Research ArticleClinical Studies
Open Access

Investigation of Effect Predictors of Desmopressin in Nocturia Patients With Nocturnal Polyuria

HIROFUMI KUROSE, NAOYUKI OGASAWARA, KOSUKE UEDA, KATSUAKI CHIKUI, KEIICHIRO UEMURA, KIYOAKI NISHIHARA, MAKOTO NAKIRI, SHIGETAKA SUEKANE and TSUKASA IGAWA
In Vivo November 2023, 37 (6) 2726-2733; DOI: https://doi.org/10.21873/invivo.13383

Abstract

Background/Aim: Effect predictors of desmopressin for nocturia associated with nocturnal polyuria are understudied. Herein, we investigated the effects of desmopressin on sleep and patient quality of life. We defined cases in which administration of desmopressin led to hours of undisturbed sleep (HUS) ≥3 hours as “marked response cases” and examined predictive factors of desmopressin treatment response. Patients and Methods: Our study included 129 patients who were administered desmopressin 50 μg for nocturia associated with nocturnal polyuria at our hospital. Efficacy and safety of desmopressin were examined using bladder diaries, International Prostate Symptom Score, Overactive Bladder Symptom Score, Athens Insomnia Scale, Patient Global Impression of Improvement (PGI-I) score, physical examinations, blood tests, and body composition analyzers, and the predictors of desmopressin efficacy were investigated. Results: Significant improvements in all endpoints were observed from the early stage onward after desmopressin treatment compared with before treatment. After treatment, HUS was significantly longer in patients with good PGI-I scores, which indicated patient satisfaction. Variation in nocturnal micturition frequency did not affect the improvement in patient satisfaction. Examination of cases defined as “marked response cases” showed that the mean night-time urine volume was an independent predictor of treatment response. Conclusion: Desmopressin can improve patients’ quality of life and sleep by extending HUS. This suggests that desmopressin may be effective in patients with high mean night-time urine volumes based on their bladder diary.

Key Words:

Nocturia is the most common lower urinary tract symptom, with a prevalence of ≥80% in people aged ≥60 years. Waking up at night two or more times to void negatively affects the quality of life (QOL) in older people by reducing the quality of sleep; furthermore, it increases the risk of fractures and depression, thus adversely affecting life prognosis (1-3). Because nocturia causes nocturnal awakening, it is closely associated with sleep disturbances, making it a highly debilitating condition that can lower QOL by causing sleep disorders (4, 5). Moreover, while nocturia decreases QOL in multiple areas of daily life, treating nocturia has been shown to improve sleep disorders and QOL (6, 7).

Low-dose desmopressin (Minirin Melt® 50 μg/25 μg) is covered by insurance in Japan since September 2019 for nocturia associated with nocturnal polyuria. While several studies have reported on the safety and efficacy of desmopressin (8, 9), few have examined the effects of desmopressin on sleep disorders and patient QOL or the effect predictors of desmopressin. Consequently, there is no consensus regarding the definition of what constitutes a desirable outcome in nocturia.

To achieve high-quality slow-wave sleep, it is important to ensure at least 3 hours of undisturbed sleep (HUS). Accordingly, in this study, we investigated the effects of desmopressin on sleep and patients’ QOL. We defined cases in which desmopressin treatment resulted in HUS ≥3 hours as “marked response cases” and examined the effect predictors of desmopressin treatment response.

Patients and Methods

Patient selection. A total of 129 men with nocturnal polyuria aged ≥60 years who visited the Chikugo City Hospital between August 2020 and March 2023 with the main complaint of nocturia were included in this study. The patients had a mean night-time urination frequency ≥2 times, and a mean nocturnal polyuria index (night-time urine volume/24-h urine volume×100%) ≥33% based on a three-day bladder diary. Patients with hyponatremia (serum sodium level <135 mEq/l), habitual or psychogenic polydipsia, heart failure (brain natriuretic peptide ≥100 pg/ml), symptom of inappropriate secretion of antidiuretic hormone, and moderate or severe renal dysfunction, and patients taking diuretics or steroids were excluded from the study based on the contraindications described in the Minirin Melt® medication guide.

Treatment was discontinued in patients who developed hyponatremia (serum sodium level <135 mEq/l) as a side effect or were unable to continue treatment due to various reasons. Since this study aimed to evaluate the therapeutic efficacy of desmopressin, such patients were excluded from the study.

Treatment and analysis procedures. Patients were first treated with behavior modification therapy, pharmacotherapy for bladder storage disorders, and treatment for sleep disorders, in accordance with the nocturia treatment guidelines. Desmopressin was started at an initial dose of 50 μg for patients with persistent nocturia associated with nocturnal polyuria. In this study, the initial dose was set at 50 μg for all patients based on previous studies on desmopressin and reports from our hospital indicating that there is dose-dependent (25 μg <50 μg) therapeutic response and there is no dose-dependent side effects (8-10). Herein, desmopressin 50 μg was generally administered in addition to alpha-1 (α1) blockers, phosphodiesterase 5 (PDE5) inhibitors, 5-alpha (5α) reductase inhibitors, anticholinergic drugs, and/or beta-3 (β3) agonists. As mentioned previously, treatment was discontinued if hyponatremia or other adverse events were observed after drug administration.

The endpoints of treatment efficacy were nocturnal urinary frequency, nocturnal urinary volume, HUS, nocturnal polyuria index (NPi), initial nocturnal urinary volume, and daily urinary frequency in the frequency-volume chart (3 days) before treatment and 1, 4, and 12 weeks after the administration of desmopressin. Additionally, the International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), Athens Insomnia Scale score before treatment and 4, 12 weeks after treatment, and Patient Global Impression of Improvement (PGI-I) score after 12 weeks of treatment were retrospectively investigated.

Furthermore, to evaluate sleep quality after desmopressin administration and the degree of satisfaction associated with the improvement of sleep quality, we investigated the following aspects: the correlation between the change in HUS before and 12 weeks after treatment; the change in Athens Insomnia Scale sore before and 12 weeks after treatment; and PGI-I 12 weeks after treatment. Body composition was measured using the body composition analyzer to investigate predictors of desmopressin efficacy. Effect predictors were investigated in relation to age, body mass index (BMI), body water content, body fat mass, muscle mass, estimated glomerular filtration rate (eGFR), night-time urine volume, mean night-time urine volume, mean urine volume, nocturnal polyuria index, and night-time micturition frequency before the administration of desmopressin.

Statistical analysis. Receiver operating characteristic (ROC) curve analysis was used to assess the cutoff values of potential predictive factors of desmopressin’s efficacy in nocturia. Data were analyzed using analysis of variance, Bonferroni’s multiple comparison test, and logistic regression analysis, and a p-value <0.05 was considered statistically significant. JMP software version 16.0 (Cary, NC, USA) was used for statistical analyses. This study was conducted with the approval of the Institutional Review Board of the Chikugo City Hospital (Approval No.: 2021–04).

Results

Patient characteristics. From the initial 129 patients, after excluding those who developed hyponatremia within 12 weeks, discontinued treatment due to other adverse events, or were unable to continue bladder diaries, 104 patients who were able to continue 12 weeks of treatment were enrolled. The retention rate at 12 weeks was 80.6%. Patient background characteristics are shown in Table I. The mean age was 77.5 years, which was older than that reported in previous studies. Approximately 90% of patients had previously undergone oral treatment for lower urinary tract symptoms (11).

View this table:
Table I.

Patient background.

Evaluation of treatment efficacy. The results of treatment efficacy evaluation using a bladder diary are shown in Figure 1. There was a significant reduction in the mean night-time urination frequency 1, 4, and 12 weeks after treatment compared with that before treatment (all p<0.001). There was a further significant reduction 12 weeks after treatment compared with that 1 week after treatment (p<0.002). Additionally, there were significant improvements in night-time urine volume (before treatment vs. 1, 4, and 12 weeks after treatment; all p<0.001), HUS (before treatment vs. 1, 4, and 12 weeks after treatment; all p<0.001), NPi (before treatment vs. 1, 4, and 12 weeks after treatment; all p<0.001), the volume of first night-time urination [before treatment vs. 1 week (p=0.0041), 4 weeks (p=0.016), and 12 weeks (p=0.045) after treatment], and frequency of urination per day (before treatment vs. 1, 4, 12 weeks after treatment; all p<0.001).

Figure 1.
Figure 1.

The results of efficacy evaluation using voiding diaries (*p<0.01, **p<0.05, ***n.s).

The results for each score are shown in Figure 2. There were significant improvements in both IPSS and IPSS-QOL 1, 4, and 12 weeks after treatment compared with that before treatment (all p<0.001). There were significant improvements in both the storage (before treatment vs. 1, 4, and 12 weeks after treatment; all p<0.001) and voiding [before treatment vs. 1 week (p=0.0084), 4 weeks (p=0.025), and 12 weeks (p<0.0001) after treatment] sub-scores of IPSS. OABSS also significantly improved compared with that before treatment (before treatment vs. 1, 4, and 12 weeks after treatment; all p<0.001). There was also a significant improvement in the Athens Insomnia Scale score, a night-time insomnia index (before treatment vs. 1, 4, and 12 weeks after treatment; all p<0.001).

Figure 2.
Figure 2.

The results for various scores (*p<0.01, **p<0.05, ***n.s). IPSS: International Prostate Symptom Score; IPSS-QOL: International Prostate Symptom Score-Quality of life; OABSS: Overactive Bladder Symptom Score; AIS: Athens Insomnia Scale.

Seventeen patients (16.3%) had a PGI-I score of 1, 41 (39.4%) had a score of 2, 30 (28.8%) had a score of 3, 16 (15.4%) had a score of 4; no patients had a score ≥5 (Table II).

View this table:
Table II.

Patient global impression of improvement.

There was a positive correlation between the change in HUS and the change in Athens Insomnia Scale score from pre- to post-treatment (p=0.0081, Pearson’s correlation coefficient: 0.278). Additionally, a larger change in HUS resulted in a better PGI-I score from pre- to post-treatment (p<0.0001, Pearson’s correlation coefficient: −0.492) (Figure 3).

Figure 3.
Figure 3.

The correlation among the change in hours of undisturbed sleep (HUS) from pre-administration, Athens Insomnia Scale (AIS) from pre-administration and Patient Global Impression of Improvement (PGI-I) score at 12 weeks.

Definition of “marked response cases”. To our knowledge, no fixed definition of a marked response exists for cases of nocturia. However, as it is a disease that affects QOL, investigation of cases with good pre-treatment PGI-I scores (A score of 1 or 2) (Table III) revealed that such patients had significantly longer post-treatment HUS (p<0.0001) and a mean nocturnal voiding frequency <1 compared with patients with pre-treatment PGI-I scores ≥3 (p<0.0001). This item of <1 nocturnal urination post-treatment may be considerably influenced by the number of nocturnal urinations pre-treatment. Therefore, patients with HUS ≥3 hours were defined as marked response cases.

View this table:
Table III.

Differences between patients with Patient Global Impression of Improvement (PGI-I) of 1 or 2 and patients with more than 3.

Examination of effect predictors of desmopressin. In the study of predictors of efficacy, cases with HUS ≥3 hours were defined as marked response cases. The univariate analysis revealed that age [≤77 years vs. ≥78 years; hazard ratio (HR)=2.70, 95% confidence interval (CI)=1.05-6.92, p=0.032], mean night time urine volume ≥230 ml (HR=5.87, 95%CI=2.01-17.1, p<0.001) and night-time voiding frequency ≤4 times (HR=3.53, 95%CI=1.41-8.83, p=0.007) were significant predictors of HUS ≥3 hours. Meanwhile, multivariate analysis demonstrated that initial nocturnal urinary volume ≥230 ml (HR=4.09, 95%CI=1.32-12.7, p=0.015) was an independent predictor of HUS ≥3 hours. Muscle mass, body fat mass, and body water content were not significant predictors (Table IV).

View this table:
Table IV.

Univariate and multivariate analysis for predictive factors of three or more hours of undisturbed sleep.

Discussion

Desmopressin was approved in Japan in 2019 for the treatment of nocturia associated with nocturnal polyuria in men, and evidence regarding its safety and efficacy is currently being accumulated. However, reports regarding effect predictors of desmopressin are scarce (8, 12). Nocturia is known to affect sleep; in particular, a nocturnal voiding frequency >2 reduces sleep quality and total sleep time, and decreases sleep quality and QOL (13). To our knowledge, this study is the first to examine the effect predictors of desmopressin in relation to HUS.

Our institution has previously reported on the efficacy of desmopressin in patients with nocturia and nocturnal polyuria, and we have demonstrated the efficacy of an initial dose of 50 μg in Japanese patients (10, 14). This study with >100 patients also used an initial dose of 50 μg; the results showed significant improvements in various endpoints 1 week after treatment compared with those before treatment, and the effects were sustained after 12 weeks, confirming the usefulness of desmopressin 50 μg for patients with nocturnal polyuria. Furthermore, there were also significant improvements in the frequency of night-time urination, night-time urine volume, the volume of first night-time urination, HUS, IPSS, IPSS-QOL, OABSS 12 weeks after treatment compared with those 1 week and 4 weeks after treatment, suggesting the efficacy of long-term administration of desmopressin 50 μg.

Herein, the continuation rate 12 weeks after treatment was 87.0%, which was significantly higher than the 51.3% continuation rate reported by Kyoda et al. (9). We believe the high therapeutic effect of desmopressin 50 μg and the fact that the treatment effect was regularly evaluated using bladder diaries to provide feedback to patients, increased patients’ motivation to continue with oral administration.

The present investigation also showed significant improvements in the Athens Insomnia Scale. The Athens Insomnia Scale is a universal insomnia assessment method that was created based on the ICD-10 diagnostic criteria; a score <4 indicates no sleep disorder, a score of 4-5 indicates slight suspicions of insomnia, and a score ≥6 indicates suspected insomnia (15). It has also been reported that nocturnal sleep is associated with HUS. Bliwise et al. reported that longer HUS was associated with greater depth, length, and quality of sleep (16). This study found a positive correlation between the change in HUS and the change in the Athens Insomnia Scale after 12 weeks of treatment, suggesting that desmopressin treatment improved sleep quality by prolonging HUS.

There is no consensus regarding the definition of a successful outcome for examining predictors of desmopressin efficacy in nocturia. While cases wherein the nocturnal voiding frequency improved by ≥2 times have been reported as successful outcomes (9), these results are considered strongly biased by pre-treatment nocturnal voiding frequency. Therefore, considering that nocturia is a disease that affects QOL, patients’ overall impressions of improvements after treatment were evaluated using the PGI-I scale (17). There are reports regarding the evaluation of urogenital prolapse and tadalafil efficacy for lower urinary tract symptoms using the PGI-I scale; however, there are very few reports regarding the evaluation of medications used for nocturia (18, 19). Herein, the PGI-I evaluation revealed that 86.7% of patients who started desmopressin with an initial dose of 50 μg had improved symptoms compared with before treatment (score ≤3), suggesting that desmopressin improves the QOL of patients with nocturnal polyuria.

Further examination of patients with good PGI-I scores (scores 1 and 2) revealed that neither improvement of nocturnal voiding frequency by ≥2 nor improvement in nocturnal voiding frequency by any number were factors that improved the satisfaction of patients with nocturia. However, patients with good PGI-I (scores 1 and 2) had significantly longer post-treatment HUS than those with scores ≥3. It is estimated that 80-90% of good quality slow-wave sleep appears in the first 3 hours after sleep begins (20). However, the time to HUS in patients with nocturia has been reported to be about 2 hours, and awakening due to nocturia has been identified as a factor that interferes with slow-wave sleep (21, 22). Therefore, as it is considered important to ensure deep sleep in the first 3 hours (HUS ≥3 hours) to obtain high-quality sleep. Accordingly, this study defined cases with HUS ≥3 hours as “marked response cases”.

Examination of cases defined as “marked response cases” (HUS ≥3 hours) revealed that mean night-time urine volume was an independent effect predictor. A high mean night-time urine volume may indicate that there are not many urinary disturbances, such as OAB or sleep disorders. Although the multivariate analysis did not indicate significance, age (young) was a significant effect predictor in the univariate analysis. Considering that high-quality slow-wave sleep decreases with age and nocturnal functional bladder capacity is lower than the daytime functional bladder capacity in patients with insomnia, it is important to evaluate patients for sleep disturbances before desmopressin administration, especially among the elderly (23). When treating nocturia, patients should be evaluated for enuresis and sleep disorders using a bladder diary; patients with low mean night-time urine volume and enuresis or sleep disorders may benefit from desmopressin after prioritizing the treatment of these disorders. Corroborating several previous studies that reported improvements in nocturia following treatment that improved sleep disorders and patients’ QOL, the results of this study suggest that desmopressin may make a considerable contribution to such outcomes.

A limitation of this study is that it is a retrospective study conducted in a single institute. However, to date, there are no studies regarding desmopressin in over 100 patients at a single institution. Furthermore, we conducted a multivariate analysis to examine the effect predictors of desmopressin; we believe these results reflect real-world clinical data. Nonetheless, further studies with larger sample sizes are necessary to investigate the proper use of desmopressin.

Conclusion

To our knowledge, this is the first study to evaluate the predictors of desmopressin efficacy in the context of HUS. Nocturia is a condition that reduces the quality of sleep and QOL. Our findings indicate that desmopressin can improve the quality of sleep and QOL by extending HUS, and it may be particularly effective in patients with high mean night-time urine volumes based on their bladder diaries.

Acknowledgements

The Authors would like to thank Editage (www.editage.com) for English language editing.

Footnotes

  • Authors’ Contributions

    Hirofumi Kurose: Conceptualization; Date curation; Investigation; Writing – original draft. Naoyuki Ogasawara and Kosuke Ueda: Data curation; Formal Analysis. Keiichiro Uemura: Investigation. Katsuaki Chikui, Kiyoaki Nishihara, and Makoto Nakiri: Supervision; Project administration. Shigetaka Suekane and Tsukasa Igawa: Writing – review & editing.

  • Conflicts of Interest

    The Authors declare no conflicts of interest in relation to this study.

  • Received July 9, 2023.
  • Revision received August 7, 2023.
  • Accepted August 8, 2023.

This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY-NC-ND) 4.0 international license (https://creativecommons.org/licenses/by-nc-nd/4.0).

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Investigation of Effect Predictors of Desmopressin in Nocturia Patients With Nocturnal Polyuria
HIROFUMI KUROSE, NAOYUKI OGASAWARA, KOSUKE UEDA, KATSUAKI CHIKUI, KEIICHIRO UEMURA, KIYOAKI NISHIHARA, MAKOTO NAKIRI, SHIGETAKA SUEKANE, TSUKASA IGAWA
In Vivo Nov 2023, 37 (6) 2726-2733; DOI: 10.21873/invivo.13383
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