Vesicare (Solifenacin Succinate) - Summary

VESICARE SUMMARY

VESIcare^® (solifenacin succinate) is a muscarinic receptor antagonist.

VESIcare is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

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NEWS HIGHLIGHTS

Published Studies Related to Vesicare (Solifenacin)

A randomized, double-blind, solifenacin succinate versus placebo control, phase 4, multicenter study evaluating urinary continence after robotic assisted radical prostatectomy. [2015]
radical prostatectomy... CONCLUSIONS: There was no effect on primary outcome but some secondary end points

Severity of overactive bladder symptoms and response to dose escalation in a randomized, double-blind trial of solifenacin (SUNRISE). [2013]
patients who requested a dose increase... CONCLUSIONS: Increasing the solifenacin dose to 10 mg further improved OAB

Solifenacin as add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms--ASSIST, randomized controlled study. [2011.07]
OBJECTIVES: To assess the efficacy and safety of solifenacin add-on therapy to tamsulosin in lower urinary tract symptoms (LUTS) men with residual overactive bladder (OAB) symptoms despite tamsulosin monotherapy... CONCLUSIONS: In male LUTS patients with residual OAB symptoms despite tamsulosin monotherapy, TAM+SOL showed efficacy on urgency, which represents OAB symptoms and was well tolerated. Copyright (c) 2011 Elsevier Inc. All rights reserved.

Tadalafil versus solifenacin for persistent storage symptoms after prostate surgery in patients with erectile dysfunction: a prospective randomized study. [2011.07]
OBJECTIVES: The occurrence of residual storage symptoms after surgical relief of bladder outlet obstruction as a result of benign prostatic enlargement (BPE) underlines the intricate mechanism involved in lower urinary tract symptoms (LUTS). The aim of the present study was to compare tadalafil with solifenacin in modifying symptoms and uroflowmetric parameters in patients with erectile dysfunction (ED) and residual storage symptoms after prostate surgery... CONCLUSIONS: In patients suffering from ED and storage symptoms after surgical treatment for LUTS-BPE, tadalafil 5mg given once daily for 12weeks provided a comparable improvement in IPSS to solifenacin 5mg given for the same period of time. (c) 2011 The Japanese Urological Association.

Efficacy of solifenacin on nocturia in Japanese patients with overactive bladder: impact on sleep evaluated by bladder diary. [2011.07]
PURPOSE: We compared changes in nocturia and sleep related parameters between the anticholinergic solifenacin and placebo in patients with overactive bladder associated with nocturia... CONCLUSIONS: Solifenacin 10 mg decreases nocturia episodes. Solifenacin 5 and 10 mg increases nighttime volume voided per micturition and may improve quality of sleep and sleep related quality of life in patients with overactive bladder. Copyright (c) 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

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Clinical Trials Related to Vesicare (Solifenacin)

Relative Bioavailability Study of Solifenacin Succinate Liquid Suspension (Fed and Fasting) Versus VESIcare Tablet (Fasting) in Healthy Volunteers [Completed]

VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate [Terminated]

A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation [Completed]
A study in healthy volunteers comparing two different liquid formulations of solifenacin with each other and with the tablet formulation.

Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms [Completed]
Most ureteral stent insertions follow ureteroscopy procedures for stone management. Stents are essentially designed to prevent the blockage of the ureter. Such blockage is often a result of inflammation caused by ureteroscopy procedures. The stent provides a secure passageway for urine as it travels from the kidneys to the bladder, circumventing potential urinary retention. In our community, only one kind of stent is used, and it is manufactured by Bard. Standard protocol involves the removal of the stent 5 to 8 days following insertion. If stenting is required for greater than 8 days, special accommodations will be made for you in this study. Unfortunately, pain and lower urinary tract symptoms are often associated with the insertion and removal of stents. It is our goal to determine whether VESIcare is capable of relieving such symptoms. As a prospective member of this study, you will be asked to complete three surveys. The first survey will ask you about your experiences of urinary urgency and pain before your surgery. If you are an emergency patient, you will be asked to remember your condition before the surgery, completing this questionnaire at your first post-op visit. If you are not an emergency patient, this survey will be completed before your surgery. If your stent is removed within 5 to 8 days of surgery, you will be asked to complete the second survey at the time of removal. You will then complete the final survey at a scheduled post-operative check-up 4 to 5 weeks later. If your stent remains inserted for greater than 8 days after surgery, you will be asked to complete the second survey 3 to 4 days after your stent was inserted. You will then complete the final survey, 7 to 8 weeks post-op. Throughout this study, both VESIcare and non-VESIcare patients will be important in determining whether VESIcare truly is capable of relieving stent pain. As such, you will be randomly assigned to one of the two groups, those receiving VESIcare, and those who are not.

Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder [Terminated]
This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

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Reports of Suspected Vesicare (Solifenacin) Side Effects

DRY Mouth (42),  Drug Ineffective (37),  Vision Blurred (33),  Fall (32),  Constipation (28),  Death (28),  Confusional State (23),  Urinary Retention (20),  Drug Interaction (17),  OFF Label USE (16), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Vesicare review by 62 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		overactive bladder
Dosage & duration:		5 mgm. by mouth, once a day taken daily for the period of 1 year and ongoing
Other conditions:		pelvic prolapse;mild asthma; allergic rhinitis; hypothyroidism
Other drugs taken:		Allegra; Nasacort; Premarin; Levoxyl; Advair Diskus
		Reported Results
Benefits:		Urinary frequency and urgency have been substantially reduced; I have a vastly improved lifestyle because these problems no longer inhibit my activities.
Side effects:		I experienced mild constipation in the beginning but because I eat a vegetarian diet I have been able to manage this side effect easily by increasing dietary fiber. No other measures have been necessary.
Comments:		My gynecologist changed me to Vesicare when I complained about side effects from the previous Rx I was on for overactive bladder. (These were dry mouth and constipation.) After beginning to take Vesicare daily, I noticed an immediate improvement, i.e., sharp decrease in the negative side effects. I plan to continue the use of Vesicare because there seem to be no prohibitions to its long term use. It may also possibly postpone surgical repair of the pelvic prolapse.

Vesicare review by 42 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		frequent urination
Dosage & duration:		10mg taken 1/day for the period of continue
Other conditions:		lack of sleep
Other drugs taken:		n/a
		Reported Results
Benefits:		I was able to hold and wait to use restroom and urges were less frequent.
Side effects:		dry mouth constipation
Comments:		I've been taking 5 mg per day for a month and I felt it was losing effectiveness so incresed to 10 mg and been taking 3 month so far. I still have some what of problem before period and have more frequent urge to goto restroom than other people but I am able to hole and wait. It is much more controlable than I wasn't taking anything.

Vesicare review by 42 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		frequent urination
Dosage & duration:		10mg taken 1/day for the period of continue
Other conditions:		lack of sleep
Other drugs taken:		n/a
		Reported Results
Benefits:		I was able to hold and wait to use restroom and urges were less frequent.
Side effects:		dry mouth constipation
Comments:		I've been taking 5 mg per day for a month and I felt it was losing effectiveness so incresed to 10 mg and been taking 3 month so far. I still have some what of problem before period and have more frequent urge to goto restroom than other people but I am able to hole and wait. It is much more controlable than I wasn't taking anything.