Changes In Nocturia Research Articles

Outcome of a Randomized, Double-Blind, Placebo Controlled Trial of Botulinum A Toxin for Refractory Overactive Bladder

We determined the effectiveness of cystoscopic administration of botulinum-A toxin compared to placebo for the treatment of urinary incontinence in subjects with idiopathic overactive bladder. Subjects were recruited from the Division of Urogynecology at the University of Rochester. Inclusion criteria were overactive bladder refractory to anticholinergic medications, multiple daily incontinence episodes and a 24-hour pad weight of 100 gm or greater. Subjects with low leak point pressures, increased post-void residual volume or neurological etiologies were excluded from study. Subjects were randomized to placebo or to 1 of 2 doses of botulinum-A toxin. The detrusor was injected at 8 to 10 sites above the trigone. Evaluations were performed at baseline, and at 3 and 6 weeks after injection, and included bladder diaries, pad weights, quality of life questionnaires and urodynamic studies. A total of 22 subjects participated in stage 1 of this 2-stage study. We report on the outcomes of stage 1 of this study. Because stage 2 is still ongoing and investigators remain blind to the doses of botulinum-A toxin, the 2 botulinum-A toxin groups were combined for this report. There were no differences in mean baseline measurements between the 2 groups. Statistically significant improvements in daily incontinence episodes, pads changed per day and quality of life questionnaires were seen in the botulinum-A toxin group with no changes in the placebo group. No change in nocturia, daily voiding frequency, peak flow or detrusor pressure was seen in either group. Of 15 subjects 4 (26%) receiving botulinum-A toxin had a post-void residual volume of 200 cc or greater and 1 subject required intermittent catheterization. Four subjects experienced a urinary tract infection, 2 (13%) in the botulinum-A toxin group and 2 (28%) in the placebo group (not significant). Botulinum-A toxin can significantly reduce urge urinary incontinence due to overactive bladder at 6 weeks. However, there is a risk of urinary retention requiring self-catheterization.

Serenoa repens for benign prostatic hyperplasia.

Benign prostatic hyperplasia (BPH), a nonmalignant enlargement of the prostate, can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto, or dwarf palm plant, Serenoa repens (also known by its botanical name of Sabal serrulatum), is one of several phytotherapeutic agents available for the treatment of BPH. This systematic review aimed to assess the effects of Serenoa repens in the treatment of LUTS consistent with BPH. Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, and The Cochrane Library), by checking bibliographies, and by handsearching the relevant literature. Trials were eligible if they (1) randomized men with symptomatic BPH to receive preparations of Serenoa repens (alone or in combination) for at least four weeks in comparison with placebo or other interventions, and (2) included clinical outcomes such as urologic symptom scales, symptoms, and urodynamic measurements. Eligibility was assessed by at least two independent observers. Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of Serenoa repens with placebo or other interventions was the change in urologic symptom-scale scores. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for side effects or adverse events was the number of men reporting side effects. In this update 9 new trials involving 2053 additional men (a 64.8% increase) have been included. For the main comparison - Serenoa repens versus placebo - 3 trials were added with 419 subjects and 3 endpoints (IPSS, peak urine flow, prostate size). Overall, 5222 subjects from 30 randomized trials lasting from 4 to 60 weeks were assessed. Twenty-six trials were double blinded and treatment allocation concealment was adequate in eighteen studies.Serenoa repens was not superior to placebo in improving IPSS urinary symptom scores, (WMD (weighted mean difference) -0.77 points, 95% CI -2.88 to 1.34, P > 0.05; 2 trials), finasteride (MD (mean difference) 0.40 points, 95% CI -0.57 to 1.37, P > 0.05; 1 trial), or tamsulosin (WMD -0.52 points, 95% CI -1.91 to 0.88, P > 0.05; 2 trials).For nocturia, Serenoa repens was significantly better than placebo (WMD -0.78 nocturnal visits, 95% CI -1.34 to -0.22, P < 0.05; 9 trials), but with the caveat of significant heterogeneity (I(2) = 66%). A sensitivity analysis, utilizing higher quality, larger trials (>/= 40 subjects), demonstrated no significant difference (WMD -0.31 nocturnal visits, 95% CI -0.70 to 0.08, P > 0.05; 5 trials) (I(2) = 11%). Serenoa repens was not superior to finasteride (MD -0.05 nocturnal visits, 95% CI -0.49 to 0.39, P > 0.05; 1 trial), or to tamsulosin (per cent improvement) (RR) (risk ratio) 0.91, 95% CI 0.66 to 1.27, P > 0.05; 1 trial).Comparing peak urine flow, Serenoa repens was not superior to placebo at trial endpoint (WMD 1.02 mL/s, 95% CI -0.14 to 2.19, P > 0.05; 10 trials), or by comparing mean change (WMD 0.31 mL/s, 95% CI -0.56 to 1.17, P > 0.05; 2 trials).Comparing prostate size at endpoint, there was no significant difference between Serenoa repens and placebo (MD -1.05 cc, 95% CI -8.84 to 6.75, P > 0.05; 2 trials), or by comparing mean change (MD -1.22 cc, 95% CI -3.91 to 1.47, P > 0.05; 1 trial). Serenoa repens was not more effective than placebo for treatment of urinary symptoms consistent with BPH.

Improvements in overactive bladder syndrome after polypropylene mesh surgery for cystocele

The International Continence Society has defined overactive bladder syndrome (OABS) by the following set of symptoms: 'urgency, with or without urge incontinence, usually with urinary frequency and nocturia'. OABS and cystocele often coexist. This study aimed to analyse the changes in the overactive bladder symptom score (OABSS) of women followed up for one year after anterior repair surgery performed using a polypropylene mesh. In this surgery, a tape with four straps designed for optimum tissue holding capacity was fixed to the obturator foramen. Thirty-four women were operated using the abovementioned mesh. The OABSS, maximal urinary flow rate (Qmax) and postvoid residual (PVR) volume were evaluated pre- and post-surgery. We observed significant improvements in the OABSS and quality of life scores before and after one year of surgery. The surgery was significantly effective in improving urgency, daytime frequency, incontinence, the Qmax and the PVR volume. No significant change in nocturia was observed post-surgery. Our study confirmed the efficacy of the propylene mesh introduction surgery for cystocele for the improvement of OABS symptoms.

A Study of Minimal Change in Nocturia Affecting Quality of Life

Purpose: It is well known that nocturia is a bothersome symptom that affects the quality of life (QoL). However, it is not known how much of a decrease in nocturnal frequency is needed to improve the QoL. We determined the minimal change in nocturnal frequency affecting the QoL of patients with nocturia. Materials and Methods: A total of 87 patients with BPH and nocturia were treated with α-blocker and desmopressin for 8 weeks. Considering that the minimal clinically important change (MCIC) is different according to the baseline value, we divided the patients into two groups (group I, II). Group I had mild to moderate nocturia with voiding ＜4 times per night, and Group II had severe nocturia with voiding ≥4 times per night. Voiding diaries and King’s Health Questionnaires (KHQs) were evaluated before and after treatment. To determine the minimal change in nocturia affecting the QoL, statistical analysis was performed by Student's t-test and ANOVA test with the change in KHQ score according to decreased numbers of nocturnal frequency. Results: Groups I and II had 35 and 52 patients, respectively. The minimal decrease in nocturnal frequency associated with a statistically significant decrease in sleep/energy domain scores was 1 time in Group I and 2 times in Group II. Conclusions: These data show that decreases in nocturia of at least 1 time in patients with mild to moderate nocturia (＜4 times/night) and of 2 times in patients with severe nocturia (≥4 times/night) are needed to

Effects of Behavioral and Drug Therapy on Nocturia in Older Incontinent Women

Objectives: To examine changes in nocturia from a multicomponent behavioral training program or drug therapy in older women with urge or mixed (urge-predominant) urinary incontinence. Design: A secondary analysis of data from a prospective, randomized clinical trial. Setting: Parent trial was an outpatient research protocol in Alabama. Participants: One hundred ninety-seven women (aged 55–92) with incontinence and urodynamic evidence of bladder dysfunction. At baseline, 131 women (66% of participants) had nocturia. Intervention: In the parent study, participants received behavioral training, including four sessions of biofeedback-assisted pelvic floor muscle exercises, drug treatment (oxybutynin IR titrated from 2.5 mg per day to 5.0 mg three times a day), or placebo. Measurements: Participant-completed bladder diaries were used to calculate changes in nocturia. Results: Behavioral training reduced nocturia by a median 0.50 episodes per night and was significantly more effective than drug treatment (median reduction=0.30 episodes; P=.02) and placebo (median reduction=0.00 episodes; P<.001). Also, drug treatment was more effective than control (P=.007). Conclusion: Both behavioral training and drug treatment reduced nocturia more than placebo, but behavioral training was the most effective.

Effects of Behavioral and Drug Therapy on Nocturia in Older Incontinent Women

To examine changes in nocturia from a multicomponent behavioral training program or drug therapy in older women with urge or mixed (urge-predominant) urinary incontinence. A secondary analysis of data from a prospective, randomized clinical trial. Parent trial was an outpatient research protocol in Alabama. One hundred ninety-seven women (aged 55-92) with incontinence and urodynamic evidence of bladder dysfunction. At baseline, 131 women (66% of participants) had nocturia. In the parent study, participants received behavioral training, including four sessions of biofeedback-assisted pelvic floor muscle exercises, drug treatment (oxybutynin IR titrated from 2.5 mg per day to 5.0 mg three times a day), or placebo. Participant-completed bladder diaries were used to calculate changes in nocturia. Behavioral training reduced nocturia by a median 0.50 episodes per night and was significantly more effective than drug treatment (median reduction=0.30 episodes; P=.02) and placebo (median reduction=0.00 episodes; P<.001). Also, drug treatment was more effective than control (P=.007). Both behavioral training and drug treatment reduced nocturia more than placebo, but behavioral training was the most effective.

Changes in Nocturia From Medical Treatment of Benign Prostatic Hyperplasia: Secondary Analysis of the Department of Veterans Affairs Cooperative Study Trial

We evaluate the efficacy of medical therapy on nocturia in men with benign prostatic hyperplasia (BPH). We performed a secondary analysis of data from the VA Cooperative Study Program Trial in which 1,229 men with BPH 45 to 80 years old were randomly assigned to receive terazosin, finasteride, combination or placebo. The 1,078 men who completed 12 months of the trial are included in this study. Of those men 1,040 (96.5%) had at least 1 episode of nocturia at baseline and 38 (3.5%) had less than 1 episode (baseline nocturia is an average of 2 measures). Of those 1,040 men 788 (75.8%) had 2 or more nocturia episodes. Overall, nocturia decreased from a baseline mean of 2.5 to 1.8, 2.1, 2.0 and 2.1 episodes in the terazosin, finasteride, combination and placebo groups, respectively. Of men with 2 or more episodes of nocturia 50% reduction in nocturia was seen in 39%, 25%, 32% and 22% in the terazosin, finasteride, combination and placebo groups, respectively. Changes in nocturia were correlated with changes in reported bother from nocturia (Pearson correlation 0.48), BPH impact index (0.32) and overall satisfaction with urinary symptoms (0.33). Terazosin and combination therapy reduced nocturia in men with BPH, yet the net advantage of terazosin over placebo was a net reduction of 0.3 nocturia episode. For a person to reach a 50% or greater reduction in nocturia, the advantage of terazosin over placebo was 17 percentage points. Changes in nocturia had a moderate impact on symptom specific quality of life measures.

Serenoa repens for benign prostatic hyperplasia.

This systematic review aimed to assess the effects of Serenoa repens in the treatment of Benign Prostatic Hyperplasia (BPH). Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library, Phytodok), by checking bibliographies, and by contacting manufacturers and researchers. Trials were eligible if they (1) randomized men with BPH to receive preparations of Serenoa repens (alone or in combination) in comparison with placebo or other BPH medications, and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements. Eligibility was assessed by at least two independent observers. Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of Serenoa repens with placebo or other BPH medications was the change in urologic symptom scale scores. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for side effects was the number of men reporting side effects. 2939 men from18 randomized trials lasting 4 to 48 weeks were assessed. 16 trials were double-blinded and treatment allocation concealment was adequate in 9 studies. Compared with placebo, Serenoa repens improved urinary symptom scores, symptoms, and urinary flow measures. The weighted mean difference (WMD) for the urinary symptom score was -1.41 points (scale range 0-19), (95%CI = -2.52, -0.30, n = 1 study) and the risk ratio (RR) for self rated improvement was 1.75 (95%CI = 1.21, 2.54, n = 6 studies). The WMD for nocturia was -0.76 times per evening (95%CI = -1.22, -0.32; n = 10 studies). The WMD for peak urine flow was 1.93 ml/sec (95%CI = 0.72, 3.14, n = 8 studies). Compared with finasteride, Serenoa repens produced similar improvements in urinary symptom scores (WMD = 0.37 IPSS points (scale range 0-35), 95%CI = -0.45, 1.19, n = 2 studies) and peak urine flow (WMD = -0.74 ml/sec, 95%CI = -1.66, 0.18, n = 2 studies). Adverse effects due to Serenoa repens were mild and infrequent. Withdrawal rates in men assigned to placebo, Serenoa repens or finasteride were 7%, 9%, and 11%, respectively. The evidence suggests that Serenoa repens improves urologic symptoms and flow measures compared with placebo. Serenoa repens produced similar improvement in urinary symptoms and flow compared to finasteride and is associated with fewer adverse treatment events. The long term effectiveness, safety and ability to prevent BPH complications are not known.

The effect of hysterectomy on urinary symptoms and residual bladder volume

This was a prospective, clinical study to evaluate the effect of abdominal and vaginal hysterectomy for benign indications on urinary symptoms and residual bladder volume. One hundred and seven women undergoing hysterectomy for benign conditions were included in the study that took place in a district general hospital between April 1998 and January 2000. Urinary symptoms such as stress incontinence of urine, urgency, frequency, nocturia, sensation of incomplete voiding and voiding difficulties were considered. A questionnaire was filled out and the residual bladder volume measured with a 'Bard' bladder scanner on three occasions--before the operation, postoperative days 3 or 4 and at the 6-week postoperative visit. Statistical analysis involved using a generalised estimating equation and significance assessed at the 5% level. Each woman acted as her own control. There was no evidence of changes in nocturia and voiding difficulties after surgery. All other symptoms and residual bladder volumes decreased significantly postoperatively. The type of hysterectomy did not have an effect.

Beta-sitosterols for benign prostatic hyperplasia.

This systematic review aimed to assess the effects of beta-sitosterols (B-sitosterol) on urinary symptoms and flow measures in men with of benign prostatic hyperplasia (BPH). Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library, Phytodok), by checking bibliographies, and by contacting manufacturers and researchers. Trials were eligible for inclusion provided they (1) randomized men with BPH to receive B-sitosterol preparations in comparison to placebo or other BPH medications, and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements. Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. Main outcome measure for comparing the effectiveness of B-sitosterols with placebo and standard BPH medications was the change in urologic symptom scale scores. Secondary outcomes included changes in nocturia as well as urodynamic measures (peak and mean urine flow, residual volume, prostate size). Main outcome measure for side effects was the number of men reporting side effects. 519 men from 4 randomized, placebo-controlled, double-blind trials, (lasting 4 to 26 weeks) were assessed. 3 trials used non-glucosidic B-sitosterols and one utilized a preparation that contained 100% B-sitosteryl-B-D-glucoside. B-Sitosterols improved urinary symptom scores and flow measures. The weighted mean difference (WMD) for the IPSS was -4.9 IPSS points (95%CI = -6.3 to -3.5, n = 2 studies). The WMD for peak urine flow was 3.91 ml/sec (95%CI = 0.91 to 6.90, n = 4 studies) and the WMD for residual volume was -28.62 ml (95%CI = -41. 42 to -15.83, n = 4 studies). The trial using 100% B-sitosteryl-B-D-glucoside (WA184) show improvement in urinary flow measures. B-sitosterols did not reduce prostate size. Withdrawal rates for men assigned to B-sitosterol and placebo were 7.8% and 8. 0%, respectively. The evidence suggests non-glucosidic B-sitosterols improve urinary symptoms and flow measures. Their long term effectiveness, safety and ability to prevent BPH complications are not known.

Cernilton for benign prostatic hyperplasia.

Benign prostatic hyperplasia (BPH), nonmalignant enlargement of the prostate, can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH has been growing steadily. Cernilton, prepared from the rye-grass pollen Secale cereale, is one of the several phytotherapeutic agents available for the treatment of BPH. This systematic review aims to assess the effects of Cernilton on urinary symptoms and flow measures in men with benign prostatic hyperplasia (BPH). Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library, Phytodok), by checking bibliographies, and by contacting manufacturers and researchers. Trials were eligible if they were: (1) randomized controlled trials or controlled clinical trials comparing Cernilton with placebo or other BPH medications in men with BPH; and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements. Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. Main outcome measure for comparing the effects of Cernilton with placebo and standard BPH medications were the change in urologic symptoms scales. Secondary outcomes included changes in nocturia as well as urodynamic measures (peak and mean urine flow, residual volume, prostate size). Main outcome measure for side effects was the number of men reporting side effects. 444 men were enrolled in 2 placebo-controlled and 2 comparative trials lasting from 12 to 24 weeks. Three studies used a double-blind method although treatment allocation concealment was unclear in all. Cernilton improved "self rated urinary symptoms" (percent reporting satisfactory or improving symptoms) versus placebo and Tadenan. The weighted risk ratio (RR) for self-rated improvement versus placebo was 2.40 [95% CI = 1.21, 4. 75], and the weighted RR versus Tadenan was 1.42 [95% CI = 1.21, 4. 75]. Cernilton reduced nocturia compared with placebo and Paraprost. Versus placebo, the weighted RR was 2.05 [95% CI = 1.41, 3.00], and versus Paraprost, the WMD was -0.40 times per evening [95% CI = -0. 73, -0.07]. Cernilton did not improve urinary flow rates, residual volume or prostate size compared to placebo or the comparative study agents. Adverse events were rare and mild. The withdrawal rate for Cernilton was 4.8% compared to 2.7% for placebo and 5.2% for Paraprost. The Cernilton trials analyzed were limited by short duration, limited number of enrollees, gaps in reported outcomes, and unknown quality of the preparations utilized. The comparative trials lacked a proven active control. The available evidence suggests Cernilton is well tolerated and modestly improves overall urologic symptoms including nocturia. Additional randomized placebo and active-controlled trials are needed to evaluate the long-term clinical effectiveness and safety of Cernilton.