A Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with and without Multiple Sclerosis. - Recurrent urine infection in OAB patients with and without MS
- Conditions
- Chronic urinary tract infection.MedDRA version: 16.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 100000004857
- Registration Number
- EUCTR2009-017939-18-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2
1.A diagnosis of overactive bladder in MS and Non-MS
patients
2.Adults aged >=18 years
3.Urinary 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
6.Pyuria on urinalysis showing =10 wbc µL-1
7.A negative result from culture of a midstream urine specimen on selective agar with a threshold of 105 cfu ml-1
8. Able to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
1.Age less than 18 years
2.Inability to consent
3.Bacteriuria of >105 cfu ml-1 identified by conventional MSU culture
4.Negative urine microscopy identified by < 10wbc/uL on a fresh, unspun sample of urine.
5.Known renal impairment - acute or chronic renal failure
6.Chronic lung disease
7. Glucose-6-phosphate deficiency
8. Acute porphyria
9.Allergy to Nitrofurantoin
10. The patient must not have taken part in other research within the previous six months and must not be participating in concurrent research.
11. The patient must not have taken part in previous studies of Nitrofurantoin
12.Pregnant or lactating females (Contraception is required in females and males who participate)
13.Intolerance to lactose
14. Concurrent use of other medicinal products which may interact with the study drug, including: Magnesium trisilicate, Sulphinpyrazone, Probenecid, Nalidixic acid, carbonic anhydrase inhibitors, and quinolone anti-infective drugs.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method