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 sites132 target enrollmentApril 20, 2012

Conditionssexual 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]

DrugsToviaz

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: sexual function of women with overactive bladder syndrome
Sponsor: Kings College Hospital NHS Foundation Trust
Enrollment: 132
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 20, 2012

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Kings College Hospital NHS Foundation Trust

Eligibility Criteria

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

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).