Desmopressin for treating nocturia in men

Julia Han; Jae Hung Jung; Caitlin J Bakker; Mark H Ebell; Philipp Dahm

doi:10.1002/14651858.CD012059.pub2

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Figure 1

PRISMA flow diagram.

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Figure 2

Risk of bias summary: review authors' judgments about each risk of bias item for each included study.

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Figure 3

Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 Desmopressin versus placebo, Outcome 1 Number of nocturnal voids (short term) (subgroup route).

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Analysis 1.2

Comparison 1 Desmopressin versus placebo, Outcome 2 Number of nocturnal voids (intermediate term).

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Analysis 1.3

Comparison 1 Desmopressin versus placebo, Outcome 3 Major adverse events (short term) (subgroup route and dose).

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Analysis 1.4

Comparison 1 Desmopressin versus placebo, Outcome 4 Major adverse events (intermediate term).

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Analysis 1.5

Comparison 1 Desmopressin versus placebo, Outcome 5 Duration of first sleep episode (short term).

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Analysis 1.6

Comparison 1 Desmopressin versus placebo, Outcome 6 Duration of first sleep episode (intermediate term).

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Analysis 1.7

Comparison 1 Desmopressin versus placebo, Outcome 7 Time to first void (short term) [minutes].

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Analysis 1.8

Comparison 1 Desmopressin versus placebo, Outcome 8 Minor adverse events (short term).

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Analysis 1.9

Comparison 1 Desmopressin versus placebo, Outcome 9 Minor adverse events (intermediate term).

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Analysis 1.10

Comparison 1 Desmopressin versus placebo, Outcome 10 Treatment withdrawal due to adverse event (short term).

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Analysis 1.11

Comparison 1 Desmopressin versus placebo, Outcome 11 Treatment withdrawal due to adverse event (intermediate term).

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Analysis 1.12

Comparison 1 Desmopressin versus placebo, Outcome 12 Number of nocturnal voids (short term) (subgroup dose).

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Analysis 1.13

Comparison 1 Desmopressin versus placebo, Outcome 13 Number of nocturnal voids (short term) (subgroup nocturnal polyuria).

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Analysis 1.14

Comparison 1 Desmopressin versus placebo, Outcome 14 Number of nocturnal voids (short term) (sensitivity run‐in period).

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Analysis 1.15

Comparison 1 Desmopressin versus placebo, Outcome 15 Major adverse events (short term) (sensitivity run‐in period).

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Analysis 1.16

Comparison 1 Desmopressin versus placebo, Outcome 16 Number of nocturnal voids (short term) (sensitivity clinical dosage).

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Analysis 1.17

Comparison 1 Desmopressin versus placebo, Outcome 17 Major adverse events (short term) (sensitivity clinical dosage).

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Analysis 2.1

Comparison 2 Desmopressin versus behaviour modification, Outcome 1 Duration of first sleep episode (short term).

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Analysis 3.1

Comparison 3 Desmopressin versus alpha‐blocker, Outcome 1 Number of nocturnal voids (short term).

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Analysis 3.2

Comparison 3 Desmopressin versus alpha‐blocker, Outcome 2 Quality of life (short term).

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Analysis 3.3

Comparison 3 Desmopressin versus alpha‐blocker, Outcome 3 Major adverse events (short term).

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Analysis 3.4

Comparison 3 Desmopressin versus alpha‐blocker, Outcome 4 Minor adverse events (short term).

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Analysis 3.5

Comparison 3 Desmopressin versus alpha‐blocker, Outcome 5 Treatment withdrawal due to adverse event (short term).

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Analysis 4.1

Comparison 4 Desmopressin plus alpha‐blocker versus alpha‐blocker, Outcome 1 Number of nocturnal voids (short term) (subgroup route and dose).

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Analysis 4.2

Comparison 4 Desmopressin plus alpha‐blocker versus alpha‐blocker, Outcome 2 Number of nocturnal voids (short term) (subgroup nocturnal polyuria).

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Analysis 4.3

Comparison 4 Desmopressin plus alpha‐blocker versus alpha‐blocker, Outcome 3 Quality of life (short term) (subgroup route and dose).

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Analysis 4.4

Comparison 4 Desmopressin plus alpha‐blocker versus alpha‐blocker, Outcome 4 Quality of life (short term) (subgroup nocturnal polyuria).

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Analysis 4.5

Comparison 4 Desmopressin plus alpha‐blocker versus alpha‐blocker, Outcome 5 Major adverse events (short term) (subgroup route and dose).

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Analysis 4.6

Comparison 4 Desmopressin plus alpha‐blocker versus alpha‐blocker, Outcome 6 Major adverse events (short term) (subgroup nocturnal polyuria).

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Analysis 4.7

Comparison 4 Desmopressin plus alpha‐blocker versus alpha‐blocker, Outcome 7 Minor adverse events (short term).

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Analysis 4.8

Comparison 4 Desmopressin plus alpha‐blocker versus alpha‐blocker, Outcome 8 Treatment withdrawal due to adverse event (short term).

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Analysis 5.1

Comparison 5 Desmopressin plus alpha‐blocker versus alpha‐blocker plus anticholinergic, Outcome 1 Number of nocturnal voids (short term).

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Analysis 5.2

Comparison 5 Desmopressin plus alpha‐blocker versus alpha‐blocker plus anticholinergic, Outcome 2 Major adverse events (short term).

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Analysis 5.3

Comparison 5 Desmopressin plus alpha‐blocker versus alpha‐blocker plus anticholinergic, Outcome 3 Minor adverse events (short term).

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Analysis 5.4

Comparison 5 Desmopressin plus alpha‐blocker versus alpha‐blocker plus anticholinergic, Outcome 4 Treatment withdrawal due to adverse event (short term).

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Summary of findings for the main comparison. Desmopressin versus placebo for men with nocturia (short term)

Participants: men with nocturia Setting: likely outpatient Intervention: desmopressin Control: placebo
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
				Assumed risk with placebo	Corresponding risk difference with desmopressin
Number of nocturnal voids assessed with: voiding diary follow‐up: range 1 to 3 months	1982 (6 RCTs)	⊕⊕⊝⊝ Low^{1 2}	‐	The mean number of nocturnal voids ranged from 1.9 to 4.57.	MD 0.61 lower (0.96 lower to 0.27 lower)
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Major adverse events follow‐up: range 1 to 3 months	536 (2 RCTs)	⊕⊝⊝⊝ Very low^{1 2 3}	RR 0.97 (0.10 to 9.03)	Study population
				29 per 1000	1 fewer per 1000 (26 fewer to 233 more)
Duration of first sleep episode assessed with: voiding diary follow‐up: range 1 to 3 months	652 (4 RCTs)	⊕⊝⊝⊝ Very low^{1 2 3}	‐	The mean duration of first sleep episode ranged from 26.21 to 174 minutes.	MD 54.61 minutes higher (13.97 higher to 95.25 higher)
Time to first void	383 (1 RCT)	⊕⊕⊝⊝ Low^{1 3}	‐	The mean time to first void was 72.9 minutes.	MD 40.8 minutes higher (17.07 higher to 64.53 higher)
Minor adverse event follow‐up: range 1 to 3 months	594 (3 RCTs)	⊕⊕⊝⊝ Low^{1 3}	RR 0.87 (0.67 to 1.13)	Study population
				257 per 1000	33 fewer per 1000 (33 more to 85 more)
Treatment withdrawal due to adverse event follow‐up: range 1 to 3 months	614 (4 RCTs)	⊕⊕⊝⊝ Low^{1 3}	RR 1.10 (0.56 to 2.15)	Study population
				49 per 1000	5 more per 1000 (21 fewer to 56 more)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
¹Downgraded by one level for study limitations: unclear or high risk of bias for one or more domains in at least 50% of the studies. ²Downgraded by one level for inconsistency: substantial heterogeneity among studies. ³Downgraded by one level for imprecision: confidence interval was wide or crossed assumed threshold of clinically important difference (or both).

Summary of findings for the main comparison. Desmopressin versus placebo for men with nocturia (short term)

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Summary of findings 2. Desmopressin versus placebo for men with nocturia (intermediate term)

Participants: men with nocturia Setting: likely outpatient Intervention: desmopressin Control: placebo
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
				Assumed risk with placebo	Corresponding risk difference with desmopressin
Number of nocturnal voids assessed with: voiding diary follow‐up: range 3 to 12 months	115 (1 RCT)	⊕⊕⊝⊝ Low^1,2	‐	Mean number of nocturnal voids was 4.14 voids.	MD 0.85 voids fewer (1.17 fewer to 0.53 fewer)
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Major adverse events follow‐up: range 3 to 12 months	115 (1 RCT)	⊕⊕⊝⊝ Low^1,2,3	RR 3.05 (0.13 to 73.39)	Study population
				‐	‐
Duration of first sleep episode assessed with: voiding diary follow‐up: range 3 to 12 months	115 (1 RCT)	⊕⊕⊕⊝ Moderate¹	‐	Mean duration of first sleep episode was 101.6 minutes.	MD 18.4 minutes higher (11.6 higher to 25.2 higher)
Time to first void ‐ not reported	‐	‐	‐	‐	‐
Minor adverse events follow‐up: range 3 to 12 months	115 (1 RCT)	⊕⊕⊝⊝ Low^1,2	RR 0.86 (0.49 to 1.49)	Study population
				328 per 1000	46 fewer per 1000 (167 fewer to 161 more)
Treatment withdrawal due to adverse event follow‐up: range 3 to 12 months	115 (1 RCT)	⊕⊕⊝⊝ Low^1,2,3	RR 3.05 (0.13 to 73.39)	Study population
				‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
¹Downgraded by one level for study limitations: unclear risk of bias for one or more domains in the included study. ²Downgraded by one level for imprecision: confidence interval was wide or crossed assumed threshold of clinically important difference (or both). ³Only one event in desmopressin group.

Summary of findings 2. Desmopressin versus placebo for men with nocturia (intermediate term)

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Summary of findings 3. Desmopressin versus behaviour modifications for men with nocturia (short term)

Participants: men with nocturia Setting: likely outpatient Intervention: desmopressin Control: fluid restriction during nighttime
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	Assumed risk with behaviour modification	Corresponding risk difference with desmopressin
Number of nocturnal voids ‐ not reported	‐	‐	‐	‐	‐
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Major adverse events ‐ not reported	‐	‐	‐	‐	‐
Duration of first sleep episode assessed with: not reported follow‐up: mean 2 months	60 (1 RCT)	⊕⊕⊝⊝ Low^1,2	‐	Mean duration of first sleep episode was 150 minutes.	MD 90 minutes higher (1.95 higher to 178.05 higher)
Time to first void ‐ not reported	‐	‐	‐	‐	‐
Minor adverse events ‐ not reported	‐	‐	‐	‐	‐
Treatment withdrawal due to adverse event ‐ not reported	‐	‐	‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; RCT: randomised controlled trial.
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
¹Downgraded by one level for study limitations: unclear risk of bias in almost all domains in the included study. ²Downgraded by one level for imprecision: confidence interval crossed assumed threshold of clinically important difference.

Summary of findings 3. Desmopressin versus behaviour modifications for men with nocturia (short term)

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Summary of findings 4. Desmopressin versus alpha‐blocker for men with nocturia (short term)

Participants: men with nocturia Setting: likely outpatient Intervention: desmopressin Control: alpha‐blocker
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
				Assumed risk with alpha‐blocker	Corresponding risk difference with desmopressin
Number of nocturnal voids assessed with: voiding diary follow‐up: range 1 to 3 months	31 (1 RCT)	⊕⊕⊕⊝ Moderate¹	‐	Mean number of nocturnal voids was 1.2 voids.	MD 0.3 voids more (0.2 fewer to 0.8 more)
Quality of life assessed with: IPSS and N‐QoL follow‐up: range 1 to 3 months	31 (1 RCT)	⊕⊕⊕⊝ Moderate¹	‐	Mean quality of life was 1.8 bothersome.	MD 0 (0.35 lower to 0.35 higher)
Major adverse events follow‐up: range 1 to 3 months	31 (1 RCT)	⊕⊕⊝⊝ Low^1,2	Not estimable	Study population
				‐	‐
Duration of first sleep episode ‐ not reported	‐	‐	‐	‐	‐
Time to first void ‐ not reported	‐	‐	‐	‐	‐
Minor adverse events follow‐up: range 1 to 3 months	31 (1 RCT)	⊕⊝⊝⊝ Very low^1,3	RR 1.07 (0.07 to 15.57)	Study population
				63 per 1000	4 more per 1000 (58 fewer to 911 more)
Treatment withdrawal due to adverse event follow‐up: range 1 to 3 months	31 (1 RCT)	⊕⊕⊝⊝ Low^1,2	Not estimable	Study population
				‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; IPSS: International Prostate Symptom Score; MD: mean difference; N‐QoL: Nocturia‐Quality of Life questionnaire; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
¹Downgraded by one level for study limitations: unclear or high risk of bias for one or more domains in the included study. ²Downgraded by one level for imprecision: no event in either group. ³Downgraded by two levels for imprecision: confidence interval was wide and crossed assumed threshold of clinically important difference.

Summary of findings 4. Desmopressin versus alpha‐blocker for men with nocturia (short term)

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Summary of findings 5. Desmopressin plus alpha‐blocker versus alpha‐blocker for men with nocturia (short term)

Participants: men with nocturia Setting: likely outpatient Intervention: desmopressin + alpha‐blocker Control: alpha‐blocker alone
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
				Assumed risk with alpha‐blocker	Corresponding risk difference with desmopressin + alpha‐blocker
Number of nocturnal voids assessed with: voiding diary follow‐up: range 1 to 3 months	341 (3 RCTs)	⊕⊕⊕⊝ Moderate¹	‐	Mean number of nocturnal voids ranged from 1.68 to 2.6.	MD 0.47 voids fewer (0.73 fewer to 0.21 fewer)
Quality of life assessed with: IPSS and N‐QoL follow‐up: range 1 to 3 months	341 (3 RCTs)	⊕⊕⊕⊝ Moderate¹	‐	Mean quality of life ranged from 1.53 to 4.4.	MD 0.29 lower (0.51 lower to 0.07 lower)
Major adverse events follow‐up: range 1 to 3 months	402 (3 RCTs)	⊕⊕⊝⊝ Low^1,2	RR 0.30 (0.01 to 7.32)	Study population
				5 per 1000	3 fewer per 1000 (5 fewer to 32 more)
Duration of first sleep episode ‐ not reported	‐	‐	‐	‐	‐
Time to first void ‐ not reported	‐	‐	‐	‐	‐
Minor adverse events follow‐up: range 1 to 3 months	402 (3 RCTs)	⊕⊝⊝⊝ Very low^1,3	RR 1.60 (0.15 to 16.82)	Study population
				80 per 1000	48 more per 1000 (68 fewer to 1000 more)
Treatment withdrawal due to adverse event follow‐up: range 1 to 3 months	402 (3 RCTs)	⊕⊕⊝⊝ Low^1,2	RR 2.84 (0.46 to 17.66)	Study population
				5 per 1000	9 more per 1000 (3 fewer to 83 more)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; IPSS: International Prostate Symptom Score; MD: mean difference; N‐QoL: Nocturia‐Quality of Life questionnaire; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
¹Downgraded by one level for study limitations: unclear or high risk of bias for one or more domains among the included studies. ²Downgraded by one level for imprecision: no event or very rare event resulting in wide confidence interval. ³Downgraded by two level for imprecision: confidence interval was wide and crossed assumed threshold of clinically important difference.

Summary of findings 5. Desmopressin plus alpha‐blocker versus alpha‐blocker for men with nocturia (short term)

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Summary of findings 6. Desmopressin plus alpha‐blocker versus alpha‐blocker plus anticholinergic for men with nocturia (short term)

Participants: men with nocturia Setting: likely outpatient Intervention: desmopressin + alpha‐blocker Control: anticholinergic + alpha‐blocker
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
				Assumed risk with alpha‐blocker + anticholinergic	Corresponding risk difference with desmopressin + alpha‐blocker
Number of nocturnal voids assessed with: voiding diary follow‐up: range 1 to 3 months	405 (1 RCT)	⊕⊕⊕⊝ Moderate¹	‐	Mean number of nocturnal voids was 6.97 voids.	MD 0.43 voids fewer (0.97 fewer to 0.11 more)
Quality of life ‐ not reported	‐	‐	‐	‐	‐
Major adverse events follow‐up: range 1 to 3 months	427 (1 RCT)	⊕⊕⊝⊝ Low^1,2	Not estimable	Study population
				‐	‐
Duration of first sleep episode ‐ not reported	‐	‐	‐	‐	‐
Time to first void ‐ not reported	‐	‐	‐	‐	‐
Minor adverse events follow‐up: range 1 to 3 months	427 (1 RCT)	⊕⊕⊝⊝ Low^1,3	RR 0.22 (0.05 to 0.98)	Study population
				45 per 1000	35 fewer per 1000 (43 fewer to 1 fewer)
Treatment withdrawal due to adverse event follow‐up: range 1 to 3 months	427 (1 RCT)	⊕⊕⊝⊝ Low^1,3	RR 0.22 (0.05 to 0.98)	Study population
				45 per 1000	35 fewer per 1000 (43 fewer to 1 fewer)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
¹Downgraded by one level for study limitations: unclear risk of bias for one or more domains in the included study. ²Downgraded by one level for imprecision: no event in either group. ³Downgraded by one level for imprecision: confidence interval crossed assumed threshold of clinically important difference.

Summary of findings 6. Desmopressin plus alpha‐blocker versus alpha‐blocker plus anticholinergic for men with nocturia (short term)

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Table 1. Baseline characteristics

Study	Setting	Trial period	Description of participants	Intervention(s) and comparator(s)	Duration of intervention (duration of follow‐up)
Ahmed 2015a	Outpatient/Egypt	2011 to 2014	People with LUTS/BPH aged ≥ 50 years with nocturia (≥ 2 voids/night), nocturnal polyuria (nocturnal urine volume > 30% of 24‐hour urine volume)	I: desmopressin 60 μg ODT + tamsulosin	3 months
				C: tamsulosin
Cannon 1999	UK	NR	Men aged > 50 years with nocturnal polyuria (using 48‐hour inpatient monitoring or 1‐week frequency volume chart)	I: desmopressin nasal spray 20 μg	4 weeks
				C: placebo
Ceylan 2013	Outpatient/Turkey	2011	Men with advanced age, complaints of LUTS and nocturia (≥ 3 times/night)	I: desmopressin nasal spray 20 μg	2 months
				C: doxazosin
Kim 2017	Multicentre/South Korea	NR	Men aged 40 to 65 years with LUTS (IPSS > 13), nocturia (≥ 2 episodes/night), and nocturnal polyuria (NPI > 33%)	I: desmopressin 0.2 mg oral + alpha‐blocker	8 weeks
				C: placebo + alpha‐blocker
Koca 2012	Outpatient/Turkey	NR	Men aged 50 to 70 years with LUTS and nocturia (≥ 2/night)	I: desmopressin 0.2 mg oral with alfuzosin	3 months
				C: alfuzosin
Mattiasson 2002	Multicentre/Denmark, Sweden, Netherlands, the UK, and the USA	NR	Men aged ≥ 18 years with nocturia (2 voids/night, nocturia index scores > 1)	I: desmopressin 0.1 mg/0.2 mg/0.4 mg oral; dose titration	3 weeks
				C: placebo
Rezakhaniha 2011	Outpatient/single centre/Iran	2008 to 2009	Older men (mean age about 63 to 64 years) with voiding ≥ 2/night	I: desmopressin 0.1 mg oral	8 weeks
				C: placebo
Serenity Pharmaceuticals 2016	Multicentre/USA and Canada	NR	Men or women aged ≥ 50 years with nocturia (≥ 2 nocturic episodes/night)	I: desmopressin nasal spray 0.75 μg, 1.0 μg, or 1.5 μg	12 weeks
				C: placebo
Shin 2014a	South Korea	2010 to 2013	Men aged ≥ 50 years with LUTS due to bladder outlet obstruction (Q_max ≤ 15 mL/second, IPSS ≥ 14) and nocturia (≥ 1 void/night)	I: desmopressin 0.2 mg oral + tamsulosin	4 weeks
				C: solifenacin + tamsulosin
Wang 2011a	Single centre/Taiwan	2007 to 2009	Men aged ≥ 65 years with BPH (IPSS > 13), nocturia (≥ 2 voids/night), and nocturnal polyuria (nocturnal urine volume > 30%)	I: desmopressin 0.1 mg oral	12 months
				C: placebo
Wang 2012	Outpatient/single centre/China	2009 to 2010	Older men (age not reported)	I: desmopressin 0.1 mg oral	8 weeks
				C: placebo
Weiss 2012a	Multicentre/Canada and the USA	2007 to 2008	Men and women aged ≥ 18 years with nocturia (≥ 2 voids/night)	I: desmopressin 10 µg, 25 µg, 50 µg, or 100 µg ODT	4 weeks
				C: placebo
Weiss 2013	Multicentre/Canada and the USA	2010 to 2013	Men aged ≥ 18 years with nocturia (≥ 2 voids/night)	I: desmopressin 50 μg, 75 µg ODT	3 months
				C: placebo
Yamaguchi 2013	Multicentre/Japan	2010 to 2011	Men and women aged 55 to 75 years with nocturia (≥ 2 voids/night)	I: desmopressin 10 µg, 25 µg, 50 µg, or 100 µg ODT	4 weeks
				C: placebo
BPH: benign prostatic hyperplasia; C: comparator; I: intervention; IPSS: International Prostate Symptom Score; LUTS: lower urinary tract symptoms; NPI: nocturnal polyuria index; NR: not reported; ODT: orally disintegrating tablet; Q_max: maximum flow rate.

Table 1. Baseline characteristics

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Table 2. Participant disposition

	Intervention(s) and comparator(s)	Sample size	Screened/eligible (n)	Randomised (n)	ITT (n)	Analysed (n: total/male)	Finishing trial (n)	Randomised finishing trial (%)	Follow‐up (extended follow‐up)¹
Ahmed 2015a	I: desmopressin + tamsulosin	100	397/273	139	123	123	107	77.0	3 months
	C: tamsulosin	100	397/273	134	125	125	103	76.9
	Total:			273	248	248	210	76.9
Cannon 1999	I: desmopressin	‐	‐/‐	‐	‐	‐	‐	‐	8 weeks (cross‐over study design)
	C: placebo	‐	‐/‐	‐	‐	‐	‐	‐
	Total:			20	‐	18	18	90.0
Ceylan 2013	I: desmopressin	‐	84/31	15	15	15	15	100.0	2 months
	C: doxazosin	‐	84/31	16	16	16	16	100.0
	Total:			31	31	31	31	100.0
Kim 2017	I: desmopressin + alpha‐blocker	‐	121/109	57	57	47	47	82.4	8 weeks
	C: placebo + alpha‐blocker	‐	121/109	52	52	39	39	75.0
	Total:			109	109	86	86	78.9
Koca 2012	I: desmopressin + alfuzosin	‐	‐/49	‐	‐	22	22	‐	3 months
	C: alfuzosin	‐	‐/49	‐	‐	23	23	‐
	Total:			49	‐	45	45	91.8
Mattiasson 2002	I: desmopressin	55	341/224	86	86	86	81	94.2	3 weeks
	C: placebo	55	341/224	65	65	65	62	95.4
	Total:			151	151	151	143	94.7
Rezakhaniha 2011	I: desmopressin	‐	93/60	30	30	30	30	100.0	8 weeks
	C: placebo	‐	93/60	30	30	30	30	100.0
	Total:			60	60	60	60	100.0
Serenity Pharmaceuticals 2016²	I1: desmopressin 0.75 μg	‐	3565/1707	458	448	448/252	401	87.5	12 weeks
	I2: desmopressin 1.0 μg	‐		188	183	183/109	163	86.7
	I3: desmopressin 1.5 μg	‐		452	439	439/251	387	85.6
	C: placebo	‐		458	446	446/258	408	89.0
	Total:			1556	1516	1516/870	1359	87.3
Shin 2014a	I: desmopressin + tamsulosin	‐	435/427	205	205	205	196	95.6	8 weeks (cross‐over study design)
	C: tamsulosin + solifenacin	‐	435/427	222	222	222	209	94.1
	Total:			427	427	427	405	94.8
Wang 2011a	I: desmopressin	45	‐/136	NR	‐	57	57	‐	12 months
	C: placebo	45	‐/136	NR	‐	58	58	‐
	Total:			126	‐	115	115	91.3
Wang 2012	I: desmopressin	‐	‐/60	30	30	30	30	100.0	8 weeks
	C: placebo	‐	‐/60	30	30	30	30	100.0
	Total:			60	60	60	60	100.0
Weiss 2012a²	I1: desmopressin 10 µg	‐	1412/799	163	155	155/82	144	88.3	4 weeks
	I2: desmopressin 25 µg	‐		158	152	152/87	148	93.7
	I3: desmopressin 50 µg	‐		158	148	148/77	138	87.3
	I4: desmopressin 100 µg	‐		160	146	146/80	135	84.4
	C: placebo	‐		160	156	156/90	145	90.6
	Total:			799	757	757/416	710	88.9
Weiss 2013	I1: desmopressin 50 µg	130	1013/395	‐	119	119	100	‐	3 months
	I2: desmopressin 75 µg	130		‐	124	124	103	‐
	C: placebo	130		‐	142	142	120	‐
	Total:			395	385	385	323	81.8
Yamaguchi 2013²	I1: desmopressin 10 µg	‐	177/139	28	28	23/11	23	82.1	3 months
	I2: desmopressin 25 µg	‐		25	25	22/11	22	88.0
	I3: desmopressin 50 µg	‐		29	29	21/10	21	72.4
	I4: desmopressin 100 µg	‐		30	30	23/11	23	76.6
	C: placebo	‐		27	27	23/11	23	85.1
	Total:			139	139	112/54	112	80.5
Overall total	Men	‐		‐	‐	2966	‐
	Women	‐		‐		1045
	Total:			4195		4011
‐ denotes not reported; C: comparator; I: intervention; ITT: intention‐to‐treat; n: number of participants. ¹Follow‐up under randomised conditions until end of trial or if not available, duration of intervention; extended follow‐up refers to follow‐up of participants once the original study was terminated as specified in the power calculation. ²Study included men and women.

Table 2. Participant disposition

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Comparison 1. Desmopressin versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of nocturnal voids (short term) (subgroup route) Show forest plot	6	1982	Mean Difference (IV, Random, 95% CI)	‐0.61 [‐0.96, ‐0.27]

1.1 Intranasal	1	870	Mean Difference (IV, Random, 95% CI)	‐0.20 [‐0.34, ‐0.06]
1.2 Sublingual	3	851	Mean Difference (IV, Random, 95% CI)	‐0.37 [‐0.71, ‐0.03]
1.3 Oral	2	261	Mean Difference (IV, Random, 95% CI)	‐1.14 [‐1.41, ‐0.86]
2 Number of nocturnal voids (intermediate term) Show forest plot	1	115	Mean Difference (IV, Random, 95% CI)	‐0.85 [‐1.17, ‐0.53]

3 Major adverse events (short term) (subgroup route and dose) Show forest plot	2	536	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.10, 9.03]

3.1 Sublingual/low dose	1	385	Risk Ratio (M‐H, Random, 95% CI)	2.53 [0.73, 8.73]
3.2 Oral/high dose	1	151	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.03, 2.37]
4 Major adverse events (intermediate term) Show forest plot	1	115	Risk Ratio (M‐H, Random, 95% CI)	3.05 [0.13, 73.39]

5 Duration of first sleep episode (short term) Show forest plot	4	652	Mean Difference (IV, Random, 95% CI)	54.61 [13.97, 95.25]

6 Duration of first sleep episode (intermediate term) Show forest plot	1	115	Mean Difference (IV, Random, 95% CI)	18.40 [11.60, 25.20]

7 Time to first void (short term) [minutes] Show forest plot	1	383	Mean Difference (IV, Random, 95% CI)	40.8 [17.07, 64.53]

8 Minor adverse events (short term) Show forest plot	3	594	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.67, 1.13]

9 Minor adverse events (intermediate term) Show forest plot	1	115	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.49, 1.49]

10 Treatment withdrawal due to adverse event (short term) Show forest plot	4	614	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.56, 2.15]

11 Treatment withdrawal due to adverse event (intermediate term) Show forest plot	1	115	Risk Ratio (M‐H, Random, 95% CI)	3.05 [0.13, 73.39]

12 Number of nocturnal voids (short term) (subgroup dose) Show forest plot	6	1982	Mean Difference (IV, Random, 95% CI)	‐0.65 [‐0.98, ‐0.33]

12.1 Very low dose (≤ 1.5 μg)	1	870	Mean Difference (IV, Random, 95% CI)	‐0.20 [‐0.34, ‐0.06]
12.2 Low dose (< 100 μg)	3	711	Mean Difference (IV, Random, 95% CI)	‐0.33 [‐0.72, 0.06]
12.3 High dose (≥ 100 μg)	4	401	Mean Difference (IV, Random, 95% CI)	‐1.03 [‐1.41, ‐0.66]
13 Number of nocturnal voids (short term) (subgroup nocturnal polyuria) Show forest plot	6	1982	Mean Difference (IV, Random, 95% CI)	‐0.61 [‐0.96, ‐0.27]

13.1 Men with nocturia	5	1867	Mean Difference (IV, Random, 95% CI)	‐0.45 [‐0.73, ‐0.17]
13.2 Men with nocturia and nocturnal polyuria	1	115	Mean Difference (IV, Random, 95% CI)	‐1.28 [‐1.64, ‐0.92]
14 Number of nocturnal voids (short term) (sensitivity run‐in period) Show forest plot	4	966	Mean Difference (IV, Random, 95% CI)	‐0.66 [‐1.17, ‐0.14]

15 Major adverse events (short term) (sensitivity run‐in period) Show forest plot	1	385	Risk Ratio (M‐H, Random, 95% CI)	2.53 [0.73, 8.73]

16 Number of nocturnal voids (short term) (sensitivity clinical dosage) Show forest plot	6	1586	Mean Difference (IV, Random, 95% CI)	‐0.76 [‐1.15, ‐0.38]

17 Major adverse events (short term) (sensitivity clinical dosage) Show forest plot	2	417	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.10, 9.71]

17.1 Sublingual/low dose	1	266	Risk Ratio (M‐H, Random, 95% CI)	2.67 [0.71, 10.11]
17.2 Oral/high dose	1	151	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.03, 2.37]

Comparison 1. Desmopressin versus placebo

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Comparison 2. Desmopressin versus behaviour modification

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Duration of first sleep episode (short term) Show forest plot	1	60	Mean Difference (IV, Random, 95% CI)	90.0 [1.95, 178.05]

Comparison 2. Desmopressin versus behaviour modification

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Comparison 3. Desmopressin versus alpha‐blocker

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of nocturnal voids (short term) Show forest plot	1	31	Mean Difference (IV, Random, 95% CI)	0.30 [‐0.20, 0.80]

2 Quality of life (short term) Show forest plot	1	31	Mean Difference (IV, Random, 95% CI)	0.0 [‐0.35, 0.35]

3 Major adverse events (short term) Show forest plot	1	31	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

4 Minor adverse events (short term) Show forest plot	1	31	Risk Ratio (M‐H, Random, 95% CI)	1.07 [0.07, 15.57]

5 Treatment withdrawal due to adverse event (short term) Show forest plot	1	31	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 3. Desmopressin versus alpha‐blocker

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Comparison 4. Desmopressin plus alpha‐blocker versus alpha‐blocker

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of nocturnal voids (short term) (subgroup route and dose) Show forest plot	3	341	Mean Difference (IV, Random, 95% CI)	‐0.47 [‐0.73, ‐0.21]

1.1 Sublingual/low dose	1	210	Mean Difference (IV, Random, 95% CI)	‐0.66 [‐0.90, ‐0.42]
1.2 Oral/high dose	2	131	Mean Difference (IV, Random, 95% CI)	‐0.31 [‐0.60, ‐0.02]
2 Number of nocturnal voids (short term) (subgroup nocturnal polyuria) Show forest plot	3	341	Mean Difference (IV, Random, 95% CI)	‐0.47 [‐0.73, ‐0.21]

2.1 Men with nocturia	1	45	Mean Difference (IV, Random, 95% CI)	‐0.30 [‐0.74, 0.14]
2.2 Men with nocturia and nocturnal polyuria	2	296	Mean Difference (IV, Random, 95% CI)	‐0.52 [‐0.86, ‐0.18]
3 Quality of life (short term) (subgroup route and dose) Show forest plot	3	341	Mean Difference (IV, Random, 95% CI)	‐0.29 [‐0.51, ‐0.07]

3.1 Sublingual/low dose	1	210	Mean Difference (IV, Random, 95% CI)	‐0.23 [‐0.49, 0.03]
3.2 Oral/high dose	2	131	Mean Difference (IV, Random, 95% CI)	‐0.44 [‐0.85, ‐0.03]
4 Quality of life (short term) (subgroup nocturnal polyuria) Show forest plot	3	341	Mean Difference (IV, Random, 95% CI)	‐0.29 [‐0.51, ‐0.07]

4.1 Men with nocturia	1	45	Mean Difference (IV, Random, 95% CI)	‐0.20 [‐0.84, 0.44]
4.2 Men with nocturia and nocturnal polyuria	2	296	Mean Difference (IV, Random, 95% CI)	‐0.34 [‐0.67, ‐0.01]
5 Major adverse events (short term) (subgroup route and dose) Show forest plot	3	402	Risk Ratio (M‐H, Random, 95% CI)	0.30 [0.01, 7.32]

5.1 Sublingual/low dose	1	248	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.2 Oral/high dose	2	154	Risk Ratio (M‐H, Random, 95% CI)	0.30 [0.01, 7.32]
6 Major adverse events (short term) (subgroup nocturnal polyuria) Show forest plot	3	402	Risk Ratio (M‐H, Random, 95% CI)	0.30 [0.01, 7.32]

6.1 Men with nocturia	1	45	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
6.2 Men with nocturia and nocturnal polyuria	2	357	Risk Ratio (M‐H, Random, 95% CI)	0.30 [0.01, 7.32]
7 Minor adverse events (short term) Show forest plot	3	402	Risk Ratio (M‐H, Random, 95% CI)	1.60 [0.15, 16.82]

8 Treatment withdrawal due to adverse event (short term) Show forest plot	3	402	Risk Ratio (M‐H, Random, 95% CI)	2.84 [0.46, 17.66]

Comparison 4. Desmopressin plus alpha‐blocker versus alpha‐blocker

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Comparison 5. Desmopressin plus alpha‐blocker versus alpha‐blocker plus anticholinergic

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of nocturnal voids (short term) Show forest plot	1	405	Mean Difference (IV, Random, 95% CI)	‐0.43 [‐0.97, 0.11]

2 Major adverse events (short term) Show forest plot	1	427	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

3 Minor adverse events (short term) Show forest plot	1	427	Risk Ratio (M‐H, Random, 95% CI)	0.22 [0.05, 0.98]

4 Treatment withdrawal due to adverse event (short term) Show forest plot	1	427	Risk Ratio (M‐H, Random, 95% CI)	0.22 [0.05, 0.98]

Comparison 5. Desmopressin plus alpha‐blocker versus alpha‐blocker plus anticholinergic

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