Ethical and well-constructed research into the surgical management of obstetric fistula: a distant hope or a real possibility?

Abstract

The number of women presenting with new obstetric fistulae at the Hamlin Fistula Hospital in Addis Ababa, Ethiopia, has fallen from 492 to 329 in the 3 year period from January 2011 to December 2014, representing a drop of 33% (personal audit of Hamlin Fistula Ethiopia operating theatre records, JW 2015). Although this is clearly good news, as it suggests improvements in maternal health are being made, residual urinary incontinence following primary surgery still remains a problem. In a series of 390 women attending for urinary fistula repair, 240 returned for follow-up, of whom 123 (51%) remained incontinent (BJOG 2008;115:1564–9). In the past, urethral buttressing procedures, such as the use of Martius or pubococcygeus grafts, have been tried, but with limited success (BJOG 2004;111:357–61). It is tempting for both resident and visiting surgeons to try more invasive procedures, such as the use of abdomino-urethral slings, bladder augmentation, and urinary diversion; however, we need to remember that treatments now being considered for women with continuing urinary incontinence following fistula repair have largely been abandoned in high-income countries because of their ineffectiveness. For example, bladder augmentation is highly morbid and is rarely performed because of the need for self-catheterization, and urinary diversion is largely only performed for malignancy in aged patients. Whereas these operations may offer hope for women with urinary incontinence following fistula surgery, women need to be informed of the risks and possible, often unknown, benefits, not least of all because the surgery is not easily reversible, and any resulting morbidity will remain for the rest of their lives. Defecation in excess of six times a night is common following a Mainz pouch, and little is known about the long-term effects for these young women. Moreover, a urinary diversion cannot be reversed, but leaves women to cope with many challenges of stoma care within a rural environment where there may be no running water or adequate sanitation. It is therefore imperative that these procedures are trialled in a logical, well-documented, and ethical way, ensuring adequate consent about treatment options and the risks that must be faced. Informed consent, in the true sense, however, is not widely practiced in countries where obstetric fistulae are prevalent, and visiting surgeons need to ensure that they do not compromise their ethical standards simply because they are working out of their familiar context. Unlike clinical trials of medical therapy, new surgical procedures are not subject to ethical scrutiny or rigorous assessment of their efficacy and impact on quality of life. Indeed, many new surgical procedures are introduced without even a rudimentary assessment of patient satisfaction. For our putative patient with a Mainz pouch described above, her continued dribbling urinary incontinence and normal bowels may be a better option than radical surgery that leaves her socially isolated and unable to return to her community. Once surgery is performed, however, there is no turning back. These operations can be done, but should they be done? And if they are to be done, should they not at least be subjected to rigorous assessment of patient-reported outcomes, such as quality of life? None declared. Completed disclosure of interests form available to view online as supporting information. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.