Recommendation 8: Clitoral reconstruction surgery is suggested for selected women living with FGM.

 

Strength of recommendation: Conditional (very-low-certainty evidence).

- Summary of the evidence -

 The evidence review for this recommendation considered the effect of clitoral reconstruction among women living with any type of FGM who have been diagnosed with sexual dysfunction disorder, vulvodynia, clitoral pain, low self-esteem and/or negative body image, compared with no intervention or non-surgical interventions. The outcomes of interest included improvements in vulvar or clitoral pain, body image and/or quality of life (research question 10, see Annex 4). The GDG reviewed evidence from 13 studies, including five retrospective cohort studies conducted in Burkina Faso, France, Netherlands (Kingdom of the) and the USA, three prospective cohort studies conducted in France, two in Spain, one in Burkina Faso, one in Egypt and a non-randomized controlled study conducted in France. Study participants were women of reproductive age who had undergone FGM. FGM types included Types I–IV with the majority of participants in the studies having Type II or Type III FGM. The certainty of the evidence in all the studies considered was assessed as being very low. The intervention in all but one of the studies was clitoral reconstruction using a technique developed by Pierre Foldès, which involves a resection of the FGM scar. The body of the clitoris is then released by preserving the innervation, and afterwards the clitoral glans is reconstituted by reimplanting the clitoral body as a glans. This technique is designed to make the clitoris more visible and accessible and to promote better function once the scar has been removed while preserving its innervation. In one study, by Mañero & Labanca, a different technique was used involving the reconstruction of the clitoral glans covered by a vaginal mucosal graft. Two studies, by Merckelbagh et al. and Mestre-Bach et al., took a multidisciplinary approach involving clitoral reconstruction alongside a sexual health counselling intervention. The main outcomes measured included the appearance of the external genitalia including the neoclitoris, improved or reduced symptoms of vulvodynia and/or clitoral pain, reduced or no pain during sexual intercourse, improved quality of life (improvement in sexual activity or orgasm), and improved satisfaction about body image. Assessment of the outcomes was based on responses at follow-up from the women who underwent the procedures, with the exception of the appearance outcome, which was also assessed by the surgical team in one of the studies.

All the included studies were judged to be of low certainty as a result of bias due to confounding except one study by Wylomanski et al., from which only limited information was provided to assess this. None of the studies reported any deviations from the intended intervention. Similarly, all the studies were judged to have only a low level of selection bias, except one study by Christopher et al., which had moderate selection bias due to reporting that participants were included only if they responded to the questionnaire that was sent to them. All studies were judged to have a low level of bias in classification of interventions and measurement of the outcome. Similarly, all studies used the same instrument for preand post-intervention assessment. Most studies had high participant retention rates, with 0–10% of participants lost to follow-up. Three studies reported a high attrition rate of over 20%. The duration of follow-up was also adequate for most of the studies, which reported follow-up of at least six months, but a study by Merckelbagh et al. reported a median follow-up of just one month (range 0–18 months). Finally, all studies were judged to be at moderate risk of bias with respect to selective reporting. In the study by Mañero & Labanca, following clitoral reconstruction, there was a reduction in pain in women who complained about pain prior to surgery. Three of the included studies, by Christopher et al., Wilson & Zaki and Karim et al., assessed the effect of the intervention on self-esteem and found an overall improvement in self-esteem following surgery. Five studies assessed the effect of the intervention on body image. All the studies reported improvement in women's body image following clitoral reconstruction using various measures. A study by Abramowicz et al. measured satisfaction with the appearance of the neoclitoris. A study by Vital et al. measured satisfaction with the appearance of their genitalia and a sense of femininity . The study by Mañero & Labanca reported a favourable increase on the Female Self-Image Genital Scale (FSGS), a validated scale which assesses a woman’s self-perception of her genitalia. In another study, by Merckelbagh et al., 39 of the 61 women who indicated physical integrity as their motivation for surgery reported aesthetic improvement and feeling more feminine. In another study, Ouédraogo et al. reported that all the women in the study (n = 94) reported satisfaction with the regained physical integrity of the clitoris. With regard to clitoral sexual function, two studies, by Abramowicz et al. and Foldès & LouisSylvestre, found that women with FGM who never experienced orgasm had higher odds of experiencing orgasm following clitoral reconstruction. The study by Ouédraogo et al. reported a similar increase in sexual function. Some studies reported an improvement in overall Female Sexual Function Index (FSFI) scores and scores on orgasm, sexual desire, and sexual arousal. Merckelbagh et al. found an increase in libido and sexual pleasure following surgery among the participants in their study. However, Mañero & Labanca reported no change in desire following surgery among the women in their study. In terms of negative outcomes, Foldès et al. reported a decrease in the number of women experiencing regular orgasm following surgery, although the difference was not statistically significant. In terms of safety and adverse events, five studies reported cases of haematoma following clitoral reconstruction surgery, three reported infections, three reported suture release, one reported oedema and acute retention of urine in one woman and another reported post-operative genital pain for three months in two women and urinary tract infection in one woman. Ouédraogo et al. reported repeat sutures among four women, while another study by some of the same authors reported loosening of cutaneous tissue among six women. Another study, by Karim et al., reported mild inflammation among three patients, while the study by Mañero & Labanca reported partial necrosis among two women. Two studies reported a revision of the surgery due to re-adherence of the labia and two other studies reported prolonged pain. Finally, two studies reported moderate fever following surgery.GRADE Table 14 in section 6 of Web Annex A provides details of all the studies included in the review for this topic

- Rationale -

The GDG noted that the evidence of clitoral reconstructive surgery as an intervention to improve clitoral pain, body image and clitoral sexual function was of very low quality since most studies were observational studies. High heterogeneity in patient populations, in the reconstruction technique, the composition of the team providing care, and in the outcomes studied made it difficult to compare outcomes. Overall, clitoral reconstruction appears to reduce vulvar pain, clitoral pain and pain during intercourse, and to improve body image, self-esteem and clitoral sexual function. The certainty of the evidence was very low for all outcomes. Most of the studies were carried out in high-income countries, except for two studies that were carried out in a low-income country (Burkina Faso). The studies were conducted among mostly African migrant women and covered a wide age group. The findings are most probably applicable to all women with FGM who have been diagnosed with sexual dysfunction disorder, vulvodynia, clitoral pain, low self-esteem and/or negative body image, but sociocultural factors might influence their expectations and outcomes. Evidence from the systematic review conducted for this research question is similar to another review, by Berg et al., which found that most women reported improvements in their sexual life following clitoral reconstruction. Another review, by Ezebialu et al., found no studies due to the inclusion criteria limiting the scope to only RCTs, CRTs and quasi-experimental studies. While most of the reviewed studies found positive outcomes, some studies reported negative outcomes, such as increased pain, sexual difficulties, lack of satisfaction with the aesthetic results and complications from the surgery. The evidence summarized in this review21 came from observational studies and was of a low or very low level of certainty, and therefore the evidence was considered in conjunction with the expert opinion of the GDG members, who felt that a recommendation was needed to respond to the high demand for the procedure, and also because of the promising findings in terms of clinical effectiveness. They also felt that standards of care that respond to the preferences of affected women are needed to contextualize the recommendation when implemented.

- Implementation remarks -

 The GDG noted that clitoral reconstruction surgery is a complex process and may be one of the available treatments that can be accessed by women living with FGM to address sexual dysfunction and pain. It is important to align expectations with potential clinical outcomes of reduced pain, improved sexual satisfaction and reduced sexual dysfunction. In most settings with high prevalence of FGM, with weak health systems and a lack of trained surgeons who have adequate support to perform the procedure, elective surgeries are uncommon, and when surgeries are performed, priority is given to emergency surgeries. The GDG cautioned that endorsing clitoral reconstruction in the absence of conclusive evidence of benefit could raise expectations that cannot be met for many women living with the consequences of FGM, who in recent years have increasingly taken interest in the procedure as a potential means of improving their psychosexual well-being. The GDG strongly endorsed the implementation of sexual health counselling as a precursor to or in conjunction with clitoral reconstruction surgery. The GDG also noted that it would be important to consider evidence on different surgical approaches to clitoral reconstruction. Current knowledge regarding the intervention comes mainly from the Foldès technique, and while other techniques exist, the available evidence on these is mainly indirect, from expert opinion and unpublished studies. For this reason, implementation of this recommendation needs to be in the context of multidisciplinary management of women living with FGM, taking a bio-psycho-social and relational approach to sexual health, and in conjunction with psychosocial support. The GDG was not able to clearly state if benefits outweigh harms since the benefits of the procedure depend on the woman, the technique used, the setting and context. Since women undergoing the surgery are often preselected, the success rate in the existing studies is not necessarily generalizable. The GDG noted that the benefits might outweigh the harms for women who have access to a skilled surgeon and other favourable factors. The GDG cautioned that a recommendation in favour of clitoral reconstruction may lead to inequitable implementation because the procedure is not yet available in the majority of countries with high FGM prevalence. 

- Research gaps -

Despite there being sufficient evidence for making a recommendation in this guideline, there remains a lack of robust evidence, and additional research is still needed to confirm the observed benefits of clitoral reconstruction surgery in women with sexual dysfunction related to FGM. Large, adequately powered observational studies that demonstrate consistent and large effects following clitoral reconstruction surgery in women and girls living with FGM provide low-certainty evidence, which can be used to guide clinical practice decisions until results from RCTs become available. These studies should document both the benefits and the adverse events, and should assess women’s sexual functions and self-image using methods and scales that would allow for comparison and pooling of data across studies. In addition, studies should assess whether outcomes of clitoral reconstruction in conjunction with sexual health counselling are better than outcomes among women receiving sexual health counselling alone.