{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T14:35:25Z","timestamp":1782311725265,"version":"3.54.5"},"reference-count":36,"publisher":"The Endocrine Society","issue":"7","license":[{"start":{"date-parts":[[2020,5,9]],"date-time":"2020-05-09T00:00:00Z","timestamp":1588982400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,7,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Purpose<\/jats:title>\n                  <jats:p>Urethral fistula and dehiscence are common after hypospadias surgery. Preoperative androgens have been considered to reduce these complications although this consideration is not evidence-based. Dermatologists have reported the benefits of topical estrogens on skin healing. We investigated whether the preoperative use of topical promestriene could reduce healing complications in hypospadias surgery. Our primary objective was to demonstrate a reduction of healing complications with promestriene vs placebo. Impact on reoperations and other complications, clinical tolerance, bone growth, and biological systemic effects of the treatment were also considered.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted a prospective, randomized, placebo-controlled, double-blind, parallel group trial between 2011 and 2015 in 4 French centers. One-stage transverse preputial island flap urethroplasty (onlay urethroplasty) was selected for severe hypospadias. Promestriene or placebo was applied on the penis for 2 months prior to surgery. The primary outcome was the presence of postoperative urethral fistula or dehiscence in the first year postsurgery. For safety reasons, hormonal and anatomical screenings were performed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Out of 241 patients who received surgery, 122 patients were randomized to receive placebo, and 119 patients received promestriene. The primary outcome was unavailable for 11 patients. Healing complications were assessed at 16.4% (19\/116) in the placebo vs 14.9% (17\/114) in the promestriene arm, and the odds ratio adjusted on center was 0.93 (95% confidence interval 0.45-1.94), P = 0.86.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions and relevance<\/jats:title>\n                  <jats:p>Although we observed an overall lower risk of complications compared to previous publications, postsurgery complications were not different between promestriene and placebo, because of a lack of power of the study or the inefficacy of promestriene.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1210\/clinem\/dgaa231","type":"journal-article","created":{"date-parts":[[2020,5,9]],"date-time":"2020-05-09T18:27:55Z","timestamp":1589048875000},"page":"2422-2429","source":"Crossref","is-referenced-by-count":9,"title":["Preoperative Topical Estrogen Treatment vs Placebo in 244 Children With Midshaft and Posterior Hypospadias"],"prefix":"10.1210","volume":"105","author":[{"given":"Daniela","family":"Gorduza","sequence":"first","affiliation":[{"name":"Centre de R\u00e9f\u00e9rence Maladies Rares D\u00e9veloppement G\u00e9nital: du F\u0153tus \u00e0 l\u2019Adulte, Hospices Civils de Lyon, Bron, France"},{"name":"Service de Chirurgie Uro-Visc\u00e9rale de l\u2019Enfant-H\u00f4pital M\u00e8re Enfant, Hospices Civils de Lyon, Bron, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingrid","family":"Plotton","sequence":"additional","affiliation":[{"name":"Centre de R\u00e9f\u00e9rence Maladies Rares D\u00e9veloppement G\u00e9nital: du F\u0153tus \u00e0 l\u2019Adulte, Hospices Civils de Lyon, Bron, France"},{"name":"Service d\u2019Endocrinologie P\u00e9diatrique, H\u00f4pital M\u00e8re-Enfant, Centre Hospitalo-Universitaire de Lyon, Bron Cedex, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Remontet","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Lyon, Lyon, France"},{"name":"Universit\u00e9 Lyon 1; CNRS, UMR 5558, Laboratoire de Biom\u00e9trie et Biologie Evolutive, Villeurbanne, France"},{"name":"Hospices Civils de Lyon, Service de Biostatistiques, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire-Lise","family":"Gay","sequence":"additional","affiliation":[{"name":"Centre de R\u00e9f\u00e9rence Maladies Rares D\u00e9veloppement G\u00e9nital: du F\u0153tus \u00e0 l\u2019Adulte, Hospices Civils de Lyon, Bron, France"},{"name":"Service d\u2019Endocrinologie P\u00e9diatrique, H\u00f4pital M\u00e8re-Enfant, Centre Hospitalo-Universitaire de Lyon, Bron Cedex, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meriem","family":"El Jani","sequence":"additional","affiliation":[{"name":"Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France"},{"name":"Universit\u00e9 de Lyon, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alaa","family":"Cheikhelard","sequence":"additional","affiliation":[{"name":"Service de chirurgie visc\u00e9rale et urologie p\u00e9diatrique, APHP, H\u00f4pital Necker, Paris, France; Universit\u00e9 Sorbonne Paris cit\u00e9, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Blanc","sequence":"additional","affiliation":[{"name":"Service de chirurgie visc\u00e9rale et urologie p\u00e9diatrique, APHP, H\u00f4pital Necker, Paris, France; Universit\u00e9 Sorbonne Paris cit\u00e9, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alaa","family":"El Ghoneimi","sequence":"additional","affiliation":[{"name":"Service de chirurgie visc\u00e9rale et urologie p\u00e9diatrique, Centre de R\u00e9f\u00e9rence des Maladies Endocriniennes Rares de la Croissance, H\u00f4pital Robert Debr\u00e9, APHP, Universit\u00e9 Paris Diderot, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc-David","family":"Leclair","sequence":"additional","affiliation":[{"name":"Service de chirurgie p\u00e9diatrique, CHU de Nantes, Nantes, Loire Atlantique, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascal","family":"Roy","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Lyon, Lyon, France"},{"name":"Hospices Civils de Lyon, Service de Biostatistiques, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrice","family":"Pirot","sequence":"additional","affiliation":[{"name":"Service pharmaceutique, Plateforme FRIPHARM, Groupement Hospitalier Edouard Herriot, Lyon Cedex, France"},{"name":"Laboratoire de Recherche et D\u00e9veloppement de Pharmacie Gal\u00e9nique Industrielle, Plateforme FRIPHARM, Facult\u00e9 de Pharmacie, Laboratoire de Biologie Tissulaire et Ing\u00e9nierie Th\u00e9rapeutique \u2013 UMR 5305, Universit\u00e9 Claude Bernard Lyon 1, Lyon Cedex, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanis","family":"Mimouni","sequence":"additional","affiliation":[{"name":"Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France"},{"name":"Universit\u00e9 de Lyon, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6854-7366","authenticated-orcid":false,"given":"Segolene","family":"Gaillard,","sequence":"additional","affiliation":[{"name":"Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France"},{"name":"Universit\u00e9 de Lyon, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Chatelain","sequence":"additional","affiliation":[{"name":"Centre de R\u00e9f\u00e9rence Maladies Rares D\u00e9veloppement G\u00e9nital: du F\u0153tus \u00e0 l\u2019Adulte, Hospices Civils de Lyon, Bron, France"},{"name":"Service d\u2019Endocrinologie P\u00e9diatrique, H\u00f4pital M\u00e8re-Enfant, Centre Hospitalo-Universitaire de Lyon, Bron Cedex, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yves","family":"Morel","sequence":"additional","affiliation":[{"name":"Centre de R\u00e9f\u00e9rence Maladies Rares D\u00e9veloppement G\u00e9nital: du F\u0153tus \u00e0 l\u2019Adulte, Hospices Civils de Lyon, Bron, France"},{"name":"Laboratoire d\u2019Hormonologie d\u2019Endocrinologie Mol\u00e9culaire et des Maladies Rares, INSERM 1208, Groupement Hospitalier Est, Hospices Civils de Lyon, Bron, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Behrouz","family":"Kassai","sequence":"additional","affiliation":[{"name":"Hospices Civils de Lyon, EPICIME-CIC 1407 de Lyon, Inserm, Department of Clinical Epidemiology, Bron, France"},{"name":"Universit\u00e9 de Lyon, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Mouriquand","sequence":"additional","affiliation":[{"name":"Centre de R\u00e9f\u00e9rence Maladies Rares D\u00e9veloppement G\u00e9nital: du F\u0153tus \u00e0 l\u2019Adulte, Hospices Civils de Lyon, Bron, France"},{"name":"Service de Chirurgie Uro-Visc\u00e9rale de l\u2019Enfant-H\u00f4pital M\u00e8re Enfant, Hospices Civils de Lyon, Bron, France"},{"name":"Universit\u00e9 Claude-Bernard-Lyon 1, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"80","published-online":{"date-parts":[[2020,5,9]]},"reference":[{"key":"2021122116311759200_CIT0001","first-page":"713e28","article-title":"Hypospadias.","volume-title":"Pediatric Urology. 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Urol."},{"issue":"2","key":"2021122116311759200_CIT0005","doi-asserted-by":"crossref","first-page":"684","DOI":"10.1016\/j.juro.2007.09.098","article-title":"The efficacy of dihydrotestosterone transdermal gel before primary hypospadias surgery: a prospective, controlled, randomized study","volume":"179","author":"Kaya","year":"2008","journal-title":"J Urol."},{"issue":"4","key":"2021122116311759200_CIT0006","doi-asserted-by":"crossref","first-page":"200.e1","DOI":"10.1016\/j.jpurol.2016.04.013","article-title":"Biometry of the hypospadic penis after hormone therapy (testosterone and estrogen): A randomized, double-blind controlled trial","volume":"12","author":"Paiva","year":"2016","journal-title":"J Pediatr Urol."},{"issue":"4","key":"2021122116311759200_CIT0007","doi-asserted-by":"crossref","first-page":"276","DOI":"10.1080\/13697130701456630","article-title":"Sex steroids and cutaneous wound healing: the contrasting influences of estrogens and 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Dermatol."},{"issue":"2","key":"2021122116311759200_CIT0011","doi-asserted-by":"crossref","first-page":"264","DOI":"10.4161\/derm.23872","article-title":"Estrogens and aging skin","volume":"5","author":"Thornton","year":"2013","journal-title":"Dermatoendocrinol."},{"issue":"2","key":"2021122116311759200_CIT0012","doi-asserted-by":"crossref","first-page":"376","DOI":"10.1016\/S0022-5347(17)43152-1","article-title":"Onlay island flap in the repair of mid and distal penile hypospadias without chordee","volume":"138","author":"Elder","year":"1987","journal-title":"J Urol."},{"key":"2021122116311759200_CIT0013","volume-title":"Group sequential methods with applications to clinical trials","author":"Jennison","year":"2000"},{"issue":"1","key":"2021122116311759200_CIT0014","doi-asserted-by":"crossref","first-page":"191","DOI":"10.1016\/S0022-5347(17)34915-7","article-title":"Changing concepts of hypospadias curvature lead to more onlay island flap 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A preliminary report","volume":"7","author":"Gorduza","year":"2011","journal-title":"J Pediatr Urol."},{"issue":"3","key":"2021122116311759200_CIT0020","doi-asserted-by":"crossref","first-page":"143.e1","DOI":"10.1016\/j.jpurol.2014.12.014","article-title":"The effect of parenteral testosterone administration prior to hypospadias surgery: a prospective, randomized and controlled study","volume":"11","author":"Asgari","year":"2015","journal-title":"J Pediatr Urol."},{"issue":"2","key":"2021122116311759200_CIT0021","doi-asserted-by":"crossref","first-page":"357","DOI":"10.1093\/neuros\/nyx020","article-title":"Long-term endocrine outcomes following endoscopic endonasal transsphenoidal surgery for acromegaly and associated prognostic factors","volume":"81","author":"Babu","year":"2017","journal-title":"Neurosurgery."},{"issue":"6","key":"2021122116311759200_CIT0022","doi-asserted-by":"crossref","first-page":"875","DOI":"10.1007\/s11255-015-0972-6","article-title":"Effects of oral 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