Perceptions of gender identity can be drastically affected by the absence of normal appearing and appropriate external genitalia. In both native male patients (cismale) who have lost their penis from acquired or congenital causes and female-to-male transgender (transmale) patients, absence of the penis often leads to significant physical and psychosocial distress.1 For transgender patients specifically, the incongruence between their true gender and inherent anatomy is associated with increased suicide rates.2–5 In both of these patient populations, phalloplasty and the creation of normal appearing external genitalia may help alleviate psychological distress.6
The goals of phalloplasty are to create an aesthetic penis that is sensate with a directable urine stream for standing micturition and stiffness adequate for penetrative sexual intercourse.7,8 Various techniques are available for reconstruction of the penis, including local tissue rearrangement, free tissue transfers, and penile prosthetics.9–12 In transmale patients, metoidioplasty, or hypertrophy of the clitoris with systemic and topical hormonal therapy followed by surgical creation of a phallus, can also be offered.13 Although there is no superior technique that perfectly satisfies all of the goals of phalloplasty, the radial forearm free flap remains the most commonly performed method.14 Other frequently used techniques include the pedicled or free anterolateral thigh flap, abdominally based flaps, the osteocutaneous fibula free flap, the functional latissimus dorsi flap, and multiple concomitant procedures for combined phalloplasty and urethroplasty.12,15–19
Available data on phalloplasty are generally limited to reports from individual institutions and rarely presented in collective form. An analysis of the aggregate results of phalloplasty has yet to be published.9,12–14,16,18,20–23 Important outcomes data, especially urethral complications, are severely lacking. In addition, comparisons between patient populations (transmale versus cismale) and between techniques (primary versus staged urethroplasty) are needed. This study examines aggregate outcomes, complications, and satisfaction after phalloplasty in adult populations.
PATIENTS AND METHODS
A comprehensive literature search of PubMed, MEDLINE, and Google Scholar databases was conducted for studies published through December of 2015 for techniques and outcomes related to total phalloplasty. The terms “penile reconstruction,” “penis reconstruction,” OR “phalloplasty” and Medical Subject Headings terms “penis/surgery” OR “phalloplasty” were queried. Independent reviewers selected additional sources after reviewing references of identified studies.12 Meta-Analysis of Observational Studies in Epidemiology guidelines and the Preferred Reporting Items for Systematic Reviews and Meta-analyses checklist were followed for data reporting.24,25
Articles were included if they reported primary evidence and outcomes in the reconstruction of greater than or equal to the distal two-thirds of the phallus for either transmale or cismale patients. Articles were excluded if they were reviews, abstracts, unpublished, or case studies with one patient; reported on a mean follow-up time less than 6 months, reconstruction of less than the distal two-thirds of the penile shaft, scrotal or urethral reconstruction without concomitant reconstruction of the penile shaft, or buried penis reconstruction; or did not specifically comment on the technique of reconstruction. Studies that reported on a repeated sample of patients from the same provider/institution were excluded for the purpose of analysis (Fig. 1). Effort was made to include all available studies and articles from any journal in the English language, and nonhuman studies and cadaver studies were excluded. Because of the state of the literature, all studies included in this analysis were Grading of Recommendations Assessment, Development, and Evaluation evidence quality of very low to low.26
Data on techniques, outcomes, complications, and patient satisfaction were collected. The sample was limited to include only articles reporting on the most common forms of phalloplasty: radial forearm free flap, anterolateral thigh flap, osteocutaneous fibula free flap, or abdominal flap.
Variables of Interest
The primary outcome of interest was urethral complications. Urethral complications consisted of postoperative fistula and stricture/stenosis. Secondary outcomes included flap complications, ability to void while standing, sexual function, and patient satisfaction. The variables were coded as binary data points. Flap complications were defined as any reported flap necrosis or partial/complete flap loss because of other complication such as infection or hematoma. Sexual function was defined as the ability to successfully perform intercourse or achieve orgasm. Patient satisfaction was determined by means of explicitly noted subjective reports of “adequate” or a greater equivalent regarding cosmesis, sexual function, or urinary function. Numeric satisfaction scores were not included in the analysis of patient satisfaction, as these data were sparse and collected in nonstandardized fashion in primary studies. Data were classified and coded by multiple raters without discrepancy when reviewed.
Other variables extracted were number of patients, follow-up time, procedure type, and patient population separated as transmale and cismale. Urethroplasty technique was classified as either primary or staged. Studies that were unclear or used both primary and staged urethroplasty techniques were not included in the analysis of this variable. Reoperation was not coded as staged urethroplasty, as the staged design was planned for the phalloplasty techniques in this analysis.
Random effects models (selected because of the heterogeneity of study populations) were used to estimate effect sizes for urethral and flap complication rates, ability to void while standing, sexual function, and patient satisfaction. Studies without reported data for a particular variable were not included in the subgroup analysis of that metric. Heterogeneity was examined using the Q value and I2 statistic. Data were analyzed using Comprehensive Meta-Analysis Version 3.0 (Biostat, Inc., Englewood, N.J.).
Characteristics of Included Studies
Ninety-two observational studies were eligible for review and 50 were included in the pooled analysis6,15,18,22,23,27–72 (Table 1). A total of 19 studies (38 percent) reported on transmale phalloplasty and 31 studies (62 percent) reported on cismale phalloplasty. Primary urethroplasty was used in 23 studies (46 percent), whereas staged urethroplasty was performed in 13 studies (26 percent). The remaining studies were either unclear in reporting or used a mix of urethroplasty techniques. Urinary and flap complications were reported in 45 studies (90 percent). Ability to void while standing, sexual function, and patient satisfaction were reported in 25 (50 percent), 24 (48 percent), and 28 studies (56 percent), respectively, although patient satisfaction data were nonstandardized and generally not quantified objectively.
Of the 19 studies (869 patients) that reported on transmale phalloplasty, five studies (26 percent) were primary urethroplasties and eight (42 percent) were staged urethroplasties. Complications were reported in 19 studies (100 percent). A total of 31 studies (482 patients) examined cismale patients. Eighteen studies (58 percent) performed primary urethroplasty and five studies (16 percent) used staged urethroplasty. Complications were reported in 26 studies (84 percent). The primary urethroplasty group included 23 studies (723 patients) and the staged urethroplasty group included 13 studies (210 patients). Further information on the nature of these studies has been previously reported.12
Urethral Complications Analysis
The pooled rate of urethral complications (45 studies, 1216 patients) was 33.3 percent (95 percent CI, 26.8 to 40.4 percent; I2, 26.63 percent; p < 0.001) (Table 2). The total urethral complication rate for transmale patients (19 studies, 856 patients) was 39.4 percent (95 percent CI, 30.6 to 48.9 percent; I2, 27.02 percent; p = 0.028), whereas the urethral complication rate for the cismale patients (26 studies, 360 patients) was 24.8 percent (95 percent CI, 16.5 to 35.4 percent; I2, 14.93 percent; p < 0.001). Of all primary urethroplasty procedures (21 studies, 692 patients), the urethral complication rate was 31.3 percent (95 percent CI, 23.9 to 39.9 percent; I2, 22.45 percent; p < 0.001), and in staged urethroplasty procedures (12 studies, 208 patients) the rate was 34.8 percent (95 percent CI, 22.5 to 49.7 percent; I2, 0 percent; p = 0.045). These effect sizes are represented graphically (Fig. 2). Further subdivision of complication rates by indication is also shown and is expanded by procedure type for transmale and cismale patients. (See Table, Supplemental Digital Content 1, which shows urethral complications, combined, http://links.lww.com/PRS/C555. See Table, Supplemental Digital Content 2, which shows urethral complications for transmale patients by procedure type, http://links.lww.com/PRS/C556. See Table, Supplemental Digital Content 3, which shows urethral complications for cismale patients by procedure type, http://links.lww.com/PRS/C557.)
Flap Complications Analysis
The pooled rate of flap complications (45 studies, 1216 patients) was 10.2 percent (95 percent CI, 7.6 to 13.5 percent; I2, 0 percent; p < 0.001) (Table 2). The transmale subgroup (19 studies, 856 patients) had a flap complication rate of 10.8 percent (95 percent CI, 7.0 to 16.2 percent; I2, 10.80 percent; p < 0.001), whereas the cismale population (26 studies, 360 patients) had a flap complication rate of 8.1 percent (95 percent CI, 5.5 to 11.7 percent; I2, 0 percent; p < 0.001). For all primary urethroplasty procedures (21 studies, 692 patients), the flap complication rate was 8.6 percent (95 percent CI, 5.3 to 13.8 percent; I2, 0 percent; p < 0.001). The flap complication rate for staged urethroplasty procedures (12 studies, 208 patients) was 16.7 percent (95 percent CI, 10.7 to 24.9 percent; I2, 0 percent; p < 0.001). Flap complications by procedure type and subgroup are shown. (See Table, Supplemental Digital Content 4, which shows flap complications, combined, http://links.lww.com/PRS/C558.)
Secondary Outcomes Analysis
The total rate of patients undergoing phalloplasty who were capable of voiding while standing (25 studies, 729 patients) was 79.0 percent (95 percent CI, 62.5 to 89.4 percent; I2, 4.33 percent; p = 0.001) (Table 3). Sexual function (24 studies, 418 patients) was achieved at a rate of 61.2 percent (95 percent CI, 44.7 to 75.4 percent; I2, 33.67 percent; p = 0.181), and reported subjective satisfaction (27 studies, 622 patients) of the final reconstruction was accomplished at a rate of 84.3 percent (95 percent CI, 76.0 to 90.2 percent; I2, 0 percent; p < 0.001). In general, secondary outcomes were relatively similar between transmale and cismale groups. Primary urethroplasty had superior outcomes for ability to void while standing, sexual function, and patient satisfaction compared with staged urethroplasty. Subgroup analysis by radial forearm free flap procedure, all other procedures, transmale patients, cismale patients, primary urethroplasty, and staged urethroplasty are shown for the secondary outcomes. (See Table, Supplemental Digital Content 5, which shows secondary outcomes: ability to void while standing, http://links.lww.com/PRS/C559. See Table, Supplemental Digital Content 6, which shows secondary outcomes: sexual function, http://links.lww.com/PRS/C560. See Table, Supplemental Digital Content 7, which shows secondary outcomes: patient satisfaction, http://links.lww.com/PRS/C561.)
Despite well-defined functional and aesthetic goals of phalloplasty, surgical techniques used by reconstructive surgeons vary widely and are largely nonstandardized.8,12 This study sought to compare phalloplasty outcomes between transmale and cismale patients and between different urethroplasty techniques (primary versus staged). Secondarily, outcomes were assessed individually by reconstructive flap choice.
Urethral complications are a well-studied barrier in achieving functional phalloplasty and are a common cause of revision surgery.43,73,74 The overall urethral complication rate for patients undergoing phalloplasty from aggregate primary literature was 33.3 percent. Urethral complications were found to be higher in the transmale population compared with the cismale population (39.4 percent versus 24.8 percent). This may be attributable to the unique anatomical considerations in the transgender population. Dissection and preparation of the native female urethra is inherently more difficult than creating an anastomosis with a penile stump and a well-vascularized urethra in anatomical positional (e.g., following traumatic amputation of the penis).65,75 Transmale patients also had a higher flap complication rate compared with the cismale patients (10.8 percent versus 8.1 percent). Considered together, this suggests that transmale patients have a higher incidence of complications following phalloplasty than cismale patients.
Procedures using primary urethroplasty had a urethral complication rate of 31.3 percent compared with 34.8 percent for staged urethroplasty. Furthermore, a higher flap complication rate was observed for staged urethroplasty (16.7 percent) versus primary urethroplasty (8.6 percent) procedures. This may be explained by the necessity for multiple procedures in staged urethroplasty, which increases the overall surgical risks inherent in any flap, including hematoma, scar tissue formation, and necrosis. In many studies, a planned urethroplasty was used before the development of tube-in-tube design or in flaps that did not accommodate a single-stage urethroplasty.
Although the radial forearm free flap was the most commonly used flap for phalloplasty, a higher prevalence of staged urethroplasty procedures was found for other flaps. Perhaps inexperience with these less frequently used techniques was another contributor to the higher complication rates seen. It should also be noted that more data regarding the radial forearm free flap are available for scrutiny, which inherently leads to a more complete report of complications in the current literature, potentially biasing the results to some degree.
Overall, for all phalloplasty patients, the ability to void while standing and sexual function were achieved by 79.0 percent and 61.2 percent, respectively. Patients undergoing staged urethroplasty had lower rates of achieving standing micturition and worse sexual function compared with primary urethroplasty. Subjective satisfaction for all patients undergoing phalloplasty was high (84.3 percent) but sparsely reported. Satisfaction was nearly equivalent between transmale and cismale cohorts, but satisfaction rates were lower for staged urethroplasty (77.8 percent) versus primary urethroplasty (90.1 percent). It is important to note that the satisfaction metric is nonstandardized and heterogeneous because of the state of the primary literature. Satisfaction is also confounded by the fact that transmale patients acquire a new, functional phallus, whereas cismale patients receive a reconstruction from a previously functional and anatomical phallus. Nevertheless, postoperative satisfaction is a critical metric that must be included, particularly for the transgender population. Patient and provider goals do not always align, and quality-of-life outcomes are especially important for transmale patients seeking an improved sense of self and ability to live as their perceived gender.76–78 The shortcomings of satisfaction reporting in transgender surgery are well established. It is imperative that more standardized assessments are conducted for future studies, as it can be argued that patient-reported outcomes are the basis on which gender-confirming operations should be judged.
The limitations of this study are similar to those noted in most meta-analyses. The heterogeneity of the primary literature in terms of reconstructive procedures, patient indications, follow-up time, and timing and use of revision procedures is often difficult to account for in a considerable number of the included studies. Inconsistent data reporting in the primary literature limits more complex analysis of urethral complications. Indeed, variations in flap design and surgeon experience may importantly affect the functional outcomes of phalloplasty. This limitation is especially relevant for metrics such as satisfaction, for which definitive conclusions cannot explicitly be drawn. In addition, the heterogeneity of the primary literature made it difficult to determine the extent of reconstruction in cismale patients in some instances. Of the articles that discussed cismale penile reconstruction, 21 of the 31 articles presented total reconstruction of the phallus, whereas the remainder generally had a portion of patients that underwent full reconstruction in addition to other patients with partial reconstruction. However, the vast majority of the presented cismale penile reconstructions were total reconstructions. By making an effort to include all relevant studies and their respective surgical indications, it was hoped that the most comprehensive outcomes and complication data available to date in phalloplasty would be presented.
Although a heterogeneous population, patients undergoing phalloplasty have a variety of reconstructive options. Our results show that cismale patients undergoing phalloplasty have lower urethral and flap complications compared with transmale patients. In addition, phalloplasty with staged urethroplasty has higher urethral complication and flap complication rates with poorer overall outcomes. Although previous literature has examined individual procedures, aggregate data comparing outcomes currently do not exist. Despite the limitations in outcomes reporting in the primary literature, this analysis is valuable in understanding potential outcomes of phalloplasty. The results of this study ultimately centralize current phalloplasty data and serve as a resource for physicians studying and optimizing this procedure.
Phalloplasty consists of several procedural options for penile reconstruction in acquired or congenital absence of the penis, or transmale patients seeking gender-confirming surgery. Phalloplasty in transmale patients is associated with increased postoperative urethral and flap complications; nevertheless, overall satisfaction remains high. Phalloplasty with staged urethroplasty was associated with increased complications and worse patient-reported outcomes. Overall, phalloplasty is an effective and efficacious technique, which benefits patients. Thorough discussions regarding the complications of penile reconstruction are necessary before undertaking these procedures. Further analysis with prospective outcome studies and patient-reported outcomes will enhance our understanding of the best options available to different patient populations.76,79 It is imperative that we strive to develop standardized and reliable patient-reported outcomes for our transgender patients, as changes in postoperative quality-of-life and gender dysphoria are the metrics by which these operations should be judged.80,81
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