ISRCTN40720691已完成4 期
A 12 week, single centre, open label study to evaluate the effect of fesoterodine flexible dosing regimen on the sexual function of women with overactive bladder
King's College Hospital NHS Foundation Trust (UK)0 个研究点目标入组 30 人开始时间: 2011年2月8日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
相似试验
招募中
4 期
A 12 month, open label, multi-center study to evaluate the efficacy and safety of intravitreal injections of ranibizumab 0.5 mg on Cystoid, Spongy & Mixed OCT patterns secondary to Diabetic Macular Edema (DME)CTRI/2014/02/004379Dr V Narendran300
进行中（未招募）
1 期
This study is looking to see if fesoterodine has an effect on the sexual function of women with overactive bladder problems.sexual function of women with overactive bladder syndromeMedDRA version: 18.1Level: LLTClassification code 10040482Term: Sexual function abnormalSystem Organ Class: 100000004872MedDRA version: 18.0Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857EUCTR2010-023851-27-GBKings College Hospital NHS Foundation Trust132
已完成
不适用
Diabetes and EyeCTRI/2018/05/014060ovartis Healthcare Pvt Ltd30
进行中（未招募）
不适用
A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF TherapyAdult Rheumatoid Arthritis (RA)MedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisEUCTR2010-018331-18-GBF. Hoffmann-La Roche Ltd.
进行中（未招募）
不适用
A 12-week, open label, multicentre study assessing the efficcay and of Donepezil in patients discontinuing treatment with Memantine monotherapyAlzheimer's diseaseEUCTR2004-004918-17-CZPfizer Inc100