Biofeedback-Assisted pelvic floor muscle training combined with a short-duration drug regimen is safe and effective in women with overactive bladder: A randomized controlled trial.

OBJECTIVE: We hypothesized that combination therapy would provide a synergistic effect to improve treatment outcomes for overactive bladder (OAB), thus enhancing the motivation for continuous exercise, and that it would be associated with fewer adverse events than monotherapy. Therefore, we investigated whether biofeedback-assisted pelvic floor muscle training (PFMT), drug therapy, or a combination of both would be more effective in improving the symptoms of OAB. STUDY DESIGN: This randomized controlled trial included women diagnosed with OAB. Group 1 received biofeedback-assisted pelvic muscle floor training (PFMT) for 12 weeks; group 2 took 5 mg of solifenacin/day for 12 weeks; and group 3 received 5 mg of solifenacin/day in combination with biofeedback-assisted PFMT during the first 4 weeks and biofeedback-assisted PFMT for another 8 weeks. All participants had 5 follow-up visits. The primary outcomes were objective improvement of OAB symptoms and quality of life. The secondary outcomes were treatment-related adverse events, subjective improvement of OAB symptoms, and electromyographic activity of pelvic floor muscle (PFM) contraction. RESULTS: All participants reported significant improvement of OAB symptoms and quality of life. Participants in group 2 experienced more pronounced adverse events than those in group 3. Intervention duration was positively associated with subjective improvement in OAB symptoms in groups 2 and 3. Drug-related adverse events, including dry mouth, myalgia, and restlessness, had a negative impact on the subjective improvement of OAB symptoms in group 2. In group 1, exercise adherence was positively correlated with subjective improvement of OAB symptoms, whereas in group 3, PFM contraction and biofeedback effect were positively correlated with symptom improvement. CONCLUSION: Combination therapy is efficacious in treating women with OAB.

Test-retest reliability of the 20-min pad test with infusion of strong-desired volume in the bladder for female urodynamic stress incontinence.

The repeatability of the 20-min pad test has not been reported. The aim of this study was to evaluate the test-retest reliability of the 20-min pad test in women with urodynamic stress incontinence. Among 89 enrolled women, 67 (75%) women were diagnosed with urodynamic stress incontinence and were examined in this study. The mean strong-desire volume of all the women was 306.7 ± 115.7 mL. The pad weights of the test versus retest were 28.3 ± 41.2 g versus 28.4 ± 38.6 g, p = 0.29, respectively. The test and retest pad weight results had a Spearman's rho of 0.788 (p < 0.0001). The intraclass correlation coefficient was 0.793 (95% confidence interval, 0.704-0.882; p < 0.0001). The Bland-Altman plots all revealed good agreement between the test and the retest in the pad weights. In conclusion, the 20-min pad test infused with a strong-desired volume has good test-retest reliability to assess the severity of urine leakage for women with urodynamic stress incontinence.

Efficacy of bio-assisted pelvic floor muscle training in women with pelvic floor dysfunction.

OBJECTIVES: To evaluate the efficacy of 12-week pelvic floor muscle training (PFMT) using bio-assisted surface electromyography (EMG) feedback in women with complex pelvic floor dysfunction (PFD); to further differentiate the effect of exercise adherence from the biofeedback per se; and to assess and compare the severities of overactive bladder (OAB) symptoms, stress urinary incontinence (SUI), and stage of prolapse with the women's perception of symptom cure or improvement following the program. STUDY DESIGN: This prospective observational study was conducted between December 2015 and November 2018 at a medical center in Taiwan. It included 83 women with PFD, manifesting solely as either OAB or SUI with (group 1) or without (group 2) concomitant stages I and II pelvic organ prolapse (POP). All women underwent a 12-week bio-assisted PFMT. The main outcome was the electromyographic activity of the pelvic floor muscles (PFMs). The severities of OAB symptoms, SUI, and stage of POP were assessed both subjectively and objectively before and after the intervention. RESULTS: A notable improvement of PFM function was identified after 12 weeks of training in all women with PFD. The number of effective PFM contractions achieved during bio-assisted PFMT was positively correlated with the improvement of PFM function in both groups of women in different body positions, except in the standing position in group 2. Exercise adherence, however, had no significant impact on the efficacy of the training. There was a significant improvement over time and high consistency between subjective and objective improvements of OAB symptoms and SUI severity after the completion of PFMT. Nonetheless, only the Ba point of the POP-Quantification system in women with POP showed a significant improvement after the intervention. CONCLUSION: PFMT using surface EMG biofeedback significantly improves PFM function in women with complex PFD, and thus, has a significant therapeutic effect on OAB, SUI, and bladder prolapse.

Blockade of PD-L1 Enhances Cancer Immunotherapy by Regulating Dendritic Cell Maturation and Macrophage Polarization.

The immuno-inhibitory checkpoint PD-L1, regulated by tumor cells and antigen-presenting cells (APCs), dampened the activation of T cells from the PD-1/PD-L1 axis. PD-L1-expressing APCs rather than tumor cells demonstrated the essential anti-tumor effects of anti-PD-L1 monotherapy in preclinical tumor models. Using the murine tumor model, we investigated whether anti-PD-L1 antibody increased the antigen-specific immune response and anti-tumor effects induced by the antigen-specific protein vaccine, as well as the possible mechanisms regarding activation of APCs. Anti-PD-L1 antibody combined with the PEK protein vaccine generated more potent E7-specific immunity (including the number and cytotoxic activity of E7-specific cytotoxic CD8+ T lymphocytes) and anti-tumor effects than protein vaccine alone. Anti-PD-L1 antibody enhanced the maturation of dendritic cells and the proportion of M1-like macrophages in tumor-draining lymph nodes and tumors in tumor-bearing mice treated with combinatorial therapy. PD-L1 blockade overturned the immunosuppressive status of the tumor microenvironment and then enhanced the E7 tumor-specific antigen-specific immunity and anti-tumor effects generated by an E7-specific protein vaccine through modulation of APCs in an E7-expressing small tumor model. Tumor-specific antigen (like HPV E7 antigen)-specific immunotherapy combined with APC-targeting modality by PD-L1 blockade has a high translational potential in E7-specific cancer therapy.

Comparison of clinical outcomes between tailored transvaginal mesh surgery and native tissue repair for pelvic organ prolapse.

BACKGROUND/PURPOSE: The most suitable surgical technique for pelvic organ prolapse (POP) remains undetermined. The aim of this study was to compare clinical outcomes of the tailored transvaginal mesh (TVM) surgery and vaginal native tissue repair (NTR) surgery for POP. METHODS: Between November 2011 and August 2014, medical records of 339 women receiving POP surgeries were reviewed. RESULTS: Compared with the NTR group (n = 169), the use of TVM surgery (n = 170) was a predictor for longer operation time (coefficient = 25.2 min, P < 0.001) and larger blood loss (coefficient = 79.9 mL, P < 0.001) by multivariable analysis. However, a higher recurrence rate of cystoceles (log-rank test, P = 0.001) was found in the NTR group, compared with the TVM group; but not apical prolapse (P = 0.32) or rectocele (P = 0.45). Multivariable analysis revealed that the TVM surgery (hazard ratio = 0.24, 95% confidence interval = 0.09-0.64, P = 0.004) and old age (hazard ratio = 1.07, 95% confidence interval = 1.02-1.11, P = 0.005) were independent predictors for the recurrence of cystoceles. Based on the receiver operating characteristic curve (ROC) analysis, the cut-off age value was 64 years with an ROC area of 0.65. In women with intact uterus (n = 162), the recurrence rate of cystoceles was lower in the TVM group (log-rank test, P = 0.0001), compared with the NTR group. However, there was no between-group difference in the recurrence rate of cystoceles in women with prior or concomitant hysterectomy (n = 177, P = 0.17). CONCLUSION: In women with intact uterus, the TVM group has a lower recurrence rate of cystoceles than the NTR group. In addition, old age, especially more than 64 years old, is a risk factor for cystocele recurrence.

Efficacy of pelvic floor training with surface electromyography feedback for female stress urinary incontinence.

AIMS: The aim of the study is to compare the efficacy of an 8-week pelvic floor muscle training program with surface electromyography feedback, performed in different body positions (supine, sitting, and standing), in women with stress urinary incontinence. DESIGN: This is a prospective observational study performed January 2014 to May 2016. METHODS: The training program was performed by 110 women with stress urinary incontinence, each completing 4 individual training sessions. The main outcome was the electromyography activity of the pelvic floor muscles and of the synergistic abdominal muscles. Outcome measures were evaluated at 4 time points, namely at baseline and at 2, 4, and 8 weeks of training. RESULTS: A notable effect of training was identified at week 2, which was sustained through to week 8. Training yielded a significant improvement in increased sustained voluntary contraction of the pelvic floor muscles in all 3 positions. The efficacy of training was influenced by the duration of training, age, body mass index, and history of vaginal delivery. CONCLUSION: Training of the pelvic floor muscles, with positive reinforcement by surface electromyography feedback of the pelvic floor muscles and of the synergistic abdominal muscles, was effective for the treatment of stress urinary incontinence in women and should be considered as a feasible option by healthcare providers.

Comparisons of the Clinical Outcomes and Urodynamic Effects of Mirabegron versus Tolterodine Treatment for Female Overactive Bladder Syndrome: A Subgroup Analysis of a Controlled, Randomised, Prospective Study.

OBJECTIVES: The impact of mirabegron on clinical outcome and urodynamic parameters may be important for clinical practice. Thus, the aim of this study was to compare the clinical outcomes and urodynamic effects of mirabegron (Betmiga 50 mg) versus tolterodine (Detrusitol ER 4 mg) treatment for women with overactive bladder syndrome (OAB). METHODS: Women with OAB were randomized to receive 12 weeks of mirabegron 50 mg, tolterodine extended-release 4 mg or placebo treatment. The clinical outcomes and urodynamic effects were compared between the subgroups. RESULTS: Thirty-three women completed 12 weeks of mirabegron (n = 12), tolterodine (n = 12) or placebo (n = 9) treatment. A significant increase in the volumes at strong desire to void and a decrease in the daytime frequency episodes were identified in the mirabegron and tolterodine groups (all P < 0.05). Nonetheless, a decrease in the total voided volume was identified following mirabegron treatment but not tolterodine (P = 0.02). CONCLUSIONS: Mirabegron and tolterodine exhibit similar changes in the urodynamics and bladder diary parameters. However, mirabegron may decrease the total voided volume. These findings may serve as an initial guide or assist in consultations regarding the treatment of OAB patients with mirabegron.

Leptomeningeal metastasis of poorly differentiated uterine cervical adenosquamous carcinoma following reirradiation to metastatic vertebrae: A case report.

RATIONALE: Leptomeningeal metastasis from cervical adenosquamous carcinoma is extremely rare especially after radiotherapy for vertebral metastasis. PATIENT CONCERNS: A 52-year-old woman with International Federation of Gynecology and Obstetrics (FIGO) stage IIB adenosquamous carcinoma of cervix presented with bilateral lower limbs weakening after 2 courses radiotherapy to thoracic vertebral metastases. DIAGNOSES: Initial spine magnetic resonance imaging (MRI) showed no obvious nerve compression, and radiation myelopathy was suspected by the clinician. Progressive multifocal neurological signs developed one month after completion of spine re-irradiation. She was diagnosed with leptomeningeal metastasis by MRI and cerebrospinal fluid (CSF) study. INTERVENTIONS: She received whole brain irradiation with a dose of 30 Gy in 10 fractions. Systemic chemotherapy with cisplatin (50 mg/m) and topotecan (0.75 mg/m) was administered sequentially. OUTCOMES: She died with progressive disease two months after the diagnosis of leptomeningeal metastases. LESSONS: Poorly differentiated advanced-stage cervical adenosquamous carcinoma is an aggressive neoplasm with a worse outcome. Leptomeningeal metastasis should be included in the differential diagnosis for patients with multifocal craniospinal neurological signs. A combination of detailed neurological examinations, MRI and CSF study allowed us to establish a correct diagnosis of leptomeningeal metastasis and initiate treatment in a timely manner.

Optimizing Laparoscopically Extracorporeal Knot Tying Using a Novel Pusher Device.

The aim of this study was to evaluate the efficacy and feasibility of a novel pusher device for performing extracorporeal knot tying. Each of the 3 laparoscopists randomly performed 10 device-assisted double sheet bends (the device group), ten 4s modified Roeder sliding knots (the sliding group), and 10 laparoscopic traditional extracorporeal static surgeon's knots (the static group). All knots and 5 unknotted threads were measured for strength. The device group had higher knot strength, lower knotting failure rate, and shorter knotting time compared with the sliding group. The knot strengths of the successful knots in the device group were consistent with those obtained in the static group, and higher than the sliding group. Our laparoscopic novel pusher device should be an effective device in assisting knot tying with the advantages of steady and strong knot strength, lower failure rate, and shorter knotting time.

Frequent nocturia episodes, a suboptimal response to treatment, and small bladder capacity predict the need for persistent antimuscarinic therapy or re-treatment after discontinuation of antimuscarinics in female overactive bladder.

OBJECTIVE: The aim of the study was to investigate predictive factors of the need for persistent antimuscarinic therapy or re-treatment (PR) after discontinuation of antimuscarinic therapy for women with overactive bladder syndrome (OAB). METHODS: All consecutive OAB women were enrolled in a prospective cohort study, and treated with solifenacin for 12 weeks in a University Hospital. Factors affecting PR were analyzed by Cox regression analysis. RESULTS: A total of 122 women were enrolled, and 107 women underwent 12-week solifenacin treatment. The dropout rate was 12.3%. The median follow-up period was 20.4 weeks (25-75 interquartile range: 16-102.3 wk). Twenty-seven (25%) women had PR. The median PR-free interval was 125.4 weeks (95% CI = 58.4 to - wk). Nocturia episodes (hazard ratio = 1.54), a suboptimal response (hazard ratio = 2.53), and the strong-desire volume (hazard ratio = 0.992) were independent predictors of PR by Cox backward stepwise regression analysis. The areas under the receiver-operating characteristic curves for nocturia episodes, a suboptimal response, and the strong-desire volume to predict PR were only 0.65, 0.63, and 0.59, respectively. In addition, normalized urinary nerve growth factor level was not significant (hazard ratio = 1.005, P = 0.68) for predicting PR. Furthermore, normalized urodynamic findings did not correlate with PR, a suboptimal response, or changes of Overactive Bladder Symptom Score and urinary nerve growth factor level. CONCLUSIONS: Frequent nocturia episodes, a suboptimal response, and small bladder capacity may predict PR after solifenacin treatment. These findings may serve as an initial guide in consultation regarding the treatment of OAB.

Clinical and urodynamic effects of baclofen in women with functional bladder outlet obstruction: Preliminary report.

AIM: To investigate the efficacy and urodynamic effects of baclofen in women with functional bladder outlet obstruction. METHODS: Between January 2011 and December 2012, women who underwent baclofen treatment for functional bladder outlet obstruction, defined as <15 mL/s maximum flow rate and >20 cmH2 O detrusor pressure at maximum flow rate, but without significant anatomic causes, were retrospectively reviewed. Urodynamic variables at baseline and after 12 weeks of treatment were compared. RESULTS: Twenty women with functional bladder outlet obstruction underwent 12 weeks of baclofen treatment (oral baclofen 5 mg, three times daily). All patients reported improvement in voiding dysfunction symptoms after treatment, and no significant adverse effects were found on review of medical records. All patients underwent urodynamic studies after 12 weeks' treatment. Voided volume, voiding efficiency and maximum flow rate at voiding cystometry were significantly improved (mean, 273 vs. 368 mL, P = 0.002; 62.8% vs. 73.6%, P <0.001, and 10.3 vs. 11.6 mL/s, P = 0.046; respectively). Moreover, baclofen did not affect continence function, as indicated by non-significant changes in the parameters of urethral pressure profiles. CONCLUSIONS: Oral baclofen can improve symptoms of voiding dysfunction, voided volume, voiding efficiency and maximum flow rate in women with functional bladder outlet obstruction. None of the patients experienced intolerable side-effects. Thus, oral baclofen may be used as an initial treatment for women with symptoms of voiding dysfunction.

Clinical Outcomes and Urodynamic Effects of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse.

OBJECTIVE: To evaluate the clinical outcomes and urodynamic effects of tailored anterior transvaginal mesh surgery (ATVM) and tailored posterior transvaginal mesh surgery (PTVM). METHODS: We developed ATVM for the simultaneous correction of cystocele and stress urinary incontinence and PTVM for the simultaneous correction of enterocoele, uterine prolapse, vaginal stump prolapse, and rectocele. RESULTS: A total of 104 women enrolled. The median postsurgical follow-up was 25.5 months. The anatomic cure rate was 98.1% (102/104). Fifty-eight patients underwent urodynamic studies before and after surgeries. The pad weight decreased from 29.3 ± 43.1 to 6.4 ± 20.9 g at 3 months. Among the 20 patients with ATVM, 13 patients had objective stress urinary incontinence (SUI) at baseline while 8 patients came to have no demonstrated SUI (NDSUI), and 2 improved after surgery. Among the 38 patients who underwent ATVM and PTVM, 24 had objective SUI at baseline while 18 came to have NDSUI, and 2 improved after surgery. Mesh extrusion (n = 4), vaginal hematoma (n = 3), and voiding difficulty (n = 2) were noted postoperatively. Quality of life was substantially improved. CONCLUSIONS: Our findings document the advantages of these two novel pelvic reconstructive surgeries for pelvic organ prolapse, which had a positive impact on quality of life. ATVM surgery additionally provided an anti-incontinence effect. This clinical trial is registered at ClinicalTrials.gov (NCT02178735).

Utilizing preoperative 20-minute pad testing with vaginal gauze packing for indicating concomitant midurethral sling during cystocele repair.

OBJECTIVE: To investigate the feasibility of using preoperative 20-minute pad testing with vaginal gauze packing for cystocele reduction to indicate a concomitant midurethral sling during cystocele repair. STUDY DESIGN: Retrospective review of the records of consecutive women with pelvic organ prolapse quantification≥stage II symptomatic cystocele who visited the urogynecologic outpatient clinics and underwent cystocele repair between July 2005 and December 2010. Only patients who underwent preoperative urodynamic studies and 20-minute pad testing with vaginal gauze packing for cystocele reduction were enrolled. RESULTS: Twenty-one patients did not demonstrate any stress urinary incontinence. For evident stress urinary incontinence (>1g pad weight before reduction), the criterion of ≥8g pad weight before reduction was chosen for concomitant midurethral sling. For patients with occult stress urinary incontinence (≤1g pad weight before reduction), the criterion of ≥8g pad weight after reduction was chosen as an indication for concomitant midurethral sling. Among 22 patients with evident stress urinary incontinence (<8g) without concomitant midurethral sling, only one patient (4.5%) received a midurethral sling during the follow-up period (median follow-up interval: 30.5 months). Among 21 patients with occult stress incontinence but <8g after reduction without concomitant midurethral sling, only one patient (4.8%) received midurethral sling during the follow-up period (median follow-up interval: 38 months). CONCLUSIONS: A preoperative 20-minute pad test with vaginal gauze packing for cystocele reduction is a feasible and practical method to decide for a concomitant midurethral sling.

Evaluation of bladder diary parameters based on correlation with the volume at strong desire to void in filling cystometry.

Accurate assessment of patient bladder capacity is important in determining the proper initial treatment for lower urinary tract dysfunctions and as well as for monitoring therapeutic outcomes. However, urodynamic study is an invasive procedure. Thus, it is important to find a surrogate for invasive urodynamic study, and the aim of this study is to identify the parameter from patient-recorded bladder diary that is best correlated to the volume at strong desire to void (VSD) derived from urodynamic studies. A total of 900 women who underwent urodynamic studies at a university hospital between January 2009 and December 2011. Correlation between bladder diary parameters and VSD was investigated by Spearman rank-correlation coefficient. Days 1 to 3 average maximum daytime voided volumes excluding the first morning void (DVVmaxavg) (mean 263 ml) had the highest correlation with VSD (mean 261 ml; ρ = 0.51, p<0.001). The predictive value of VSD was 146+0.44 × DVVmaxavg. The days 1, 2, and 3 daytime maximum voided volumes excluding the first morning void (DVVmax) were all significantly associated with VSD and had similar mean volumes (ρ = 0.43-0.46, all p<0.001). DVVmaxavg had the highest area under the receiver operating characteristic curve (0.75; 95% confidence interval = 0.72-0.78) for predicting bladder oversensitivity. The threshold of DVVmaxavg <250 ml had good predictive value for detecting bladder oversensitivity (sensitivity 70.9%; specificity 65.8%), and day 1 DVVmax <250 ml had similar sensitivity (70.6%) and specificity (59.1%). Besides, the correlation coefficients (ρ) between day 1, day 2 and day 3 DVVmax and DVVmaxavg were good with a range of 0.70-0.89. In conclusion, DVVmaxavg was the bladder diary parameter best correlated with VSD. DVVmaxavg and day 1 DVVmax may be useful in screening for bladder oversensitivity.

Stereotactic body radiation therapy via helical tomotherapy to replace brachytherapy for brachytherapy-unsuitable cervical cancer patients - a preliminary result.

AIM: To review the experience and to evaluate the results of stereotactic body radiation therapy (SBRT) via helical tomotherapy (HT), for the treatment of brachytherapy-unsuitable cervical cancer. METHODS: Between September 1, 2008 to January 31, 2012, nine cervical cancer patients unsuitable for brachytherapy were enrolled. All of the patients received definitive whole pelvic radiotherapy with or without chemotherapy, followed by SBRT via HT. RESULTS: The actuarial locoregional control rate at 3 years was 78%. The mean biological equivalent dose in 2-Gy fractions of the tumor, rectum, bladder, and intestines was 76.0 ± 7.3, 73.8 ± 13.2, 70.5 ± 10.0, and 43.1 ± 7.1, respectively. Only two had residual tumors after treatment, and the others were tumor-free. Two patients experienced grade 3 acute toxicity: one had diarrhea; and another experienced thrombocytopenia. There were no grade 3 or 4 subacute toxicities. Three patients suffered from manageable rectal bleeding in months 11, 14, and 25, respectively. One stage I VA patient experienced fistula formation in month 3. CONCLUSION: SBRT via HT provides the possibility for treatment of locally advanced cervical cancer in patients who are unsuitable for brachytherapy. Long-term follow up and enrollment of more such patients to receive SBRT via the HT technique are warranted.

Helical tomotherapy provides efficacy similar to that of intensity-modulated radiation therapy with dosimetric benefits for endometrial carcinoma.

BACKGROUND: The purpose of this study was to compare the efficacy of intensity-modulated radiotherapy (IMRT) and helical tomotherapy for endometrial cancer. METHODS: Between November 1, 2006 and November 31, 2010, 31 patients with histologically confirmed endometrial cancer were enrolled. All enrolled patients received total abdominal hysterectomy and bilateral salpingo-oophorectomy with adjuvant whole pelvic IMRT or helical tomotherapy. RESULTS: The actuarial 3-year overall survival, disease-free survival, locoregional control, and distant metastasis-free rates for the IMRT and helical tomotherapy groups were 87.5% versus 100%, 91.7% versus 51.7%, 91.7% versus 83.3%, and 91.7% versus 51.7%, respectively. The conformal index and uniformity index for IMRT versus helical tomotherapy was 1.25 versus 1.17 (P = 0.04) and 1.08 versus 1.05 (P < 0.01), respectively. Two of 31 patients with cervical stump failure were noted, one in the IMRT group and the other in the helical tomotherapy group. No acute or late grade 3 or 4 toxicities were noted, including proctitis, or genitourinary or gastrointestinal disturbances. CONCLUSION: Helical tomotherapy is as effective as IMRT and has better uniformity and conformal indices, and critical organ-sparing properties. Prospective clinical trials are needed to evaluate the comparative efficacy of IMRT versus helical tomotherapy.

Laparoscopic intracorporeal knot tying using a novel device.

BACKGROUND: Laparoscopic intracorporeal knot tying has traditionally been considered the most difficult skill in laparoscopic surgery. We developed a novel device for assisting laparoscopic intracorporeal knotting that transforms a pre-tied slip knot into a secure double sheet bend. The aim of this study is to check the feasibility of using this novel device to assist in performing laparoscopic knot tying. METHODS: We used a laparoscopic trainer with a piece of plastic artificial skin as an experimental model. Twenty laparoscopic device-assisted double sheet bends (experimental group) and 20 traditional laparoscopic two-turn flat square knots (control group) were performed in random order. After cutting the loop and the ends of each knot, all 40 knotted threads and an additional eight unknotted threads were transferred to a tensiometer to test their strength using the single-strand method. Post-knotting variables of the two groups were compared. RESULTS: Knot strength (mean ± standard deviation) did not differ between the two groups (experimental group: 2.26 ± 0.50 kg vs. control group: 2.03 ± 0.94 kg; P = 0.51). The knot efficiencies of the experimental and control group were 60.6 and 54.4% (P = 0.51), respectively. However, the experimental group had a lower knot failure rate (5 vs. 40%, P = 0.02) and shorter knotting time (37.0 ± 9.2 vs. 107.0 ± 47.7 s, P < 0.001) compared with the control group. CONCLUSIONS: This novel device significantly shortened the knotting time of laparoscopic intracorporeal knot tying, and did not compromise the success rate or strength of the knot.

Comparisons of urodynamic effects, therapeutic efficacy and safety of solifenacin versus tolterodine for female overactive bladder syndrome.

AIM: To evaluate the urodynamic effects, therapeutic efficacy and safety of solifenacin versus tolterodine treatment for women with overactive bladder syndrome. METHODS: Patients were randomized to receive either solifenacin 5 mg or tolterodine ER 4 mg once a day for 12 weeks at each four-week visit in a post-marketing study. Only women (solifenacin [n = 26] vs. tolterodine [n = 22]) were included in this subgroup analysis. Adverse events and changes of urodynamic values and clinical data were compared between the solifenacin and tolterodine groups. RESULTS: The volume voided per micturition increased in the solifenacin group (n = 21) (P = 0.04). The strong desire to void and pad-test result improved in the tolterodine group (n = 21; P = 0.02 and 0.03, respectively). There were no between-group differences in changes of any urodynamic data, voiding diary values or adverse events after treatment; however, changes of heart rate differed between the two groups (P = 0.0004), especially at visit 2 (solifenacin vs. tolterodine, -4.3 vs. 3.8, P = 0.02) and visit 3 (-3.2 vs. 4.8, P = 0.03). CONCLUSIONS: Both solifenacin and tolterodine had similar urodynamic effects, therapeutic efficacy and adverse events in treating women with overactive bladder syndrome; however, tolterodine had a greater effect in increasing heart rate than solifenacin.