OBJECTIVE: Our study was aimed at evaluating the efficacy of therapy with promestriene, a synthetic diethyl-ether of estradiol with no distal hormonal effects, in patients undergoing surgical correction for stress urinary incontinence (SUI). MATERIALS AND METHODS:Ninety-eight healthy, postmenopausal women, non-users of hormone replacement therapy, with a diagnosis of SUI and vulvovaginal dystrophy, were recruited and openly randomized into two main groups. Group I (48 patients) received promestriene 10 mg daily, by vaginal capsule, for 21 days before the operation. Group II (50 patients) underwent the surgical procedure with TVT (Tension-free Vaginal Tape) directly, without pharmacological preparation. The results were collected and analyzed using SAS software (version 8). RESULTS: The two groups were homogeneous in terms of age, parity and body mass index. There were no significant differences between the two groups with respect to the time required to accomplish the TVT, blood loss, length of hospital stay, blood component measurements and postoperative subjective symptoms. There were slight differences postoperatively in problems during intercourse and the appearance of new genital symptoms, but again they were not shown to be statistically significant. CONCLUSIONS: Our results, although preliminary and subjective, confirm the efficacy of remedial surgical treatment of SUI with TVT. Preoperative administration of promestriene seems to favor trophism and vascularization of the whole muscular and fascial support of the pelvic floor and facilitates performance of the operation, but is not supported statistically.
RCT Entities:
OBJECTIVE: Our study was aimed at evaluating the efficacy of therapy with promestriene, a synthetic diethyl-ether of estradiol with no distal hormonal effects, in patients undergoing surgical correction for stress urinary incontinence (SUI). MATERIALS AND METHODS: Ninety-eight healthy, postmenopausal women, non-users of hormone replacement therapy, with a diagnosis of SUI and vulvovaginal dystrophy, were recruited and openly randomized into two main groups. Group I (48 patients) received promestriene 10 mg daily, by vaginal capsule, for 21 days before the operation. Group II (50 patients) underwent the surgical procedure with TVT (Tension-free Vaginal Tape) directly, without pharmacological preparation. The results were collected and analyzed using SAS software (version 8). RESULTS: The two groups were homogeneous in terms of age, parity and body mass index. There were no significant differences between the two groups with respect to the time required to accomplish the TVT, blood loss, length of hospital stay, blood component measurements and postoperative subjective symptoms. There were slight differences postoperatively in problems during intercourse and the appearance of new genital symptoms, but again they were not shown to be statistically significant. CONCLUSIONS: Our results, although preliminary and subjective, confirm the efficacy of remedial surgical treatment of SUI with TVT. Preoperative administration of promestriene seems to favor trophism and vascularization of the whole muscular and fascial support of the pelvic floor and facilitates performance of the operation, but is not supported statistically.
Authors: Jerry G Blaivas; Rajveer S Purohit; Matthew S Benedon; Gabriel Mekel; Michael Stern; Mubashir Billah; Kola Olugbade; Robert Bendavid; Vladimir Iakovlev Journal: Nat Rev Urol Date: 2015-08-18 Impact factor: 14.432
Authors: Andrea Tinelli; Daniel A Tsin; Antonello Forgione; Ricardo Zorron; Giovanni Dapri; Antonio Malvasi; Tahar Benhidjeb; Radmila Sparic; Farr Nezhat Journal: J Turk Ger Gynecol Assoc Date: 2017-09-01