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

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MATERIALS AND METHODS<br />

Between June 2001 <strong>and</strong> September 2009, 17 consecutive young women with<br />

MRKH syndrome were surgically treated with neovaginoplasty according to<br />

the Wharton-Sheares-George technique at the Department <strong>of</strong> Obstetrics <strong>and</strong><br />

Gynecology, Medical University <strong>of</strong> Vienna, Austria. All operations were<br />

performed by the same gynecologist (R.W.).<br />

All women underwent an extensive preoperative diagnostic workup, including<br />

an intravenous pyelography to detect anomalies <strong>of</strong> the urinary tract.<br />

The surgical procedure is described in detail by Sch€atz et al. (36). After local<br />

pretreatment with estriol cream for 3 weeks, a diagnostic laparoscopy was<br />

performed under general anesthesia for orientation <strong>and</strong> confirmation <strong>of</strong> the<br />

abdominal organs. Afterward, the rudimentary M€ullerian ducts (which could<br />

be identified in all patients, 2 cm dorsal to the external urethral ostium <strong>and</strong> 1<br />

cm paramedially) were dilated incrementally by gently pushing Hegar dilatators<br />

(2.5–14) in the direction <strong>of</strong> the pelvic axis (Fig. 1). The median raphe<br />

was intersected with diathermy, <strong>and</strong> subsequently, a vaginal mold, coated<br />

with estriol, was inserted into the newly created cavity. On the seventh<br />

day, the vaginal mold was exchanged for a larger one. Based on our experience<br />

as well as recommendations in the literature (16, 19, 30), patients were<br />

advised to continue using the plastic mold for the first 3 postoperative<br />

months, day <strong>and</strong> night, to prevent stenosis <strong>and</strong> shrinking <strong>of</strong> the <strong>neovagina</strong>.<br />

After this period, normal sexual intercourse was possible.<br />

All patients with MRKH syndrome who had been treated surgically according<br />

to the Wharton-Sheares-George technique at the Department <strong>of</strong> Obstetrics<br />

<strong>and</strong> Gynecology, Medical University <strong>of</strong> Vienna, Austria (n ¼ 17),<br />

were invited for a follow-up evaluation, conducted from September 2009<br />

to February 2010. Three women were excluded from the study because <strong>of</strong><br />

a follow-up time <strong>of</strong> less than 3 months. Three patients were lost to followup<br />

because <strong>of</strong> changes in their addresses <strong>and</strong> cell phone numbers, <strong>and</strong> 1<br />

woman refused to return because <strong>of</strong> a new job a greater distance away. Therefore,<br />

10 patients could be included in this open study evaluating the longterm<br />

functional <strong>and</strong> <strong>anatomic</strong> success <strong>of</strong> the operation.<br />

Institutional Review Board approval was obtained for the study, <strong>and</strong><br />

women gave their verbal <strong>and</strong> written informed consent before inclusion.<br />

All procedures were performed in accordance with the st<strong>and</strong>ards <strong>of</strong> the responsible<br />

ethics committee.<br />

At the follow-up visit, participants underwent a gynecologic examination,<br />

including palpation, pelvic ultrasound, vaginal swab, bacterial culture, Papanicolaou<br />

(PAP) smear, hybrid capture test for human papillomavirus (HPV)<br />

typing, <strong>and</strong> biopsy. Afterward, women were asked to grade the severity <strong>of</strong><br />

pain during the examination on a 100-mm visual analogue scale (VAS). Individual<br />

quality <strong>of</strong> psychosexual life <strong>and</strong> overall subjective degree <strong>of</strong> satisfaction<br />

with the operation were assessed by 2 specific questionnaires.<br />

The Rosen Female Sexual Function Index (FSFI) questionnaire, validated<br />

for the German-speaking population, contains 19 st<strong>and</strong>ardized questions for<br />

the evaluation <strong>of</strong> female sexual quality <strong>of</strong> function (i.e., desire, arousal, orgasmic<br />

<strong>and</strong> sexual pain disorder, quality <strong>of</strong> vaginal lubrication, <strong>and</strong> global<br />

sexual <strong>and</strong> relationship satisfaction) (37). Women were also asked to fill<br />

out a second questionnaire created by our group containing 23 specific questions<br />

to elucidate the individual medical history <strong>and</strong> current situation <strong>of</strong> the<br />

patients (e.g., influence <strong>of</strong> the diagnosis <strong>and</strong> surgical treatment on selfesteem,<br />

sexual life, <strong>and</strong> relationships). Well-being scores before surgery<br />

compared with the present time were recorded at the follow-up examination.<br />

The main outcome measure <strong>of</strong> the present study was the functional (satisfaction<br />

with sexual parameters <strong>and</strong> quality <strong>of</strong> life), long-term result <strong>of</strong> the<br />

surgical procedure. In addition, we evaluated the <strong>anatomic</strong> (length <strong>and</strong> width<br />

<strong>of</strong> the <strong>neovagina</strong>, structure <strong>of</strong> the vaginal epithelium, <strong>and</strong> type <strong>of</strong> bacterial<br />

colonization) outcome.<br />

RESULTS<br />

At the time <strong>of</strong> the neovaginoplasty according to Wharton-Sheares-<br />

George, the mean age <strong>of</strong> the patients was 20.0 5.8 years (range,<br />

15–34 years). Mean follow-up since the operation was 33.5<br />

22.4 months (range, 3–77 months).<br />

All operations had been performed without major complications.<br />

In 6 patients, minor old blood secretions were found during the<br />

Fertility <strong>and</strong> Sterility â<br />

FIGURE 1<br />

Vaginal dimple—rudimentary M€ullerian ducts. Hegar is pointing to<br />

the left M€ullerian duct.<br />

Walch. Long-term outcomes <strong>after</strong> Wharton-Sheares-George surgery. Fertil Steril 2011.<br />

exchange <strong>of</strong> the vaginal mold on the seventh postoperative day. In<br />

1 patient, elevated body temperature occurred postoperatively concomitant<br />

with fluid retention in the <strong>neovagina</strong>l region but was<br />

treated effectively with antibiotics; no surgical intervention was<br />

needed. Eight patients reported mild abdominal pain during the first<br />

postoperative days; analgesic medication was administered. Mean<br />

operation time, including diagnostic laparoscopy (additional adhesiolysis<br />

in 1 patient <strong>and</strong> tubectomy in another), was 46 9 minutes<br />

(range, 30–65 minutes). The mean time for Wharton-Sheares-<br />

George dilation was 21.5 2 minutes (range, 20–25 minutes).<br />

Four <strong>of</strong> the 10 patients (40%) presented with congenital inguinal<br />

hernia in their medical history. In all <strong>of</strong> these patients, surgical treatment<br />

had been performed successfully in the past. In one <strong>of</strong> the patients,<br />

multiple skeletal anomalies (Morbus Sprengel) <strong>and</strong> a throat<br />

fistula had also been found. Another patient demonstrated a pelvic<br />

kidney on the left side.<br />

At the follow-up investigation, the external genitals were regular<br />

in all patients, <strong>and</strong> no prolapse <strong>of</strong> the <strong>neovagina</strong> had occurred postoperatively<br />

in any <strong>of</strong> the patients. A gynecologic examination with 2<br />

st<strong>and</strong>ard specula (Breisky anterior speculum, 100 25; Matzenauer<br />

posterior speculum, 100 25 mm; KLS Martin Group) could be<br />

performed in every patient. The mean score for severity <strong>of</strong> pain during<br />

the examination was 12 11 (range, 0–30; no pain at all, 0 <strong>and</strong><br />

maximum, 100).<br />

In 9 <strong>of</strong> 10 patients, the <strong>neovagina</strong> appeared macroscopically<br />

regular; in 1 patient, the process <strong>of</strong> epithelialization was not yet<br />

complete because the time since the operation was relatively short<br />

(

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