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2. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory
surgical procedure under local anesthesia for treatment of female
urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct
1996;7:81-6.
3. Maddern GJ, Middleton PF, Grant AM. Urinary stress inconti-
nence. BMJ 2002;325:389-90.
4. Hilton P. Trials of surgery for stress incontinence: thoughts on the
‘‘Humpty Dumpty principle.’’ BJOG 2002;109:1081-8.
5. McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Random-
ized trials in surgery: problems and possible solutions. BMJ
2002;324:1448-51.
0002-9378/$ - see front matter � 2005 Elsevier Inc. All rights reserved.
doi:10.1016/j.ajog.2004.08.018
Letters to the Editors 985
Reply
To the Editors: We are grateful to Professor Schuesslerfor his kind comments about our recent publication.We recognize that, although this is one of the largesttrials of surgery for stress incontinence, the statisticalpower is limited because of a failure to recruit up toour calculated sample size. Although this was raisedin an editorial in the British Medical Journal, it wascertainly not ‘‘uncovered,’’ as Prof Schuessler suggests;it had already been emphasized in our discussion, inboth the 6-month publication1 and subsequent corres-pondence2 and the current publication.3 It does remain,of course, one of the few surgical trials in this area withany statistical power to support its conclusions.
The variation in cure rates for the different centersthat participated in the trial was discussed in a commen-tary that illustrated the potential pitfalls of trials ofsurgery for stress incontinence.4 Although this was aninteresting observation in this context, the trial wasnot designed to assess differences in individual centers’performances, and as such, this analysis was not per-formed when the trial was reported; conclusions fromsuch subgroup analyses have no statistical power what-ever. The design of the trial was intentionally pragmaticto reflect the outcome of surgery across a range of
0002-9378/$ - see front matter � 2005 Elsevier Inc. All rights reserved.
doi:10.1016/j.ajog.2004.08.019
Effects of gastroschisis on ga
To the Editors: We read with interest the article of Aina-Mumuney et al,1 in which the authors describe increasedmorbidity and mortality among infants with gastroschi-sis who have a prenatally dilated stomach. These infantshad a significantly prolonged time to full oral feedings,and a longer mean overall length of hospital stay.Despite the clinical importance of gastric dilation, the
surgeons, whether they be urologists, urogynecologists,or gynecologists. It was never intended to gain insightinto the ‘‘best possible’’ cure rates for these proceduresbut to optimize the extent to which the results couldbe generalized outside of the trial setting.
Karen Ward, MRCOGPaul Hilton, MD, FRCOG*
Urogynaecology Unit, 3rd Floor, Leazes WingDirectorate of Women’s Services, Royal Victoria Infirmary
Newcastle-upon-Tyne, NE1 4LP UK*E-mail: [email protected]
References
1. Ward K, Hilton P. Prospective multicentre randomised trial of
tension-free vaginal tape and colposuspension as primary treatment
for stress incontinence. BMJ 2002;325:67-70.
2. Hilton P, Ward KL. Pleasing some of the people none of the time.
BMJ 2002;325:1361.
3. Ward KL, Hilton P. A prospective multicenter randomized trial of
tension-free vaginal tape and colposuspension for primary urody-
namic stress incontinence: two-year follow-up. Am J Obstet
Gynecol 2004;190:324-31.
4. Hilton P. Trials of surgery for stress incontinence: thoughts on the
‘‘Humpty Dumpty principle.’’ BJOG 2002;109:1081-8.
stric dilation
authors did not discuss the potential pathophysiologicmechanism for the dilation or potential obstetric preven-tative approaches. Of the 13 infants with gastric dila-tion, 8 demonstrated no evidence of gastrointestinal(GI) obstruction. Furthermore, among the 21 infantswithout a dilated stomach, there were 5 cases of GI ob-struction. Thus, it appears that GI obstruction does not