The probability of re-treatment after discontinuation of a 3-month versus a 6-month course of solifenacin for female overactive bladder: A prospective randomized controlled study☆
Introduction
Overactive bladder syndrome (OAB) is characterised by urinary urgency, with or without incontinence, and frequently with frequency and nocturia [1]. Antimuscarinic agent is one of the first-line pharmacologic therapies for OAB [[2], [3], [4]]. Many women with OAB were menopausal, and the prevalence of OAB wet symptoms increased with advancing age [5].
The recurrence rate has been reported with an incidence of 42.3% at 3 months and 52.2% at 6 months after discontinuation of antimuscarinics for OAB patients [6]. Frequent nocturia episodes, a suboptimal response to treatment, small bladder capacity, old age and severe urgency have been identified as contributing factors in re-treatment of OAB after discontinuation of 3-month antimuscarinic treatment [7,8]. In addition, it has been reported that the median time to assess efficacy is 3 months [9], and local vaginal estrogen therapy has been proposed to delay OAB recurrence [10].
In our previous study with a 3-month treatment period, small bladder capacity were found to one of the predictors of OAB re-treatment [9]. Antimuscarinics can increase bladder capacity [11]. We speculated that prolonged antimuscarinic treatment may further increase bladder capacity, and theoretically decrease the need for re-treatment. Therefore, we are interested in whether prolonged antimuscarinic treatment could decrease the need of re-treatment of female OAB. Several studies have evaluated the efficacy of 12-month solifenacin therapy, and sustained improvements in symptoms have been found [12,13]. However, owing to low percentage (35%) of patients still on their original solifenacin treatment at 12 months [14], we decided to choose a treatment period of six months for the comparison group.
Thus, the main purpose of this study was to conduct a randomized controlled trial for comparing re-treatment probability after 3 versus 6 months of antimuscarinic treatment. A secondary aim was to identify risk factors predicting re-treatment.
Section snippets
Methods
This prospectively randomized controlled trial was performed in a tertiary referral center. Consecutive women with OAB symptoms who exhibited symptoms of OAB for ≥3 months were randomly assigned to receive 5 mg solifenacin once a day for either 12 or 24 weeks. National Taiwan University Hospital Research Ethics Committee approved the protocol (No: 201212143RINB; ClinicalTrials.gov Identifier: NCT01876186, date of registration: June 12, 2013). The methods were carried out in accordance with the
Results
Between July 2013 and March 2015, 182 women were enrolled in this study (Fig. 1) and 91 patients were allocated to the 3-month group and the other 91 patients to the 6-month group. Sixty-five (35.7%) of the 182 patients did not complete the presumed treatment duration (Fig. 1). Sixty-three (69.2%) patients of the 3-month group completed 12 weeks of solifenacin treatment, and 54 (59.3%) patients of the 6-month group completed 24 weeks of solifenacin treatment (Fig. 1).
Except for urinary
Discussion
There were no differences between the 3-month and 6-month groups in the re-treatment probabilities (Fig. 2A & B). Similarly, Lee et al. also reported treatment duration of tolterodine was not associated with the re-treatment of antimuscarinics [25]. Thus, we suggest that there is no need to extend treatment period for decreasing re-treatment rate.
Choo et al. reported that old age, detrusor overactivity and higher baseline USS predict re-treatment [7]. Nonetheless, in our study, age (59.2 ± 13.7
Conclusions
Prolonged antimuscarinic treatment does not decrease re-treatment probability of OAB. Nonetheless, female patients with increased parity, advanced incontinence severity and suboptimal response to antimuscarinic treatment are prone to seek re-treatment of OAB due to recurrence of symptoms. In addition, patients with more serious physical limitation related to OAB are prone to complete scheduled treatment period. The above findings could be served as a guide in consultation regarding for
Contributors
Sheng-Mou Hsiao was responsible for data analysis and the writing of the paper.
Ting-Chen Chang was responsible for data curation.
Ho-Hsiung Lin was responsible for conceptualization and administration of the study.
Conflict of interest
The authors declare that they have no conflict of interest.
Funding
This study has been funded partially by a grant from the National Science Council, Executive Yuan, R.O.C. (NSC102-2314-B-002-108).
Ethics statements
National Taiwan University Hospital Research Ethics Committee approved the protocol (No: 201212143RINB; ClinicalTrials.gov Identifier: NCT01876186, date of registration: 12/06/2013). The methods were carried out in accordance with the relevant guidelines and regulations. Informed consent was obtained from all participants.
Provenance and peer review
This article has undergone peer review.
Research data (data sharing and collaboration)
There are no linked research data sets for this paper. Data will be made available on request.
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This work was carried out at the Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, Taiwan.