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Effect of combined systematized behavioral modification education program with desmopressin in patients with nocturia: a prospective, multicenter, randomized, and parallel study

By S.Y. Cho, K.-S. Lee, J.H. Kim, J.T. Seo, M.-S. Choo, and J.C. Kim, J.B. Choi, M. Song, J.-Y. Chun, S.-J. Oh

International Neurourology Journal, Volume 18, Issue 4, December 2014, Pages 213–220

Editor's comments:
The authors performed a prospective, multicenter, randomized parallel study that involved 8 centers in Korea. Male and female patients aged 20 years or more who had nocturia and nocturnal polyuria (2 or more nightly voids) were randomized 1:1 to receive 0.1 mg or 0.2 mg of desmopressin monotherapy or a combination of desmopressin therapy with a systematized behavioral modification program (SBMP) whose efficacy was previously demonstrated by the same authors in another publication.

Patients excluded from the study were those with diabetes insipidus, polydipsia with hyponatremia with a serum sodium level of less than 135 mmol/L, urinary incontinence, urinary tract infections, indwelling catheters, planned pregnancies, surgical histories involving the prostate gland or urethra, and patients taking drugs known or suspected to interact with desmopressin. Patients in the combination therapy group underwent an education program, in which they watched videos that explained the normal physiology underlying the process of urine formation and urination, and the necessity of the behavioral modification program was explained to them.

The primary endpoints were a change in the mean number of nocturnal voids and the proportion of 50% responders during the 3-month treatment period. The secondary endpoints were changes in the bladder diary parameters, International Consultation on Incontinence Questionnaire–Nocturia scores, and nocturia quality-of-life questionnaire scores, and improvements in self-perception for nocturia. As results, desmopressin monotherapy and the combination of desmopressin with the SBMP reduced the number of nocturnal voids. Combined desmopressin and SBMP therapy was associated with an increase in the bladder capacity nocturnal polyuria index in patients with nocturnal polyuria. Furthermore, combination therapy increased the study completion rate and the persistence of desmopressin in patients with nocturnal polyuria.

This study highlights the importance of treating patients with nocturia and nocturnal polyuria by combination therapy in which behavioral modifications should always be taken into account.

ABSTRACT 

Background:

Purpose 
The aims of this study were to investigate the efficacy of combining the systematized behavioral modification program (SBMP) with desmopressin therapy and to compare this with desmopressin monotherapy in the treatment of nocturnal polyuria (NPU).

Methods 
Patients were randomized at 8 centers to receive desmopressin monotherapy (group A) or combination therapy, comprising desmopressin and the SBMP (group B). Nocturia was defined as an average of 2 or more nightly voids. The primary endpoint was a change in the mean number of nocturnal voids from baseline during the 3-month treatment period. The secondary endpoints were changes in the bladder diary parameters and questionnaires scores, and improvements in self-perception for nocturia.

Results 
A total of 200 patients were screened and 76 were excluded from the study, because they failed the screening process. A total of 124 patients were randomized to receive treatment, with group A comprising 68 patients and group B comprising 56 patients. The patients' characteristics were similar between the groups. Nocturnal voids showed a greater decline in group B (-1.5) compared with group A (-1.2), a difference that was not statistically significant. Significant differences were observed between groups A and B with respect to the NPU index (0.37 vs. 0.29, P=0.028), the change in the maximal bladder capacity (-41.3 mL vs. 13.3 mL, P<0.001), and the rate of patients lost to follow up (10.3% [7/68] vs. 0% [0/56], P=0.016). Self-perception for nocturia significantly improved in both groups.

Conclusions 
Combination treatment did not have any additional benefits in relation to reducing nocturnal voids in patients with NPU; however, combination therapy is helpful because it increases the maximal bladder capacity and decreases the NPI. Furthermore, combination therapy increased the persistence of desmopressin in patients with NPU.