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François Haab - One of the best experts on this subject based on the ideXlab platform.

  • 75NC007 device for noninvasive stress urinary incontinence management in women: a randomized controlled trial
    International Urogynecology Journal, 2012
    Co-Authors: Jean-nicolas Cornu, Stéphane Mouly, Gérard Amarenco, Bernard Jacquetin, Calin Ciofu, François Haab
    Abstract:

    Introduction and hypothesis Management of stress urinary incontinence (SUI) with Intravaginal Devices is an alternative to surgical management, but data of a high level of evidence remain scarce. Our goal was to assess efficacy, tolerance, and acceptability of the 75NC007 Intravaginal device for SUI management. Methods A phase III, multicenter randomized controlled trial was conducted. After an initial washout period with no treatment, allowing baseline evaluation, women with SUI were randomly assigned to a treatment or control group (no treatment). The primary endpoint was the reduction of incontinence episode frequency (IEF), according to bladder diaries, as compared to baseline. Secondary endpoints were variation of the Urinary Symptom Profile (USP) score, of 24-h pad test, and of CONTILIFE questionnaire scores as compared to baseline. Intent-to-treat and per-protocol analyses were conducted. Results Fifty-five patients were enrolled and analyzed (26 controls and 29 treated). The mean relative variations of IEF, SUI USP subscore, and overactive bladder (OAB) USP subscore were more significant in the treatment group than in the control group (−31.7 ± 65.1 % vs −7.6 ± 24.5 %, p  = 0.002, −2.4 ± 2.6 vs 0.2 ± 2.2, p  = 0.004, and −1.5 ± 2.8 vs 0.2 ± 1.8, p  = 0.016, respectively). The dysuria USP subscore was slightly decreased in the treatment group. CONTILIFE scores were slightly improved in the treatment group. Pad test variations were not different between groups. No serious adverse event was noted throughout the entire study. Conclusions The 75NC007 Intravaginal device is a safe and effective noninvasive treatment of SUI in women.

  • 75NC007 device for noninvasive stress urinary incontinence management in women: a randomized controlled trial
    International Urogynecology Journal, 2012
    Co-Authors: Jean-nicolas Cornu, Stéphane Mouly, Gérard Amarenco, Bernard Jacquetin, Calin Ciofu, François Haab
    Abstract:

    Introduction and hypothesis Management of stress urinary incontinence (SUI) with Intravaginal Devices is an alternative to surgical management, but data of a high level of evidence remain scarce. Our goal was to assess efficacy, tolerance, and acceptability of the 75NC007 Intravaginal device for SUI management.

Julio A. Luna - One of the best experts on this subject based on the ideXlab platform.

  • Design and evaluation of a recyclable Intravaginal device made of ethylene vinyl acetate copolymer for bovine estrus synchronization
    Drug Delivery and Translational Research, 2020
    Co-Authors: Ignacio M. Helbling, Federico Karp, Alejandro Cappadoro, Julio A. Luna
    Abstract:

    In bovine estrus synchronization, Intravaginal Devices made of silicone are used to administer exogenous progesterone with the aim of maintain plasmatic levels above 2 ng ml^−1 during the treatment. After their use, Devices must be discarded. There is an important concern on the environmental impact of the disposal of these used products due mainly to the non-degradability of the silicone and to the residual content of the hormone. Different alternatives are being studied, and the use of ecological materials appears as the more important. The objective of the present contribution was to design and evaluate a recyclable Intravaginal prototype using ethylene vinyl acetate copolymer (EVA). Devices were fabricated by an injection-molding technique and characterized in terms of dimensions, loading efficiency, release rate, and wing tension. An analysis was first conducted to compare three different matrices and two supports. Secondly, the best candidate prototype was assayed in both beef and dairy cattle. Finally, used matrices were recycled measuring the progesterone content in the resulting Devices and testing them in vitro. According to release tests, no differences were observed between the three matrices both in vitro and in vivo. On the contrary, a better performance was achieved when a support with a more flexible Y shape was used in comparison with a rigid T geometry. Successful results were observed in non-lactating cows, with plasma concentrations above the threshold value defined for the synchronization therapy. However, lower progesterone levels resulted when Devices were tested in animals with large milk production. By last, recycled matrices presented a similar initial content and in vitro release rate than original matrices. These findings could open the possibility to use recyclable EVA Devices as an alternative to the non-degradable silicone Intravaginal inserts. Future research must be carried out to optimize the performance of the recycled matrices in dairy cattle. Modifications of the release surface and/or the initial loading can give a solution to the lower values observed in these animals. Graphical abstract

J F Fonseca - One of the best experts on this subject based on the ideXlab platform.

  • use of different Intravaginal Devices and doses of progesterone to induce synchronous estrus in santa ines sheep
    Animal reproduction, 2015
    Co-Authors: J F Prates, F R B Oliveira, A L R S Maia, M I C Ferreira, J M G Souzafabjan, F Z Brandao, J F Fonseca
    Abstract:

    The embryo transfer (ET) routine in sheep implies in successive and increased use of gonadotropin stimuli to ewes. Because these conditions can decrease the fertility of the females, it has been recommended to interval ET procedures with gestations. The objective of this study was to test the efficiency of protocols to induce synchronous estrus in Santa Ines donor ewes. The study was conducted from January to March in Coronel Pacheco-MG. Twenty four ewes previously subjected to six successive non-surgical embryo recovery were equally allocated according body weight (kg) and condition score (BCS; variation 1 to 5) in three experimental groups. Ewes of G1 (n=8; 57.6±12.0 kg; 3.3±0.8), G2 (n=8; 58.5±13.8 kg; 3.4±0.5) and G3 (n=8; 56.6±13.5 kg; 3.3±0.6) received Intravaginal Devices containing P4 for six days plus 37.5µg d-cloprostenol (Prolise®; ARSA S.R.L., Buenos Aires, Argentina) latero-vulvar and 300 IU eCG (Novormon 5000®; Coopers, Sao Paulo, Brazil) i.m. 24 h before device removal. It was used CIDR (G1; CIDR®; 330mg P4, Pfizer Saude Animal, Sao Paulo, Brasil), human absorbent (G2 and G3; O.B®; Johnson & Johnson, Sao Jose dos Campos, Brazil) imbibed with 200 (G2) or 400mg (G3) P4 (Evocanil®; Zodiac Produtos Farmaceuticos, Diadema, Brazil). After device removal, ewes were twice daily (morning/afternoon) checked for estrus and natural mated not exceeding four mating per ram per day.Statistical data are presented in descriptive form. Estrous response and interval to estrus were respectively 100.0% and 41.3±12.2h for G1, 62.5% and 30.0±7.0h for G2 and 100.0% and 28.5±14.2h for G3. Pregnancy rate was 50% (4/8), 25% (2/8) and 50% (4/8) to ewes from G1, G2 and G3, respectively. Overall pregnancy rate considering only ewes mated was 47.6% (10/21). Results of this study suggest that the use of alternative device and source of P4 can be considered to induction of synchronous estrus in Santa Ines ewes after successive non-surgical embryo collections.

  • autoclaved previously used Intravaginal progesterone Devices induces estrus and ovulation in anestrous toggenburg goats
    Animal Reproduction Science, 2011
    Co-Authors: J M G Souza, A L R S Maia, Ciro Alexandre Alves Torres, Felipe Zandonadi Brandao, J H Bruschi, Joao Henrique Moreira Viana, Eunice Oba, J F Fonseca
    Abstract:

    Abstract Intravaginal progesterone Devices are used worldwide for estrus induction in goats. Reused Devices are able to induce estrus; however, this can be a health risk within a flock. The objective was to compare new and previously used (and autoclaved) progesterone-releasing Intravaginal Devices for induction of estrus and ovulation in seasonally anestrous Toggenburg goats. Anestrous goats (n = 42) received new Intravaginal Devices containing 0.3 g progesterone (CONTROL), or similar Devices previously used for either 6 (USED6) or 12 d (USED12) and subsequently autoclaved. All goats received 5 mg dinoprost at device insertion and 200 IU eCG 5 d later, and all Devices were removed after 6 d. After device removal, estrus was monitored and females displaying signs of estrus were mated by fertile bucks. Transrectal ovarian ultrasonography was performed after device removal until detection of ovulation. Blood samples were collected for determination of plasma progesterone concentration at different times. There was no difference (P > 0.05) among groups CONTROL, USED6 or USED12 for: estrus response (87, 100 or 100%, respectively); duration of estrus (32.3 ± 2.3, 25.2 ± 3.4 or 27.3 ± 4.1 h); ovulation rate (100, 88 or 100%); number of ovulations (1.5 ± 0.2, 1.9 ± 0.3 or 1.7 ± 0.3); and pregnancy rate (60, 58 or 67%). Plasma progesterone (P4) concentrations were greater (P

  • 172 reuse of autoclaved Intravaginal progesterone device to estrous synchronization in toggenburg goats in the breeding season
    Reproduction Fertility and Development, 2011
    Co-Authors: J M G Souza, J. H. M. Viana, A L R S Maia, Felipe Zandonadi Brandao, J H Bruschi, C A A Torres, M C Silva, V J F Freitas, J F Fonseca
    Abstract:

    Reusing Intravaginal Devices represents an important alternative to reduce costs; however, this practice may increase disease transmission. The aim of this study was to evaluate the efficacy of reusing autoclaved Intravaginal progesterone Devices for oestrous synchronization in Toggenburg goats in the breeding season was studied. This study was done in March and April of 2009, in Piau, MG, Brazil (latitude 21°35′ and longitude 43°15′). Sixty-seven Toggenburg nulliparous (n = 17; 35.3 ± 5.4 kg and 3.3 ± 0.2) and pluriparous (n = 50; 52.9 ± 9.8 kg and 3.4 ± 0.3) goats were assigned according to weight and body condition score (BCS, 1 to 5 scale) into 3 treatments. Animals received new Devices (n = 25; 48.2 ± 11.5 kg and BCS 3.4 ± 0.3) containing 0.33 g of progesterone (Eazi-Breed CIDR®, Pfizer Animal Health, Sao Paulo, Brazil) or autoclaved (121°C, 1 atm, 15 min) Devices previously used for 6 days (n = 23; 48.3 ± 13.0 kg and 3.5 ± 0.3) or 12 days (n = 22; 48.2 ± 11.0 kg and 3.4 ± 0.3). All goats received 5 mg dinoprost (Lutalyse®, Pfizer Animal Health) in the vulvar submucosa on the day of CIDR insertion (Day 0) and 200 IU eCG (Novormon 5000®, Sintex Industria Bioquimica, Buenos Aires, Argentina) 1 day before CIDR removal, also in the vulvar submucosa. The CIDR were removed on day 6, and goats were bred twice daily with fertile bucks at oestrous onset and 24 h later if they were still in oestrus. Parametric variables were analysed by ANOVA and SNK tests by the SAEG® program. Nonparametric variables were analysed using the chi-square test by the BioEstat® program. The results are described as mean ± SD. Oestrous response and conception rates did not differ (P > 0.05) among goats treated with the new Devices (75.0; 54.2%) or those previously used for 6 (81.8; 50.0%) or 12 days (71.4; 47.6%), respectively. No differences were detected between nulliparous (82.3; 52.9%) and pluriparous (72.0; 50.0%) goats. The interval from device removal to oestrus and duration of oestrus were not different (P > 0.05) among animals receiving a new device (39.3 ± 15.8; 30.7 ± 16.6 h) or previously used Devices for 6 (32.7 ± 11.5; 31.8 ± 7.3 h) or 12 day (40.8 ± 20.7; 32.8 ± 13.2 h) treatments, respectively, or between nulliparous (41.6 ± 14.9; 30.9 ± 13.9 h) and pluriparous (35.6 ± 16.8; 32.1 ± 12.8 h) goats. Since no differences were detected in the evaluated variables among goats receiving reused autoclaved Devices or new ones, it can be suggested that the autoclaving process did not affect the efficiency of reusing Intravaginal progesterone Devices for oestrous synchronization in Toggenburg goats in the breeding season. Probably, P4 concentrations in goats receiving reused autoclaved Devices reached at least minimum concentrations to promote oestrous response, since a non-treated group would not show oestrus in this level of synchronization as in goats in this study. This technique can be a simple and valuable tool to reduce sanitary risks of disease transmission without altering fertility in goats. CNPq, Pfizer Animal Health, Embrapa Goats, and Sheep Research, CAPES.

Linda Cardozo - One of the best experts on this subject based on the ideXlab platform.

  • external electrical stimulation compared with Intravaginal electrical stimulation for the treatment of stress urinary incontinence in women a randomized controlled noninferiority trial
    Neurourology and Urodynamics, 2019
    Co-Authors: Roger R Dmochowski, Catherine M Lynch, Mitchell Efros, Linda Cardozo
    Abstract:

    AIMS To compare the efficacy and safety of a neuromuscular external electrical stimulation device (INNOVO; "NMES") with an FDA-approved Intravaginal device (iTouch sure; "comparator device") for the treatment of stress urinary incontinence (SUI). METHODS This prospective, single-blind, multicenter, noninferiority study randomized women with SUI to treatment with the NMES or the comparator device for 12 weeks. The primary endpoint was the proportion achieving >50% reduction in pad weight from baseline to 12 weeks in the provocative pad weight test. RESULTS Most subjects in both groups achieved >50% reduction in pad weight in the provocative pad test at week 12 (NMES 56.3%; comparator 63.0%), although noninferiority was not established. Significant improvements in pad tests, number of incontinence episodes, and pads used per day, and incontinence quality of life score were seen with both Devices at week 12, with no clinically relevant between-group differences. Adverse events were predominantly mild/moderate and there were few discontinuations due to adverse events. The incidence of urinary tract/vaginal infections was higher with the comparator device than the NMES (7.7% versus 0%). The most common device-related adverse effect with the NMES was device discomfort (9.0%), which was generally manageable by modifying the stimulation intensity. CONCLUSIONS The NMES significantly improved objective and subjective measures of SUI, although statistical noninferiority was not established. The NMES was well tolerated and associated with fewer urinary tract infections than the comparator. The NMES provides a safe, clinically effective, conservative treatment option for female SUI and a low-risk alternative to Intravaginal Devices.

A L R S Maia - One of the best experts on this subject based on the ideXlab platform.

  • use of different Intravaginal Devices and doses of progesterone to induce synchronous estrus in santa ines sheep
    Animal reproduction, 2015
    Co-Authors: J F Prates, F R B Oliveira, A L R S Maia, M I C Ferreira, J M G Souzafabjan, F Z Brandao, J F Fonseca
    Abstract:

    The embryo transfer (ET) routine in sheep implies in successive and increased use of gonadotropin stimuli to ewes. Because these conditions can decrease the fertility of the females, it has been recommended to interval ET procedures with gestations. The objective of this study was to test the efficiency of protocols to induce synchronous estrus in Santa Ines donor ewes. The study was conducted from January to March in Coronel Pacheco-MG. Twenty four ewes previously subjected to six successive non-surgical embryo recovery were equally allocated according body weight (kg) and condition score (BCS; variation 1 to 5) in three experimental groups. Ewes of G1 (n=8; 57.6±12.0 kg; 3.3±0.8), G2 (n=8; 58.5±13.8 kg; 3.4±0.5) and G3 (n=8; 56.6±13.5 kg; 3.3±0.6) received Intravaginal Devices containing P4 for six days plus 37.5µg d-cloprostenol (Prolise®; ARSA S.R.L., Buenos Aires, Argentina) latero-vulvar and 300 IU eCG (Novormon 5000®; Coopers, Sao Paulo, Brazil) i.m. 24 h before device removal. It was used CIDR (G1; CIDR®; 330mg P4, Pfizer Saude Animal, Sao Paulo, Brasil), human absorbent (G2 and G3; O.B®; Johnson & Johnson, Sao Jose dos Campos, Brazil) imbibed with 200 (G2) or 400mg (G3) P4 (Evocanil®; Zodiac Produtos Farmaceuticos, Diadema, Brazil). After device removal, ewes were twice daily (morning/afternoon) checked for estrus and natural mated not exceeding four mating per ram per day.Statistical data are presented in descriptive form. Estrous response and interval to estrus were respectively 100.0% and 41.3±12.2h for G1, 62.5% and 30.0±7.0h for G2 and 100.0% and 28.5±14.2h for G3. Pregnancy rate was 50% (4/8), 25% (2/8) and 50% (4/8) to ewes from G1, G2 and G3, respectively. Overall pregnancy rate considering only ewes mated was 47.6% (10/21). Results of this study suggest that the use of alternative device and source of P4 can be considered to induction of synchronous estrus in Santa Ines ewes after successive non-surgical embryo collections.

  • autoclaved previously used Intravaginal progesterone Devices induces estrus and ovulation in anestrous toggenburg goats
    Animal Reproduction Science, 2011
    Co-Authors: J M G Souza, A L R S Maia, Ciro Alexandre Alves Torres, Felipe Zandonadi Brandao, J H Bruschi, Joao Henrique Moreira Viana, Eunice Oba, J F Fonseca
    Abstract:

    Abstract Intravaginal progesterone Devices are used worldwide for estrus induction in goats. Reused Devices are able to induce estrus; however, this can be a health risk within a flock. The objective was to compare new and previously used (and autoclaved) progesterone-releasing Intravaginal Devices for induction of estrus and ovulation in seasonally anestrous Toggenburg goats. Anestrous goats (n = 42) received new Intravaginal Devices containing 0.3 g progesterone (CONTROL), or similar Devices previously used for either 6 (USED6) or 12 d (USED12) and subsequently autoclaved. All goats received 5 mg dinoprost at device insertion and 200 IU eCG 5 d later, and all Devices were removed after 6 d. After device removal, estrus was monitored and females displaying signs of estrus were mated by fertile bucks. Transrectal ovarian ultrasonography was performed after device removal until detection of ovulation. Blood samples were collected for determination of plasma progesterone concentration at different times. There was no difference (P > 0.05) among groups CONTROL, USED6 or USED12 for: estrus response (87, 100 or 100%, respectively); duration of estrus (32.3 ± 2.3, 25.2 ± 3.4 or 27.3 ± 4.1 h); ovulation rate (100, 88 or 100%); number of ovulations (1.5 ± 0.2, 1.9 ± 0.3 or 1.7 ± 0.3); and pregnancy rate (60, 58 or 67%). Plasma progesterone (P4) concentrations were greater (P

  • 172 reuse of autoclaved Intravaginal progesterone device to estrous synchronization in toggenburg goats in the breeding season
    Reproduction Fertility and Development, 2011
    Co-Authors: J M G Souza, J. H. M. Viana, A L R S Maia, Felipe Zandonadi Brandao, J H Bruschi, C A A Torres, M C Silva, V J F Freitas, J F Fonseca
    Abstract:

    Reusing Intravaginal Devices represents an important alternative to reduce costs; however, this practice may increase disease transmission. The aim of this study was to evaluate the efficacy of reusing autoclaved Intravaginal progesterone Devices for oestrous synchronization in Toggenburg goats in the breeding season was studied. This study was done in March and April of 2009, in Piau, MG, Brazil (latitude 21°35′ and longitude 43°15′). Sixty-seven Toggenburg nulliparous (n = 17; 35.3 ± 5.4 kg and 3.3 ± 0.2) and pluriparous (n = 50; 52.9 ± 9.8 kg and 3.4 ± 0.3) goats were assigned according to weight and body condition score (BCS, 1 to 5 scale) into 3 treatments. Animals received new Devices (n = 25; 48.2 ± 11.5 kg and BCS 3.4 ± 0.3) containing 0.33 g of progesterone (Eazi-Breed CIDR®, Pfizer Animal Health, Sao Paulo, Brazil) or autoclaved (121°C, 1 atm, 15 min) Devices previously used for 6 days (n = 23; 48.3 ± 13.0 kg and 3.5 ± 0.3) or 12 days (n = 22; 48.2 ± 11.0 kg and 3.4 ± 0.3). All goats received 5 mg dinoprost (Lutalyse®, Pfizer Animal Health) in the vulvar submucosa on the day of CIDR insertion (Day 0) and 200 IU eCG (Novormon 5000®, Sintex Industria Bioquimica, Buenos Aires, Argentina) 1 day before CIDR removal, also in the vulvar submucosa. The CIDR were removed on day 6, and goats were bred twice daily with fertile bucks at oestrous onset and 24 h later if they were still in oestrus. Parametric variables were analysed by ANOVA and SNK tests by the SAEG® program. Nonparametric variables were analysed using the chi-square test by the BioEstat® program. The results are described as mean ± SD. Oestrous response and conception rates did not differ (P > 0.05) among goats treated with the new Devices (75.0; 54.2%) or those previously used for 6 (81.8; 50.0%) or 12 days (71.4; 47.6%), respectively. No differences were detected between nulliparous (82.3; 52.9%) and pluriparous (72.0; 50.0%) goats. The interval from device removal to oestrus and duration of oestrus were not different (P > 0.05) among animals receiving a new device (39.3 ± 15.8; 30.7 ± 16.6 h) or previously used Devices for 6 (32.7 ± 11.5; 31.8 ± 7.3 h) or 12 day (40.8 ± 20.7; 32.8 ± 13.2 h) treatments, respectively, or between nulliparous (41.6 ± 14.9; 30.9 ± 13.9 h) and pluriparous (35.6 ± 16.8; 32.1 ± 12.8 h) goats. Since no differences were detected in the evaluated variables among goats receiving reused autoclaved Devices or new ones, it can be suggested that the autoclaving process did not affect the efficiency of reusing Intravaginal progesterone Devices for oestrous synchronization in Toggenburg goats in the breeding season. Probably, P4 concentrations in goats receiving reused autoclaved Devices reached at least minimum concentrations to promote oestrous response, since a non-treated group would not show oestrus in this level of synchronization as in goats in this study. This technique can be a simple and valuable tool to reduce sanitary risks of disease transmission without altering fertility in goats. CNPq, Pfizer Animal Health, Embrapa Goats, and Sheep Research, CAPES.