Clinical trial NCT01505439: A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence
Official title: A Prospective, Open Label, Single Arm, Multicenter Study to Estimate the Efficacy and Safety of Solifenacin in Female With Clinically Significant Stress Urinary Incontinence and Urgency Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stress Urinary Incontinence
Urgency Urinary Incontinence
Keywords: solifenacin
bladder symptom
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2012-01-06
Enrollment: 311
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to investigate the effects of solifenacin on urgency urinary incontinence symptoms and incontinence quality-of-life (I-QoL) in female patients with clinically significant stress urinary incontinence accompanied by urgency urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Patients are selected from those who meets one of criteria
* Patients with a positive cough provocation test
* Based on 3-day voiding diary, patients with:

  * Urinary frequency (eight or more micturitions per day or 24 hours)
  * Urinary urgency (two or more episodes per day or 24 hours)
  * Urge incontinence (three or more episodes for 3 days)

Exclusion Criteria:

* Breast-feeding women or females of childbearing potential with the intention to become pregnant during the study
* Post-void residual urine volume (PRV) of 150 cc or more
* Patients who experienced acute ureteral obstruction requiring an indwelling catheter
* Patients who experienced clinically significant pelvic organ prolapse or lower urinary tract surgery within 6 months prior to the initiation of the present study
* Patients who underwent a urinary incontinence operation within 1 year
* Any condition that, in the opinion of the investigator, is a contraindication for anticholinergic treatment, including severe narrow-angled glaucoma, urinary retention, gastric retention, severe myasthenia, severe hepatic insufficiency or severe ulcerative colitis
* Significant hepatic or renal disease, defined as having greater than twice the upper limit of the reference ranges for serum concentrations of aspartate aminotransferase (AST \[SGOT\]), alanine aminotransferase (ALT \[SGPT\]), alkaline phosphatase or creatinine
* Patients who have any of neurological disorders such as stroke, multiple sclerosis, spinal cord injury, and Parkinson's disease
* Patients who use an indwelling catheter or practice intermittent self-catheterization
* Recurrent UTIs defined as having been treated for symptomatic UTIs 3 times or more in the last year
* Symptomatic acute urinary tract infection (UTI) during the run-in period
* Patients who received any of the following prohibited concomitant drugs within 14 days prior to randomization: Treatment performed within the 14 days preceding randomization, or expected to initiate treatment during the study with:

  * Any anticholinergics other than the trial drug
  * Any drug treatment for overactive bladder. Estrogen treatment started more than 2 months prior to inclusion is allowed
* Patients taking an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
* Patients with chronic constipation or history of severe constipation
* Treatment with any of potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole)
* Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study initiation and not agreeing to use such methods during the entire study period and for at least 1 month thereafter. Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives, surgical procedures (tubal ligation or vasectomy), or continence
* Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Primary outcomes:
measure: Changes in the number of urge urinary incontinence episodes per 24 hours between baseline and week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Percent change in the mean number of urge urinary incontinence episodes per 24 hours
timeFrame: Baseline, week 4 and week 12
measure: Change in the mean number of urge urinary incontinence episodes per 24 hours
timeFrame: Baseline, week 4 and week 12
measure: Change in the mean frequency of urination per 24 hours
timeFrame: Baseline, week 4 and week 12
measure: Percent change in the mean frequency of urination
timeFrame: Baseline, week 4 and week 12
measure: Changes in the mean and sum rating on the Bladder Sensation Scale per 24 hours
timeFrame: Baseline, week 4 and week 12
measure: Change in the mean number of severe urgency episodes per 24 hours
timeFrame: Baseline, week 4 and week 12
measure: Changes in overactive bladder symptom score (OABSS) questionnaire
timeFrame: Baseline, week 4 and week 12
measure: Changes in short urogenital distress inventory (UDI-6)
timeFrame: Baseline, week 4 and week 12
measure: Changes in short incontinence impact questionnaire (IIQ-7)
timeFrame: Baseline, week 4 and week 12
measure: Safety assessed by the incidence and severity of side effects
timeFrame: For 12 weeks
Other outcomes:
Locations:
city: Chonam
country: Korea, Republic of
facility: Site KR00001
city: Chungnam
country: Korea, Republic of
facility: Site KR00002
city: Daegu
country: Korea, Republic of
facility: Site KR00003
city: Incheon
country: Korea, Republic of
facility: SIte KR00004
city: Pusan
country: Korea, Republic of
facility: Site KR00005
city: Seoul
country: Korea, Republic of
facility: Site KR00006
Study officials:
References: