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Meta-Analysis
. 2014 Sep 8;2014(9):CD007291.
doi: 10.1002/14651858.CD007291.pub3.

Vaginal dilator therapy for women receiving pelvic radiotherapy

Tracie Miles  1 , Nick Johnson
Affiliations
Meta-Analysis

Vaginal dilator therapy for women receiving pelvic radiotherapy

Tracie Miles et al. Cochrane Database Syst Rev. .

Abstract

Background: Vaginal dilation therapy is advocated after pelvic radiotherapy to prevent stenosis (abnormal narrowing of the vagina), but can be uncomfortable and psychologically distressing.

Objectives: To assess the benefits and harms of different types of vaginal dilation methods offered to women treated by pelvic radiotherapy for cancer.

Search methods: Searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2013, Issue 5), MEDLINE (1950 to June week 2, 2013), EMBASE (1980 to 2013 week 24) and CINAHL (1982 to 2013).

Selection criteria: Comparative data of any type, which evaluated dilation or penetration of the vagina after pelvic radiotherapy treatment for cancer.

Data collection and analysis: Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no trials and therefore analysed no data.

Main results: We identified no studies for inclusion in the original review or for this update. However, we felt that some studies that were excluded warranted discussion. These included one randomised trial (RCT), which showed no improvement in sexual scores associated with encouraging women to practise dilation therapy; a recent small RCT that did not show any advantage to dilation over vibration therapy during radiotherapy; two non-randomised comparative studies; and five correlation studies. One of these showed that objective measurements of vaginal elasticity and length were not linked to dilation during radiotherapy, but the study lacked power. One study showed that women who dilated tolerated a larger dilator, but the risk of objectivity and bias with historical controls was high. Another study showed that the vaginal measurements increased in length by a mean of 3 cm after dilation was introduced 6 to 10 weeks after radiotherapy, but there was no control group; another case series showed the opposite. Three recent studies showed less stenosis associated with prophylactic dilation after radiotherapy. One small case series suggested that dilation years after radiotherapy might restore the vagina to a functional length.

Authors' conclusions: There is no reliable evidence to show that routine, regular vaginal dilation during radiotherapy treatment prevents stenosis or improves quality of life. Several observational studies have examined the effect of dilation therapy after radiotherapy. They suggest that frequent dilation practice is associated with lower rates of self reported stenosis. This could be because dilation is effective or because women with a healthy vagina are more likely to comply with dilation therapy instructions compared to women with strictures. We would normally suggest that a RCT is needed to distinguish between a casual and causative link, but pilot studies highlight many reasons why RCT methodology is challenging in this area.

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Conflict of interest statement

TPM and NJ have an academic research grant from the Royal United Hospital NHS Trust to correlate vaginal dilator use with vaginal anatomy. The findings of this review helped inform the trial rationale and design. The lead author has received educational grants, equipment for research and a travel grant to attend the IGCS in Santa Monica in 2007, IGCS meeting subgroup in Prague 2010 and ASTRO meeting in Miami 2011 from Owen Mumford, manufacturers of Amielle 2010. The lead author is also the president of the National Forum of Gynaecology Oncology Nurses and Owen Mumford and MDTI (dilator manufacturers) have been some of the outside agencies who have paid to attend the annual national scientific meetings. They have also supported the National Forum's journal and provided a grant to Health Care Education (Bristol) for lecturing and consultancy. Sh! of London provided equipment for a research project.

Both authors have written reviews, guidelines and scientific studies in the field of dilation therapy and the lead author is the chair of the international guidelines group and the Macmillan UK lead nurse for assessing the late effects of radiotherapy.

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References

References to studies excluded from this review

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Miles 2012a {unpublished data only}
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Miles 2012b {unpublished data only}
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Poma 1980 {published data only}
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References to ongoing studies

Bruner 2011 {unpublished data only}
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NCI UP 10G01 {published and unpublished data}
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References to other published versions of this review

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