substantial recovery and adaptation. Indeed, Monteiro et al. report that overall, all patients had a dysfunctional FSFI score, with a mean of 21.58. However, when analyzing only the sexually active population, the mean score was 26.67, indicating adequate sexual function. In this cohort, the satisfaction domain also had the highest score^[2].

Regarding the questionnaire assessing genital self-image (FGSIS), the score at 12 months in our population was 24 (range: 21-26), comparable to other series, such as 22.6 in the series by Buncamper et al. and 21.8 in another series by the same group^[6,29]. Furthermore, we found an interesting comparison with the scores of cisgender women in a representative sample of the U.S. population (21.3)^[18]. The results obtained from the FGSIS suggest that the participants were generally positive about their genital self-image. Unfortunately, no data are available for such a comparison in the Italian population.

The progressive improvement in FGSIS scores over time suggests that as the postoperative period advances, patients tend to develop a more positive perception of their neogenitalia, reflecting increasing satisfaction and adaptation to their surgical outcomes. This trend aligns with previous findings in GAS, where initial concerns about appearance and functionality tend to decrease as patients become more accustomed to their bodies and experience improved quality of life. In this context, recent survey data^[43] demonstrated that transgender women who had undergone vaginoplasty reported significantly higher FGSIS scores compared with those awaiting surgery (79.4% ± 17.1% vs. 50.6% ± 15.1%, P < 0.0001). Interestingly, in the postoperative cohort, no correlation was found between FGSIS scores and sexual health outcomes, suggesting that genital self-image and sexual function may evolve independently. This supports the notion that sexual health in transgender women is a multifactorial construct, requiring multidimensional and population-specific assessment tools^[43].

Considering the positive findings observed at least 12 months after surgery, multivariate analyses were carried out to identify factors potentially associated with overall patient satisfaction. However, no clear preoperative or intraoperative predictors of adverse satisfaction outcomes emerged in our cohort. Interestingly, although not statistically significant, a trend was observed toward better sexual function (oMtFSFI scores) in patients who were active smokers and lower satisfaction in patients over 35 years old. These findings may reflect unmeasured psychosocial or behavioral factors not captured in our dataset, and highlight the importance of integrating broader health and lifestyle variables in future prospective studies. Further studies with larger sample sizes are needed to better define risk factors and optimize patient selection and perioperative management.

Furthermore, these data reinforce the importance of long-term follow-up in assessing functional outcomes beyond the early postoperative phase and underline the value of patient education in GAS. A multidisciplinary approach remains essential to ensure both surgical success and long-term functional well-being. Moreover, there is a pressing need for transgender-specific tools to evaluate sexual function and patient satisfaction, given the limitations of instruments designed for cisgender populations, to better capture the unique aspects of neovaginal physiology and patient-reported satisfaction.

A primary limitation of this study, shared with other reports on similar populations, is the low post-surgical adherence to research protocols, resulting in small sample sizes and underpowered analyses^[44,45]. Additional limitations include the retrospective, single-center design, short follow-up, and patient attrition. The lack of standardized protocols for assessing complications and outcomes further limits the generalizability of findings. Identifying the most effective vaginoplasty technique for AMAB patients remains challenging because of heterogeneity in surgical approaches, patient populations, and outcome measures. Future prospective, multicenter studies with standardized surgical techniques, longer follow-up, and validated instruments - such as the recently developed GENDER-Q^[46], specifically designed to assess patient-reported outcomes in GAS - are essential to improve comparability and data reliability. Notably, the GENDER-Q was not employed in our cohort because of its recent introduction and unavailability at the time of data collection.

Penoscrotal vaginoplasty represents an effective and reliable surgical option in GAS for AMAB patients, offering favorable outcomes and high satisfaction rates. Beyond the technical success, this study provides valuable longitudinal data showing progressive improvements in sexual function and genital self-image over the first postoperative year. These findings emphasize the importance of long-term follow-up and set realistic expectations for patients, who should be counseled that optimal functional outcomes may take several months to achieve. This gradual recovery process underlines the need for structured postoperative support and reinforces the value of specialized, multidisciplinary care.