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Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder. (SHRINK)

Primary Purpose

Detrusor Overactivity, Overactive Bladder

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Placebo
solifenacin
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Detrusor Overactivity focused on measuring Vesicare, Solifenacin, Detrusor Overactivity, Urinary Nerve Growth Factor, Overactive Bladder, Bladder wall thickness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptoms of overactive bladder (OAB), including urinary frequency, urgency or urge incontinence, for greater than or equal to 3 months
  • Urodynamic diagnosis of detrusor overactivity (DO)
  • Either naïve to anti-muscarinic treatment (i.e. no prior history of use of anti-muscarinic agents) or 6-months anti-muscarinic treatment free (i.e. have had no anti-muscarinic treatment within 6 months) prior to the screening visit
  • Bladder post-void residual volume of less than 30 ml
  • Available to complete the study

Exclusion Criteria:

  • History of stress urinary incontinence, urethral sphincter incompetence or neurogenic detrusor overactivity
  • History, signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis), obstruction or urogenital pro-lapse (greater than grade II)
  • History of urinary tract operation within 6 months prior to screening
  • Indwelling catheter or permanent catheter fitted
  • History of pelvic area radiotherapy treatment
  • Uncontrolled diabetes mellitus
  • History of fibromyalgia
  • Post-partum or breast-feeding within 3 months prior to screening visit
  • Either pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants or injectable contraceptives)
  • Positive pre-study hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus (HIV) result at time of screening
  • History of drug and / or alcohol abuse at time of screening
  • History of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior chamber or deemed to be at risk for these conditions
  • Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment or who are on treatment with a potent cytochrome p450 (CYP) 3A4 inhibitor, e.g. Ketoconazole
  • Currently dosing with medication(s) intended to treat overactive bladder symptoms or has a history of non-drug treatment, such as electrical therapy, magnetic field stimulation, pelvic floor treatment or bladder training intended to treat overactive bladder symptoms within 6 months prior to screening, as described in the list of prohibited medications
  • Currently receiving or has a history of treatment with alpha blockers, botulinum toxin (cosmetic use is acceptable), resiniferatoxin or pelvic floor muscle relaxants within 9 months prior to screening
  • Participated in any clinical study less than or equal to 3 months prior to screening

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Solifenacin 5 mg

Solifenacin 10 mg

Arm Description

Participants received 2 placebo tablets once daily for 12 weeks.

Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.

Participants received two 5 mg solifenacin tablets once daily for 12 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline to Week 12 in Bladder Wall Thickness
Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.
Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.

Secondary Outcome Measures

Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.
Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12
Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.
Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness
Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.
Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine
Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.
Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours
The average number of micturitions (urinations) and incontinence episodes (any involuntary leakage of urine) per day was derived from the number of events recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours
The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. An urgency event is defined as any micturition or incontinence episode classified by the participant as a grade 3 or 4 on the PPIUS scale. The average number of urgency events per day is derived from the diary data completed by participants on the 3 days prior to the Baseline and Week 12 visits.
Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours
The average number of micturitions (urinations) per 24 hours was derived from the number of micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours
An urgency micturition is defined as any micturition classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of urgency micturitions per 24 hours was derived from the number of urgency micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was calculated from the number of incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours
An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of grade 3 or 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours
An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of grade 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Change From Baseline to Week 12 in Mean Level of Urgency
The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean level of urgency was calculated by adding the PPIUS grade for all events (micturition or incontinence) and dividing by the number of episodes recorded in the diary over 3 days prior to the Baseline and Week 12 visits.
Change From Baseline to Week 12 in Total Urgency Score
The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The total urgency score was calculated by adding all PPIUS scores over a 3-day period prior to the Baseline and Week 12 visits for each participant.
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.
Change From Baseline in Patient Assessment of Urgency Bother
The participants' perception and impression of bother associated with their condition were assessed using the Urgency Bother-Visual Analog Scale (UB-VAS). The participant was asked to place a vertical mark on a 100 mm line to indicate how much bother has urgency been for them in the past week, whereby 'no bother at all' is represented on the left end (score = 0) and 'worst possible bother' (score = 100) at the right end of the line. A negative change from Baseline indicates improvement.
Change From Baseline in Patient Assessment of Treatment Satisfaction
The treatment satisfaction visual analog scale (TS_VAS) asks patients to rate their satisfaction with treatment by placing a vertical mark on a 100 mm line where the endpoints are labeled 'No, not at all' on the left (score = 0) to 'Yes, completely satisfied' on the right (score = 100). A positive change from Baseline indicates improvement.
Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D). The EQ-5D is a standardized instrument for use as a measure of health outcome and is based on the following 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension participants were asked to select the statement which best described their health that day, from level 1 (indicating no problems) to 3 (indicating extreme problems/unable to perform). Improvement was defined as a change from a state of being unable to perform or extreme problems at Baseline to no problems or to some or moderate problems at Week 12, and from some or moderate problems to no problems. Worsening was defined as a change from no problems at Baseline to some or moderate problems or to a state of being unable to perform or extreme problems at Week 12, and from some or moderate problems to a state of being unable to perform or extreme problems.
Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale
The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D) visual analog scale (VAS). Health status is completed by the participant indicating their own health state today by drawing a line on a vertical scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement.
Change From Baseline in Symptom Bother Score
Overactive bladder symptoms were assessed using the symptom bother scale of the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising an 8-item symptom bother scale and 25 health-related quality of life items (see next outcome measure). In the symptom bother scale participants were asked how much they had been bothered by selected bladder symptoms during the past 4 weeks. Each question has a 6-point Likert scale response ranging from 'not at all' (1) to 'a very great deal' (6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvement.
Change From Baseline in Health-Related Quality of Life (HRQL)
Health-related quality of life was assessed by the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising of an 8-item symptom bother scale (see previous outcome measure) and 25 HRQL items comprising 4 subscales (concern, coping, social interaction and sleep) and a total HRQL score. Participants were asked how their overall bladder symptoms had affected their life in the past 4 weeks. Each of the 25 HRQL questions has a 6-point Likert scale response ranging from 'none of the time' (1) to 'all of the time' (6). The HRQL subscale scores were calculated by summing the responses of the items within each subscale.The HRQL total score was calculated by adding the 4 HRQL subscale scores,. All scores were transformed to a scale from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline in HRQL score indicates improvement.
Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)
Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.
Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine
Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.
Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement: ≥ 1 point improvement compared to Baseline; Major Improvement: ≥ 2 point improvement compared to Baseline; Deterioration: ≥ 1 point deterioration compared to Baseline.

Full Information

First Posted
March 24, 2010
Last Updated
February 15, 2017
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01093534
Brief Title
Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.
Acronym
SHRINK
Official Title
A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and Urinary Nerve Growth Factor in Female Subjects With Overactive Bladder and a Diagnosis of Detrusor Overactivity - A Double-blind, Randomised, Placebo-controlled, Parallel Group, Multi-centre Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose is to see if solifenacin has any effect on bladder wall thickness and urine inflammatory marker measurements after 12 weeks of treatment.
Detailed Description
Participants satisfying all selection criteria at the end of the 2-week, single blind, placebo run-in period were randomized to receive 12-week double-blind treatment with solifenacin 5 mg or 10 mg once daily, or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Detrusor Overactivity, Overactive Bladder
Keywords
Vesicare, Solifenacin, Detrusor Overactivity, Urinary Nerve Growth Factor, Overactive Bladder, Bladder wall thickness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
547 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 2 placebo tablets once daily for 12 weeks.
Arm Title
Solifenacin 5 mg
Arm Type
Experimental
Arm Description
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
Arm Title
Solifenacin 10 mg
Arm Type
Experimental
Arm Description
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching solifenacin placebo tablet
Intervention Type
Drug
Intervention Name(s)
solifenacin
Other Intervention Name(s)
YM905, Vesicare
Intervention Description
Tablet for oral administration
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Bladder Wall Thickness
Description
Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.
Time Frame
Baseline and Week 12
Title
Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
Description
Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12
Description
Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.
Time Frame
Week 12
Title
Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12
Description
Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.
Time Frame
Week 12
Title
Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness
Description
Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.
Time Frame
Baseline, Week 6 and Week 12
Title
Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine
Description
Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.
Time Frame
Baseline, Week 6 and Week 12
Title
Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours
Description
The average number of micturitions (urinations) and incontinence episodes (any involuntary leakage of urine) per day was derived from the number of events recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours
Description
The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. An urgency event is defined as any micturition or incontinence episode classified by the participant as a grade 3 or 4 on the PPIUS scale. The average number of urgency events per day is derived from the diary data completed by participants on the 3 days prior to the Baseline and Week 12 visits.
Time Frame
12 weeks
Title
Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours
Description
The average number of micturitions (urinations) per 24 hours was derived from the number of micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours
Description
An urgency micturition is defined as any micturition classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of urgency micturitions per 24 hours was derived from the number of urgency micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours
Description
The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was calculated from the number of incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours
Description
An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of grade 3 or 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours
Description
An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The average number of grade 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Mean Level of Urgency
Description
The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean level of urgency was calculated by adding the PPIUS grade for all events (micturition or incontinence) and dividing by the number of episodes recorded in the diary over 3 days prior to the Baseline and Week 12 visits.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Total Urgency Score
Description
The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The total urgency score was calculated by adding all PPIUS scores over a 3-day period prior to the Baseline and Week 12 visits for each participant.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
Description
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Patient Assessment of Urgency Bother
Description
The participants' perception and impression of bother associated with their condition were assessed using the Urgency Bother-Visual Analog Scale (UB-VAS). The participant was asked to place a vertical mark on a 100 mm line to indicate how much bother has urgency been for them in the past week, whereby 'no bother at all' is represented on the left end (score = 0) and 'worst possible bother' (score = 100) at the right end of the line. A negative change from Baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Patient Assessment of Treatment Satisfaction
Description
The treatment satisfaction visual analog scale (TS_VAS) asks patients to rate their satisfaction with treatment by placing a vertical mark on a 100 mm line where the endpoints are labeled 'No, not at all' on the left (score = 0) to 'Yes, completely satisfied' on the right (score = 100). A positive change from Baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D
Description
The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D). The EQ-5D is a standardized instrument for use as a measure of health outcome and is based on the following 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension participants were asked to select the statement which best described their health that day, from level 1 (indicating no problems) to 3 (indicating extreme problems/unable to perform). Improvement was defined as a change from a state of being unable to perform or extreme problems at Baseline to no problems or to some or moderate problems at Week 12, and from some or moderate problems to no problems. Worsening was defined as a change from no problems at Baseline to some or moderate problems or to a state of being unable to perform or extreme problems at Week 12, and from some or moderate problems to a state of being unable to perform or extreme problems.
Time Frame
Baseline and Week 12
Title
Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale
Description
The participants' quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D) visual analog scale (VAS). Health status is completed by the participant indicating their own health state today by drawing a line on a vertical scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Symptom Bother Score
Description
Overactive bladder symptoms were assessed using the symptom bother scale of the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising an 8-item symptom bother scale and 25 health-related quality of life items (see next outcome measure). In the symptom bother scale participants were asked how much they had been bothered by selected bladder symptoms during the past 4 weeks. Each question has a 6-point Likert scale response ranging from 'not at all' (1) to 'a very great deal' (6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Health-Related Quality of Life (HRQL)
Description
Health-related quality of life was assessed by the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising of an 8-item symptom bother scale (see previous outcome measure) and 25 HRQL items comprising 4 subscales (concern, coping, social interaction and sleep) and a total HRQL score. Participants were asked how their overall bladder symptoms had affected their life in the past 4 weeks. Each of the 25 HRQL questions has a 6-point Likert scale response ranging from 'none of the time' (1) to 'all of the time' (6). The HRQL subscale scores were calculated by summing the responses of the items within each subscale.The HRQL total score was calculated by adding the 4 HRQL subscale scores,. All scores were transformed to a scale from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline in HRQL score indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)
Description
Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine
Description
Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)
Description
The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement: ≥ 1 point improvement compared to Baseline; Major Improvement: ≥ 2 point improvement compared to Baseline; Deterioration: ≥ 1 point deterioration compared to Baseline.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptoms of overactive bladder (OAB), including urinary frequency, urgency or urge incontinence, for greater than or equal to 3 months Urodynamic diagnosis of detrusor overactivity (DO) Either naïve to anti-muscarinic treatment (i.e. no prior history of use of anti-muscarinic agents) or 6-months anti-muscarinic treatment free (i.e. have had no anti-muscarinic treatment within 6 months) prior to the screening visit Bladder post-void residual volume of less than 30 ml Available to complete the study Exclusion Criteria: History of stress urinary incontinence, urethral sphincter incompetence or neurogenic detrusor overactivity History, signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis), obstruction or urogenital pro-lapse (greater than grade II) History of urinary tract operation within 6 months prior to screening Indwelling catheter or permanent catheter fitted History of pelvic area radiotherapy treatment Uncontrolled diabetes mellitus History of fibromyalgia Post-partum or breast-feeding within 3 months prior to screening visit Either pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants or injectable contraceptives) Positive pre-study hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus (HIV) result at time of screening History of drug and / or alcohol abuse at time of screening History of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior chamber or deemed to be at risk for these conditions Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment or who are on treatment with a potent cytochrome p450 (CYP) 3A4 inhibitor, e.g. Ketoconazole Currently dosing with medication(s) intended to treat overactive bladder symptoms or has a history of non-drug treatment, such as electrical therapy, magnetic field stimulation, pelvic floor treatment or bladder training intended to treat overactive bladder symptoms within 6 months prior to screening, as described in the list of prohibited medications Currently receiving or has a history of treatment with alpha blockers, botulinum toxin (cosmetic use is acceptable), resiniferatoxin or pelvic floor muscle relaxants within 9 months prior to screening Participated in any clinical study less than or equal to 3 months prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Chair
Facility Information:
City
New York
State/Province
New York
ZIP/Postal Code
11530
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
12601
Country
United States
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
City
Linz
ZIP/Postal Code
4020
Country
Austria
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Varba
ZIP/Postal Code
9010
Country
Bulgaria
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3N1
Country
Canada
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 4S5
Country
Canada
City
Brantford
State/Province
Ontario
ZIP/Postal Code
N3R 4N3
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
City
Podoli
ZIP/Postal Code
147 00
Country
Czech Republic
City
Marseille
ZIP/Postal Code
13285
Country
France
City
Paris
ZIP/Postal Code
75970
Country
France
City
Aachen
ZIP/Postal Code
52074
Country
Germany
City
Berlin
ZIP/Postal Code
10115
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Munich
ZIP/Postal Code
81679
Country
Germany
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
City
Avellino
ZIP/Postal Code
83100
Country
Italy
City
Milan
ZIP/Postal Code
20132
Country
Italy
City
Milan
ZIP/Postal Code
20153
Country
Italy
City
Rome
ZIP/Postal Code
00133
Country
Italy
City
Varese
ZIP/Postal Code
21100
Country
Italy
City
Arendal
ZIP/Postal Code
4809
Country
Norway
City
Drammen
ZIP/Postal Code
3004
Country
Norway
City
Haugesund
ZIP/Postal Code
5507
Country
Norway
City
Tonsberg
ZIP/Postal Code
3103
Country
Norway
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
City
Warszawa
ZIP/Postal Code
00-846
Country
Poland
City
Warszawa
ZIP/Postal Code
01-432
Country
Poland
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland
City
Warszawa
ZIP/Postal Code
02-929
Country
Poland
City
Timisoara
ZIP/Postal Code
300376
Country
Romania
City
Moscow
ZIP/Postal Code
101000
Country
Russian Federation
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117815
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123836
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125206
Country
Russian Federation
City
Nizhniy Novgorod
ZIP/Postal Code
603018
Country
Russian Federation
City
Saint Peterburg
ZIP/Postal Code
197089
Country
Russian Federation
City
Saint Peterburg
ZIP/Postal Code
199044
Country
Russian Federation
City
Yaroslavl'
Country
Russian Federation
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28031
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Madrid
ZIP/Postal Code
28905
Country
Spain
City
Lund
ZIP/Postal Code
22185
Country
Sweden
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
City
Ankara
ZIP/Postal Code
06018
Country
Turkey
City
Istanbul
ZIP/Postal Code
34664
Country
Turkey
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
City
Harrow
ZIP/Postal Code
HA1 3JU
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
City
London
ZIP/Postal Code
W2 2YP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=122
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.

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