Phase 4
Completed N=640
A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
Source: ClinicalTrials.gov NCT01371994 ↗Enrolled (actual)
640
Serious AEs
1.9%
Results posted
Oct 2014
Primary outcomePrimary: Time From First Dose to Urinary Continence — NA; NA days — p=0.1745
Summary
The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of solifenacin succinate versus placebo in participants who are incontinent after Robotic Assisted Radical Prostatectomy.
This study will also assess the effect of 12 weeks of treatment with solifenacin succinate versus placebo on quality of life (QOL) as measured by questionnaires.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From First Dose to Urinary Continence |
NA; NA | 0.1745 |
| SECONDARY Percentage of Participants Who Gain Continence During 12-week Treatment Period |
10.4; 11.8; 18.8; 21.1; 19.1; 26.5 | 0.4833 |
| SECONDARY Average Daily Pad Usage at Baseline |
5.0; 4.7 | — |
| SECONDARY Change From Baseline in Average Daily Pad Usage |
-1.9; -2.0; -2.5; -2.8; -3.1; -3.4 | 0.3604 |
| SECONDARY American Urology Association Symptom Score (AUASS) at Baseline |
16.7; 16.2 | — |
| SECONDARY Change From Baseline in American Urology Association Symptom Score (AUASS) |
-7.7; -8.0; -7.4; -7.7 | 0.5186 |
| SECONDARY American Urology Association Quality of Life (QOL) Score at Baseline |
4.8; 4.7 | — |
| SECONDARY Change From Baseline in American Urology Association Quality of Life (QOL) Score |
-1.9; -2.1; -1.8; -2.0 | 0.1493 |
| SECONDARY International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline |
14.1; 13.8 | — |
| SECONDARY Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score |
-5.7; -6.2; -5.5; -6.0 | 0.1279 |
| SECONDARY Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed |
43.6; 37.9 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed |
-37.9; -37.6; -36.8; -34.4 | 0.8876 |
| SECONDARY Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working |
35.5; 34.1 | — |
| SECONDARY Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working |
-21.8; -23.8; -20.8; -21.8 | 0.4126 |
| SECONDARY Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment |
42.5; 44.8 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment |
-30.4; -33.7; -30.0; -31.1 | 0.2402 |
| SECONDARY Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment |
41.6; 41.4 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment |
-28.2; -30.2; -28.4; -28.8 | 0.4067 |
| SECONDARY Time From Baseline to First Day of Returning to Work |
5.0; 5.0 | 0.2700 |
Eligibility Criteria
Inclusion Criteria
- Ambulatory
- Willing and able to complete the daily pad use diary,
American Urology Association Symptom Score (AUASS) with Bother Score, the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), and the Work Productivity and Activity Impairment Questionnaire (WPAI)
- Has not used any medication for over-active bladder symptoms for at least 14 days prior to enrollment
- Diagnosed with prostate cancer, treated by Robotic Assisted Radical Prostatectomy, is voiding spontaneously and has urinary incontinence one week after removal of the indwelling catheter which requires management with 2 to 10 pads inclusive per day (24 hour days) for 7 consecutive days
Exclusion Criteria
- Evidence of severe neurologic damage post-prostatectomy
- Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stone; uncontrolled narrow angle glaucoma; urinary or gastric retention or neurogenic bladder
- Symptomatic for urinary tract infection or has a urine culture result which requires treatment as determined by the investigator.
- Clinically significant history of hepatic or renal impairment (2 X Upper Limit of Normal (ULN) values in alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine clearance 2.0 ULN, AST > 2.0 ULN, serum creatinine > 1.5 mg/L, blood glucose > 130 mg/dL, blood urea nitrogen (BUN) > 23 mg/dL.
- Severe hypertension on peri-operative evaluation which is defined as a sitting systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg, and which is not corrected
- Electrolytes (sodium, potassium, chloride or bicarbonate) that are not in normal range and clinically significant as determined by the investigator in the perioperative period. Can be eligible if electrolytes are corrected to within normal range prior to randomization
- Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives, whichever is longer, prior to the initiation of Screening.
Data sourced from ClinicalTrials.gov (NCT01371994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.