This study is looking to see if fesoterodine has an effect on the sexual function of women with overactive bladder problems.

Phase 1

• Conditions: sexual function of women with overactive bladder syndrome; MedDRA version: 18.1Level: LLTClassification code 10040482Term: Sexual function abnormalSystem Organ Class: 100000004872; MedDRA version: 18.0Level: LLTClassification code 10059617Term: Overactive bladderSystem Organ Class: 100000004857; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2010-023851-27-GB
• Lead Sponsor: Kings College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-20
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified