|Year : 2016 | Volume
| Issue : 2 | Page : 33-36
Clinical research on the therapeutic effects of the combination of rociverine and suoquan in the treatment of female patients with overactive bladder
Cheng Liu, Xuejun Liu, Duo Liu, Jiagui Mu, Dongsheng Zhu, Dongwei Yao
Department of Urological Surgery, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China
|Date of Submission||22-Feb-2016|
|Date of Acceptance||08-May-2016|
|Date of Web Publication||1-Jul-2016|
Department of Urological Surgery, The Second People's Hospital of Lianyungang, No. 41, Hailian East Road, Lianyungang 222000, Jiangsu
Source of Support: None, Conflict of Interest: None
Aim: The aim of this study is to explore the efficacy and safety of combination of rociverine with suoquan in the treatment of female patients with overactive bladder (OAB). Methods: A total of 142 cases of female patients with OAB were accepted outpatient treatment from October 2011 to October 2014, and randomly divided into 3 groups. A total of 53 patients were assigned to the oral rociverine alone group with 10 mg tablets, 3 times per day; 48 patients were assigned to the oral suoquan capsule alone group, with 1.8 g, 3 times per day; and 51 patients were assigned to the oral combination group, with 10 mg rociverine and 1.8 g suoquan, 3 times per day. The treatment duration for all groups was 4 weeks. Three-day voiding diaries were recorded for all patients before selection and after a 4-week course of therapy. The number of micturition events, urgent voiding events, incontinence events, nocturia events in a 24 h period was recorded. In addition, the changes in voided volume, subjective indicator OAB symptom scores (OABSS), and adverse reactions were recorded for efficacy and safety evaluation. Results: The total number of urination events, urgent voiding events, incontinence events, and nocturnal voiding events within a 24 h period between treatment groups was significant. In addition, the volume of voided urine and OABSS was significantly different between groups (P < 0.05). When comparing the therapeutic effects of the combination group to the single drug rociverine and suoquan groups, the difference was statistically significant (P < 0.05). The comparative difference between rociverine alone and suoquan alone groups was not statistically significant (P > 0.05). The drug adverse reaction rate of the combination group (7.8%) was less than that of rociverine alone group (22.6%). The comparative difference between the 2 groups was statistically significant (P = 0.032). Conclusion: The combination of rociverine and suoquan for the treatment of female patients with OAB has a favorable therapeutic effect and a good safety profile.
Keywords: Overactive bladder, rociverine tablets, suoquan capsule, therapeutic effect
|How to cite this article:|
Liu C, Liu X, Liu D, Mu J, Zhu D, Yao D. Clinical research on the therapeutic effects of the combination of rociverine and suoquan in the treatment of female patients with overactive bladder. Transl Surg 2016;1:33-6
|How to cite this URL:|
Liu C, Liu X, Liu D, Mu J, Zhu D, Yao D. Clinical research on the therapeutic effects of the combination of rociverine and suoquan in the treatment of female patients with overactive bladder. Transl Surg [serial online] 2016 [cited 2020 Jan 21];1:33-6. Available from: http://www.translsurg.com/text.asp?2016/1/2/33/185196
| Introduction|| |
Overactive bladder (OAB) is a syndrome presenting as urinary urgency, frequent urination, increase in nocturnal micturition events, and may be accompanied by incontinence. OAB is a common disease, and studies show that the incidence in women over 40 years of age in Europe and Canada is 16.6% and 13.9% respectively. The incidence in Hong Kong was shown to be 15% in recent communications. ,, OAB is mainly observed in female patients and may seriously impact quality of life (QOL).  Treatment options for OAB include therapeutic lifestyle changes, behavioral therapy, drug therapy, neurostimulation, Botox treatment, and surgical intervention. Drug therapy, however, remains the primary therapeutic approach in clinical practice at present.  A total of 152 cases of patients with OAB admitted into the Second People's Hospital of Lianyungang from October 2011 to October 2014 were studied. The efficacy and safety of combination rociverine and suoquan in the treatment of female patients with OAB is reported below.
| Methods|| |
Between October 2011 and October 2014, 142 cases of female patients with OAB admitted to the Second People's Hospital of Lianyungang were included in the study. Patients with symptoms of urgent urination, defined as ≥ 8 times within 24 h, and ≥ 2 nocturnal voiding events, associated with single void urinary volumes of < 200 mL, urinary incontinence, OAB symptom scores (OABSS) urinary urgency score ≥ 2, or total OABSS > 3 were included.  Subjects were required to have a negative urinalysis and urine cultivation.
Exclusion criteria are listed as below: (1) Patients with neurogenic bladder or other urethral dysfunction disorders, (2) patients with pelvic or gynecologic disease, (3) patients with medical disorders associated with contraindications to study drugs such as myasthenia gravis or glaucoma, (4) patients with congenital disorders of the urinary system, (5) patients with critical disorders of the renal, hepatic, cardiovascular, cerebrovascular, and hematopoietic systems, and (6) patients unable to reliably complete follow-up.
Experiment grouping and therapeutic schedule
The patients were randomly divided into 3 groups: (1) Rociverine group (53 patients), 10 mg rociverine (produced by Berlin-Chemie, Berlin, Germany), by oral administration, 3 times per day; (2) suoquan group (48 patients), 1.8 mg suoquan (produced by Hunan Hansen Pharmaceutical Co., Ltd., Yiyang, Hunan, China), by oral administration, 3 times per day; and (3) combination group (51 patients), 10 mg rociverine with 1.8 g suoquan by oral administration, 3 times per day. The duration of treatment for 3 groups was 4 weeks. This study was approved by the hospital Ethics Committee. All patients signed an institutional informed consent.
Efficacy and safety evaluation
Three-day voiding diaries were kept for each group of patients before selection and after the 4-week course of therapy, recording the total number of micturition events, urgent micturition events, urinary incontinence events, nocturnal voiding events, and change in voided volumes. The subjective indicator OABSS was observed before and after the treatment. Comparative analysis was performed on data before and after the therapy, as well as results among groups to evaluate therapeutic effects. Adverse events and laboratory abnormalities were recorded.
SPSS 20.0 statistical software (SPSS Inc., Chicago, IL, USA) was adopted for statistical treatment. Measurement data were indicated as mean ± standard deviation. t-test and Fisher's exact test were adopted for statistical analysis. P < 0.05 was considered statistically significant.
| Results|| |
Pretreatment clinical data comparison on three groups of patients
There was no significant difference between groups when comparing age, weight, duration of disease, 24 h total number of urinary events, urgent urinary events, incontinence events, nocturia events, voiding volumes, or OABSS (P < 0.05) [Table 1].
|Table 1: Clinical data comparison on three groups of patients with overactive bladder before the treatment ( x − ±s)|
Click here to view
Therapeutic effects evaluation of the three groups of patients posttreatment
All the patients completed the course of therapy, without drug withdrawal, dose adjustment, or dropout. The OABSS, total number of voiding events, urgent micturition events, incontinence events in 24 h, number of nocturia events, and voided volumes after treatment for the three groups are shown in [Table 2]. The differences in outcome for all indicators among the 3 groups of patients before and after treatment are statistically significant (P < 0.05).
While comparing the combination group to the rociverine alone group and suoquan alone group, the difference is statistically significant (P < 0.05). The comparative difference between the single drug rociverine and suoquan groups is not statistically significant (P > 0.05) [Table 2].
|Table 2: Comparison of all indicators in the three groups of patients with overactive bladder before and after the treatment ( x − ±s)|
Click here to view
Drug adverse reactions of three groups of patients
Since there were no adverse reactions observed in the single drug suoquan group, we compared the anticholinergic side effects of xerostomia, blurred vision, headache, and constipation between the rociverine group and combination group. The results are shown in [Table 3]. The total adverse reaction rate of rociverine group was 22.6% (12/53) and that of the combination group was 7.8% (4/51), a statistically significant difference (P = 0.03). The adverse reaction rate of combination group was less than that of single drug rociverine group. There were no serious adverse events in any group.
| Discussion|| |
The incidence rate of OAB is quite high, especially among females.  The incidence in older women is the highest with a significant impact on QOL. Obesity and elevated body mass index impact the number of serious OAB symptoms.  In spite of a large volume of research on the complicated neurologic interactions between the brain, sacral spinal cord, and detrusor muscle, there is still little agreement on the pathological process of OAB. ,, Consequently, therapeutic methods of OAB are varied. Drug therapy is the mainstay of therapy for most clinicians. Behavioral interventional measures include bladder training, pelvic muscle exercises, and biological feedback. Other less widely used therapeutic methods include sacral neurostimulation, Botox injections, and surgical treatment.
Detrusor muscle relaxation is mediated by the stimulation of the choline M receptor. Consequently, anticholinergic agents are the primary class of drugs used for OAB treatment. At present, drugs commonly used include tolterodine tartrate and solifenacin succinate. Rociverine is a new type of synthetic spasmolytic agent. The chemical constituents include 2-diethylamine-1-methyl ethyl (cis-vinylene)-1-hydroxyl-2-carboxylic ester. It is a drug with dual spasmolytic action on visceral smooth muscle, exerting both smooth muscle relaxation and anti-cholinergic effects. It is mainly used to alleviate pain symptoms caused by various disorders of the digestive and urinary systems. Previous literature reports favorable therapeutic effects on treatment of renal colic,  spasmodic pain associated with cystoscopy,  and on OAB symptoms following transurethral resection of prostate in combination with Tamsulosin.  Studies by Barbier et al.  and Hoti et al.  indicate that rociverine inhibits the impact of calcium ions on direct relaxation of smooth muscle, thereby alleviating OAB symptoms through inhibition of parasympathetic nerves, inhibition of smooth muscle spasmodic contraction, and adjusting adenosine triphosphate enzymatic activity of calmodulin and actin.
Traditional Chinese Medicine (TCM) believes that incontinence of urine is closely related to warm-reinforcing kidney Qi and bladder perturbation.  Suoquan capsule is pure natural herbal preparation, mainly composed of dioscorea opposita, fructus alpiniae oxyphyllae, and lindera aggregata. In the remedy, fructus alpiniae oxyphyllae strengthens the YangQi of spleen and kidneys, integrates Qi, and arrests seminal emission. Lindera aggregata is conducive to guiding Qi downward and relieving depression. It is a preferred agent for smoothing meridian Qi and blood, thus contributing to recovery of YangQi, dispersing cold air, and improving kidney Yang deficiency. The combination of these drugs has the function of nourishing the kidney and arresting polyuria. It is commonly used for treating infantile enuresis, senile urinary incontinence, diabetes insipidus, nocturia, and other urinary system diseases. The therapy principle of OAB may be related to bladder detrusor contraction caused by anti-acetylcholine agents that lead to detrusor relaxation and bladder neck contraction, increasing bladder storage capacity, leading to a decrease in micturition events. Tan et al.  reported that suoquan capsule improved detrusor diastolic and retractile function of acute aging rats, histoenzymology, and sensibility of neurotransmitter nerve receptors.
The main adverse reactions of rociverine are anticholinergic and include xerostomia, blurred vision, and constipation. We were interested in examining whether a synergistic effect of adverse effects was present with the combination of study drugs. All therapy variables in the 3 groups improved significantly after treatment. The difference is statistically significant when comparing pretreatment status to posttreatment status (P < 0.05), which suggests that the therapeutic regimens have a favorable effect on improving the symptoms of patients with OAB. Comparison of the combination group to single drug rociverine demonstrates improved therapeutic outcome, suggesting synergy between the 2 drugs. The possible mechanism may be the result of superimposition of anticholinergic effects. However, specific mechanisms need to be further studied.
TCM believes that 5 kinds of fluid comprise the totality of body fluid. These kinds of fluid are generated by 5 internal organs. They function to effect the moistening, nourishing, and adjustment of body fluid metabolism. Among them, saliva is the body fluid originating from kidney. Saliva is derived from kidney essence. If the kidney essence failed to nourish the body, the patient would suffer from xerostomia and dry eyes as the mouth and eyes are not well nourished. If the kidney essence failed to moisten the apertures, the patient will experience dizziness. Suoquan has the therapeutic effects of nourishing the kidney, increasing spermatogenic production, and increasing general body fluid production, reducing the occurrence of xerostomia. The total adverse reaction rate of the single drug rociverine group was 22.6% and that of the combination group was 7.8%. The comparative difference of the 2 groups is statistically significant (P = 0.032), and combination of rociverine and suoquan may significantly reduce the incidence of adverse reactions while controlling OAB symptoms. This, in turn, may improve the compliance of patients on treatment. Shen et al.  adopted the combination of suoquan with tolterodine tartrate in the treatment of patients with OAB and demonstrated reduction of adverse reactions, such as xerostomia, dry eyes, and constipation caused by choline receptor inhibition.
| Conclusion|| |
The combination of rociverine with suoquan in the treatment of female patients with OAB is characterized by improved outcomes, fewer side effects, and a reliable safety profile. The long-term therapeutic effects need to be observed in future studies through the expansion of sample sizes and lengthening of treatment duration.
Financial support and sponsorship
This study was supported by the grant from the Scientific Research Project of the Second People's Hospital of Lianyungang (No. 1323).
Conflicts of interest
There are no conflicts of interest.
| References|| |
Herschorn S, Gajewski J, Schulz J, Corcos J. A population-based study of urinary symptoms and incontinence: The Canadian Urinary Bladder Survey. BJU Int
Milsom I, Abrams P, Cardozo L, Roberts RG, Thüroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. A population-based prevalence study. BJU Int
Siu JY. Communicating under medical patriarchy: Gendered doctor-patient communication between female patients with overactive bladder and male urologists in Hong Kong. BMC Womens Health
Milsom I, Kaplan SA, Coyne KS, Sexton CC, Kopp ZS. Effect of bothersome overactive bladder symptoms on health-related quality of life, anxiety, depression, and treatment seeking in the United States: Results from EpiLUTS. Urology
Allahdin S, Oo N. An overview of treatment of overactive bladder syndrome in women. J Obstet Gynaecol
Gormley EA, Lightner DJ, Burgio KL, Chai TC, Clemens JQ, Culkin DJ, Das AK, Foster HE Jr., Scarpero HM, Tessier CD, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol
2012;1886 (6 Suppl): 2455-63.
Hung MJ, Chou CL, Yen TW, Chuang YC, Meng E, Huang ST, Kuo HC. Development and validation of the Chinese Overactive Bladder Symptom Score for assessing overactive bladder syndrome in a RESORT study. J Formos Med Assoc
van der Vaart CH, de Leeuw JR, Roovers JP, Heintz AP. The effect of urinary incontinence and overactive bladder symptoms on quality of life in young women. BJU Int
Lee UJ, Scott VC, Rashid R, Behniwal A, Wein AJ, Maliski SL, Anger JT. Defining and managing overactive bladder: Disagreement among the experts. Urology
Drake MJ. Do we need a new definition of the overactive bladder syndrome? ICI-RS 2013. Neurourol Urodyn
Chapple CR, Martinez-Garcia R, Selvaggi L, Toozs-Hobson P, Warnack W, Drogendijk T, Wright DM, Bolodeoku J; STAR Study Group. A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: Results of the STAR trial. Eur Urol
Ibrahim MI, Alzeeniny HA, Ellaithy MI, Salama AH, Abdellatif MA. Drotaverine to improve progression of labor among nulliparous women. Int J Gynaecol Obstet
Marsala F. Therapy of acute spastic pain of the biliary and urinary tracts with rociverine. Minerva Med
D′Agostino G, Condino A, Gallinari P, Boselli C, Agazzi A, Tonini M. An appraisal of recently patented compounds for bladder overactivity and urinary incontinence. Expert Opin Ther Pat
Barbier P, Renzetti AR, Turbanti L, Di Bugno C, Fornai F, Vaglini F, Maggio R, Corsini GU. Stereoselective inhibition of muscarinic receptor subtypes by the eight stereoisomers related to rociverine. Eur J Pharmacol
Hoti E, Censi R, Ricciutelli M, Malaj L, Barboni L, Martelli S, Valleri M, Di Martino P. Validation of an HPLC-MS method for rociverine tablet dissolution analysis. J Pharm Biomed Anal
Shu-Wen L, Qing-He W, Ping H, Hong-Ying C. Experimental study of suoquan capsule on renin-angiotensin-aldosterone system in rats with diuresis and deficiency of kidney. China J Exp Tradit Med Formulae
Tan Y, Huang P, Cao H, Shi M, Wu Q. Influence of Suoquan capsule on detrusor of D-galactose mimetic rats. Zhongguo Zhong Yao Za Zhi
Shen H, Yang CB, Wu WW, Xie ZW, Jing HM. Therapeutic effects of Yiqi Suoquan decoction on 36 old female patients with urge urinary incontinence. Zhejiang J Integr Tradit Chin West Med
[Table 1], [Table 2], [Table 3]