Path-related pain after implantation of anterior transvaginal mesh: perspective from anatomical study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) is a common gynecological disease caused by defects in pelvic support tissue that manifests as the descent of the pelvic organs, significantly impacting patient quality of life. Transvaginal mesh (TVM) is an effective treatment (Grade A). However, postoperative pain in the groin and medial thigh is very common. Although the use of mesh for transvaginal POP repair has been prohibited or the indications for such use have been extensively limited in many places, it is still an alternative in some countries. Therefore, the safety of the use of mesh still needs to be discussed. The current research on postoperative pain has mainly focused on management. The pathophysiology is unclear. METHODS: In this study, anterior TVM surgery was performed on ten frozen cadavers. The obturator area was carefully dissected. We explored the relative position of the polypropylene mesh to the internal segment of the obturator nerve in the obturator canal. RESULTS: Four out of 20 obturator explorations were insufficient to allow conclusions to be drawn. We observed a small branch of the obturator nerve, which is a new anatomical finding that we named the obturator externus muscle branch. This structure terminated in the external obturator muscle in 6 out of the 16 successfully dissected obturator areas. The mean distance between the superficial mesh arm and this nerve branch was 7.5 mm. The mean distance between the deep mesh arm and the closest nerve branch was 5.5 mm. CONCLUSION: The path of the obturator externus muscle branch of the obturator nerve ran close to the mesh arm. It may provide a clinical anatomical basis explaining the observed postoperative pain.

Impact of human umbilical cord-derived stem cells (HUMSCs) on host responses to a synthetic polypropylene mesh for pelvic floor reconstruction in a rat model.

In order to evaluate the effects of human umbilical cord-derived stem cells (HUMSCs) on the biocompatibility of and tissue response to a polypropylene (PP) mesh (Gynemesh™ PS) implanted in rat vaginas, HUMSCs were isolated and characterized in vitro and then combined with Gynemesh™ PS to create a tissue-engineered mesh. This tissue-engineered mesh and pure PP mesh were implanted in the submucosae of the posterior vaginal walls of rats. Mesh/tissue complexes were harvested at 1, 4 and 12 weeks after implantation. Histological evaluations including an assessment of the inflammatory reaction, neovascularization and fibrosis around the mesh fibers were performed and real-time quantitative polymerase chain reaction (RT-PCR) was used to analyze the mRNA expression of genes involved in wound healing at the tissue-mesh interface. After being seeded onto the PP mesh scaffold, HUMSCs grew and proliferated well in vitro culture. One week after implantation, the HUMSC-seeded mesh elicited a greater inflammatory response than the pure PP mesh (3.33 ± 0.21 vs. 2.63 ± 0.18, p = 0.026), while 4 and 12 weeks after implantation, the inflammatory response in the HUMSC-seeded mesh was lower than that in the unseeded mesh (p < 0.05). At 12 weeks, the HUMSC-seeded mesh induced a lower expression of matrix metalloproteinase (MMP)-1 and a higher expression of anti-inflammatory cytokine interleukin (IL)-4. HUMSCs may decrease the inflammatory response and improve the biocompatibility of a conventional synthetic mesh and may have the potential to reduce postoperative complications such as mesh exposure or erosion.

The in vivo biocompatibility of titanized polypropylene lightweight mesh is superior to that of conventional polypropylene mesh.

OBJECTIVE: To evaluate the histological response to and changes in the biomechanical properties of titanized polypropylene lightweight mesh and conventional polypropylene mesh at 1 and 12 weeks following implantation in the sheep vagina. METHODS: We compared a titanized polypropylene lightweight mesh (TiLOOP Mesh) to a conventional polypropylene mesh (Gynemesh PS) in a sheep vagina model. Explants were harvested after 1 and 12 weeks (n = 6/mesh type/time point) for histological observation. After 12 weeks, mesh-tissue complex specimens were biomechanically assessed by a uniaxial tension system. RESULTS: One week after implantation, there was no significant difference in the inflammatory response between the two groups. Twelve weeks after implantation, the TiLOOP light mesh elicited a lower inflammatory response than was observed for the Gynemesh PS (1.44 ± 0.61 vs 2.05 ± 0.80, P = .015). Twelve weeks after implantation, the collagen I/III ratio was lower in the TiLOOP light mesh group than in the Gynemesh PS group (9.41 ± 5.06 vs 15.21 ± 8.21, P = .019). The messenger RNA expression levels of the inflammatory factors interleukin 10 and tumor necrosis factor α were lower in the TiLOOP Mesh group than in the Gynemesh PS group at both 1 and 12 weeks (P < .05). There were no significant differences in any of the evaluated biomechanical characteristics between the two meshes (P > .05). CONCLUSION: Although the titanized polypropylene lightweight mesh induces slightly less tissue reactivity and has better in vivo biocompatibility, further studies should be conducted including the complications and the success rate of pelvic organ prolapse in patients before recommending it in pelvic floor reconstruction.

Experimental study of a new original mesh developed for pelvic floor reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: Most synthetic meshes used in transvaginal surgery are made of polypropylene, which has a stable performance, but does not easily degrade in vivo. However, mesh-related complications are difficult to address and have raised serious concerns. A new biomaterial mesh with good tissue integration and few mesh-related complications is needed. To evaluate the effect of a new bacterial cellulose (BC) mesh on pelvic floor reconstruction following implantation in the vagina of sheep after 1 and 12 weeks. METHODS: The meshes were implanted in the submucosa of the posterior vagina wall of sheep. At 1 and 12 weeks after surgery, mesh-tissue complex (MTC) specimens were harvested for histological studies and biomechanical evaluation. At 12 weeks after surgery, MTC specimens were biomechanically assessed by a uniaxial tension "pulley system". RESULTS: The BC mesh elicited a higher inflammatory response than Gynemesh™PS at both 1 and 12 weeks after implantation. Twelve weeks after implantation, the BC mesh resulted in less fibrosis than Gynemesh™PS. Compared with the Gynemesh™PS group, the BC mesh group had increased mRNA expression of MMP-1, MMP-2, and MMP-9 (P < 0.05), but decreased expression of the anti-inflammatory factor IL-4 (P < 0.05). Twelve weeks after implantation, the ultimate load and maximum elongation percentage of the BC mesh were significantly lower than those of Gynemesh™PS. CONCLUSIONS: The BC mesh could not be a promising biomaterial for pelvic floor reconstructive surgery unless the production process and parameters were improved.

Regulating Tumor-Associated Macrophage Polarization by Cyclodextrin-Modified PLGA Nanoparticles Loaded with R848 for Treating Colon Cancer.

Purpose: This study aimed to develop a novel and feasible modification strategy to improve the solubility and antitumor activity of resiquimod (R848) by utilizing the supramolecular effect of 2-hydroxypropyl-beta-cyclodextrin (2-HP-ß-CD). Methods: R848-loaded PLGA nanoparticles modified with 2-HP-ß-CD (CD@R848@NPs) were synthesized using an enhanced emulsification solvent-evaporation technique. The nanoparticles were then characterized in vitro by several methods, such as scanning electron microscopy (SEM), differential scanning calorimetry (DSC), Fourier transform infrared (FTIR) spectroscopy, particle size analysis, and zeta potential analysis. Then, the nanoparticles were loaded with IR-780 dye and imaged using an in vivo imaging device to evaluate their biodistribution. Additionally, the antitumor efficacy and underlying mechanism of CD@R848@NPs in combination with an anti-TNFR2 antibody were investigated using an MC-38 colon adenocarcinoma model in vivo. Results: The average size of the CD@R848@NPs was 376 ± 30 nm, and the surface charge was 21 ± 1 mV. Through this design, the targeting ability of 2-HP-ß-CD can be leveraged and R848 is delivered to tumor-supporting M2-like macrophages in an efficient and specific manner. Moreover, we used an anti-TNFR2 antibody to reduce the proportion of Tregs. Compared with plain PLGA nanoparticles or R848, CD@R848@NPs increased penetration in tumor tissues, dramatically reprogrammed M1-like macrophages, removed tumors and prolonged patient survival. Conclusion: The new nanocapsule system is a promising strategy for targeting tumor, reprogramming tumor -associated macrophages, and enhancement immunotherapy.

Anatomic and sexual outcomes after vaginoplasty using tissue-engineered biomaterial graft in patients with Mayer-Rokitansky-Küster-Hauser syndrome: a new minimally invasive and effective surgery.

INTRODUCTION: Recent years have seen continuous reports about the successful reconstruction of numerous organs with the application of tissue-engineering techniques. Thus, we assess the outcomes for vagina reconstruction using tissue-engineered biological material, which we suggested previously as an ideal graft for vaginoplasty. AIM: To evaluate the anatomic and sexual outcomes in patients undergoing vaginoplasty using tissue-engineered biomaterial mesh. METHODS: This prospective study included 53 patients with Mayer-Rokitansky-Küster-Hauser syndrome admitted to our hospital. Patients underwent vaginoplasty with tissue-engineered biological material (acellular dermal matrix). Postoperatively, a silicone vaginal dilator (length: 10 cm, diameter: 3.5 cm) was advised to be used for the first 3-6 months to prevent contraction of the neovagina. Follow-up was performed at 4 weeks, 12 weeks, 12 months, and then annually. Twenty-four age-matched women who underwent health examinations during the same time period were selected as a health control group and answered Female Sexual Function Index (FSFI) questionnaires for the purpose of comparing sexuality. MAIN OUTCOME MEASURES: Anatomic success was defined by a vaginal length ≥ 8 cm and a width allowing the easy introduction of two fingers. Sexual outcomes were assessed at the 12-month follow-up according to body image perception and FSFI questionnaires validated for the Chinese-speaking population. RESULTS: No severe intra-operative complications occurred. No graft-related infection, rejection, or detachment was recorded. The cost for tissue-engineered biomaterial graft was $1,900 (¥ 12,000) per person. Postoperatively, granulomatous polyps occurred in 6/53 patients (11.3%) at the vaginal vault and were removed in an outpatient clinic. During a mean follow-up of 21.1 months, the anatomic success rate was 100%, and all of the patients were satisfied with their body image. Postoperatively, 42 patients were followed up for more than 1 year, and 32 of them were sexually active. Among the 24/32 patients (75%) who answered the FSFI questionnaire, the mean total FSFI score was 26.7 ± 3.5, which was similar to that of the control group (25.6 ± 7.4, P = 0.46). The similarity was also observed in six separate domains of the functional aspect of female sexuality. CONCLUSIONS: Vaginoplasty with tissue-engineered biomaterial graft is a safe, effective, minimally invasive cosmetic procedure that provides near normal sexual function for patients with vaginal aplasia.

Cell Wall Pectin Content Refers to Favored Delivery of Negatively Charged Carbon Dots in Leaf Cells.

In this work, we systematically investigated how cell wall and cell wall components affect the delivery of charged carbon quantum dots (CDs, from -34 to +41 mV) to leaf cells of cucumber and Arabidopsis plants. Four different types of leaf cells in cucumber and Arabidopsis were used, i.e., protoplasts (without cell wall), isolated individual cells (cell wall hydrolyzed with pectinase), regenerated individual cells (cell wall regenerated from protoplast), and intact leaf cells (intact cell wall, in planta). Leaf cells were incubated with charged CDs (0.5 mg/mL) for 2 h. Confocal imaging results showed that protoplasts, regenerated individual cells, and leaf cells showed favored uptake of the negatively charged CDs (-34 mV) compared to the PEI (polyethylenimine) coated and positively charged carbon dots [PEI600-CDs (17 mV) and PEI10K-CDs (41 mV)], while in isolated individual cells, the trend is opposite. The results of the content of the cell wall components showed that no significant changes in the total cell wall content were found between isolated individual cells and regenerated individual cells (1.28 vs 1.11 mg/106 cells), while regenerated individual cells showed significant higher pectin content [water-soluble pectin (0.13 vs 0.06 mg/106 cells, P < 0.01), chelator-soluble pectin (0.04 vs 0.01 mg/106 cells, P < 0.01), and alkaline pectin (0.02 vs 0.01 mg/106 cells, P < 0.01)] and significant lower cellulose content (0.13 vs 0.32 mg/106 cells, P < 0.01) than the isolated individual cells. No difference of the hemicellulose content was found between isolated individual cells and regenerated individual cells (0.20 vs 0.21 mg/106 cells). Our results suggest that compared with cellulose and hemicellulose in the cell wall, the pectin is a more important factor referring to the favored uptake of negatively charged carbon dots in leaf cells. Overall, this work provides a method to study the role of cell wall components in the uptake of nanoparticles in plant cells and also points out the importance of understanding the interactions between cell barriers and nanoparticles to design nanoparticles for agricultural use.

Advances in anti-adhesive materials in preventing pelvic and abdominal post-operative adhesions.

Post-operative adhesions are a common complication of pelvic and abdominal surgeries. Many approaches for preventing post-operative adhesions have been developed. This review summarizes the recent advances in this topic.

[Creation of an animal model for post-operative adhesion prevention].

OBJECTIVE: To establish a rabbit double uterine horn model for assessing the time-course of pelvic adhesions and evaluating the effectiveness of different anti-adhesive materials in reducing adhesions. METHODS: A total of 330 Japanese white rabbits underwent laparotomy, followed by uterine horn incision. Animals were euthanized after 3, 7, 14, 28, and 42 days, respectively. RESULTS: The surgical procedure was smooth. Rabbit double uterine horn model was applied for the evaluation of pelvic adhesions in a three-dimension fashion. Each of the three means-gauze abrasion, needle holder clamping, and direct uterine incision induced postoperative pelvic adhesions, among which direct uterine incision was the best to mimic conditions after gynecological operations. Under normal circumstances, degradation of filmy fibrinous adhesions by locally released proteases of the fibrinolytic system occurred within 3 days of injury. The regeneration of the mesothelium was completed within 7 days. Collagen reached its peak by day 14. Anti-adhesive materials were supposed to be completely absorbed by day 28, and their effectiveness in preventing pelvic adhesions was confirmed at this time point. Whether their effect can be maintained after the absorption of the anti-adhesive materials was investigated in 42 days. CONCLUSIONS: The animal model was successfully established. It well mimics the postoperative pelvic adhesions after direct uterine horn injury and thus is a suitable model for studying site-specific adhesions. Observations on the 3rd, 7th, 14th, 28th, and 42nd post-operative days provided a full picture of the adhesion formation process.

[Distribution specificity of human fucosyltransferase 5 and its expression and localization in spermatids].

OBJECTIVE: To investigate distribution specificity of human fucosyltransferase 5 (FUT5) as well as its expression and localization in spermatids. METHODS: Human semen, vaginal swab, saliva and venous blood from healthy individuals were collected. The spermatids were isolated and the spermatid membrane protein was then extracted. Expression levels of FUT5 from human spermatid membrane, seminal plasma, vaginal fluid, saliva and serum were detected by immunoblotting technique. The expression and localization of FUT5 in spermatids were analyzed by immunofluorescent method. RESULTS: Immunoblotting technique showed that FUT5 was expressed on spermatid membranes and in serum, but not in seminal plasma, vaginal fluid and saliva. The expressed FUT5 on spermatids was mostly localized on head of spermatids by fluorescent microscopy, suggesting that there was certain amount of FUT5 on human spermatid membrane, and the spermatids might be isolated from mixed stains with vaginal fluid by antigen-antibody reaction. CONCLUSION: Human FUT5 shows a characteristic distribution specificity, and this feature may be used for identification of mixed stain involved in criminal sexual offence in future forensic practice.

Effectiveness of Self-cut vs Mesh-Kit Titanium-Coated Polypropylene Mesh for Transvaginal Treatment of Severe Pelvic Organ Prolapse: A Multicenter Randomized Noninferiority Clinical Trial.

Importance: Transvaginal mesh (TVM) can increase the durability of vaginal surgical procedures for pelvic organ prolapse (POP) and may be indicated in certain situations despite concerns about mesh-related complications. In addition, the expense of commercial mesh kits has limited their use. The effectiveness, safety, and cost of a self-cut mesh procedure compared with a commercial mesh-kit procedure for the surgical treatment of women with POP is unclear. Objective: To assess the 1-year effectiveness and safety of self-cut titanium-coated polypropylene mesh compared with a precut commercial mesh kit for the transvaginal surgical treatment of women with severe symptomatic POP. Design, Setting, and Participants: This multicenter randomized noninferiority clinical trial was conducted at 11 hospitals in 8 provinces of China. A total of 336 women with symptomatic stage 3 to 4 POP were enrolled between January 22, 2018, and November 11, 2019, with follow-up through December 11, 2020. Interventions: Participants were randomized to receive a TVM procedure using either self-cut mesh (self-cut mesh group) or a precut commercial mesh kit (mesh-kit group), both of which used the same titanium-coated polypropylene mesh. Main Outcomes and Measures: The primary outcome measure was composite surgical success at 1 year, which was defined as the absence of vaginal bulge symptoms, no additional retreatment for POP, and no vaginal prolapse at or beyond the hymen. Secondary outcomes included symptom-specific pelvic floor function and quality-of-life measures as well as perioperative complications, including mesh-related complications and hospitalization costs. Complications were categorized using the Clavien-Dindo system (with grade 1 indicating any deviation from the normal postoperative course but not requiring grade 2-4 interventions; grade 2, need for pharmacological treatment, blood transfusion, and/or total parenteral nutrition; grade 3, the need for surgical, endoscopic, and/or interventional radiological procedures; and grade 4, life threatening). Results: Among 336 female participants (mean [SD] age, 63.3 [5.9] years; all of Chinese ethnicity), 169 patients were randomized to the self-cut mesh group, and 167 were randomized to the mesh-kit group. Three patients were unavailable for follow-up after 1 year. In the intention-to-treat analysis, 162 women (95.9%) in the self-cut mesh group had outcomes that met the definition of surgical success; this result was noninferior to the surgical success rate observed in the mesh-kit group (146 women [87.4%]; risk difference, 8.5%; 95% CI, 2.2%-14.3%; P = .006). The frequency of Clavien-Dindo grade 1 to 3 perioperative complications was not significant between groups (12 of 166 women [7.2%] in the self-cut mesh group vs 20 of 161 women [12.4%] in the mesh-kit group; P = .14). Vaginal mesh exposure rates in women examined at 1 year were similar (4 women [2.4%] in the self-cut mesh group vs 8 women [4.8%] in the mesh-kit group; P = .23). Median (IQR) total hospitalization costs were $3663.00 ($3258.90-$4495.10) in the self-cut mesh group vs $6144.00 ($5434.90-$7160.20) in the mesh-kit group (P < .01), representing savings of $2481.00 (40.4%) with the use of self-cut mesh. Conclusions and Relevance: In this clinical trial, the composite surgical success rate of a self-cut mesh procedure was noninferior to that of a commercial mesh-kit procedure using the same titanium-coated polypropylene mesh and reduced hospitalization expenses by 40.4%. These findings suggest that the use of self-cut mesh procedures may be advantageous for the surgical treatment of some women with severe POP, particularly those in countries with low and middle income. Trial Registration: ClinicalTrials.gov identifier: NCT03283124.

A perfusable, multifunctional epicardial device improves cardiac function and tissue repair.

Despite advances in technologies for cardiac repair after myocardial infarction (MI), new integrated therapeutic approaches still need to be developed. In this study, we designed a perfusable, multifunctional epicardial device (PerMed) consisting of a biodegradable elastic patch (BEP), permeable hierarchical microchannel networks (PHMs) and a system to enable delivery of therapeutic agents from a subcutaneously implanted pump. After its implantation into the epicardium, the BEP is designed to provide mechanical cues for ventricular remodeling, and the PHMs are designed to facilitate angiogenesis and allow for infiltration of reparative cells. In a rat model of MI, implantation of the PerMed improved ventricular function. When connected to a pump, the PerMed enabled targeted, sustained and stable release of platelet-derived growth factor-BB, amplifying the efficacy of cardiac repair as compared to the device without a pump. We also demonstrated the feasibility of minimally invasive surgical PerMed implantation in pigs, demonstrating its promise for clinical translation to treat heart disease.

Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial.

BACKGROUND: Pelvic organ prolapse (POP) is a common health problem and has significant negative effects on a woman's quality of life. The transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our previous case-series study showed that the use of self-cut mesh had a good success rate (91.8% at 1-year follow-up) and low complication rate. This trial is designed to compare a self-cut titanium-coated polypropylene mesh procedure with a mesh kit for the treatment of symptomatic stage III-IV anterior or apical prolapse in terms of efficacy, safety and cost-effectiveness. METHODS: The trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite success rate at 1-year follow-up. The secondary outcomes are anatomic outcomes of each vaginal segment (anterior, posterior and apical) using the POP-Q score, subjective improvement of quality of life according to questionnaires, intraoperative parameters, complications and costs. Analysis will be performed according to the intention-to-treat principle. Based on a comparable success rate of 90% and 10% as the margin (ß = 0.2 and one-sided α = 0.025), about 312 patients in total from 11 centers will be recruited including 10% dropout. The aims of the research are to demonstrate whether the self-cut mesh procedure is non-inferior to the mesh-kit procedure and to investigate the performance of titanium-coated mesh for vaginal prolapse repair. DISCUSSION: This multicenter non-inferiority trial will evaluate whether the efficacy and safety of self-cut mesh is non-inferior to mesh kits in women with severe symptomatic stage III-IV anterior or apical prolapse. If we are able to show that the self-cut mesh procedure is non-inferior to the mesh-kit procedure in success rates, then the self-cut mesh procedure may be more cost-effective. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03283124. Registered on 17 January 2018.

Comparing vaginal tape and transobturator tape for the treatment of mild and moderate stress incontinence.

OBJECTIVE: To compare the efficacy and safety of the tension-free vaginal tape (TVT) and transobturator suburethral tape (TVT-O) procedures for the treatment of mild and moderate stress urinary incontinence (SUI). METHODS: A total of 56 women were randomly selected to undergo the TVT-O or the TVT procedure. In some patients, vaginal repair or vaginal hysterectomy was done simultaneously for associated indications. RESULTS: Mean blood loss and hospital stay duration were the same for the 2 groups, but mean +/- SD operative time was significantly shorter in the TVT-O than in the TVT group (16+/-4 min vs 27+/-6 min; P<0.001). On the second day following surgery a residual urine volume less than 100 mL was noted in 86% and 89% of the patients in the TVT-O and TVT groups, respectively; cure was achieved in 92.9% and 92.6% of the patients. No serious complications occurred in either group. Outcome was subjectively assessed, with the patients followed-up for a mean of 27.6 months. CONCLUSION: No significant differences in rates of cure, postoperative urine retention, or operative complications were found following the TVT-O or the TVT procedure.

Efficacy and Safety of Everolimus for Maintenance Immunosuppression of Kidney Transplantation: A Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Conversion to everolimus is often used in kidney transplantation to overcome calcineurin inhibitor (CNI) nephrotoxicity but there is conflicting evidence for this approach. OBJECTIVES: To investigate the benefits and harm from randomized clinical trials (RCTs) involving the conversion from CNI to everolimus after kidney transplantation. METHODS: Databases were searched up to March 2016. Two reviewers independently assessed trials for eligibility and quality, and extracted data. Results are expressed as risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). RESULTS: Eleven RCTs, with a total of 1,633 patients, met the final inclusion criteria. Patients converted to everolimus had improved renal function at 1 year posttransplant with an estimated glomerular filtration rate (eGFR) of 5.36 mL/min per 1.73 m2 greater than patients remaining on CNI (p = 0.0005) and the longer-term results (> 1 year) of renal function was identical to that of 1 year. There was not a substantial difference in graft loss, mortality, and the occurrence of adverse events (AEs) or serious AEs. However, the risks of acute rejection and trial termination due to AEs with everolimus are respectively 1.82 and 2.63 times greater than patients staying on CNI at 1 year posttransplant (p = 0.02, p = 0.03, respectively). Further, those patients who converted to everolimus had a substantially greater risk of anemia, hyperlipidemia, hypercholesterolemia, hypokalemia, proteinuria, stomatitis, mouth ulceration, and acne. CONCLUSIONS: Conversion from CNI to everolimus after kidney transplantation is associated with improved renal function in the first 5 years posttransplant but increases the risk of acute rejection at 1 year posttransplant and may not be well endured.

Efficacy and safety of solifenacin succinate tablets versus solifenacin succinate tablets with local estrogen for the treatment of overactive bladder in postmenopausal women--a multicenter, randomized, open-label, controlled comparison study.

OBJECTIVE: The aim of the study was to compare the effectiveness and safety of solifenacin succinate tablets alone or combined with local estrogen for overactive bladder treatment in postmenopausal women. METHODS: This multicenter, randomized, open, parallel-controlled clinical trial enrolled 104 women between January 2012 and August 2013. Participants meeting the inclusion criteria were randomized 1:1 to 12 weeks of treatment with group A (solifenacin 5 mg qd + promestriene vaginal capsules intravaginally) or group B (solifenacin 5 mg qd). Before and after 12 weeks of treatment, symptoms (urinary urgency, frequency, and urge incontinence) were analyzed. Our primary outcome was the change from baseline to the end of treatment in the mean number of voids in 24 hours. Quality of life (QoL) was assessed using International Prostate Symptom Score and Overactive Bladder Symptom Score questionnaires and safety according to the incidence of adverse events. The t test or the Mann-Whitney U test was used to compare continuous variables, and the χ(2) test or Fisher's exact test was used to compare categorical variables. RESULTS: The median decreases in the mean number of voids in 24 hours in groups A and B were 5.2. and 4.3, respectively, which were not significantly different. The median decreases in urgency episodes in groups A and B were 2.0 and 2.5, respectively. In addition, the QoL scores significantly changed in both groups (both P < 0.05). The most common adverse event was dry mouth (19.2% in both groups). CONCLUSIONS: Solifenacin with or without local estrogen was effective and safe for overactive bladder treatment in postmenopausal women. The addition of local estrogen improved subjective feelings and QoL.

Tension-free polypropylene mesh-related surgical repair for pelvic organ prolapse has a good anatomic success rate but a high risk of complications.

BACKGROUND: Food and Drug Administration announcements have highlighted the standard rate of mesh-related complications. We aimed to report the short-term results and complications of tension-free polypropylene mesh (PROSIMA™) surgical repair of pelvic organ prolapse (POP) using the standard category (C), timing (T), and site (S) classification system. METHODS: A prospective cohort study of 48 patients who underwent PROSIMA™ mesh kit-related surgical repairs were followed for two years at Peking Union Medical College Hospital. Recurrence was defined as symptomatic POP quantification (POP-Q) Stage II or higher (leading edge ≥ -1 cm). The Patient Global Impression of Change Questionnaire, the Chinese version of the Pelvic Floor Impact Questionnaire short-form-7 and POP/Urinary Incontinence Sexual Questionnaire short-form-12 were used to evaluate the self-perception and sexual function of each patient. Mesh-related complications conformed to the International Urogynecological Association/International Continence Society joint terminology. The paired-sample t-test, one-way analysis of variance, Fisher's exact test, Kaplan-Meier survival analysis and log-rank test were used to analyze data. RESULTS: All patients were followed up for ≥12 months; 30 (62.5%) patients completed the 24 months study. We observed a 93.8% (45/48) positive anatomical outcome rate at 12 months and 90.0% (27/30) at 24 months. Recurrence most frequently involved the anterior compartment (P < 0.05). Pelvic symptoms improved significantly from baseline (P < 0.05), although the patients' impressions of change and sexual function were not satisfying. Vaginal complication was the main complication observed (35.4%, 17/48). The survival analysis did not identify any relationship between vaginal complication and anatomical recurrent prolapse (POP-Q ≥ Stage II) (P = 0.653). CONCLUSIONS: Tension-free polypropylene mesh (PROSIMA™ )-related surgical repair of POP has better short-term anatomical outcomes at the apical and posterior compartments, but a low patient satisfaction rate. The mesh complications were not the definitive cause of recurrence.

[Therapeutic effect of sirolimus against chronic allograft nephropathy in kidney transplant recipients].

OBJECTIVE: To investigate the efficacy and safety of sirolimus in management of chronic allograft nephropathy (CAN). METHODS: A retrospective study was conducted involving 31 CAN patients followed up since March 2002, who experienced a change from a calcineurin inhibitor (CNI)-based regimen to a SRL-based regimen. Serum creatinine (Cr) in these patients was compared before and after the regimen change, and the adverse events associated with SRL were analyzed. RESULTS: Till March 2007 when the study closed, 15 patients reached the primary endpoint for resuming dialysis, 8 had improved and 8 had stable renal function. In patients with high Cr(0)(> or =3 mg/L, n=12), 9 resumed dialysis and 2 had improved renal function, but one of the patients with renal improvement eventually died due to infection; in the patients with low Cr(0)(<3 mg/L, n=19), 5 resumed dialysis, 8 had stable renal function and 6 had improved renal function, showing significant difference between the 2 groups (P=0.003). Altogether 14 patients reached the secondary endpoint for ceasing SRL for severe infection (5 patients, of whom 4 resumed dialysis and 1 died of infection) or adverse events associated with SRL (9 patients, of whom 4 resumed dialysis, 2 had stable and 3 had improved renal function). Hyperlipidemia (51.6%), leukocytopenia (41.9%), mouth ulcer (29.0%) and liver function lesion (16.1%) were the commonest adverse events in these patients, and totalling 13 severe adverse events were recorded, including 2 fatal cerebral hemorrhage, 3 fatal infection episodes, and 8 pulmonary and urinary infections that require hospitalization. CONCLUSION: Conversion from a CNI-based to SRL-based regimen can be effective for some CAN cases, especially for those with Cr(0) below 3 mg/L. Attention must be given to adverse events like hyperlipidemia and leukocytopenia, as well as the related cerebral vascular accidents and infections.