EUCTR2010-023851-27-GB进行中（未招募）1 期
A 12 week, multi centre, open label study to evaluate the effect of fesoterodine flexible dosing regimen on the sexual function of women with overactive bladder. - Fesoterodine and sexual function
Kings College Hospital NHS Foundation Trust0 个研究点目标入组 132 人开始时间: 2012年4月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Female outpatients aged 18 – 80 years.
- •2.Overactive bladder symptoms (subject reported) for =3 months prior to screening visit according to ICS guidelines.
- •3.Mean number of Urgency episodes =3 per 24 hours as verified by the screening bladder diary prior to baseline / Visit 2.
- •4.Sexually active .
- •5.Able and willing to complete the micturition bladder diaries and all trial related questionnaires, comply with scheduled clinic visits and clinical trial procedures.
- •6.Capability of understanding and having signed the informed consent form after full discussion of the treatment and its risks and benefits.
- •7.Able to speak, read and write in English.
- •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 132
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 132
排除标准
- •1.Any condition that would contraindicate the use of fesoterodine including, but not limited to: hyposensitivity to the active substance (fesoterodine fumarate) or any of the excipients, or to peanut, lactose or soya; urinary retention; gastric retention; uncontrolled narrow angle glaucoma; myasthesia gravis; moderate or severe hepatic impairment; severe renal impairment; severe ulcerative colitis; and 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 (eg. Incontinence surgery, diverticulectomy, OTIS urethrotomy) with the exception of any minor surgery (eg. 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 =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:
- •a.Any other drug treatment for OAB
- •b.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.Use of 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 the expectation to start any during the trial.
- •15.Administration of medication capable of inducing hepatic enzyme metabolism or transport (eg rifampicin, carbamazepine, phenytoin, phenobarbital, or St John’s Wort) at any point in the study or within the 6 weeks prior to Visit 2 (baseline).
- •16.Treatment with potent CYP2D6 inhibitors such as bupropion, cinacalcet, fluoxetine, paroxetine or quinine at any point during the study
- •17.Participated in any interventional clinical trial or received an investigational drug within 4 weeks prior
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