Table 1.

Summated findings from every study containing any data on vaginal dilation following radiotherapy

Author/date	Outcomes	Notes	Risk of bias	Authors’ assessment
Poma 1980	5 case reports	5 women who developed radiation stenosis who have never had treatment or intercourse during or after therapy. They were parous, aged between 47 and 55 and their radiotherapy had been between 3 and 9 years previously (5 cases at 8, 8, 9, 3 and 9 years). Women were taught to massage their vagina many years after their radiotherapy with an oestrogen cream (2 g) twice a day until vaginal depth became evident	Case histories only	Grade V Excluded study
Robinson 1999	Global sexual health scores Knowledge about sexuality, cancer and vaginal dilation compliance	The authors present a regression analysis demonstrating that intervention was associated with greater compliance but this only affected younger women. In the younger age group (less than 41.5 median age of the population), 5.6% in the control group complied compared to 44% in the intervention group. In the older group compliance was 55.6% in the control group versus 48% in the intervention group. This demonstrates that the younger women did comply and therefore randomisation has succeeded in creating 2 distinct groups, one who rarely dilated and one that complied with instructions to dilate. Mean sexual healthy scores (SD) were the same in the 2 groups. The sexual health score in the experimental group was 0.401 (0.081) compared to 0.513 (0.126) in the group who rarely dilated (control group). This was independent of age	The original paper may have been edited for brevity and did not describe how participants were randomly allocated or how contamination was minimised. However, the lead author confirms that appropriate techniques were applied. Random allocation involved sealed numbered envelopes sequenced by random number table and there were no incomplete data sets. Allocation was not concealed and the timing of sexual health score is not defined	Grade Ib Excluded study
Decruze 1999	Clinical assessment of stenosis at 1 year after radiotherapy	There were 35 women in each group. 20 had stenosis who did not use a stent compared to 4 who had stenosis who did use a stent. The 4 that did use a stent who had stenosis were noteworthy because one was too frightened to use, one was confused, and 2 did not understand how to use it. Once these 4 women had been encouraged to use it properly the authors say that the stenosis improved but no further details were given	The age was different in the 2 groups with those having no stent being on average 5 years older and there is no description of how women were allocated the stent. Allocation was not concealed from the assessors and neither assessors or patients were blinded to the technique, therefore the risk of bias has to be judged as high	Grade IV Excluded study
Bruner 1993	Vaginal length measured at pre-treatment, 6,12, 24 and beyond 24 months	This study shows a correlation between vaginal shortening and type of treatment. It does not provide data linking coital frequency to ultimate vaginal length. These data have been requested from the authors	No data available from the authors	Grade IV and no relevant data Excluded study
Jeffries 2006	Compliance with the use of dilators	This is a randomised trial allocating psychoeducational intervention specifically designed to increase compliance with vaginal dilation. 26 women were exposed to an information-motivation-behavioural skills model of enhancing compliance with behavioural change 21 women in the control group were given 30 minutes of instruction and the appropriate equipment in the last week of therapy	The data collected were restricted to information on compliance	Grade Ia but no relevant data Excluded study
Sobotkowski 2006	Vaginal length, vaginal occlusion and vaginal vault wall synechiae	Vaginal length was not different after treatment (mean length of the study group (n = 16) of 6. 5 cm +/− 2.02 and the control group (n = 15) mean 5.67 +/− 3.04. There were 4 vaginal occlusions in the control group and one in the study group. There were 4 vaginal wall synechiae in the control group and 2 in the study group. The authors concluded that the speculum and mitomycin application made no difference to vaginal length	The authors do not describe how the cases were selected, the observers and the participants were not blinded to treatment and it was not a randomised study	Grade IIIb Excluded study
Velaskar 2007	Vaginal length measured before and after a programme of dilation therapy	Case series describing 89 of 100 women with stage 3 cervix cancer treated by radiotherapy. 45 also had concomitant chemotherapy. A measurement was taken 6 to 10 weeks after completing radiotherapy. Dilation therapy was taught and measurements were reassessed 4, 8 and 12 months later. Median length increased from 6 to 9 to 10 and 10 cm again over the 4 repeated measures. It is noteworthy that 46 of 89 women were able to accommodate larger dilators after 1 year of follow up	The authors do not describe how the cases were selected, how the measurements were taken, the observers and the participants were not blinded to treatment and readers are left wondering if the change in length is just a measurement artefact. It is possible that women tolerated greater penetration depth with experience and exposure to measurement and exposure to a foreign body in the vagina. The most important problem is that there is no control group	Grade IV Excluded study