Results
Study selection and
Characteristics
A total of 3954 articles (Figure 1) were identified and 51 included
(Table i), of which 21 reported surgery duration (Figure S2), 29 vaginal
depth (Figure 2), 44 surgical complications (Figure S3), 20 complaints
(Figure S4), 33 satisfaction (Figure S5), 44 sexual function (Figure S6)
and 9 QoL (Table ii). A high intercontinental diversity of
patient-population and techniques was observed (Figure S7).
Risk of bias of included
studies
A NOS quality assessment judged on: study group selection; group
comparability; and ascertainment of exposure or outcome of interest
(Figure S8). Articles rated as 34 (66.7%) high risk, 15 (29.4%) very
high risk of bias and two (3.9%) high quality, based on bias likelihood
and completeness of reporting (Figure S9). Bias according to the NIH
tool (Figure S10) was rated as 1 (2.0%) bad, 9 (17.6%) poor, 21
(41.2%) fair and 20 (39.2%) good (Figure S11). MOOSE guidelines were
followed.39
Synthesis of results
Gender
Dysphoria
Vaginoplasty outcomes of 3,310 MtF GD-patients were reported in 35
articles (Figure S7C). The majority discussed Penoscrotal- or
Penile-inversion-vaginoplasty for reconstruction with local tissue,
where inversed penile skin forms the neovaginal cavity and
penile/scrotal skin the external genitalia. Other neovaginal lining
approaches are Intestinal-, Skin flap-, Combined- or
Peritoneal-intervention. Penoscrotal Gender Assignment Surgery (GAS) was
covered most often (19 articles), with continuous attention since 1995
(Figure S7D). GAS duration (Figure S2) increased with required tissue
quantity for reconstruction (from Penile-inversion-, to Penoscrotal- and
to Combined-intervention). GAS resulted in ‘successful’ lengths of ≥11
cm after Penoscrotal- and Intestinal-vaginoplasty and 11.57 cm (range
9.6-13.5 cm) total average length. Peritoneal-vaginoplasty for GAS is
the most recent development.
Mayer-Rokitansky-Küster-Hauser
Despite similar prevalence, surgical vaginoplasty of only 906
MRKH-patients was reported in 15 articles. These predominantly (43.93%)
involved Davydov-surgery, for simplicity and good
aesthetics.40 The oldest MRKH-publication dates from
2008 and Wharton-Sheares-George (2019) is the most recent technique.
Only Intestinal-vaginoplasty created ‘successful’ lengths and 9.45 cm
(range 8.1-10.8 cm) total average length was shorter than GAS-results.
Comparison
The oldest publication (1987) involved Penile-inversion-vaginoplasty and
remained unpublished next until 2009, when vaginoplasty techniques and
publications grew rapidly. GAS was significantly longer (274.75 min,
range 211-640 min) than MRKH-procedures (84.27 min, range 22-198 min),
where not only a partial neovagina but also the labia (minora and
majora) and clitoris are created. In both patient cohorts,
Intestinal-vaginoplasty was most time consuming (Figure S2) and reported
the longest neovaginas (Figure 2), because of abundantly available graft
tissue. Intestinal-vaginoplasty is performed significantly less often on
GD-patients (p<0.00001) based on one-tailed Z-score
Calculation (Figure S7C). Vaginoplasty is performed open or vaginally,
but Vecchietti-, Davydov- and Intestinal-vaginoplasty have laparoscopic
alternatives to decrease complication rates.41Complications were associated with length reduction and dilation
prevents up to 4 cm depth loss in the first 10 post-operative days.
Surgical
complications
Data on complications were retrieved from patient files.
Wharton-Sheares-George- and Skin Flap-interventions reported no
complications.
Gender
Dysphoria
Hemorrhage was only reported after GAS (Figure S3A/B), with
peri-operative estrogen continuation as associated risk factor.
Hemorrhage (Clavien-Dindo classification II) was often non-severe and
treated non-operatively by dressings, transfusion, cooling or adrenalin
injection. Causes included hematoma, necrosis, infection, dilation
injury, granulation or fistula and delayed wound healing.
Tissue necrosis was reported after Penile-inversion- and
Penoscrotal-GAS and decreased with graft quantity (Figure S3C).
Treatment (of Clavien-Dindo classification I – IIIb)
ranged from local wound care and surgical debridement to complete
reconstruction for major necrosis, but labia majora disunion or graft
loss was sporadically observed.
Vaginal prolapse was caused by inadequate vaginal canal
dissection or non-adherence of skin grafts. This is prevented by
sacropexy (fixation to sacrospinous ligament) or penoscrotal apex
fixation to Denonvillier’s fascia. Treatment (Clavien-Dindo
classification IIIa, b,) entailed neovaginal flap
reinsertion (using fibrin glue) or revisions for mucosal prolapse
(Figure S3E).
Stenosis 25,42 is the most common complication
reported after GAS, caused by contraction in the initial 3
post-operative months by dilation incompliance and inversely
proportional to graft quantity (Figure S3G). Treatment (Clavien-Dindo
classification IIIa, b) of introital/vaginal stenosis
consists of self-dilation, pelvic floor physiotherapy and occasional
revisions. Meatal stenosis can result from corpus spongiosum remains
that obstruct urine flow by thickening during excitement and is treated
by urethral dilation or meatotomy (with corpus spongiosum resection).
Gastrointestinal complications were caused by peri-operative
rectal injury or vascular lesion after perineal dissection or by
post-operative dilation injury, infection and retraction, abscess,
hematoma or (rare) neovaginal malignancy (Figure S3I). This is avoided
by meticulous dorsal preparation from perineal body to prostate along
Denon Villiers fascia to the tips of seminal vesicals. Treatment
(Clavien-Dindo classification IIIb) required temporary
colostomy or graft interposition between rectum and vagina.
Revisions (with Clavien-Dindo classification
IIIb) were required for introital/meatal stenosis,
necrosis, prolapse, fistula, hematoma, infection/wound dehiscence,
corpora tissue resection and mostly esthetical enhancement (of labia).
These GAS-reported revisions were inversely proportional to graft
quantity (Figure S3K). High revision rates were explained by full
health-insurance coverage and post-operative transparency of options and
were associated with decreased patient regret and dissatisfaction with
(aesthetic or functional) surgery outcome.
Mayer-Rokitansky-Küster-Hauser
Necrosis was reported often after McIndoe-surgery (Figure S3D)
with sporadic graft loss and was associated with points of maximum
tension (i.e., vaginal introitus) due to vascular spasm, restricted
blood flow or altered blood supply after transverse lesion of the spinal
cord.
Most prolapses were reported after Intestinal-vaginoplasty and
were related to inadequate vaginal canal dissection or non-adherence of
skin grafts (Figure S3F).
Stenosis after Peritoneal-vaginoplasty correlates to dilation
incompliance and is avoided by a pedicled flap from rectosigmoid colon
or four sutures at the introital, mucosa-peritoneum interface (Figure
S3H).
Gastrointestinal complications were reported after
Peritoneal-vaginoplasty (Figure S3J).
Complaints
Complaints were rarely reported. Only Bouman et al.17and Uncu et al.43 evaluated patient-reported outcomes
by a short questionnaire and satisfaction scores, respectively.
Excessive vaginal discharge (Clavien-Dindo classification I) was mostly
reported during follow up or by secretion scent assessment by physicians
(Figure S4A/B). Most studied grafts reported 0% vaginal
hair14,43,44 and are praised for their non-hair
bearing property like penile, scrotal and intestinal tissue. Complaint
treatments were not discussed.
Gender
Dysphoria
Excessive vaginal discharge was rarely reported, because mostly
penile and/or penoscrotal skin is applied without inherent mucous
producing tissue properties.
Vaginal hair growth was reported 5% by Gupta and
Gupta45 after Combined-GAS and 26.3% by Gentile et
al.46 through a patient satisfaction questionnaire.
Genital pain (Clavien-Dindo classification I) was reported after
Penile-inversion- and Penoscrotal-GAS (Figure S4E), no treatment was
mentioned. Buncamper et al.47 questioned patient
satisfaction and Rossi Neto et al.48 studied clitoral
and genital pain during follow up. Only Lawrence49 and
Sigurjonsson et al.50 applied extensive self-made
questionnaires to investigate satisfaction and pain, respectively.
Fecal issues (diarrhea, bowel complaints, incomplete emptying -
Clavien-Dindo classification I) were assessed after Intestinal-GAS by
Amsterdam Hyperactive Pelvic Floor Scale-Women
(AHPFS-W)51 by Bouman et al.17 and
after Penoscrotal-GAS by established
questionnaires52–54 by Kuhn et
al.55 and were left untreated (Figure S4F). These
questionnaires also assessed urinary issues.
Urinary issues (urgency, stress incontinence, stream misdirection
- Clavien-Dindo classification I-II) were reported during follow up
after Penile-inversion-, Penoscrotal- and Combined-GAS (Figure
S4E).25,48,56–60 Only Lawrence49and Kuhn et al.55 used self-made and established
questionnaires.52–54 Urinary issues were caused by
small prostates, perineal dissection and urethral sphincter injury and
often non-surgically resolved by medication or pelvic floor
physiotherapy.
Mayer-Rokitansky-Küster-Hauser
Excessive vaginal discharge was predominantly reported after
MRKH-vaginoplasty with mucus producing applied grafts. All
McIndoe-patients experienced vaginal discharge with scent and
Intestinal-vaginoplasty reported more discharge complaints amongst
MRKH-patients. Vaginal discharge was often gradually decreasing and
mainly present in the initial 3-6 post-operative months. Physicians
often consider self-lubrication an advantage of Intestinal-vaginoplasty,
but not all patients agree on this.
Vaginal hair growth was reported 42% during follow up by
Hayashida et al.61 after McIndoe-surgery.
Satisfaction
Body self-image was often assessed with the General Health Survey
(SF-36)62,63 and Female Genital Self-Image
Satisfaction (FGSIS) questionnaire.16,17,25,47,64Diverse evaluation tools assessed 2-point,14,43,65–673-point,68 5-point56,60 or 10-point
satisfaction scales42,69 or surgeons’ view on
aesthetics.70,71 Dissatisfaction was assessed with
2-point,58,65,72,73 3-point17,25,47or 5-point50,70,71 scales or by examiner’s rating of
the vulva59 and the Short Questionnaire for
Self-Evaluation of Vaginoplasty (SQSV) was applied most
often.17,25
Gender
Dysphoria
Aesthetic satisfaction (Figure S5A) was high after Penoscrotal-,
Intestinal- and Combined-GAS. Penile-inversion-, Penoscrotal- and
Intestinal-GAS reported dissatisfaction (Figure S5E) and highanatomical satisfaction (Figure S5C), based on patient-reported
outcome as yes/no14,50,58,60,65,66,74 or ‘deep enough
for vaginal intercourse with a man’.17,25,59Regret was solely investigated after GAS, absent in 2-point
evaluations,65,66,69,74 sporadic and present after
Penile-Inversion- and Penoscrotal-GAS (Figure S5G). Regret was
associated with pain, vaginal hair and lower satisfaction and caused
once by an unfulfilling new life. Another regretful patient (without
mentioned cause) would undertake surgery again.
Mayer-Rokitansky-Küster-Hauser
Aesthetic satisfaction (Figure S5B) was high after Intestinal-
and Peritoneal-vaginoplasty. Full anatomical satisfaction was
achieved for all MRKH-procedures (Figure S5D), based on assessment of
patient-satisfaction72,73,75 or anatomical
standard.41,64,76 Intestinal-vaginoplasty reporteddissatisfaction (Figure S5F) and Peritoneal-Vaginoplasty reported
full anatomical and overall satisfaction.
Sexual
functionality
Intercourse initiation was at 6-8 months, at 70% epithelialization or
when desired. Sexual activity varied gravely as 21-100% at 1-132
post-operative months during assessment (Figure S6A/B). The definitions
of sexual activity in the included articles varied as regular
activity,58,73,74,77any14,17,78–80,41,44,60,61,66,70,72,75 in the last
month,47,62 vaginal
intercourse43,45,81,82 with a man25or married with sexual activity.83
Sexual function was assessed most often with the Female Sexual
Function Index
(FSFI).16,17,76,78,80,81,84,25,47,62–64,70,72,73Dyspareunia was also reported by 5-point,604-point,59 3-point68 and
2-point17,25,70,72,73,76,79,83,43,44,48,55,58,61,64,66self-made questionnaires and present after all but the
Wharton-Sheares-George-technique (Figure S6C/D).
Satisfaction with sexual function (overall, orgasmic function or
vagina depth) amongst sexually active (or married76)
patients was also reported by diverse 10-point,695-point,46,60 3-point,68,71,852-point14,41,87,43,55,61,65,66,75,79,86 and self-made
questionnaires (Figures S6E/F). Sexual dysfunction associated with
inadequate depth,45 lubrication issues, sexual
discomfort, sporadic ejaculation and clitoral erection (after
Penile-inversion-surgery)25 and excessive secretion,
dyspareunia25,61,79 and vaginal
stenosis.43
Gender
Dysphoria
Dyspareunia was inversely proportional to graft quantity.
Intestinal-GAS reported full functional
satisfaction 16 and fullsensation 16,17 (Figure S6G). Despite high
sexual responsiveness, orgasmic capacity was post-surgically diminished
in some to most GAS-patients.
Mayer-Rokitansky-Küster-Hauser
Sexual activity was higher and initiated earlier after
(Intestinal) MRKH-procedures than after (Intestinal-)GAS. With
Wharton-Sheares-George-surgery, satisfaction increased over time
from 6-12 post-operative months.78 Orgasmic and
erotic sensation were seldom reported (Figure
S6H).64,75,76 Fertility was restored in three
patients.44
Quality of
life
QoL was assessed in 9 articles (Table i) with Self-designed, Beck
Depression Inventory (BDI),88 Short-Form-36
(SF-36),89 Fragen zur Lebenszufriedenheit
(FLZ),90–92 Patient Health Questionnaire 4
(PHQ-4),93 Rosenberg Self-esteem Scale
(RSES),94 Subjective Happiness Scale
(SHS),95 Satisfaction With Life Scale
(SWLS)96,97 and Cantril’s Ladder of Life Scale
(CLL)98 questionnaires.
Gender
Dysphoria
Intestinal-GAS reported 100% slight-to-extreme satisfaction with life,
that ranged from struggling to thriving life.17Penile-inversion-vaginoplasty reported normalQoL 99 and partnered patients scored higher on
vitality, social functioning and mental health.63 Skin
flap-GAS reported minimal depression by decreased sexual
satisfaction.62 Penoscrotal-vaginoplasty improved
personality, lifestyle and self-esteem,71,100 body and
femineity satisfaction100 and overall
QoL49,69,77 with low post-operative
depression71,100 and anxiety.100Anatomical satisfaction and sensation correlated to increased and
genital pain to decreased QoL-scores.49 Despite mostly
positive QoL-outcomes, one study reported low general life satisfaction
and unaltered aesthetic satisfaction compared to pre-operative
results.69
Mayer-Rokitansky-Küster-Hauser
One QoL -study reported on MRKH-patients and showed 22.2%
mild/moderate depression.70