Ethical patient care and good medical practice aims to promote patient autonomy, shared decision making and informed consent.  Informed consent begins with the giving of information often as a verbal discussion which may be supplemented by additional written information or signposting to the appropriate information source.  The discussion should include the risks and benefits of an intervention and what alternatives are available.  The process ends with the giving of consent assuming the patient has the capacity to understand the information, retain the information and weigh the information to communicate a decision.  For surgical procedures, a signature on a consent form serves as evidence for consent. 

Pelvic organ prolapse has a likely prevalence of 25-35% of women with a lifetime risk of surgical intervention at 11-19% [1-3].   The aim of this study was to assess a woman’s understanding of surgical risks for vaginal prolapse surgery not utilising mesh.

An electronic questionnaire was created using the Qualtrics platform. The questionnaire began with an introduction about vaginal prolapse and its treatment options including no treatment, pelvic floor muscle training, a vaginal pessary or vaginal surgery.  This was followed by further information on vaginal prolapse surgery such as operation recovery, operation methods and the short and long term complications.

The information provided to women was taken from validated and peer reviewed publications by the Royal College of Obstetricians and Gynaecologists consent advice as well as the British Society of Urogynaecology patient advice leaflets.  Website links to additional information was embedded in the questionnaire for women to review.  After reviewing this information, women were asked if they would like to continue to complete an anonymous questionnaire.  Ten questions were presented to focus on the woman’s understanding of the risks of the surgery.

The questionnaire link was circulated to women aged over 18 years with no professional gynaecology knowledge by email or using instant messaging methods.

89 women had provided consent to complete the questionnaire after reading the surgery information.  There were 65 completed questionnaires.  Figure 1 shows the age distribution of women completing the questionnaire.  The questionnaire took a mean of 8 minutes (range 2-33 minutes) to complete.  There was a moderate positive correlation between time to complete the questionnaire and age (r=0.416 p<0.001, Pearson Corr Coeff).

After reading the information about surgical risks 95% (62/65) of the women felt they understood the surgical risks and 98% knew where to find additional information if required.  Overall only 20% of women answered all ten questions correctly, 26% had one incorrect answer and 54 % had between 2-7 incorrect answers.  There were no significant differences in the ability to answer individual questions as shown in figure 2 correctly between women who felt they understood the risks compared with the women who did not (Chi Squared p>0.05).  There was no significant difference in the mean number of correct questions answered between the women who understood the risks of surgery and those who did not (p= 0.121 Independent T-Test). There was no correlation between the age category of the responder or the time it took to complete the questionnaire with the number of questions correctly answered.  

91% (59/65) of women understood that the surgery was associated with complications that could require further interventions such as further prolapse surgery or treatment of vaginal adhesions at a later date.  Of these, 55% (32/59) of responders correctly acknowledged that this could be perceived as a common risk affecting at least 10% or 10 in every 100 women.  

74% (48/65) of responders identified that unintended bowel injury could occur and require repair with 85% (41/48) recognising that this was a rare risk.  Figure 2 shows the responses to questions that were answered with a yes or a no.

The last question was an open question for additional comments or questions they would wish to ask.  This was answered by 41 women with six recurring themes.  12 responders had additional questions about the risks presented.  10 commented on the risks versus the benefits of the procedure, with a further 5 seeking to understand their own personalised risks better taking into account their baseline health.  Questions about the recovery were common from 9 responders.  Four women (all aged between 18 – 29) asked about the impact of prolapse surgery to fertility.  Two commented that the information needed time to understand and processed.

Most responders reported that they understood the presented surgical risks of vaginal prolapse surgery.  However when ‘tested’ only 19% (12/63) answered all the questions correctly suggesting an incomplete understanding.  Conversely those who did not understand the risks answered the questions well, suggesting a lack of confidence in their understanding.

The three questions most commonly answered incorrectly concerned the risk of serious complication with bowel injury, the appearance of the genitalia post-operatively and understanding the realistic success of the operation.  Furthermore different age groups may place increased value on different risk elements such as impact to fertility, cosmetic outcome and risk versus the actual benefit.

The disparity in our results raises ethical concerns about the understanding of the written presentation of surgical risks for vaginal prolapse surgery.  Understanding of the information is likely to be multifactorial.  However age of the woman or time taken to complete the questionnaire did not appear to impact our results.  

It is the ethical duty of the clinician completing consent to ensure that the procedural information is understood.  However how the clinician ensures this is a challenge.  We need better methods to improve patient understanding of risks.  This could include the way the information is presented as pictorial or as a flow chart, the wording used or the incorporation of techniques such as ‘teach-back’.

International urogynecology consultation chapter 1 committee 2: Epidemiology of pelvic organ prolapse: prevalence, incidence, natural history, and service needs. Int Urogynecol J. 2022 Feb;33(2):173-187
Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet. Gynecol 1997;89:501–6.
Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol 2010;116:1096–100

Continence 2S2 (2022) 100473
DOI: 10.1016/j.cont.2022.100473