promestriene and Postoperative-Complications

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.. 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.. 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.. 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.

Topics: Administration, Topical; Double-Blind Method; Estradiol; Fistula; Humans; Hypospadias; Infant; Male; Plastic Surgery Procedures; Postoperative Complications; Preoperative Care; Prospective Studies; Surgical Wound Dehiscence; Treatment Outcome; Urethral Diseases; Urologic Surgical Procedures, Male

The literature advocates preoperative vaginal estrogen (VE) therapy to reduce mesh exposure in pelvic organ prolapsed (POP); however, there are no comparative studies so far. This study aims to compare the effects of preoperative VE and non-VE therapy for the incidence of mesh exposure in postmenopausal women after transvaginal pelvic reconstructive surgery (PRS) with mesh.. A randomized noninferiority single-surgeon study of 186 women with severe POP was conducted. Ninety-three women (VE group) received 0.5 g promestriene cream twice a week transvaginally for 6 weeks before PRS with mesh, and 93 women (non-VE group) underwent PRS with mesh 6 weeks after enrollment without pharmacologic preparation. The primary outcome was the occurrence of mesh exposure within 1 year.. Overall, 173 of 186 participants (93.0%) completed 1-year follow-up. In an intention-to-treat analysis, the proportion of participants experiencing mesh exposure was 16.1% (15 of 93) in the VE group versus 12.9% (12 of 93) in the non-VE group (P = 0.024 for noninferiority). Both exposure area and time to exposure did not differ between the two groups. Similarly, no detectable differences at month 12 were found in terms of anatomic success, good response on the Patient Global Impression of Change, improvement in quality of life and sexual function, and complications. The result of per-protocol analysis agreed with that seen in the intention-to-treat analysis.. In postmenopausal women with severe POP who underwent transvaginal PRS with mesh, non-VE therapy before surgery was noninferior to VE therapy regarding mesh exposure rate within 1 year of follow-up.

Topics: Administration, Intravaginal; Aged; Estradiol; Estrogens; Female; Humans; Incidence; Middle Aged; Pelvic Organ Prolapse; Plastic Surgery Procedures; Postmenopause; Postoperative Complications; Preoperative Care; Surgical Mesh; Treatment Outcome; Vagina; Vaginal Creams, Foams, and Jellies