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| A randomised, double blind validation of the significance of occult pyuria for the symptoms of the overactive bladder |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN20127069 |
| Date ISRCTN assigned | 21/08/2007 |
| Local reference number(s) | OAB/AB/07 |
| Public title | A randomised, double blind validation of the significance of occult pyuria for the symptoms of the overactive bladder |
| Scientific title | |
| Acronym | NOD (Nitrofurantoin in Overactive Detrusor) |
| Disease/condition/study domain | Overactive bladder |
| Study hypothesis | Study hypothesis amended as of 11/09/2007: The aim of this study is to determine whether treatment with nitrofurantoin improves total 24 hour incontinence episodes in patients presenting with symptoms of overactive bladder, who have significant numbers of inflammatory cells in their urine but a negative urine culture. Study hypothesis provided at time of registration: The aim of this study is to determine whether treatment with pivmecillinam improves total 24 hour incontinence episodes in patients presenting with symptoms of overactive bladder, who have significant numbers of inflammatory cells in their urine but a negative urine culture. |
| Design/methodology | Randomised, placebo-controlled, double-blind trial. |
| Research ethics review | Submitted to the Moorfield and Whittington Ethics Committee for review as of 04/06/2007. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Adults aged 18 years or older 2. Both males and females 3. Symptoms of frequency more than or equal to 8 per day; urgency with or without urge incontinence 4. Able to complete a bladder diary chart for at least three days in one week 5. Able to complete a symptom questionnaire |
| Participants - exclusion criteria | 1. Age less than 18 years 2. Inability to consent 3. Bactiuria of >105 Colony Forming Unit (CFU) /ml identified by conventional Midstream Urine Specimen (MSU) culture 4. Negative urine microscopy identified by <10 White Blood Cells (WBC)/uL on a fresh, unspun sample of urine |
| Patient information material | |
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 01/10/2008 |
| Status of trial | Ongoing |
| Target number of participants | 30 in each arm |
| Interventions | Interventions amended as of 23/11/2007: Intervention group: Nitrofurantoin (Brand Name: Macrodantin®) 100 mg orally b.d (twice daily) for 6 weeks Control group: Placebo administered orally, twice daily for 6 weeks Please note that this change is due to difficulty in finding suitable placebo for the pivmecillinam preparation. Interventions provided at time of registration: Intervention group: Pivmecillinam will be administered orally at a dose of 400 mg twice daily Control group: Placebo administered orally, twice daily |
| Primary outcome measure(s) | Change in number of incontinence episodes per 24 hours, assessed by bladder diary chart recorded by the patients during the intervention. |
| Secondary outcome measure(s) | Secondary outcome measure amended as of 11/09/2007: 1. To determine whether treatment with nitrofurantoin improves other symptoms of over active bladder, the following will be assessed: 1.1. 24-urinary frequency 1.2. Urgency score assessed at 2 weekly intervals until the end of the trial at 6 weeks 1.3. Average voided volume assessed at 2 weekly intervals until the end of the trial at 6 weeks 1.4. Quality of life (I-Qol) assessed at 2 weekly intervals until the end of the trial at 6 weeks 2. Assessment to determine whether pus cells are eliminated from the urine, <10 WBC/uL, after long-term treatment with nitrofurantoin. This will be measured at 2 weekly intervals until the end of the trial at 6 weeks 3. Recording side effects of treatment Secondary outcome measures provided at time of registration: 1. To determine whether treatment with Pivmecillinam improves other symptoms of over active bladder, the following will be assessed: 1.1. 24-urinary frequency 1.2. Urgency score assessed at 2 weekly intervals until the end of the trial at 6 weeks 1.3. Average voided volume assessed at 2 weekly intervals until the end of the trial at 6 weeks 1.4. Quality of life (I-Qol) assessed at 2 weekly intervals until the end of the trial at 6 weeks 2. Assessment to determine whether pus cells are eliminated from the urine, <10 WBC/uL, after long-term treatment with Pivmecillinam. This will be measured at 2 weekly intervals until the end of the trial at 6 weeks 3. Recording side effects of treatment |
| Sources of funding | The Whittington Hospital NHS Trust (UK) |
| Sponsor name | The Whittington Hospital NHS Trust (UK) |
| Sponsor details | Magdala Avenue Highgate Hill London United Kingdom N19 5LW |
| Sponsor telephone | +44 (0)207 288 5269 |
| Sponsor fax | +44 (0)207 288 5302 |
| Sponsor email | james.malone-lee@ucl.ac.uk |
| Contact name | Prof James Malone-Lee |
| Contact details | Department of Medicine Clerkenwell Building Archway Campus Highgate Hill London United Kingdom N19 5LW |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN20127069 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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