Results
Study selection and
Characteristics
The PRISMA flow diagram of the meta-analysis is shown in (Figure 1). A
total of 3954 articles were identified. Of 47 included articles
(overview in table i), 19 reported on operation times (Figure S1), 26 on
vaginal length (Figure 2), 40 on surgical complications (Figure S2), 20
on complaints (Figure S3), 30 on satisfaction (Figure S4), 40 on sexual
function (Figure S5) and 9 on QoL (table ii). A high intercontinental
diversity of patient-population and techniques was observed (Figure
S6a/S6b).
Risk of bias of included
studies
Quality of nonrandomised studies was assessment by NOS and judgment of:
study group selection; group comparability; and ascertainment of
exposure or outcome of interest (Figure S8). Manuscripts were judged as
31 (66.0%) (B) high risk of bias, 15 (31.9%) (C) very high risk of
bias and one (2.1%) (A) high quality, based on likelihood of bias and
completeness of reporting (Figure S9). Bias was assessed with the NIH
tool (Figure S10). Studies were judged as 1 (2.1%) (A) bad, 9 (19.1%)
(B) poor, 19 (40.4%) (C) fair, 18 (38.3%) (D) good and 0 (E) excellent
(Figure S11). In both assessments no weighting was used. MOOSE
guidelines were followed.53
Synthesis of
results
Surgical outcomes of 2927 MtF Gender Dysphoria-patients were reported in
32 articles (Figure S7a). The majority is treated by penoscrotal- or
penile-inversion vaginoplasty, to allow reconstruction from local tissue
as the inversed penile skin forms the neovaginal cavity and
penile/scrotal skin the external genitalia with alternative neovaginal
lining by an intestinal- graft-, Skin flap- or Combined interventions.
Treatment of 853 MRKHS-patients was reported in 15 articles and
predominantly (44,20%) involved Davydov surgery. Even though
non-surgical MRKH-treatment options are associated with low
satisfaction, vaginal prolapse, fatigue, long-term agony and mental as
well as emotional stress,4,5 this is still favoured by
many patients and physicians. The intestinal surgery proportion of
MRKH-patients, differs significantly from GD-patients
(p<0.00001) based on one-tailed Z-score Calculation (Figure
S7a). The Skin flap vaginoplasty proportion of MRKH- and GD-patients,
are not significantly different. Vecchietti-, Davydov- and Intestinal
vaginoplasty can alternatively be performed laparoscopically to decrease
complication rates,54 all other techniques are
performed by open or vaginal approaches.
Highest publication quantity involved penoscrotal SRS, that was reported
in 18 out of 32 GD-related articles, with continuous attention since
1995 (Figure S7b). Davydov was reported in the majority of
MRKHS-surgeries, due to simplicity and good
aesthetics.55 The oldest publication (1987) involved
penile-inversion vaginoplasty and stayed unpublished next until 2009,
when vaginoplasty publications and performed techniques grew rapidly.
The oldest included MRKHS publication dates from 2008 and
Wharton-Sheares-George (2019) is the latest surgical technique.
Surgical outcomes -
complications
The average vaginoplasty duration is 198.0 min (152-244 min) (Figure
S1). Combined vaginoplasty (312 min) is the longest procedure, where
penile-inversion- (216 min) or penoscrotal (286 min) surgery is combined
with a secondary approach. SRS duration increased with required tissue
quantity for reconstruction and were slightly longer (216-378 min) than
MRKH-procedures (26-300 min).
Pooled complications showed 5% hemorrhage and 1% gastrointestinal
complications (peri-operative), and 1% prolapse, 3% tissue necrosis,
6% stenosis and 31% revisions (long-term post-operative) after
complications or patient-reported aesthetic complaints (Figure S2).
Combined vaginoplasty reported most hemorrhagic complications (29%)
(Figure S2a). Hemorrhage only resulted from SRS, was often non-severe
and treated non-operatively by dressings, transfusion, cooling or
adrenalin injection. Bleedings resulted from hematoma, necrosis,
infection, dilation injury, granulation or fistula and delayed wound
healing. Associated risk factors are clotting disorders and smoking,
peri-operative estrogen continuation (depending on administration route
and also decreases bleeding during sponge body dissection by erectile
reflex elimination) and NSAIDs are sometimes avoided (Hontscharuk et al.
2021).
Gastrointestinal complications were predominantly reported after SRS,
with 2% after penile-inversion- and penoscrotal surgery and 3% after
intestinal vaginoplasty (Figure S2b) and were associated with dilation
injury, infection and retraction, abscess, hematoma or (rare) neovaginal
malignancy. Recto-neovaginal fistula presented after peri-operative
rectal injury or vascular lesion by perineal dissection and may require
temporary colostomy or graft interposition between rectum and vagina.
Rectal injury may be avoided by meticulous dorsal preparation from
perineal body to prostate along Denonvilliers fascia to the tips of
seminal vesicals.
Intestinal vaginoplasty reported most prolapses (4%) (Figure S2c),
after inadequate vaginal canal dissection or non-adherence of skin
grafts, with BMI as only known predictor. Treatment entailed neovaginal
flap repositioning/reinsertion (using fibrin glue) and revisions for
mucosal prolapse, whereas sacropexy (graft fixation to the sacrospinous
ligament) or penoscrotal apex fixation to Denonvillier’s fascia help
avoid prolapse.
McIndoe surgery reported most tissue necrosis (17%) (Figure S2d), often
at points of maximum tension (i.e., the vaginal introitus) due to
vascular spasm, restricted blood flow or altered blood supply after
transverse lesion of the spinal cord. Smoking, diabetes and
cardiopulmonary conditions are predictors and may be reduced by
patient-behaviour. Treatment involved local wound care and surgical
debridement or reconstruction for major necrosis, but labia majora
disunion or graft loss was sporadically observed.
Most reported complication is introital-, meatal- or vaginal
stenosis14,58 and is mainly seen after
penile-inversion vaginoplasty (19%) (Figure S2e), due to lack of
compliance with dilation (or regular intercourse) to prevent contraction
in the initial 3 post-operative months. Treatment entailed daily
self-dilation, pelvic floor physiotherapy and occasional revisions after
suture line rupture by forceful dilation. Meatal stenosis is treated by
urethral dilation or meatotomy with optional resection of corpus
spongiosum remains that obstruct urine flow by thickening during
excitement. Predictor for meatal stenosis is early transurethral
catheter removal, whereas prolonged catheterization increases risk of
urinary tract infections. A pedicled flap from rectosigmoid colon or
four sutures at the introital, mucosa-peritoneum interface during
Davydov surgery help avoid stenosis.
Revisions were reported after penile-inversion- (37%), penoscrotal-
(29%), intestinal- (42%) and combined (12%) SRS (Figure S2f), for
introital/meatal stenosis, necrosis, prolapse, fistula, hematoma,
infection/wound dehiscence, corpora tissue resection and mostly
esthetical enhancement (of labia). High revision rates were associated
with full health-insurance coverage and post-operative transparency of
options and rarely led to patient regret or dissatisfaction with
(aesthetic or functional) surgery outcome.
Wharton-Sheares-George interventions reported no complications.
Anatomy
The average neovagina length was 10.18 cm (9.05-11.31 cm) (Figure 2).
Intestinal vaginoplasty reported the longest (13.08 cm) and
Wharton-Sheares-George the shortest neovagina (7.60 cm). Only
Intestinal- and Penoscrotal vaginoplasty resulted in ‘successful’
lengths of ≥11 cm. Complications were associated with length reduction
and dilation prevents up to 4 cm depth loss in the first 10
post-operative days.
Complaints
Complaint-reports were rare and included 25% excessive secretion, 6%
genital pain, 42% hair growth, 11% fecal- and 17% urinary issues
(Figure S3). Surgeons consider self-lubrication an advantage of
Intestinal vaginoplasty and 28% of the patients consider it a gradually
decreasing, non-excessive or non-irritating problem. All McIndoe
patients complained about excessive secretion with scant as major issue
and only this group reported hair growth. Davydov patients reported 8%
excessive secretion during the initial 3 months. Pain (clitoral or pain
during sexual arousal or intercourse) was reported after
Penile-inversion- (4%) and Penoscrotal (8%) interventions. Fecal
issues involved bowel complaints after intestinal SRS (3%) and fecal
urgency or incomplete bowel emptying after penoscrotal (17%)
interventions. Urinary issues (urgency, stress incontinence or
misdirection of the stream) were solely reported with SRS after
penile-inversion- (21%), penoscrotal- (21%) and combined (1%)
surgery. Small prostates, pelvic floor dysfunction (by perineal
dissection) and urethral sphincter injury are known predictors for
urinary incontinence and is often non-surgically resolved by medication
or pelvic floor physiotherapy.
Satisfaction
Patient-reported outcomes (Figure S4) included 10% overall
dissatisfaction, 1% regret, 95% aesthetics- and 93% anatomical
satisfaction. Highest reports were seen for dissatisfaction after
Intestinal vaginoplasty (23%), overall satisfaction after Combined
interventions (98%) and anatomical satisfaction after McIndoe-,
Peritoneal- and Vecchietti surgery (100%). Sporadic regret was reported
after Penile-inversion- (4%) and Penoscrotal interventions (1%), and
was associated with hair, clitoral pain and lower satisfaction. One
patient regretted an unfulfilling new life and another (without
mentioned cause) would undertake surgery again.
Sexual
functionality
Pooled outcomes (Figure S5) showed 75% sexual activity, 13%
dyspareunia, 87% sensation and 84% function satisfaction. Penoscrotal
surgery (61%) reported lowest and Skin flap surgery (100%) the highest
sexual activity. Dyspareunia was reported for all except
Wharton-Sheares-George technique. McIndoe-surgery (69%) reported lowest
and Intestinal vaginoplasty (98%) reported highest dyspareunia.
Functionality was reported good/excellent for Combined-, Intestinal-,
Penoscrotal- and Peritoneal surgery, acceptable for McIndoe- and poor
for Penile-inversion surgery. Intercourse initiation variated with 6-8
months, if desired, or at 70% epithelialization.
Most MRKH-patients initiated intercourse 1-4.5 months after
intestinal-surgery and after Skin flap-surgery with 110.3% improvement
despite dyspareunia. All sexually active patients from a mixed cohort
declared full functional- and aesthetic satisfaction. All MRKH-patients
were highly to fully satisfied. After McIndoe- and
intestinal-vaginoplasty there was respectively one complaint on
excessive secretion and sexual arousal. Fertility was restored in 3
MRKH-cases. Wharton-Sheares-George surgery required molds for 6 months,
with increased FSFI-scores from 6 to 12 post-operative months. Most
peritoneal-vaginoplasty patients had full functional- and anatomical
satisfaction within 12 months, except for one mild dyspareunia complaint
(resolved by lubrication) and one case of sexual dysfunction due to
vaginal stenosis. GD-patients were less sexually active, but FSFI-scores
were similar for transwomen after intestinal- and penile-inversion
vaginoplasty and for MRKHS-patients after sigmoid vaginoplasty.
SRS-subjects mostly confirmed sexual responsiveness, although orgasmic
capacity was post-surgically diminished in some to most patients.
Penile-inversion-surgery reported ≥50% sexual dysfunction with good
overall and aesthetic satisfaction, but low functionality satisfaction
(caused by inadequate depth, lubrication issues, sexual discomfort and
sporadic ejaculation, clitoral erection and pain during initial
penetration or after sex). Most penoscrotal-patients had regular
intercourse, adequate or satisfactory depth and achieved
neoclitorus-stimulated orgasms. Excessive erectile tissue, recurrent
bleeding after or suture line rupture during intercourse, pain,
cosmetical dissatisfaction, orgasm difficulties, inadequate depth,
stenosis or insensate clitoris (corresponding with
penile-inversion-patients) caused sexual dysfunction. Some
SRS-complaints about sexual function, are correlated to gender dysphoria
and the old male body physique. Penoscrotal-surgery significantly
increased femininity and sexual activity.
Quality of
Life
Patient-reported QoL was studied in 9 articles (table ii), with one
MRKHS-patient assessment mixed with intestinal-patients, showing 22.2%
mild/moderate post-operative depression. Happiness after
Intestinal-vaginoplasty was normal, with 100% slight-to-extreme
satisfaction with life.59–61 QoL after
Penile-inversion-vaginoplasty was normal62 and
partnered patients scored higher on vitality, social functioning and
mental health. Penoscrotal-surgery improved personality, lifestyle,
self-esteem and overall QoL63,64 with low
depression-scores and normative anxiety.64,65 It also
increased body and femineity satisfaction.66–69Skin-flap GD-patients reported minimal depression, due to decreased
sexual satisfaction.70 More in general, anatomical
satisfaction and sensation increased, whereas genital pain correlated to
decreased QoL-scores.