Overactive bladder syndrome Urological and Genital Diseases Other disorders of urinary system
Conditions
Interventions
All patients have a two week wash out period and are then started on Fesoterodine fumarate 4mg taken orally once a day for four weeks. At this point the patient will have a discussion with the study d
Sponsors
King's College Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the trial: 1. Female outpatients aged 18 -? 80 years 2. Overactive bladder symptoms (subject reported) for greater than or equal to 3 months prior to screening visit according to International Continence Society (ICS) guidelines 3. Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the screening bladder diary prior to baseline/visit 2 4. Mean number of urgency episodes greater than or equal to 3 per 24 hours as verified by the screening bladder diary prior to baseline/visit 2 5. Sexually active with a mean frequency of sexual activity greater than or equal to 1 per week 6. Able and willing to complete the micturition bladder diaries and all trial related questionnaires, comply with scheduled clinic visits and clinical trial procedures 7. Capability of understanding and having signed the informed consent form after full discussion of the treatment and its risks and benefits
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the trial: 1. Any condition that would contraindicate the use of fesoterodine including, but not limited to: 1.1. Hyposensitivity to the active substance (fesoterodine fumarate) or any of the excipients, or to peanut or soya 1.2. Urinary retention 1.3. Gastric retention 1.4. Uncontrolled narrow angle glaucoma 1.5. Myasthesia gravis 1.6. Moderate or severe hepatic impairment 1.7. Severe renal impairment 1.8. Severe ulcerative colitis 1.9. Toxic megacolon 2. Stage 3 or greater pelvic organ prolapse, defined as tissue protuding to or beyond the introitus in lithotomy position at rest (without increase in intra abdominal pressure) 3. History of lower urinary tract surgery (e.g. incontinence surgery, diverticulectomy, OTIS urethrotomy) with the exception of any minor surgery (e.g. Cystoscopic procedures) 4. A known history of interstitial cystitis or a significant pain component associated with OAB symptoms, uninvestigated haematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia, or bladder outlet obstruction, radiation cystitis, genitor-urinary tuberculosis, bladder calculi, urethral obstruction or detrusor-sphincter dysynergia 5. Subjects with bladder stones. Subjects with a previous history of bladder stones may be included. 6. Previous history of acute urinary retention requiring catheterisation, clinically relevant bladder outlet obstruction or severe voiding difficulties in the judgement of the investigator prior to visit 2 (baseline) 7. Use of an indwelling or an intermittent self-catheterisation programme 8. Symptoms of incontinence being predominantly stress urinary incontinence as determined by the investigator 9. Urinary tract infection (UTI) as shown by the results of the urinalysis at screening or recurrent urinary tract infections (RUTIs) defined as treatment for UTI greater than or equal to 3 times in the last year 10. Use of any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks prior to Visit 1 (screening) 11. Treatment with antimuscarinic OAB medication with 2 weeks prior to visit 2 (baseline), including any preparation containing: darifenacin, oxybutynin, propiverine, tolterodine, fesoterodine, solifenacin and trospium 12. Initiation of treatment during the 12 week trial period with: 12.1. Any other drug treatment for OAB 12.2. Any drugs with significant anticholinergic, antispasmodic, parasympathetic, or cholinergic agonistic effects 13. Intermittent or unstable use of diuretics or alpha blockers, or tricyclic antidepressants, oestrogen therapy and any 5AR inhibitors or initiation of such treatment(s) within 2 weeks prior to visit 2 (baseline) 14. Treatment with moderate or potent CYP3A4 inhibitors, such as grapefruit juice, macrolide antibiotics (erythromycin, clarithromycin), immunosuppressants (cyclosporine), azole antifungal agents (ketonazole, itraconazole), protease inhibitors within 3 weeks prior to visit 2 (baseline), or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in item scores of the Pelvic Organ Prolapse and Urinary Incontinence Sexual Questionnaire - short form (PISQ-12) and the Sexual Quality of Life questionnaire (SQOL) at week 12 relative to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bladder diary: 1.1. Change in mean number of micturitions per 24hours at week 12 relative to baseline 1.2. Change in mean number of nocturnal micturitions per 24 hours at week 12 relative to baseline in subjects with greater than 0 episodes during the 3-day baseline diary period. (Nocturnal micturitions are defined as those occurring between the time the subject goes to bed with the intention of sleeping and the time she rises to start the next day). 1.3. Percentage change in urinary urgency incontinence (UUI) episodes per 24 hours at week 12 relative to baseline in subjects with greater than 0 UUI episodes during the 3-day baseline diary period 1.4. Change in mean number of urgency episodes per 24 hours at week 12 relative to baseline. (Urgency episodes are defined as those with a Patient Perception of Intensity of Urgency Score (PPIUS) rating of greater than or equal to 3 in the diary. 1.5. Percentage change in urgency episodes per 24 hours at week 12 relative to baseline 2. Patient questionnaires: 2.1. Patient Perception of Bladder Condition (PPBC): change in PPBC at week 12 relative to baseline 2.2. King's Health Questionnaire (KHQ): change in total score of each domain at week 12 relative to baseline 2.3. Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL): change in total score of each domain at week 12 relative to baseline 2.4. Self Assessment Goal Achievement Questionnaire (SAGA): achievement of patient orientated goals at 12 weeks relative to baseline | — |
Countries
United Kingdom
Outcome results
None listed