Significant Improvement In Urgency Research Articles

A QUALITATIVE STUDY EXPLORING MEANINGFUL IMPROVEMENT IN BOWEL URGENCY AMONG ADULTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Abstract BACKGROUND Ulcerative Colitis (UC) is a chronic disease with periods of relapse and remission. Bowel urgency, the sudden or immediate need for a bowel movement, is one of the most bothersome symptoms experienced by patients with UC. This study explored how patients define urgency severity and what would be a meaningful improvement based on a numeric rating scale (NRS). METHODS In-depth interviews were conducted in the United States with 19 adults with clinician-confirmed moderate to severe UC. Participants were asked to define levels of bowel urgency severity using an 11-point NRS (where 0 = no urgency and 10 = worst possible urgency) and to describe what would be a meaningful improvement based on how this change would impact their daily life. Interviews were audio-recorded, transcribed, and coded using thematic coding in NVivo. RESULTS Mild bowel urgency was described as ranging between 0 to 3 on the 11-point scale by most UC patients (n=16, 84%). Mild was described as “almost normal” or “normal urgency” (n=6, 32%) and being able to make it to the bathroom with ease (n=5, 25%). Most participants (n=15, 79%) rated moderate urgency between 4 to 6 on the 11-point scale. At this level, participants commented that they would need to ensure they are close to a bathroom (n=7, 37%). Finally, ratings for severe urgency clustered between 6 to 8 (n=7, 37%) and 8 to 10 (n=12, 63%). Severe bowel urgency was described as an immediate or uncontrollable need (n=8, 42%) which impacts their ability to leave the home (n=7, 37%). When asked about what change on the urgency NRS would be meaningful, n=10 (53%) participants reported that a 1-point change would be meaningful, with most stating that any change was an improvement. Participants commented that a 1-point change would reflect improved emotional well-being and greater confidence to leave the home. In contrast, 9 (47%) participants wanted improvements of more than 1-point change; 5 (26%) indicated that a 2-point improvement was required to consider the change meaningful and 4 (21%) felt a 3-point change or more was needed. With this greater level of change, participants described having a significant improvement in urgency, with less frequent urges and improved emotional well-being. CONCLUSION This qualitative study revealed that UC patients largely agreed regarding ratings of ‘mild’ and ‘moderate’ bowel urgency on an 11-point severity scale. ‘Severe’ bowel urgency was split between two ranges suggesting the existence of ‘very severe’ bowel urgency. In addition, the majority of UC patients perceived a 1 or 2-point reduction on the urgency NRS as a meaningful change in their lives.

P253 A qualitative study exploring meaningful improvement in bowel urgency among adults with moderate to severe Ulcerative Colitis

Abstract Background Ulcerative Colitis (UC) is a chronic disease with periods of relapse and remission. Bowel urgency, the sudden or immediate need for a bowel movement, is one of the most bothersome symptoms experienced by patients with UC. This study explored how patients define urgency severity and what would be a meaningful improvement based on a numeric rating scale (NRS). Methods In-depth interviews were conducted in the United States with 19 adults with clinician-confirmed moderate to severe UC. Participants were asked to define levels of bowel urgency severity using an 11-point NRS (where 0 = no urgency and 10 = worst possible urgency) and to describe what would be a meaningful improvement based on how this change would impact their daily life. Interviews were audio-recorded, transcribed, and coded using thematic coding in NVivo. Results Mild bowel urgency was described as ranging between 0 to 3 on the 11-point scale by most UC patients (n=16, 84%). Mild was described as “almost normal” or “normal urgency” (n=6, 32%) and being able to make it to the bathroom with ease (n=5, 25%). Most participants (n=15, 79%) rated moderate urgency between 4 to 6 on the 11-point scale. At this level, participants commented that they would need to ensure they are close to a bathroom (n=7, 37%). Finally, ratings for severe urgency clustered between 6 to 8 (n=7, 37%) and 8 to 10 (n=12, 63%). Severe bowel urgency was described as an immediate or uncontrollable need (n=8, 42%) which impacts their ability to leave the home (n=7, 37%). When asked about what change on the urgency NRS would be meaningful, n=10 (53%) participants reported that a 1-point change would be meaningful, with most stating that any change was an improvement. Participants commented that a 1-point change would reflect improved emotional well-being and greater confidence to leave the home. In contrast, 9 (47%) participants wanted improvements of more than 1-point change; 5 (26%) indicated that a 2-point improvement was required to consider the change meaningful and 4 (21%) felt a 3-point change or more was needed. With this greater level of change, participants described having a significant improvement in urgency, with less frequent urges and improved emotional well-being. Conclusion This qualitative study revealed that UC patients largely agreed regarding ratings of ‘mild’ and ‘moderate’ bowel urgency on an 11-point severity scale. ‘Severe’ bowel urgency was split between two ranges suggesting the existence of ‘very severe’ bowel urgency. In addition, the majority of UC patients perceived a 1 or 2-point reduction on the urgency NRS as a meaningful change in their lives.

Clinical Benefits of Telotristat Ethyl in Patients With Neuroendocrine Tumors and Low Bowel Movement Frequency: An Observational Patient-Reported Outcomes Study.

We evaluated carcinoid syndrome (CS) symptoms and the real-world effectiveness of telotristat ethyl (TE) among patients with ≤3 bowel movements (BM) per day. Patients with CS initiating TE between March and November 2017 could participate in a nurse support program collecting demographic and CS symptom data before TE initiation (baseline) and during ≥1 monthly follow-up within 3 months. Symptoms for patients averaging ≤3 BM/d at baseline were evaluated using pre/post-Student t tests. Sixty-eight patients reported ≤3 BM/d at baseline. Symptom burden was high and similar to participants with higher daily BM frequency. After 3 months of TE, most patients reported stable or improved symptoms with significant improvements in urgency (88%; mean [SD], -13.2 [32.2]), stool consistency (88%; -1.3 [2.0]), BMs per day (81%; -0.2 [1.2]), abdominal pain (86%; -13.7 [25.8]), nausea (85%; -30.9 [35.7]), and daily flushing episodes (83%; -1.7 [4.4]; all except BMs per day, P < 0.05). This analysis illustrates high CS symptom burden among patients with relatively low daily BM frequency. After initiating TE, patients reported significant improvements in urgency, stool consistency, abdominal pain, nausea, and flushing episodes. Clinicians and population health managers should consider CS symptom burden beyond daily BM frequency when evaluating treatment selection.

Clinical Efficacy of Solifenacin in the Management of Diabetes Mellitus-Associated Versus Idiopathic Overactive Bladder Symptoms: A Multicenter Prospective Study.

PurposeTo compare the clinical efficacy of anticholinergics for managing diabetes mellitus-associated overactive bladder (DM OAB) versus idiopathic overactive bladder (OAB) in Korean women.MethodsWe conducted a multicenter, prospective, parallel-group, open-label, 12-week study. Women (20–65 years old) with OAB symptoms for over 3 months were assigned to the DM OAB and idiopathic OAB groups. Changes in the Overactive Bladder Symptom Score (OABSS), urgency, urinary urgency incontinence, nocturia, daytime frequency according to a voiding diary, uroflowmetry, and postvoid residual urine volume (PVR) at the first visit (V1), week 4 (V2), and week 12 (V3) were compared.ResultsNo significant difference was found between the baseline patient characteristics of the DM OAB and idiopathic OAB groups. Treatment with solifenacin was associated with improvements in urgency, urinary urgency incontinence, nocturia, frequency according to a voiding diary, and the total OABSS between V1 and V2 and between V1 and V3. Moreover, a significant improvement in urgency and urge incontinence was found between V2 and V3 in the DM OAB group. However, no significant changes were found in any other parameters. There were no significant differences between the DM OAB group and the idiopathic OAB group except for urgency and urge incontinence at V2 (3.71 vs. 2.28 and 0.47 vs. 0.32, respectively).ConclusionsThe patients who received solifenacin demonstrated improved urgency, urinary urgency incontinence, nocturia, frequency according to a voiding diary, and total OABSS. Management with solifenacin was equally effective for both DM-related OAB and idiopathic OAB.

Mirabegron as adjuvant treatment for patients with interstitial cystitis/bladder pain syndrome.

Interstitial cystitis/bladder pain syndrome (IC/BPS) patients represent a heterogeneous group with pain and urinary storage symptoms and varying responses to current treatment options. The novel beta-3 agonist, mirabegron, has been shown to improve storage symptoms of patients with bladder overactivity; however, its effect on symptoms in the IC/BPS population has yet to be studied. Patients diagnosed at a single IC centre with IC/BPS undergoing standard therapy were treated with additional daily mirabegron 25 mg and seen in followup post-treatment. Patients completed the Interstitial Cystitis Symptom Index and Problem Index (ICSI/ICPI), and the Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) prior to and following mirabegron treatment. Global (NRS) and symptom-specific outcomes were assessed by comparing the pre- and post-treatment mean scores using tailed-t test (p<0.05 considered statistically significant). A total of 23 patients were available for review pre- and post-mirabegron treatment. There was no significant difference in ICSI (p=0.448), ICPI (p=0.352), or PUF (p=0.869) pre- and post-treatment. Analysis of symptom-specific outcomes show statistically significant improvements in urgency (p=0.048); however, no statistically significant improvements in frequency (p=0.951) or pain (p=0.952) were observed with mirabegron therapy. IC/BPS patients treated with mirabegron had improvement of urinary urgency, but no significant benefit in terms of pain or urinary frequency. This data suggests that mirabegron's role in the IC/BPS patient should be that of adjuvant treatment to ameliorate urgency.

Outcomes from treating bile acid malabsorption using a multidisciplinary approach.

Despite bile acid malabsorption affecting >1 % of the population, the outcomes of treatment are largely unreported. This study evaluated the effectiveness of a structured intervention for this condition. This was a retrospective evaluation of prospectively recorded patient reported outcome measures in a consecutive cohort of patients diagnosed with bile acid malabsorption seen in a cancer centre gastroenterology clinic. Every patient completed a 7-day food diary, a gastrointestinal symptom rating scale questionnaire and Bristol stool chart before the first clinic appointment and the symptom questionnaire and Bristol stool chart before all subsequent appointments. Patients who reported any episodes of type 6 or 7 stool were referred for a (75)Selenium (Se) homocholic acid taurine scan. Abnormal gastrointestinal symptoms were investigated and treated systematically using a peer reviewed management algorithm. Between 2011 and 2013, 136 men, 146 women, median age 66 years (range 19-89) underwent a scan. 143 (51 %) had 7-day isotope retention of ≤20 %. 105 (73 %) had previously undergone pelvic radiotherapy and 67 (47 %) GI surgery. 123 (86 %) were treated with low-fat diets, 79 (55 %) with a bile acid sequestrant, 73 (51 %) both. On discharge, 100 (70 %) patients reported an overall symptom improvement (mean -4.2 points, p < 0.0001). In patients who had only bile acid malabsorption and no other gastrointestinal diagnoses, 77 % (41/53) reported a mean improvement of -5.4 points (p < 0.0005). Patients reported a clinically significant improvement in urgency, faecal incontinence, wind, nocturnal defaecation, tiredness, abdominal pain, bloating, and steatorrhoea, (p = <0.0005). Stool frequency was reduced and stool consistency was improved. In this large cohort of complex patients, bile acid malabsorption is common and a multidisciplinary approach to managing gastrointestinal symptoms is effective.

Treatment Satisfaction, Symptom Control, and Quality of Life (Qol) with Lanreotide Autogel (Lan) in Neuroendocrine Tumour (Net) Patients with Carcinoid Syndrome (Cs): Results from the Symnet Study

ABSTRACT Aim: CS associated with NETs can have a negative impact on patients' QoL. Here, QoL data are evaluated from the SymNET study. Methods: SymNET was a large observational study of NET patients with a history of CS-related diarrhoea treated with LAN for >3 mo (NCT01234168). Patient-reported outcomes were assessed at a routine clinic visit. Primary endpoint was patient satisfaction with diarrhoea control (PSD). Symptoms were evaluated using medical records. QoL was assessed using the EORTC QLQ-C30 and QLQ-GI.NET21 questionnaires, which assess functional dimensions (QLQ-C30; higher scores = better QoL) and symptoms (QLQ-C30 and QLQ-GI.NET21; lower scores = better QoL). Overall QoL was evaluated according to satisfaction with CS symptom control. Results: Among 273 patients enrolled, 76% [95% CI: 70, 81%] were ‘completely’ or ‘rather’ satisfied with diarrhoea control. There was a clinically significant reduction in stool number and statistically significant improvements in urgency, leakage, and associated pain since LAN initiation. Scores for the QLQ-C30 global health status were high (mean [SD] 65.5 [22.1], median [range] 66.7 [0–100]), while scores for the QLQ-GI.NET21 endocrine and gastrointestinal subscales were low (endocrine, mean [SD] 19.4 [21.3], median [range] 11.1 [0–100]; gastrointestinal, mean [SD] 22.9 [17.8], median [range] 20.0 [0–87]). Patients who expressed a high PSD scored well on their overall rating of QoL (Table); in total, 70% of patients who were ‘rather’ or ‘completely satisfied’ had ‘good’, ‘very good’, or ‘excellent’ QoL. QoL according to PSD n (%) Rather' or ‘completely’ satisfied (n = 200) Neither satisfied nor dissatisfied (n = 46) ‘Rather’ or ‘completely’ dissatisfied (n = 18) Overall QoL Very poor, poor, or slightly poor 28 (14) 12 (26) 5 (28) Neither poor nor good 32 (16) 12 (26) 6 (33) Good, very good, or excellent 140 (70) 22 (48) 7 (39) Conclusions: In a real world setting, CS symptom control with LAN treatment translates into favourable levels of satisfaction among NET patients. Higher satisfaction levels were consistent with higher global health QoL scores. Further analyses are ongoing to evaluate factors associated with better QoL. Disclosure: P. Ruszniewski: Ipsen: Consultant/advisory role; honoraria; research funding; partner is Ipsen employee. Novartis: honoraria and research funding; M. Caplin: IPSEN: honoraria for consultant/advisory role. NOVARTIS: Consulting fee, Advisory Committees or Review Panels; LEXICON: Consulting fee, Advisory Committees or Review Panel; J.W. Valle: Ipsen: consulting, honoraria; P. Niccoli: Ipsen: consulting and honoraria; P. Maisonobe: Ipsen: Employment and salary; P. Atlan: Ipsen: Employment and salary. All other authors have declared no conflicts of interest.

A Randomized Controlled Trial Comparing Colonic Irrigation and Oral Antibiotics Administration Versus 4% Formalin Application for Treatment of Hemorrhagic Radiation Proctitis

Several treatments have been described for hemorrhagic radiation proctitis. The treatment outcomes are variable. Colonic irrigation and oral antibiotics for hemorrhagic radiation proctitis have been recently reported to be a novel and promising therapeutic approach. However, a comparative study of this treatment has never been investigated. This study aimed to compare colonic irrigation and oral antibiotics (irrigation group) versus 4% formalin application (formalin group) for treatment of hemorrhagic radiation proctitis. This was a randomized controlled trial. This study was conducted in a tertiary care/university-based hospital. Fifty patients with hemorrhagic radiation proctitis were randomly assigned to each treatment group (n = 25). For individuals allocated to the irrigation group, daily self-administered colonic irrigation with 1 L of tap water and a 1-week period of oral antibiotics (ciprofloxacin and metronidazole) were prescribed. For individuals allocated to the formalin group, 4% formalin application for 3 minutes was performed. Patients' symptoms and the endoscopic findings of each group were collected. Patient satisfaction was surveyed. The outcomes were evaluated at 8 weeks after the initiation of treatment. There was a significant improvement in rectal bleeding and bowel frequency in both treatment groups, but significant improvement in urgency, diarrhea, and tenesmus was demonstrated only in the irrigation group. The comparative study between 2 treatments revealed greater improvement in rectal bleeding, urgency, and diarrhea in the irrigation group. Twenty of 24 patients in the irrigation group and 10 of 23 patients in the formalin group were satisfied with the treatment. This trial cannot illustrate whether the antibiotics and the irrigation were equally important because of the limitation of a 2-armed design. The treatment with colonic irrigation and oral antibiotics appears to be more effective than 4% formalin application for hemorrhagic radiation proctitis treatment and achieves higher patient satisfaction.

Propiverine hydrochloride in Japanese patients with overactive bladder: A randomized, double‐blind, placebo‐controlled trial

The aim of this study was to investigate the efficacy and safety of propiverine for overactive bladder (OAB) in Japanese patients. In this multicentre, randomized, double-blind study, patients ≥ 20 years old with symptoms of OAB for ≥ 12 weeks were allocated to either propiverine (20 mg once daily) or placebo for 12 weeks. Efficacy and quality of life were assessed using a 7-day bladder diary, the OAB symptom score, and King's Health Questionnaire. Safety was mainly assessed by adverse events and the QTc interval. A total of 567 patients were allocated. Change in number of micturitions/24 h was significantly greater in the propiverine group than in the placebo group (-1.86 vs-1.36, P = 0.001). Compared to placebo, propiverine produced significant improvements in urgency, urgency incontinence, urine volume/micturition, and the OAB symptom score. Significant improvements in urgency, urgency incontinence, and micturition frequency were observed at the first 4 weeks of treatment. All nine domains of King's Health Questionnaire were improved more with propiverine than with placebo. Adverse effects with propiverine were mostly mild, and no patient developed QTc interval prolongation exceeding 500 ms. Propiverine is effective for Japanese OAB patients by improving their symptoms and quality of life with a predictable side-effect profile.

Patient‐selected goals in overactive bladder: a placebo controlled randomized double‐blind trial of transdermal oxybutynin for the treatment of urgency and urge incontinence

To assess patient selected goal improvement with transdermal oxybutynin, in a representative population of adult women with overactive bladder (OAB). Adult women with ≥ 3 month history of OAB symptoms, with or without urgency urinary incontinence, were recruited from a tertiary referral urogynaecology unit. Participants were allocated to either transdermal oxybutynin 3.9 mg/day or matching placebo patches in a double-blind, randomized parallel group design, over 4 weeks. Patient-selected goal achievement was defined as the primary outcome measure. Participants selected their own goals for treatment at baseline, and subsequently scored achievement of these goals on a visual analogue scale. They completed 3-day bladder diaries incorporating the Patients Perception of Intensity of Urgency Scale (PPIUS) to assess urgency and urgency incontinence episodes. Quality of life was assessed using the King's Health Questionnaire (KHQ). A total of 96 women were randomized; 78 (81.3%) participants completed 4 weeks double-blind treatment. There was no significant difference between mean goal achievement in the transdermal oxybutynin and placebo groups (41.9% (SD 31.3) vs 32.2% (SD 27.3), P= 0.203). Transdermal oxybutynin was associated with significant improvements in urgency episodes (-1.23 episodes/day (SD1.40) vs -0.21 episodes/day (SD 1.58), P= 0.01). Both groups made non-significantly different improvements in KHQ scores; 18 (38.2%) patients in the transdermal oxybutynin group experienced either erythema or pruritus, with 7 (14.9%) experiencing at least one systemic adverse event. In women with OAB, in comparison with placebo, transdermal oxybutynin 3.9 mg/day leads to significant objective improvements in urinary urgency, but with no significant difference observed in achievement of patients' own goals for therapy, or improvement in disease specific quality of life.

Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double‐blind, placebo‐controlled, rising‐dose trial

To examine the effects of the antimuscarinic agent solifenacin on urinary urgency, using a range of novel and established outcome measures, as urgency is the principal symptom of the overactive bladder syndrome (OAB). The study (SUNRISE, solifenacin in the treatment of urgency symptoms of OAB in a rising dose, randomized, placebo-controlled, double-blind, efficacy trial) was a randomized, double-blind, 16-week, placebo-controlled, multicentre study of solifenacin 5/10 mg in 863 patients with symptoms of OAB for > or = 3 months. The primary efficacy variable was the change from baseline to endpoint in the number of episodes of severe urgency with or without urgency incontinence per 24 h, as measured using the Patient Perception of Intensity of Urgency Scale, grade 3 + 4. Secondary efficacy variables included patient-reported outcomes for bladder condition, urgency bother and treatment satisfaction. A 3-day voiding diary was used to record micturition frequency and episodes of urgency and incontinence. A 7-day diary was used to assess speed of onset of effect. Solifenacin 5/10 mg was significantly more effective than placebo in reducing the mean number of episodes of severe urgency with or without incontinence per 24 h from baseline to endpoint (-2.6 vs -1.8, P < 0.001). There were also statistically significant differences in favour of solifenacin 5/10 mg over placebo for all secondary variables measured at endpoint, including patient-reported outcomes. There was a significant improvement in urgency as early as day 3 of treatment. Treatmente-mergent adverse events with solifenacin 5/10 mg were mainly mild or moderate in severity, and only led to discontinuation in 3.6% of patients. Solifenacin significantly reduced the number of urgency episodes and the extent of urgency bother, and was well tolerated; it was effective as early as day 3 of treatment.

Efficacy of solifenacin in patients previously treated with tolterodine extended release 4 mg: Results of a 12-week, multicenter, open-label, flexible-dose study

Objective: This study evaluated the use of solifenacin in patients experiencing residual urgency symptoms during treatment with tolterodine extended release (ER) 4 mg for overactive bladder (OAB).Methods: This was a 12-week, multicenter, openlabel, flexible-dose study of the efficacy, tolerability, and effects on health-related quality of life (HRQL) of solifenacin in patients aged ≥18 years who had symptoms of OAB for ≥3 months, had been treated with tolterodine ER 4 mg for ≥4 weeks, and wished to switch therapy because of a lack of sufficient subjective improvement in urgency. At baseline (before washout of tolterodine), patients had to have ≥3 urgency episodes/24 hours. After ≥14 days' washout of tolterodine, all patients received oral solifenacin 5 mg/d, with the option of a dose increase to 10 mg at weeks 4 and 8. On 3 consecutive days before the prewashout, postwashout (no drug treatment for OAB), and week 4, 8, and 12 visits (during and at the end of treatment with solifenacin), patients used a bladder diary to document daily symptoms of urgency, urge incontinence, frequency, nocturia, and nocturnal voids. Changes in these measures at study end were compared with prewashout and postwashout values. The Patient Perception of Bladder Condition (PPBC) and Overactive Bladder Questionnaire (OAB-q) were used to assess patient-reported outcomes at prewashout, postwashout, and week 12. Tolerability was evaluated based on the nature, frequency, and severity of observed or reported adverse events (AEs).Results: Of 606 patients screened, 441 received study medication (mean [SD] age, 61.4 [13.8] years; 88.9% white; 88.2% female). Diary-documented urgency changed from a mean of 6.0 episodes/24 hours at prewashout to 2.6 episodes/24 hours at study end, a mean decrease of 3.4 episodes/24 hours (95% CI, -3.8 to -3.0; P < 0.001). The frequency of all other diary variables was also significantly reduced from prewashout to study end (P < 0.001). The mean PPBC score changed from 4.2 points at prewashout to 3.0 points at study end, a mean improvement of 1.2 points (95% CI, -1.3 to -1.1; P < 0.001). Changes in all OAB-q scales and domains (symptom bother, coping, concern, sleep, social interaction, and total HRQL) from prewashout and postwashout to study end were also statistically significant (P < 0.001). Treatment-emergent AEs were mainly mild or moderate (237/261 [90.8%]) and led to few discontinuations (16/441 [3.6%]). Treatment-emergent AEs included anticholinergic AEs such as dry mouth (77 [17.5%]), constipation (51 [11.6%]), and blurred vision (10 [2.3%]).Conclusions: Among these patients with residual urgency after treatment with tolterodine ER 4 mg, solifenacin was associated with significant improvements in urgency and other diary-documented symptoms of OAB. Patients receiving solifenacin also had significant improvements in HRQL and the perceived bother of OAB. Clinical Trials Identification Number: NCT00454740.

How should patients with an overactive bladder manipulate their fluid intake?

OBJECTIVE To assess how the symptoms of overactive bladder (OAB) syndrome in adults are affected by decreasing or increasing fluid input, and the effect of fluid manipulation on quality of life. PATIENTS AND METHODS Adults with symptoms of OAB were randomized in a two-group, prospective, cross-over trial following a 4-day screening period (to establish baseline values) using frequency/volume charts, if they had a mean of eight or more voids and one or more urgency and/or urgency incontinence episodes in 24-h. Patients were asked to either increase or decrease their fluid intake, from baseline, as follows: group 1, 4 days drinking 25% less than baseline, and 2 days normal, then 4 days at 50% less than baseline, and 2 days normal, then 4 days at 25% more than baseline, and 2 days normal, and then 4 days at 50% more than baseline. Group 2 did the reverse. The primary endpoint was the change in the frequency of unwanted events during a 24-h period. RESULTS In all, 67 patients were contacted, 40 recruited and 24 were eligible. There was a significant reduction in frequency, urgency and nocturia when patients decreased their fluid input by 25%. Increasing fluid input by 25% and 50% resulted in a worsening of daytime frequency. Overall there was no statistically significant improvement in quality of life but there was some subjective improvement in urgency and nocturia, as measured by a validated instrument, in the group that decreased their fluid input by 25%; ≈300 mL of daily fluid came from water-containing foods. CONCLUSIONS Fluid manipulation is a cheap, noninvasive and easy way to help control the symptoms of OAB. Patients have difficulty in either decreasing or increasing their fluid input by 50%. Patients can now be told to expect a significant improvement in urgency, frequency and nocturia episodes if they reduce their fluid input by 25%.

How should patients with an overactive bladder manipulate their fluid intake?

To assess how the symptoms of overactive bladder (OAB) syndrome in adults are affected by decreasing or increasing fluid input, and the effect of fluid manipulation on quality of life. Adults with symptoms of OAB were randomized in a two-group, prospective, cross-over trial following a 4-day screening period (to establish baseline values) using frequency/volume charts, if they had a mean of eight or more voids and one or more urgency and/or urgency incontinence episodes in 24-h. Patients were asked to either increase or decrease their fluid intake, from baseline, as follows: group 1, 4 days drinking 25% less than baseline, and 2 days normal, then 4 days at 50% less than baseline, and 2 days normal, then 4 days at 25% more than baseline, and 2 days normal, and then 4 days at 50% more than baseline. Group 2 did the reverse. The primary endpoint was the change in the frequency of unwanted events during a 24-h period. In all, 67 patients were contacted, 40 recruited and 24 were eligible. There was a significant reduction in frequency, urgency and nocturia when patients decreased their fluid input by 25%. Increasing fluid input by 25% and 50% resulted in a worsening of daytime frequency. Overall there was no statistically significant improvement in quality of life but there was some subjective improvement in urgency and nocturia, as measured by a validated instrument, in the group that decreased their fluid input by 25%; approximately 300 mL of daily fluid came from water-containing foods. Fluid manipulation is a cheap, noninvasive and easy way to help control the symptoms of OAB. Patients have difficulty in either decreasing or increasing their fluid input by 50%. Patients can now be told to expect a significant improvement in urgency, frequency and nocturia episodes if they reduce their fluid input by 25%.

Early Effect on the Overactive Bladder Symptoms following Botulinum Neurotoxin Type A Injections for Detrusor Overactivity

ObjectivesLimited studies to date have reported on the onset of effect of intradetrusor botulinum neurotoxin type A (BoNTA) injections when used to treat the symptoms of the overactive bladder (OAB). Furthermore, few studies have examined the effect of BoNTA on urgency and nocturia, now recognised as the most bothersome symptoms of the OAB syndrome. We studied the immediate effect of BoNTA on the OAB symptoms by recording the daily changes during the week after treatment of patients with neurogenic or idiopathic detrusor overactivity (NDO/IDO). MethodsTwenty-four patients (16 NDO, 8 IDO) treated with 300mu BOTOX® (NDO) or 200mu (IDO) completed a 4-d voiding diary before and 4 wk after treatment and a 7-d diary starting the day immediately after injections. Data were analysed for intragroup daily changes during the first week and for further changes at 4 wk. Parametric t tests were used for statistical analysis (significance at p<0.05). ResultsThe two groups were comparable at baseline for all studied variables. In NDO, significant improvements in urgency, frequency, and nocturia were seen at day 2 post injection and in incontinence at day 3, and were sustained at 4 wk. In IDO, the first significant change in urgency, frequency, and incontinence was seen at day 4, with urgency showing the most consistent changes thereafter. All parameters significantly improved at 4 wk. ConclusionsIntradetrusor BoNTA ameliorates all OAB symptoms within the first week after treatment, but urgency is most rapidly and consistently affected, suggesting an early effect on bladder afferent pathways. Differences in the toxin dose or possibly underlying pathophysiology may account for an earlier trend for symptomatic improvement in the NDO patients.

Solifenacin treatment for overactive bladder in Hispanic patients: patient-reported symptom bother and quality of life outcomes from the VESIcare® Open-Label Trial

The primary goal of overactive bladder (OAB) treatment is to reduce symptoms and improve health-related quality of life (HRQoL). Although trials open enrolment to everyone, most OAB studies feature Caucasians. Here we present Hispanic data. VESIcare Open-Label Trial was a 12-week, open-label, flexible-dosing study in patients with OAB symptoms for >or=3 months. All patients started on solifenacin 5 mg/day, with a dosing option of 5 or 10 mg/day at weeks 4 and 8. Three patient-reported outcome (PRO) measures assessed symptom improvement and treatment satisfaction: the Patient Perception of Bladder Condition (PPBC) scale, a Visual Analogue Scale (VAS), the Overactive Bladder Questionnaire (OAB-q). 94/2205 patients in the full population were Hispanic. Urgency was most frequently reported at baseline (93.6%), followed by frequency (91.5%), nocturia (84.0%) and urge incontinence (UI) (67.0%). Frequency was reported as the most bothersome symptom (MBS) by a higher proportion of Hispanics than the full population (40.4% vs. 28.1%). UI was reported as the MBS by a smaller proportion of Hispanics (18.1% vs. 27.3%). Patients reporting moderate-to-severe problems related to bladder condition at baseline reported improvement to 'some minor problems' at week 12. Over 72.0% of patients experienced PPBC score improvement. Both groups reported significant improvements in urgency, UI, frequency and nocturia on the VAS (all p<0.001) and all OAB-q domains (all p<0.001) at week 12. Although numbers were small, Hispanics receiving solifenacin for OAB reported improvement from baseline in symptom bother and HRQoL, as assessed by three independent PRO measures.

Clinical efficacy of tolterodine with or without a simplified pelvic floor exercise regimen

Objectives To investigate whether the combination of tolterodine plus (Tp) a simple pelvic floor muscle exercise (PFME) program would provide improved treatment benefits compared with tolterodine alone (Ta) in patients with symptoms of overactive bladder (OAB). Methods After a 1–2 week run-in period, 480 patients with symptoms of urinary frequency (≥8 micturitions/24 hr), urgency, and urge incontinence (≥1 episode/24 hr), were randomized to receive tolterodine 2 mg bid with or without a simple PFME program for 24 weeks in this multinational study. Treatment efficacy was assessed by comparing the change from baseline in 3-day micturition diary recordings. Results After 24 weeks' treatment, in the Ta group the urgency episodes reduced from mean of 4.1 to 1.5 (83% reduction) while in the Tp group the urgency episodes reduced from 4.2 to 2.1 (78.7% reduction). Mean incontinence episodes per day decreased from 3.21 (standard deviation (SD) 3.4) to 0.95 (SD 1.9) in Ta group and from 3.44 (SD 3.4) to 1.25 (SD 2.7) in the Tp group. Similarly, the number of micturition/24 hr were significantly reduced, from 12.78 to 9.20 (27.3% reduction) in the Ta group and from 11.87 to 9.29 (23% reduction) in the Tp group. There was an improvement in the patients' perception of urinary symptoms in 85.9% of patients on Ta and 81.7% patients on Tp PFME. There were no statistically significant differences between the groups with regard to any of the outcome parameters. Conclusions Tolterodine therapy for 24 weeks results in significant improvement in urgency, frequency, and incontinence, however, no additional benefit was demonstrated for a simple PFME program. Neurourol. Urodynam. 23:48–53, 2004. © 2003 Wiley-Liss, Inc.

A one-year open-label study of the safety and efficacy of lamotrigine in the treatment of bipolar depression

Objective: This study evaluated the use of solifenacin in patients experiencing residual urgency symptoms during treatment with tolterodine extended release (ER) 4 mg for overactive bladder (OAB).Methods: This was a 12-week, multicenter, openlabel, flexible-dose study of the efficacy, tolerability, and effects on health-related quality of life (HRQL) of solifenacin in patients aged ≥18 years who had symptoms of OAB for ≥3 months, had been treated with tolterodine ER 4 mg for ≥4 weeks, and wished to switch therapy because of a lack of sufficient subjective improvement in urgency. At baseline (before washout of tolterodine), patients had to have ≥3 urgency episodes/24 hours. After ≥14 days' washout of tolterodine, all patients received oral solifenacin 5 mg/d, with the option of a dose increase to 10 mg at weeks 4 and 8. On 3 consecutive days before the prewashout, postwashout (no drug treatment for OAB), and week 4, 8, and 12 visits (during and at the end of treatment with solifenacin), patients used a bladder diary to document daily symptoms of urgency, urge incontinence, frequency, nocturia, and nocturnal voids. Changes in these measures at study end were compared with prewashout and postwashout values. The Patient Perception of Bladder Condition (PPBC) and Overactive Bladder Questionnaire (OAB-q) were used to assess patient-reported outcomes at prewashout, postwashout, and week 12. Tolerability was evaluated based on the nature, frequency, and severity of observed or reported adverse events (AEs).Results: Of 606 patients screened, 441 received study medication (mean [SD] age, 61.4 [13.8] years; 88.9% white; 88.2% female). Diary-documented urgency changed from a mean of 6.0 episodes/24 hours at prewashout to 2.6 episodes/24 hours at study end, a mean decrease of 3.4 episodes/24 hours (95% CI, -3.8 to -3.0; P < 0.001). The frequency of all other diary variables was also significantly reduced from prewashout to study end (P < 0.001). The mean PPBC score changed from 4.2 points at prewashout to 3.0 points at study end, a mean improvement of 1.2 points (95% CI, -1.3 to -1.1; P < 0.001). Changes in all OAB-q scales and domains (symptom bother, coping, concern, sleep, social interaction, and total HRQL) from prewashout and postwashout to study end were also statistically significant (P < 0.001). Treatment-emergent AEs were mainly mild or moderate (237/261 [90.8%]) and led to few discontinuations (16/441 [3.6%]). Treatment-emergent AEs included anticholinergic AEs such as dry mouth (77 [17.5%]), constipation (51 [11.6%]), and blurred vision (10 [2.3%]).Conclusions: Among these patients with residual urgency after treatment with tolterodine ER 4 mg, solifenacin was associated with significant improvements in urgency and other diary-documented symptoms of OAB. Patients receiving solifenacin also had significant improvements in HRQL and the perceived bother of OAB. Clinical Trials Identification Number: NCT00454740.