We compared the effects of bladder training and/or tolterodine as first line treatment in female patients with overactive bladder (OAB). One hundred and thirty-nine female patients with OAB were randomized to treatment with bladder training (BT), tolterodine (To, 2 mg twice daily) or both (Co) for 12 weeks. Treatment efficacy was measured by micturition diary, urgency scores and patients' subjective assessment of their bladder condition. Mean frequency and nocturia significantly decreased in all treatment groups, declining 25.9% and 56.1%, respectively, in the BT group; 30.2% and 65.4%, respectively, in the To group; and 33.5% and 66.3%, respectively in the Co group (p<0.05 for each). The decrease in frequency was significantly greater in the Co group than in the BT group (p<0.05). Mean urgency score decreased by 44.8%, 62.2% and 60.2% in the BT, To, and Co groups, respectively, and the improvement was significantly greater in the To and Co groups than in the BT group (p<0.05 for each). Although BT, To and their combination were all effective in controlling OAB symptoms, combination therapy was more effective than either method alone. Tolterodine alone may be instituted as a first-line therapy, but may be more effective when combined with bladder training.
Urinary Incontinence; Overactive Bladder; Bladder Training; tolterodine
This study was undertaken to identify risk factors for postoperative voiding dysfunction and factors having impact on patient global satisfaction after a tension-free vaginal tape (TVT) procedure. Two hundred and eighty-five women who underwent the TVT procedure for stress urinary incontinence were analyzed to identify risk factors predictive of voiding dysfunction. Postoperative voiding dysfunction was defined as a peak urinary flow rate (PFR) <10 mL/sec (straining voiding, n=17) or residual urine volume >30% of bladder capacity (incomplete emptying, n=13). The global satisfaction rate was 91.6%. Voiding dysfunction developed in 29 (10.2%) patients. Among the factors, PFR was only factor of significance for voiding dysfunction. There was no significant difference between patients with and without voiding dysfunction in terms of their satisfaction. But postoperative PFR <10 mL/sec significantly compromised global satisfaction after the surgery. In those patients with a preoperative PFR <20 mL/sec, there were more patients with postoperative PFR <10 mL/sec. Peak urinary flow rate is an important factor for the postoperative voiding dysfunction. The inevitable decline in PFR can compromise patients' satisfaction with the procedure, when their postoperative PFR was <10 mL/sec.
Tension-free Vaginal Tape; Urinary Incontinence; Patient Satisfaction; Physiopathology; Dysfunction; Urination Disorders
Psychometric properties of the overactive bladder questionnaire (OAB-q) were recently examined. However, since the cross-cultural adaptation of a non-English version of the OAB-q has never been demonstrated, we evaluated the psychometric properties of a Korean version of the OAB-q in a Korean population with OAB.
A prospective cohort study involving 116 women with 58 OAB and 58 control subjects was performed and convergent validity was assessed. Total and subscale OAB-q scores of the control and OAB groups were compared to their sensitivity to score changes before and after administering anti-cholinergic medication for 12 weeks. Short form 36 and King's health questionnaire (KHQ) were also used for comparison or correlation.
Assessment of face validity showed that the Korean version of the OAB-q was reasonable with OAB-q subscale scores being significantly different between the control and patient groups. Significant correlation (range, -0.29 to -0.81) was found between the OAB-q scores and KHQ results for the OAB patients. Cronbach's alpha coefficients (range, 0.77 to 0.95) indicated excellent internal consistency and test-retest analysis involving 35 OAB patients showed that each questions as well as subscale scores were reproducible. Each score of OAB-q also showed statistically significant sensitivity to changes following anti-muscarinic treatment for OAB (n=27, P<0.001 except for social, P=0.059).
The Korean version of the OAB-q is a valid and reliable instrument to measure outcomes in Korean patients with OAB.
Overactive urinary bladder; Quality of life; Questionnaires; Psychometrics
To compare the efficacy and safety of Sulosin D (PACIFICPHARMA, Korea) and Harnal D (ASTELLAS PHARMA KOREA, Korea) in treating patients with lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
Materials and Methods
This randomized, controlled, open-label, multicenter non-inferiority study was conducted at four sites in Korea. We randomly assigned 123 patients with an International Prostate Symptom Score (IPSS) ≥12 to receive either Sulosin D or Harnal D treatment for 8 weeks. The primary outcome was the mean change in IPSS from baseline to endpoint. Secondary outcomes were the mean change from baseline to endpoint in IPSS quality of life subscores, maximum uroflowmetry (Qmax), and post-voiding residuals (PVR).
In all, 123 patients were randomly assigned (60 Sulosin D and 63 Harnal D). The changes in the total IPSS from baseline in the Sulosin D- and Harnal D-treated groups were -4.97 and -4.03, respectively. There were significant decreases compared with baseline in both groups. The mean difference (Sulosin D - Harnal D) was -0.91 (with a two-sided 90% confidence interval), inferring that Sulosin D was not inferior to Harnal D. The mean changes in the IPSS subscore, Qmax, and PVR from baseline were comparable between the groups (both p>0.05). During the treatment periods, the incidence of adverse events was 23.33% and 34.92% in the Sulosin D and Harnal D groups, respectively (p=0.1580).
We demonstrate the non-inferiority of Sulosin D to Harnal D in patients with lower urinary tract symptoms associated with BPH.
Drugs, generic; Prostatic hyperplasia; Tamsulosin
To investigate the efficacy and safety of desmopressin in patients with mixed nocturia, Patients aged ≥18 yr with mixed nocturia (≥2 voids/night and a nocturnal polyuria index [NPi] >33% and a nocturnal bladder capacity index [NBCi] >1) were recruited. The optimum dose of oral desmopressin was determined during a 3-week dose-titration period and the determined dose was maintained for 4 weeks. The efficacy was assessed by the frequency-volume charts and the sleep questionnaire. The primary endpoint was the proportion of patients with a 50% or greater reduction in the number of nocturnal voids (NV) compared with baseline. Among 103 patients enrolled, 94 (79 men and 15 women) were included in the analysis. The proportion of patients with a 50% or greater reduction in NV was 68 (72%). The mean number of NV decreased significantly (3.20 to 1.34) and the mean nocturnal urine volume, nocturia index, NPi, and NBCi decreased significantly. The mean duration of sleep until the first NV was prolonged from 118.4±44.1 to 220.3±90.7 min (P<0.001). The overall impression of patients about their quality of sleep improved. Adverse events occurred in 6 patients, including one asymptomatic hyponatremia. Desmopressin is an effective and well-tolerated treatment for mixed nocturia.
Urinary Bladder; Deamino Arginine Vasopressin; Hyponatremia; Nocturia; Nocturnal Polyuria
To evaluate the incidence of genitourinary mycoplasmas and the efficacy of antibiotics in women with overactive bladder (OAB) symptoms.
Materials and Methods
Women with OAB symptoms (micturition ≥8/24 hours and urgency ≥1/24 hours) for ≥3 months were screened for Mycoplasma hominis (M. hominis), Ureaplasma urealyticum (U. urealyticum), and Chlamydia trachomatis (C. trachomatis). Specimens from urethral and cervical vaginal swabs were examined for M. hominis and U. urealyticum by using the Mycoplasma IST2 kit and for C. trachomatis by using PCR. Women with positive results were treated with a 1 g dose of azithromycin. Persistent infection was treated with doxycycline. Changes in a 3-day bladder diary, Patient Perception of Bladder Condition (PPBC), and International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) were evaluated 4 weeks after negative conversion. Patient satisfaction was assessed.
Of 84 women screened, 42.8% were positive (U. urealyticum, 40.5%; M. hominis, 7.1%; C. trachomatis, 3.6%; two organisms, 8.3%). After treatment, 82.7% obtained negative conversion, and their median number of micturition episodes decreased from 10.6/24 hours to 8.1/24 hours (p=0.002). PPBC and domain scores of the ICIQ-FLUTS (filling and quality of life) significantly improved. About 87.5% women with negative conversion were satisfied with the treatment.
Considering diagnostic tests and treatment for genitourinary mycoplasmas might be beneficial before invasive workup or treatment in women with OAB symptoms.
Chlamydia trachomatis; Mycoplasma hominis; Overactive urinary bladder; Ureaplasma urealyticum
To evaluate the efficacy and safety of the tension-free placement of a monofilament polypropylene mesh for the repair of an anterior vaginal wall prolapse (AVWP).
Materials and Methods
Women aged ≥ 30 years with an AVWP stage of II or greater were included. Forty-nine women underwent trans-vaginal repair using a Gynemesh™ PS. Forty-six women who had symptomatic stress urinary incontinence received a midurethral sling (MUS). At the 12-month follow-up, evaluations were made for changes in the Pelvic Organ Prolapse Quantification (POP-Q) stage and Pelvic Floor Distress Inventory. Cure was defined as a POP-Q stage of 0 and improvement as a stage of I. Complications were also evaluated.
The cure rate was 71.4%, and the improvement rate was 18.4%. Obstructive/discomfort, irritative, and stress subscale scores of the Urinary Distress Inventory anterior and posterior subscale scores of the POP Distress Inventory and the obstructive subscale score of the Colo-Rectal-Anal Distress Inventory were significantly improved. Thirty-two of the 46 women (69.6%) who received MUS procedures reported no leakage after surgery. Complications were 2 cases of increased intraoperative bleeding and 1 case of vaginal erosion.
Trans-vaginal repair using a Gynemesh™ PS is a feasible and effective procedure for the treatment of AVWP with no significant complications.
Pelvic organ prolapse; Lower urinary tract symptoms; Surgery
We have assessed the efficacy and safety of Escherichia coli extract (ECE; Uro-Vaxom®) which contains active immunostimulating fractions, in the prophylactic treatment of chronically recurrent cystitis. Forty-two patients with more than 2 episodes of cystitis in the proceeding 6 months were treated for 3 months with one capsule daily of ECE and observed for a further 6 months. The primary efficacy criterion was the number of episodes of recurrent cystitis during the 6 months after treatment compared to those during the 6 months before treatment. At the end of the 9-month trial, 34 patients (all women) were eligible for statistical analysis. Their mean age was 56.4 yr (range, 34-75 yr), and they had experienced recurrent urinary tract infections for 7.2±5.2 yr. The number of recurrences was significantly lower during the 6-month follow-up period than during the 6 months preceding the trial (0.35 vs. 4.26, P<0.001). During the follow-up, 28 (82.4%) patients had no recurrences and 4 (11.8%) had 1 each. In patients who relapsed, ECE alleviated cystitis symptoms, including painful voiding, frequency and urgency. There were no serious adverse events related to the study drug. Our study demonstrates the efficacy and safety of ECE in the prophylactic treatment of chronically recurrent cystitis.
Cystitis; Immunization; Escherichia coli; OM-8930; Prevention and Control
We aimed to evaluate the anatomical and functional outcomes of posterior intravaginal slingplasty (P-IVS) for the treatment of a vaginal vault or uterine prolapse (VP/UP).
Materials and Methods
This was a 12-month prospective, multicenter, observational study. Women aged over 30 years who presented with stage II or greater VP/UP underwent P-IVS by four urologists at four university hospitals. Preoperatively, pelvic examination by use of the Pelvic Organ Prolapse Quantification (POP-Q) system, the Pelvic Floor Distress Inventory (PFDI) questionnaire, the 3-day frequency volume chart, and uroflowmetry were completed. At the 12-month follow-up, changes in the POP-Q, PFDI, frequency volume chart, and uroflowmetry parameters were assessed. Cure was defined as VP/UP stage 0 and improvement as stage I.
The cure and improvement rates among the 32 women were 65.6% and 34.4%, respectively. All subscale scores of the Urinary Distress Inventory, the general subscale score of the Pelvic Organ Prolapse Distress Inventory, and the rectal prolapse subscale score of the Colo-Rectal-Anal Distress Inventory were significantly improved. There were no significant changes in the frequency volume chart or uroflowmetry parameters. There was one case of surgery-related transfusion.
Trans-vaginal repair by P-IVS is an effective and safe procedure for restoring the anatomical defect and improving the associated pelvic floor symptoms in women with VP/UP.
Prospective studies; Treatment outcome; Pelvic organ prolapse
We evaluated the therapeutic effects of tamsulosin for women with non-neurogenic voiding dysfunction. Women who had voiding dysfunctions for at least 3 months were included. Inclusion criteria were age ≥18 yr, International Prostate Symptom Score (IPSS) of ≥15, and maximum flow rate (Qmax) of ≥12 mL/sec and/or postvoid residuals (PVR) of ≥150 mL. Patients with neurogenic voiding dysfunction or anatomical bladder outlet obstruction were excluded. All patients were classified according to the Blaivas-Groutz nomogram as having no or mild obstruction (group A) or moderate or severe obstruction (group B). After 8 weeks of treatment, treatment outcomes and adverse effects were evaluated. One hundred and six patients were evaluable (70 in group A, 36 in group B). After treatments, mean IPSS, bother scores, Qmax, PVR, diurnal and nocturnal micturition frequencies and scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS-SF) were changed significantly. Eighty-nine patients (84%) reported that the treatment was beneficial. The proportion of patients reported that their bladder symptoms caused "moderate to many severe problems" were significantly decreased. No significant difference were observed between the groups in terms of IPSS, bother score, Qmax, PVR, micturition frequency, and BFLUTS-SF changes. Adverse effects related to medication were dizziness (n=3), de novo stress urinary incontinence (SUI) (n=3), aggravation of underlying SUI (n=1), fatigue (n=1). Tamsulosin was found to be effective in female patients with voiding dysfunction regardless of obstruction grade.
Urination Disorders; Female; Adrenergic alpha-Antagonists; Outcomes Assessment
We assessed the long-term effects of the tension-free vaginal tape (TVT) procedure for stress urinary incontinence (SUI) on voiding, storage, and patient satisfaction.
Materials and Methods
This retrospective study examined the records of 134 patients who had undergone the TVT procedure for SUI and were followed up for more than 5 years. Voiding function was evaluated by measuring maximum urinary flow rate (MFR), post-void residual urine volume (PVR), and storage function by using a voiding diary. Patients were asked to describe their satisfaction with the operation.
MFR was lower at 1 month compared with the preoperative level, but had recovered to preoperative levels by 5 years postoperatively. However, some patients with >50%, 25-50%, and <25% decreases in the MFR at 1 month postoperatively showed a decrease in the MFR of >50% at 5 years. PVR increased over the 5 postoperative years. Of the patients with urgency and urgency incontinence, 43.8% and 48.1% showed improvement, respectively, whereas new patients developed postoperatively. Thus, the total number of patients with urgency or urgency incontinence remained similar over the 5 years. In those with a changed voiding pattern, patient satisfaction was negatively affected by de novo urgency and urgency incontinence and decreased MFR.
Any obstructive effect of the TVT procedure diminished over time in most patients, although a decrease in the MFR was sustained in some patients. With regard to overactive bladder symptoms, some patients were cured and some patients complained of de novo symptoms. The most major factor affecting patient satisfaction was de novo urgency.
Patient satisfaction; Suburethral slings; Stress urinary incontinence
We evaluated the long-term efficacy of laparoscopic Burch colposuspension for stress urinary incontinence (SUI) in women. A total of 68 patients who underwent extraperitoneal laparoscopic Burch colposuspensions with more than a 3-yr follow-up were included. The colposuspension was performed by using two non-absorbable sutures on each side. The patients were considered to be cured of SUI if they had a negative result of cough stress test and there were no reports of urine leakage during physical stress. The mean follow-up period was 52 months (range, 36 to 83 months). The overall subjective cure rate was reported in 49 patients (72%). There was no significant difference between the cured and non-cured group in terms of clinical parameters. The cure rate tended to decline gradually over time and it was more deteriorated significantly after 4 yr of surgery. Based on these results, we recommend that long-term follow-up is needed when evaluating the clinical efficacy of anti-incontinence surgery.
Urinary Incontinence, Stress; Laparoscopy; Follow-Up Studies