This randomised controlled trial (RCT) by Kroese et al. tackles an interesting, common gynaecological condition of significant clinical importance. It is original work as the previous RCTs (Ander-sen et al. Acta Obstet Gynecol Scand 1992;71:59-62; Gennis et al. Am J Emerg Med 2005;23:414-15) were small, and not as well designed. When appropriately designed, conducted and reported, RCTs represent the reference standard in evaluating healthcare interventions. This RCT demonstrated that in women with an abscess or cyst of the Bartholin gland, treatment with Word catheter or marsu-pialisation resulted in comparable recurrence rates. Median time from ran-domisation to treatment was 3 hours shorter for Word catheter than for mar-supialisation. Maximal and average pain experienced during treatment were both higher in the Word catheter group compared with marsupialisation. However, pain scores after treatment were comparable , although those women undergoing marsupialisation required more analgesia during the first postoperative day. There are obviously other confounding factors affecting the recurrence rate, such as diabetes. How did the authors address that issue and was there any trend difference in the diabetic group? In other words, in a woman with diabetes how can the authors reliably make inferences that the recurrence is method/technique-related and not attributed to her dia-betes? This RCT is well designed, conducted and adequately implemented the Consolidated Standards of Reporting Trials recommendations (CONSORT) (Schulz, et al. BMJ 2010;340:c332). One of these recommendations is that the trial's results be discussed in light of the totality of the available evidence. There is explicit reference in the discussion to the results of the systematically conducted , published review of previously reported studies, explaining why the current study was justified. I agree with the authors' statements that the strengths of this RCT are the following. 1. The multicentre design within 19 hospitals reflects daily practice, and allows generalisation of the results. 2. A robust follow up, exclusion criteria and follow-up strategy have been conducted. However, I am not sure why women under 18 years were excluded, not under 16 years for instance. I wonder whether the latter would have expedited the recruitment and shortened the duration of the study (2010-14)? 3. The sample size calculation meant that the RCT is adequately powered to result in meaningful conclusions. 4. Statistical analysis was performed according to the intention-to-treat principle. This RCT also adapts the proposal by Docherty et al. (BMJ 1999; 318:1224-5) stating the main results, the strengths and limitations, interpretation/ comparison with the previous reviews/ RCTs and literature, but could have elaborated further on implication on clinical practice. The authors stated that 'In our opinion, our data therefore favour treatment of a Bartholin cyst or abscess with a Word catheter since this is the fastest procedure, relieving pain sooner after diagnosis,...
Re: Word catheter and marsupialisation in women with a cyst or abscess of the Bartholin gland (WoMan-trial): a randomised clinical trial Sir, We read with interest the paper by Kroese et al., who found similar 1-year recurrence rates of Bartholin cyst or abscess after Word catheter and marsupialisation. 1 In the WoMan trial, we would be interested to know on what basis did the authors assume a recurrence rate of the cyst or abscess of the Bartholin's gland of 20% after Word catheter placement whereas the literature they quoted in the Introduction suggested the rate to be between 3 and 17%? This did not match with the trial aim of assessing whether marsupialisation could reduce the recurrence rate from 20% to 15%. However, in the results of this trial, where the reported rate of recurrence was 10% for cyst or abscess needing treatment, the authors acknowledged in the Discussion that this was in keeping with the figures quoted in the literature. We are therefore unclear what the expected or target rates of recurrence were and on what basis they were derived.It was also stated that the women tolerated the procedure well: did authors conduct any survey on patient satisfaction to assess the acceptability?Finally, the authors mentioned the cost-effectiveness of using the Word catheter: was any financial analysis performed, which we presume would include the cost for follow-up and for removal of catheter? & Authors' reply Sir, We thank Dr Subba and Dr Matts for their interest in our randomised controlled trial comparing Word catheter and marsupialisation for the treatment of a cyst or abscess of the Bartholin gland. ReferenceThe recurrence rates on which we based our sample size had a very broad range, as they varied in length of follow up, with a maximum of 6 months in most studies. As our primary end point was recurrence within 12 months, we decided to use the high end of the range reported in the literature as our estimated recurrence rate, i.e. 20%. We then found that a difference of at least a 5% recurrence rate would be clinically relevant and therefore calculated a sample size large enough to find such a difference.Patient satisfaction was measured by pain scores during treatment and 1, 2 and 3 days after treatment and 1 week after treatment, by painkiller use and by direct questions on how troublesome the pain was perceived as. In the Word catheter group, 25 (49%) women perceived no pain or little discomfort during treatment, versus 31 (72%) in the marsupialisation group (relative risk = 0.57; 95% CI 0.34-0.96; P = 0.023). Additional information on pain perception and limitations in daily activities is provided in Table 1.In brief, a Word catheter placement will give a short increase of pain, which half of patients will find troublesome. However, the pain due to the abscess will be relieved sooner and pain in the first 24 hours after treatment is better tolerated than after marsupialisation. This information can be used in shared decision-making.Although
This chapter is devoted to the pelvic floor (PF). Maternity care has always considered the PF muscles an essential part of the birth and its disturbances. Gradually, the pelvic floor became a vital element for both sexual pleasure and sexual problems. This chapter will start by explaining its role in posture and movement, and sexuality and delineate the differences between the normotonic, the hypotonic, and the hypertonic pelvic floor and their influences on sexuality. The chapter also gives some elementary education on assessing pelvic floor function. After explaining the PF concerning pregnancy and birth, the chapter will address aspects of prevention and prehabilitation. In other words, this chapter will also deal with how to optimally prepare the pregnant woman for a relaxed birth with as low as possible negative consequences regarding vaginal laxity or pelvic floor prolapse. For the severe pelvic floor disturbances and their implications on sexuality and quality of life, the reader is recommended to look at Chap. 16.This chapter is part of ‘Midwifery and Sexuality’, a Springer Nature open-access textbook for midwives and related healthcare professionals.
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