Non-surgical dilation for vaginal agenesis is promising, but better research is needed

26 03 2012

To the Editor:

We write with concerns about the paper “Mayer-Rokitansky-Küster-Hauser syndrome: a review of 245 consecutive cases managed by a multidisciplinary approach with vaginal dilators” (1). Whilst we agree with the authors that non-surgical dilation supported by a multi-disciplinary team is a promising approach, we also wish to highlight the deficiencies in this report.

The methods section consists of a description of the dilation programme with no research methodology in what is positioned as an intervention study. There is no mention of ethical approval or consent. Referral and attendance at a clinical service per se cannot be construed as informed consent to be researched. There is no description of how patients were recruited for the study or how women were assessed for treatment completion – whether at clinic, by telephone, or postal questionnaires. The abstract states functional vaginal length as one of the main outcome measures, whilst the results refer to anatomical vaginal length. These are different assessments, depending on whether an individual is sexually active. The authors refer to “clinical examination” but do not describe what this entailed, and although they defined success as a vaginal length of more than 6 cm, there was no description of how this was derived.

The paper refers to assessment of sexual satisfaction, but no information on measurement was offered. The authors refer to their own publication on a subset of 60 women whose data have already been published. This was a retrospective account whereby some of the women had completed treatment 20 years previously.

Although possible risks of dilation are alluded to in the discussion, there is no further mention of this in the results. The authors refer to “brief psychological screening” but do not describe rationale, objectives, or method. Psychological interventions could have influenced outcome (2, 3), but the extent of utilisation was not described, nor the effects subjected to statistical analysis.

There is no information as to when the final assessment was made. This is a study of patients seen over 12 years but no information is provided on how long ago treatment was completed, the time taken to complete the programme, or compliance with treatment. Complications were assessed using a web-based helpline, and no mention was made of long-term follow-up at the clinic.

The authors claim that only one paper has been published on this topic since the ACOG Committee Opinion paper in 2006. This is not the case (4, 5, 6). To not have a full literature review in such a contentious area is unhelpful for readers.

The authors claimed 100% success for length and sexual function in all patients who completed their programme. Such a claim needs to be based on multiple assessments using a repeated measures design, with robust statistical analysis. The paper is little more than a description of a clinic database and working practices. In positioning it as an intervention study, it risks distorting the evidence base. We urge clinicians and researchers to arrive at their own conclusions.

Sarah Creighton, F.R.C.O.G.
Consultant Gynaecologist, University College Hospital, London, UK

Naomi Crouch, M.R.C.O.G.
Senior Clinical Fellow, University Hospitals Bristol NHS Trust, Bristol UK

Rebecca Deans, F.R.A.N.Z.C.O.G.
Lecturer in Paediatric and Adolescent Gynaecology,
Royal Hospital for Women and University of New South Wales, Australia

Alfred Cutner, F.R.C.O.G.
Consultant Gynaecologist, University College Hospital, London, UK

Lina Michala, M.R.C.O.G.
Lecturer in Paediatric and Adolescent Gynaecology, University of Athens, Greece

Mana Barnett, D.Psych.
Counselling Psychologist, University College Hospital, London, UK

Cara Williams, M.R.C.O.G.
Clinical Fellow, University College Hospital, London, UK

Lih-Mei Liao, Ph.D.
Consultant Clinical Psychologist, University College Hospital, London, UK

References

1. Edmonds DK, Rose GL, Lipton MG, Quek J. Mayer-Rokitansky-Küster-Hauser syndrome: a review of 245 consecutive cases managed by a multidisciplinary approach with vaginal dilators. Fertil Steril 2012 97:686-690.

2. Bean EJ, Mazur T, Robinson AD. Mayer-Rokitansky-Küster-Hauser syndrome: sexuality, psychological effects, and quality of life. Journal of Pediatric Adolescent Gynecology 2009; 22:339-346.

3. Holt RE, Slade P. (2003). ‘Living with an incomplete vagina and womb: an interpretative phenomenological analysis of the experience of vaginal agenesis.’ Psychology, Health and Medicine 2003; 8:19-33.

4. Ismail-Pratt IS, Bikoo M, Liao LM, Conway GS, Creighton SM. Normalization of the vagina by dilator treatment alone in Complete Androgen Insensitivity syndrome and Mayer-Rokitansky-Küster-Hauser syndrome. Hum Reprod 2007;22:2020-4.

5. Bach F, Glanville JM, Balen AH. An observational study of women with mullerian agenesis and their need for vaginal dilator therapy. Fertil Steril 2001;96:483-6.

6. Liao LM, Conway GS, Ismail-Pratt I, Bikoo M, Creighton SM. Emotional and sexual wellness and quality of life in women with Rokitansky syndrome. Am J Obstet Gynecol 2011;205:117e1-6.

Published online in Fertility and Sterility doi:10.1016/j.fertnstert.2012.03.040

The authors declined to reply to this letter.

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