Functional and anatomic results after creation of a neovagina ...

Functional and anatomic results after creation of
a neovagina according to Wharton-Sheares-George in
patients with Mayer-Rokitansky-K€uster-Hauser
syndrome—long-term follow-up
Katharina Walch, M.D., a Eleen Kowarik, M.D., a Katharina Leithner, M.D., b Theresa Sch€atz, M.D., c
Daniela D€orfler, M.D., a and Rene Wenzl, M.D. a
a Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, b Department of Psychiatry, Medical
University of Vienna, Vienna; and c University Clinic of Gynecology and Obstetrics with Perinatology, Salzburg, Austria
Objective: To evaluate the long-term outcomes and degree of satisfaction after neovaginoplasty according to
Wharton-Sheares-George in women with Mayer-Rokitansky-K€uster-Hauser syndrome.
Design: Open, monocentric follow-up study.
Setting: University hospital and referral center for pediatric and adolescent gynecology.
Patient(s): Ten patients with Mayer-Rokitansky-K€uster-Hauser syndrome with neovaginas created according to
Wharton-Sheares-George 3 to 77 months ago.
Intervention(s): Gynecologic follow-up examination, including vaginal swab, bacterial culture, Papanicolaou
smear, hybrid capture test for human papillomavirus typing, biopsy, pelvic ultrasound, and 2 questionnaires
concerning global quality of life and degree of sexual satisfaction.
Main Outcome Measure(s): Satisfaction with sexual function, quality of life, length and width of neovagina, structure
of vaginal epithelium, and type of bacterial colonization.
Result(s): Functional long-term follow-up results showed a high subjective degree of general well-being and
sexual satisfaction in affected women. A satisfactory neovaginal length (mean, 8.3 1.06 cm; range, 7–10 cm)
and width (mean, 3.3 0.5 cm; range, 2.5–4 cm) was obtained. As revealed by smears and biopsy, the
neovagina resembled a natural vagina with regard to type of bacterial colonization and structure of epithelium.
Conclusion(s): The goal of any method of creating a neovagina is to provide the patient the possibility to have satisfactory
sexual intercourse and to enhance well-being and quality of life. These aims can be achieved by creating
a neovagina according to Wharton-Sheares-George. (Fertil SterilÒ 2011;96:492–7. Ó2011 by American Society for
Reproductive Medicine.)
Key Words: Wharton-Sheares-George, Mayer-Rokitansky-K€uster-Hauser (MRKH) syndrome, neovagina, sexual
function, quality of life
Mayer-Rokitansky-K€uster-Hauser (MRKH) syndrome is characterized
by a rare congenital malformation of the female genital tract,
with an incidence of 1 in 4,000 newborn girls (1, 2). The
syndrome, caused by an embryologic growth failure of the
M€ullerian ducts, is characterized by complete or partial agenesis
of the vagina and uterus and can be associated with urinary tract,
skeletal, and other congenital abnormalities (3–5).
Individuals with MRKH syndrome commonly present with a normal
female 46,XX karyotype and regular ovarian endocrine function,
leading to the development of secondary sexual characteristics and
normal adolescent progress. The etiology of the syndrome, which is
the second most common cause of primary amenorrhea, is unknown
(2, 3). A multifactorial mode of inheritance, including genetic and
environmental factors, seems to be the most likely explanation (6).
Received March 7, 2011; revised May 26, 2011; accepted June 1, 2011;
published online June 30, 2011.
K.W. has nothing to disclose. E.K. has nothing to disclose. K.L. has nothing
to disclose. T.S. has nothing to disclose. D.D. has nothing to
disclose. R.W. has nothing to disclose.
Reprint requests: Rene Wenzl, M.D., Department of Obstetrics and
Gynecology, Medical University of Vienna, Waehringer Guertel 18-20,
A-1090 Vienna, Austria (E-mail: rene.wenzl@meduniwien.ac.at).
492
The absence of a vagina has a profound psychologic impact on
a young woman’s sense of femininity, emotional stability, and
self-confidence, and the demand for a normal sexual life requires
the creation of an adequate neovagina (7–10). Numerous
procedures and techniques of vaginal reconstruction, both surgical
and nonsurgical, have been proposed (11–33). The goal of any
method is to create a neovaginal canal of adequate diameter and
length to allow for sexual intercourse.
The major differences among the various methods for creating
a neovagina are access, mode of dilatation, and type of tissue used
to cover the neovaginal cavity. The Frank technique and its modification
by Ingram, the McIndoe operation, the Vecchietti approach,
the Davydov procedure, and the Williams vaginoplasty are currently
the most popular methods (11–15, 17, 18, 22, 23).
In 2005, our group (34–36) published the George modification
of the Wharton-Sheares technique as a simple, safe, and effective
surgical option for creating a neovagina, leading to satisfying anatomic
and functional results. The aim of this study was to present
for the first time the long-term follow-up and to evaluate the subjective
degree of satisfaction in our series of patients with MRKH
syndrome after creation of a neovagina according to Wharton-
Sheares-George.
Fertility and Sterility â Vol. 96, No. 2, August 2011 0015-0282/$36.00
Copyright ª2011 American Society for Reproductive Medicine, Published by Elsevier Inc. doi:10.1016/j.fertnstert.2011.06.004

MATERIALS AND METHODS
Between June 2001 and September 2009, 17 consecutive young women with
MRKH syndrome were surgically treated with neovaginoplasty according to
the Wharton-Sheares-George technique at the Department of Obstetrics and
Gynecology, Medical University of Vienna, Austria. All operations were
performed by the same gynecologist (R.W.).
All women underwent an extensive preoperative diagnostic workup, including
an intravenous pyelography to detect anomalies of the urinary tract.
The surgical procedure is described in detail by Sch€atz et al. (36). After local
pretreatment with estriol cream for 3 weeks, a diagnostic laparoscopy was
performed under general anesthesia for orientation and confirmation of the
abdominal organs. Afterward, the rudimentary M€ullerian ducts (which could
be identified in all patients, 2 cm dorsal to the external urethral ostium and 1
cm paramedially) were dilated incrementally by gently pushing Hegar dilatators
(2.5–14) in the direction of the pelvic axis (Fig. 1). The median raphe
was intersected with diathermy, and subsequently, a vaginal mold, coated
with estriol, was inserted into the newly created cavity. On the seventh
day, the vaginal mold was exchanged for a larger one. Based on our experience
as well as recommendations in the literature (16, 19, 30), patients were
advised to continue using the plastic mold for the first 3 postoperative
months, day and night, to prevent stenosis and shrinking of the neovagina.
After this period, normal sexual intercourse was possible.
All patients with MRKH syndrome who had been treated surgically according
to the Wharton-Sheares-George technique at the Department of Obstetrics
and Gynecology, Medical University of Vienna, Austria (n ¼ 17),
were invited for a follow-up evaluation, conducted from September 2009
to February 2010. Three women were excluded from the study because of
a follow-up time of less than 3 months. Three patients were lost to followup
because of changes in their addresses and cell phone numbers, and 1
woman refused to return because of a new job a greater distance away. Therefore,
10 patients could be included in this open study evaluating the longterm
functional and anatomic success of the operation.
Institutional Review Board approval was obtained for the study, and
women gave their verbal and written informed consent before inclusion.
All procedures were performed in accordance with the standards of the responsible
ethics committee.
At the follow-up visit, participants underwent a gynecologic examination,
including palpation, pelvic ultrasound, vaginal swab, bacterial culture, Papanicolaou
(PAP) smear, hybrid capture test for human papillomavirus (HPV)
typing, and biopsy. Afterward, women were asked to grade the severity of
pain during the examination on a 100-mm visual analogue scale (VAS). Individual
quality of psychosexual life and overall subjective degree of satisfaction
with the operation were assessed by 2 specific questionnaires.
The Rosen Female Sexual Function Index (FSFI) questionnaire, validated
for the German-speaking population, contains 19 standardized questions for
the evaluation of female sexual quality of function (i.e., desire, arousal, orgasmic
and sexual pain disorder, quality of vaginal lubrication, and global
sexual and relationship satisfaction) (37). Women were also asked to fill
out a second questionnaire created by our group containing 23 specific questions
to elucidate the individual medical history and current situation of the
patients (e.g., influence of the diagnosis and surgical treatment on selfesteem,
sexual life, and relationships). Well-being scores before surgery
compared with the present time were recorded at the follow-up examination.
The main outcome measure of the present study was the functional (satisfaction
with sexual parameters and quality of life), long-term result of the
surgical procedure. In addition, we evaluated the anatomic (length and width
of the neovagina, structure of the vaginal epithelium, and type of bacterial
colonization) outcome.
RESULTS
At the time of the neovaginoplasty according to Wharton-Sheares-
George, the mean age of the patients was 20.0 5.8 years (range,
15–34 years). Mean follow-up since the operation was 33.5
22.4 months (range, 3–77 months).
All operations had been performed without major complications.
In 6 patients, minor old blood secretions were found during the
Fertility and Sterility â
FIGURE 1
Vaginal dimple—rudimentary M€ullerian ducts. Hegar is pointing to
the left M€ullerian duct.
Walch. Long-term outcomes after Wharton-Sheares-George surgery. Fertil Steril 2011.
exchange of the vaginal mold on the seventh postoperative day. In
1 patient, elevated body temperature occurred postoperatively concomitant
with fluid retention in the neovaginal region but was
treated effectively with antibiotics; no surgical intervention was
needed. Eight patients reported mild abdominal pain during the first
postoperative days; analgesic medication was administered. Mean
operation time, including diagnostic laparoscopy (additional adhesiolysis
in 1 patient and tubectomy in another), was 46 9 minutes
(range, 30–65 minutes). The mean time for Wharton-Sheares-
George dilation was 21.5 2 minutes (range, 20–25 minutes).
Four of the 10 patients (40%) presented with congenital inguinal
hernia in their medical history. In all of these patients, surgical treatment
had been performed successfully in the past. In one of the patients,
multiple skeletal anomalies (Morbus Sprengel) and a throat
fistula had also been found. Another patient demonstrated a pelvic
kidney on the left side.
At the follow-up investigation, the external genitals were regular
in all patients, and no prolapse of the neovagina had occurred postoperatively
in any of the patients. A gynecologic examination with 2
standard specula (Breisky anterior speculum, 100 25; Matzenauer
posterior speculum, 100 25 mm; KLS Martin Group) could be
performed in every patient. The mean score for severity of pain during
the examination was 12 11 (range, 0–30; no pain at all, 0 and
maximum, 100).
In 9 of 10 patients, the neovagina appeared macroscopically
regular; in 1 patient, the process of epithelialization was not yet
complete because the time since the operation was relatively short
(

TABLE 1
Gynecologic examination and questionnaire findings for the overall degree of satisfaction with the result of the operation, sex life,
and diameter of the neovagina.
Patient 1 2 3 4 5 6 7 8 9 10 Mean ± SD
Length of neovagina (cm) 8 10 8 7 7 10 8 8 8 9 8.3 ( 1,06)
Width of neovagina (cm) 3 4 3 3 2.5 4 3.5 3.5 3 3 3.3 ( 0,5)
Satisfaction with sex life (VAS
100–0; 100, very satisfied; 0,
not satisfied)
82 100 27 86 53 50 100 100 100 99 79.7 ( 26.7)
Pain during sexual intercourse
(VAS 0-100; 0, no pain at all;
100, maximum pain)
31 0 N/A a
33 N/A a
N/A a
0 0 65 0
Satisfaction with results of the
operation (VAS,
100-0, 100: very satisfied 0:
not satisfied)
100 99 98 99 97 92 100 100 93 98 97.6 ( 2.9)
Would you choose this
surgical technique again?
yes yes yes yes yes yes yes yes probably not yes
a Not applicable because patients 3, 5, and 6 did not have sexual intercourse at the time of follow-up.
Walch. Long-term outcomes after Wharton-Sheares-George surgery. Fertil Steril 2011.
Nine of 10 patients would definitively choose this surgical technique
again; 1 woman was undecided. The mean well-being scores
before and after the operation, using a 100-point VAS (perfect wellbeing,
100), were 52.7 20.5 and 87.8 15.2, respectively (Fig. 2).
FIGURE 2
The average increase in mean well-being was 35.1 27.4 and was
statistically significant (P¼.003). Nine of the 10 patients mentioned
that their self-esteem had improved markedly as a consequence of
the operation.
Comparison between well-being scores before the creation of a neovagina according to Wharton-Sheares-George and at the time of the
follow-up investigation.
Walch. Long-term outcomes after Wharton-Sheares-George surgery. Fertil Steril 2011.
494 Walch et al. Long-term outcomes after Wharton-Sheares-George surgery Vol. 96, No. 2, August 2011

TABLE 2
Female Sexual Function Index values for the 7 sexually active patients with MRKH after Wharton-Sheares-George surgery, compared with equivalent mean FSFI values for
patients with MRKH syndrome after alternative surgical techniques and for healthy individuals.
Laparoscopic
modified
Vecchietti
technique
(n [ 27)
Fertility and Sterility â
Healthy
women
(n [ 131)
Laparoscopic
Vecchietti
technique
(n [ 40)
Laparoscopic
Davydov
technique
(n [ 6)
Laparoscopic
Davydov
technique
(n [ 40)
Davydov
laparoscopic
vaginoplasty
(n [ 25)
Sigmoid
vaginoplasty
(n [ 11)
Amnion
vaginoplasty
(n [ 5)
Wharton-
Sheares-George
surgery (n [ 7)
Desire 4.3 1.3 4.9 1.2 4.7 0.9 4.4 0.9 4.3 0.7 3.9 1.2 4.4 0.8 4.2 0.9 4.1 1.1
Arousability 5.4 0.5 5.0 0.8 4.9 0.6 4.4 1.1 4.7 0.8 4.0 1.1 4.8 0.8 4.6 1.0 5.0 1.0
Lubrication 5.1 1.5 4.0 0.7 5.0 0.9 4.5 1.4 5.1 0.6 4.4 1.0 5.0 0.8 4.5 1.0 5.5 0.9
Orgasm 4.9 1.0 5.5 1.0 5.3 0.8 4.1 1.3 5.0 0.6 3.3 1.6 4.6 1.0 4.4 0.9 5.0 1.2
Satisfaction 5.1 1.5 5.3 1.4 4.7 1.6 4.6 1.1 4.8 1.5 4.0 1.8 5.4 0.6 5.2 1.2 5.1 1.2
Pain 5.1 1.1 5.3 1.8 3.5 2.4 4.4 1.4 4.7 1.0 1.9 1.9 5.0 0.9 5.2 1.0 5.5 1.0
Total score 29.9 4.3 30.0 6.9 28.0 5.0 26.5 5.6 31.8 0.8 21.4 5.3 29.0 3.2 30.2 1.0 30.2 6.1
Reference 16 20 38 17 27 18 17 37
Note: Values are given as means SD. Patients without sexual activity within the past month were not included in this FSFI evaluation. Total FSFI score ranges from 0 to 36.
Walch. Long-term outcomes after Wharton-Sheares-George surgery. Fertil Steril 2011.
Seven of the 10 examined patients had had repeated sexual intercourse
(defined as intercourse at least 2 times per month) since the
operation, and 5 of these 7 women were able to experience orgasm.
The mean average frequency of intercourse in the 7 sexually active
women was 10.14 9 times per month. At the time of follow-up, 5
of 10 patients had a partner and 1 of them was married. Three
women had no regular sexual intercourse because they had no
partner.
A detailed analysis of the FSFI scores in our group, compared
with those of other common surgical techniques for creating a neovagina,
and in relation to healthy women with a natural vagina
(control female population), is presented in Table 2 (16–18, 20,
27, 37, 38).
Neovaginal smears showed a remarkable resemblance to those
from normal vaginal epithelium: the presence of D€oderlein bacilli
could be detected in 80%. None of the women had used D€oderlein
vaginal tablets within 3 months before the follow-up investigation.
Gardnerella vaginalis (4 of 10) and HPV infection (low-grade squamous
intraepithelial lesions) (1 patient) were also observed.
In 8 women, we successfully obtained a biopsy of the epithelialized
neovagina; in all patients, the biopsy showed nonkeratinizing
stratified squamous epithelium (Supplemental Fig. 1, available online).
One women refused the biopsy because she worried about
the pain. In another case, the biopsy did not contain enough tissue
material to allow for histologic diagnosis. In both of these patients,
the neovagina appeared macroscopically regular.
DISCUSSION
Management of patients with MRKH syndrome includes, along with
proper psychologic support, the creation of a neovagina to give affected
women the opportunity to have a normal sexual life. Various
treatment options are available (11–36), including nonoperative
methods such as progressive dilatation (11, 12); numerous surgical
techniques such as skin grafts (13, 28, 35), fasciocutaneous flaps
(26), buccal mucosa (30), amnion (16), peritoneal (19, 23),
intestinal (20, 21, 24), and vesical transplants (31); and epithelialization
from the outer skin layer (22, 25, 36). There is, however, no
consensus about which procedure should be considered the ideal
strategy.
Surgical treatment options must be functional, minimally invasive,
quick, simple, reliable, safe, and cost effective (39–41).
The neovaginoplasty according to Wharton-Sheares-George seems
to meet these criteria and represents an operative method of creating
a functional vagina with high success rates, without most of the
attendant disadvantages and complications of traditional procedures
(36).
For the creation of a neovagina according to Wharton-Sheares-
George, laparotomy, application of a traction device (as in the
Vecchietti approach, still the most commonly used procedure in European
countries, which can be associated with remarkable discomfort
and potential serious complications such as urinary stress
incontinence and injuries to neighboring organs), or pressure to
the peritoneum is not needed; the trauma is limited to the area of
the neovagina (in contrast to intestinal vaginoplasty and the Davydov
procedure), and the anatomy of the intrapelvic structures are unaltered
(17, 18, 36). Therefore, postoperative pain and discomfort
can be kept to a minimum. Another advantage of this surgical
technique is the fact that the functional axis of the neovagina is
identical to the anatomic axis of the ‘‘natural’’ vagina, allowing
for satisfactory sexual intercourse.
495

According to our data, the Wharton-Sheares-George technique
provides functionally and anatomically very satisfactory results. In
all 10 patients with follow-up, neovaginas were at least 2 fingers
in width and 7 to 10 cm in length; were pink, clean, moist, and expandable;
and provided satisfactory sexual function, as assessed by
high scores on the FSFI questionnaire, comparable with those of
controls. We compared recently published FSFI scores for the
most popular surgical techniques (Table 2), which revealed that similarly
good results could be achieved regardless of the method used,
indicating that the simplest procedure associated with minimal
complications should be favored.
The neovagina, created by the Wharton-Sheares-George technique,
is very similar in its macroscopic appearance and its microscopic
structure to the normal vagina. The observation that in the
woman with a relatively short follow-up time of less than 4 months,
the process of epithelialization was not entirely complete at the cranial
end of the neovaginal vault leads to the assumption that the ingrowth
of epithelial cells starts from the vulvar region and proceeds
in the cranial direction. The nonkeratinizing, stratified squamous epithelium
seems to migrate from the edges of the neovagina inward or
—alternatively—might arise from pluripotent stem cells located in
the obliterated M€ullerian ducts.
In this method, we do not require allogenic transplants, autologous
transplants, or pluripotent stem cells, all recently reported as
new and promising tissue engineering techniques in the animal
model (42, 43). One should be aware that all of these procedures
carry characteristic complications and potential risks (e.g., failure
to grow; bleeding; infection; necrosis; rejection; shrinking of the
graft, possibly associated with neovaginal stenosis and
dyspareunia; and a broad visible scar at the graft donor site).
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According to the results of our long-term follow-up study, there is
evidence that these aims can be achieved by creating a neovagina
according to Wharton-Sheares-George.
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SUPPLEMENTAL FIGURE 1
Biopsy of the neovagina with nonkeratinizing stratified squamous
epithelium. Hematoxylin and eosin stain, 100 magnification.
Walch. Long-term outcomes after Wharton-Sheares-George surgery. Fertil Steril 2011.
497.e1 Walch et al. Long-term outcomes after Wharton-Sheares-George surgery Vol. 96, No. 2, August 2011