Psychosexual and functional outcomes after creation of a neovagina with laparoscopic Davydov in patients with vaginal agenesis

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1 Psychosexual and functional outcomes after creation of a neovagina with laparoscopic Davydov in patients with vaginal agenesis Lisa M. Allen, M.D., a,c Kerith L. Lucco, M.D., a,e Cortney M. Brown, M.D., b Rachel F. Spitzer, M.D., a,c and Sari Kives, M.D. a,d a Department of Obstetrics and Gynecology, University of Toronto, The Hospital for Sick Children, Toronto, Ontario, Canada; b Department on Obstetritics/Gynecology, Maryland General Hospital, Baltimore, Maryland; c Mount Sinai Hospital and d St. Michael s Hospital, Toronto, Ontario, Canada; and e Department of Obstetrics and Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco General Hospital, San Francisco, California Objective: To describe sexual function and satisfaction after laparoscopic Davydov vaginoplasty in patients with an absent vagina due to Mayer-Rokitansky-Kuster-Hauser syndrome or androgen insensitivity syndrome compared with a control female population. Design: A descriptive study of standardized, validated psychosexual and functional outcomes using a self-report questionnaire. Setting: Two tertiary care hospitals at an academic medical center. Patient(s): Six women with Mayer-Rokitansky-Kuster-Hauser syndrome or androgen insensitivity syndrome who underwent laparoscopic Davydov. Intervention(s): Patients postoperatively completed a self-report survey of their medical, surgical, and sexual history and the standardized, validated Female Sexual Function Index (FSFI) and select questions from the Golombok Rust Inventory of Sexual Satisfaction (GRISS). Main Outcome Measure(s): Total scores and domain scores (desire, arousal, lubrication, orgasm, pain, satisfaction) on the FSFI were compared with a published control population of women. Descriptive results of domain questions on the selected questions of the GRISS were identified. Result(s): Six patients, aged years, returned the questionnaires. Responses to the modified GRISS are represented by visual frequency of response bar graphs. Compared with the control population, the patients scores were lower for arousability, lubrication, orgasm, and comfort on the FSFI. Conclusion(s): Sexual function appears impaired in these six women who underwent laparoscopic Davydov as assessed by the FSFI. This may reflect characteristics of the patient population, as well as the inclusion of all patients data even if they did not attempt vaginal intercourse in the previous month. (Fertil Steril Ò 2010;-:- -. Ó2010 by American Society for Reproductive Medicine.) Key Words: M ullerian agenesis, Mayer-Rokitansky-Kuster-Hauser syndrome, androgen insensitivity syndrome, Davydov, sexual function, vaginoplasty, surgical therapy, neovagina Vaginal agenesis due to Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome or androgen insensitivity syndrome occurs in approximately 1 in 5,000 and 1 in 20,000 live female births, respectively. The standard technique recommended by experts for creation of a neovagina is by gradual self-dilation with the support of a multidisciplinary team (1). In the rare cases of failed vaginal dilation, various surgical methods have been used for creation of a neovagina. Most surgical methods involve creating a neovaginal space and lining the space with different materials: split-thickness skin graft (McIndoe procedure) (2), buccal mucosa or artificial skin; colovaginoplasty (3); or the Davydov procedure using pelvic peritoneum (4 6). The Vecchietti procedure is an alternative whereby the neovagina is Received June 28, 2009; revised January 3, 2010; accepted February 2, L.M.A. has nothing to disclose. K.L.L. has nothing to disclose. C.M.B. has nothing to disclose. R.F.S. has nothing to disclose. S.K. has nothing to disclose. Reprint requests: Lisa M. Allen, M.D., Ontario Power Generation Building, 700 University Avenue, 3rd Floor, Toronto, Ontario M5G 1Z5, Canada (FAX: ; lallen@mtsinai.on.ca). created by dilation with a traction device attached with wires to a Lucite olive placed at the vestibule (7). Davydov vaginoplasty may be performed by laparotomy (6) or with laparoscopic assistance. At least five case series have described creation of a neovagina by laparoscopic Davydov (4, 8 11). Several studies report patients sexual function after surgical creation of a neovagina (2, 3, 7, 12 18). At present only one study, however, reports validated psychosexual outcomes after laparoscopic Davydov (5). The objective of this study is to describe patients self reported sexual function and satisfaction after laparoscopic Davydov vaginoplasty and compare them to a control (no disorder of sexual development, nonsurgical) female population described in the literature (19). MATERIALS AND METHODS With Research Ethics Board approval at Mount Sinai Hospital and St. Michael s Hospital, (REB# E and C respectively) nine patients with MRKH or androgen insensitivity syndrome who underwent laparoscopic Davydov with the same surgical team in Toronto, Canada, between September 2004 and May 2006 were mailed a study questionnaire after /10/$36.00 Fertility and Sterility â Vol. -, No. -, doi: /j.fertnstert Copyright ª2010 American Society for Reproductive Medicine, Published by Elsevier Inc.

2 TABLE 1 Demographics, sexual activity, and total FSFI per patient. Sexual activity (previous 4 wk) FSFI (total score) Sexual activity (before surgery) Patient Age (y) Diagnosis Reason for diagnosis Previous surgery Ethnicity Relationship status 1 24 AIS Birth Vaginoplasty White Common law Attempted Yes Don t Know Amenorrhea No Greek No partner No No 22.4 Yes 26.4 Yes (after first surgery) White Single (with sexual partner) Amenorrhea McIndoe vaginoplasty 3 52 Hypoplastic vagina, no uterus None Yes MURCS Amenorrhea No White Single (with sexual partner) 5 23 Vaginal agenesis Amenorrhea No White No partner Yes (no IC) No Don t know Sexual problems No Filipino/Asian Sexual partner None Yes 27.8 Note: FSFI ¼ Female Sexual Function Index; AIS ¼ androgen insensitivity syndrome; MURCS ¼ Mullerian duct aplasia, renal aplasia, and cervicothoracic somite dysplasia; IC ¼ intercourse. obtaining verbal consent. The study design allowed women to complete a validated survey instrument anonymously, remote from any clinic visits with their surgeons. The questionnaire contained short answer and multiple choice sections on the patients diagnosis, medical, surgical, and sexual histories. Nineteen questions were included from the Female Sexual Function Index (FSFI) and 17 questions were included from the Golombok Rust Inventory of Sexual Satisfaction (GRISS) adapted with permission (Copyright Pearson Assessment 2009). The FSFI and GRISS are standardized, validated self-report questionnaires with six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain (19, 20). Reponses to the modified GRISS are represented by visual frequency of response bar graphs. The FSFI responses were analyzed using Student s t-tests with a pooled estimate of the SD. The control population consisted of non-dsd (Disorder of Sexual Development), nonsurgical, North American women published in the literature. RESULTS Of nine patients contacted, all of whom had verbally agreed to receive the study questionnaire, six returned the questionnaire, for a response rate of 67%. Patients self-reported diagnoses included androgen insensitivity, hypoplastic vagina, Mullerian-renal-cervicosomite abnormalites (MURCS) association, vaginal agenesis, and don t know (2 respondents). The diagnosis was made at birth (1 patient), due to primary amenorrhea (4 patients), and secondary to sexual problems (1 patient). Patients ages at laparoscopic Davydov were 19, 22, 23, 23, 26, and 52 years, respectively, for a mean age of 27.5 years (SD 12.2 years). The 52 year-old woman had previous colpopoesis with a McIndoe procedure at age 26 years, and another patient with androgen insensitivity syndrome had undergone prior vaginoplasty. The remaining 4 patients had no previous genital surgeries. Selfreported ethnicity for the respondents was white (4 patients), Greek (1 patient), and Filipino/Asian (1 patient) (Table 1), All six patients wore a stent or used a dilator after surgery. At the time of the questionnaire two patients reported that they were still wearing the mold; the remaining participants reported using the mold for 6 12 months postoperatively. Self-reported complications after surgery included no problems (1 patient), persistent vaginal discharge (3 patients), narrowing of the vagina (3 patients), recurrent urinary tract infections (1 patient), pain with intercourse (1 patient), difficulty with intercourse due to vagina seeming too small (2 patients), and difficulty with intercourse due to lack of lubrication (2 patients). The average number of complications reported per patient was 2.1 with a range of 0 6. Patients reported thinking their vaginas were presently OK/normal (2 patients), smaller than average (2 patients), narrow (1 patient), short (1 patient), and small (2 patients). Three patients indicated that they would like (their) vaginas longer. Regarding the appearance of their genital area, patients were generally happy with it (4 patients), thought everything seems fine (2 patients), and thought a sexual partner would notice that it is different from other women (1 patient). With regard to sexual activity before surgery, the most common response was that they were not (3/6 respondents). One respondent had attempted to be sexually active, one was sexually active but without penetration, and one woman with a previous McIndoe vaginoplasty was sexually active before the current surgery after an earlier vaginoplasty. After surgery, 67% (4/6) were sexually active within the 4 weeks immediately before completing the survey. When questioned with regard to their relationship status, one woman was in a common-law relationship, one had a sexual partner although did not indicate relationship status, two women were single 2 Allen et al. Sexual outcomes after laparoscopic Davydov Vol. -, No. -,

3 TABLE 2 Responses to modified Golombuk-Russ Inventory of Sexual Satisfaction (GRISS) questions. Theme Question Always Usually Occasionally Hardly ever Never Interest and desire Do you feel interested in sex? **** * Are there weeks when you don t have sex? * * * ** Do you avoid having sex with your partner? * * * ** Do you become tense and anxious when * ** * * you & your partner want to have sex? Do you refuse to have sex with your partner? * ** Arousal Do you become easily aroused? ** ** * Do you enjoy having your genitals stroked? ** ** Does your vagina become moist during intercourse? * * ** * Vaginal Size Do you find your vagina is so tight that your partner s penis can t enter it? Is it impossible to insert your finger into your vagina without discomfort? Is it impossible for your partner s penis to enter your vagina without discomfort? * ** ** ** ** * *** ** Orgasm Are you able to experience an orgasm with ** * * * your partner? Do you find it possible to have an orgasm? * ** Can you reach orgasm when your partner stimulates your clitoris? ** * * ** * Satisfaction Do you find your sexual relationship with your partner satisfactory? Do you enjoy having sexual intercourse with your partner? Do you feel there is love and affection in your sexual relationship with your partner? *** * * * * ** * ** * * * Note: See text for explanation of asterisks. with a sexual partner, and two indicated that they had no current sexual partner (Table 1). Responses to the modified GRISS are represented visually in Table 2. Each response to a question is indicated by an asterisk. In each row, the left side represents a poorer outcome, and the right side, a better outcome. Not each respondent answered each question of the survey. The first row illustrates responses to questions on the theme of interest/desire. Four patients never refuse to have sex with their partners, however, three usually or always become tense and anxious when their partner wishes to have sex. Row 2 depicts responses to questions about arousal. Five women occasionally, usually, or always become easily aroused, with a similar proportion of women reporting lubrication with intercourse. All of those who responded to the question usually or always enjoy genital contact in a nonpenetrative manner. Row 3 illustrates responses to questions about vaginal size. Although all patients hardly ever or never have difficulty inserting fingers into their vaginas, three occasionally or usually find their vaginas too tight for penile entry, and four occasionally or usually find penile entry uncomfortable. Row 4 depicts responses to questions about orgasm. Three patients reported that they hardly ever or never experience an orgasm with their partner. However, three women answered that they usually or always achieve orgasm with clitoral stimulation. Finally, row 5 illustrates responses to questions about satisfaction. Three patients hardly ever find their relationship with their partner satisfactory, and three patients hardly ever or never feel love and affection in their sexual relationship with their partner. Three women reported that they usually or always enjoy having sexual intercourse with their partner. Table 3 shows the FSFI scores of the patients compared with the scores of the control population. The FSFI scores are calculated with a maximum of 6 for each domain and 36 for the total. Compared with the control population, the patients scores were statistically significantly lower in the domains of arousability, lubrication, orgasm, and comfort. Total scores less than 23 are considered poor, scores of are considered good, and scores more than 30 are considered very good (3, 5). Total FSFI scores in patients were , mean versus 30 5 in the control population (P¼.005). DISCUSSION For women with vaginal agenesis who fail dilation therapy for creation of a neovagina, there exist many potential surgical alternatives. The ideal surgical procedure should be simple, with minimal complications, a short recovery, create a vagina of adequate depth and width, ideally of stratified squamous epithelium (vaginal mucosa), and most important allow for satisfying sexual function. At present limited data are available on psychosexual surgical Fertility and Sterility â 3

4 TABLE 3 Female Sexual Function Index (FSFI) scores. Controls, mean ± SD (n [ 131) Patients, mean ± SD (n [ 6) t-value P value Desire (range 2.4 6) Arousability (range ) a Lubrication (range ) a Orgasm (range ) a Satisfaction (range 2.1 6) Comfort (range 0 5.2) a Full score (range ) a a Statistically significant differences from the control population. outcomes using validated measures to guide patient and surgical choices. Based on the results of a self administered questionnaire, at 6 months postoperative, sexual function appears impaired in the current study of six women who underwent laparoscopic Davydov compared with controls. The FSFI scores of the patients were statistically significantly lower, both as a total value and in the domains of arousability, lubrication, orgasm, and comfort. A validated psychosexual assessment using the FSFI, after neovaginal surgery has been applied following the Vechietti procedure, sigmoid colpopoesis, and the laparoscopic Davydov (3, 5, 7). A study of the Vechietti procedure administered the FSFI to 27 women with MRKH 12 months after surgery. These patients had similar scores as controls in the domains of desire, arousal, and satisfaction, but statistically lower in lubrication, orgasm, and comfort (7). Communal et al., (3) reported on sexual function in 16 consecutive patients with MRKH after sigmoid colpopoeisis. Their overall mean FSFI score was 28 5, with little difference from healthy patients for each domain of sexual function. Giannesi et al. (5) applied the FSFI to 28 women after a laparoscopic Davydov procedure. The full score did not differ from their control group, nor did they find statistically significant differences in any of the domains between the patients undergoing surgery and their controls; however, they did find a trend to less satisfying sexuality in the patients undergoing surgery, with the most difference in the domain related to comfort and lubrication. The desire domain on the FSFI was one of the two domains not statistically significantly different from women without DSD (controls in the current study). The GRISS questions on how easily women become aroused, enjoyment of nonpenetrative sex, and lubrication were answered more positively than other question groupings overall. Hence interest in sexuality after surgery is maintained; however, challenges persist with regard to the physical aspects of the vagina. Three of the patients reported that they would like (their) vaginas longer. This is consistent with the GRISS responses with regard to penetrative intercourse, where 66% answered that it is impossible for the penis to enter their vagina without discomfort and with the lower scores on the FSFI domain of comfort. It may therefore be appropriate for our team to reassess the length and width of the vaginal mold used in our setting, something that varies among different surgeons performing this procedure. Despite that the surgery pertained to only the vagina, orgasmic capacity was reported dichotomously. Half the GRISS responses indicated good orgasmic response with clitoral stimulation, yet 50% of women reported that they never or usually never were able to achieve orgasm with their partner. The orgasm domain of the FSFI was statistically lower than controls. Another series assessing patients with MRKH using the FSFI after Vechietti vaginoplasty demonstrated similar differences in the orgasm domain from patient controls (7). Given that neither surgical procedure should impact on the sensate nature of the clitoris, these results emphasize that for women with DSD diagnoses the assumption that creation of a vagina will resolve any sexual dysfunction is incorrect. Women might have discomfort after surgical colpoeisis related to functional length of the neovagina; however, the discomfort could also relate to emotional barriers with secondary vaginismus. Although the first explanation may require a change in surgical technique, the latter requires a different, multidisciplinary management approach that may include psychology, psychiatry, and sexual therapy. A limitation to our study design is the fact that the current study protocol only assessed the women postoperatively. We have no knowledge of the women s sexual function on the six domains assessed before surgery. It is conceivable that the surgery enhanced the women s sexual function and decreased disorder in these domains but not to the level of a non-dsd, nonsurgical population (the control group) (19). In conclusion, sexual function appears impaired in these six women who underwent laparoscopic Davydov compared with controls. These results differ from a previous report on sexual functioning after laparoscopic Davydov (5). Poorer scores may be attributed to the inclusion of all patients data, even if they reported no attempt at vaginal intercourse in the past 4 weeks. Lower scores may also reflect differences in the study patient population; more patients in this group had failed dilation or undergone previous surgery. Our patient population consisted solely of women who had failed vaginal dilation and in 33% also failed previous surgical procedures. Overall, however, these results require reflection on current surgical technique and on surgical neovaginoplasty compared with vaginal dilation. They also emphasize the need for perioperative support, not only from the surgeon but ideally from psychology and sexual therapy to optimize outcomes. Future studies should address preoperative sexual function compared with postoperative sexual function after creation of a neovagina, and should compare sexual function in women using vaginal dilation exclusively versus women who have undergone each of the various surgical approaches. We advise assessment of sexuality separate from clinical assessments by surgeons to allow women to answer in a more forthright manner. 4 Allen et al. Sexual outcomes after laparoscopic Davydov Vol. -, No. -,

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