OBJECTIVE: To investigate the efficacy of desmopressin nasal spray on daytime urinary incontinence in women. PATIENTS AND METHODS: A multicentre, multinational, randomized, double-blind, placebo-controlled, cross-over exploratory study of women (aged 18-80 years) complaining of severe daytime urinary incontinence was conducted in three centres (King's College Hospital; Boras County Hospital and Skejby Hospital). Seventy-five patients were screened of whom 64 were randomized. In all, 60 women received study medication (safety population) and 57 completed the study. The intention-to-treat population comprised 59 patients and there were 41 in the per protocol analysis. The primary efficacy endpoint was the number of periods with no leakage for 4 h after dosing. Women were instructed to take the drug at a time of their choosing, but >/= 4 h before bedtime. Secondary efficacy variables included the time to first void or incontinence episode, volume leaked per incontinence episode, total volume voided and number of periods with no leakage. All measurements were made over 7 days on desmopressin and 3 days on placebo. RESULTS: There was a higher mean (sd) incidence of periods with no leakage in the first 4 h on desmopressin, at 62 (35)%, than on placebo, at 48 (40)%, and during the first 8 h, at 55 (37)% vs 40 (41)%. There was also a higher frequency of dry days on desmopressin than on placebo; 36% of patients had no leakage on virtually all treatment days (6 or 7) for 4 h after dosing. At 4-8 h the incidence of periods with no leakage on desmopressin was 68 (35)% vs 63 (41)% on placebo, and thereafter the incidence was similar. The time from dosing to first incontinence episode was longer on desmopressin, at 6.3 (2.5) h, vs 5.2 (3.3) h, whilst the volume leaked per incontinence episode was lower on desmopressin than placebo. The total volume voided was consistently lower on desmopressin, at 1180 (58) mL vs 1375 (57) mL, over the 24-h period after administration. There were no serious or severe adverse events reported. Seven women (11%) withdrew from the study, of whom five did not attend for the final visit and two (3%) because of mild adverse events. CONCLUSIONS: The results of this exploratory study suggest that desmopressin is an effective and safe treatment in women with daytime urinary incontinence, and allows them to choose when they need treatment, thus improving motivation, which may aid compliance with therapy.
RCT Entities:
OBJECTIVE: To investigate the efficacy of desmopressin nasal spray on daytime urinary incontinence in women. PATIENTS AND METHODS: A multicentre, multinational, randomized, double-blind, placebo-controlled, cross-over exploratory study of women (aged 18-80 years) complaining of severe daytime urinary incontinence was conducted in three centres (King's College Hospital; Boras County Hospital and Skejby Hospital). Seventy-five patients were screened of whom 64 were randomized. In all, 60 women received study medication (safety population) and 57 completed the study. The intention-to-treat population comprised 59 patients and there were 41 in the per protocol analysis. The primary efficacy endpoint was the number of periods with no leakage for 4 h after dosing. Women were instructed to take the drug at a time of their choosing, but >/= 4 h before bedtime. Secondary efficacy variables included the time to first void or incontinence episode, volume leaked per incontinence episode, total volume voided and number of periods with no leakage. All measurements were made over 7 days on desmopressin and 3 days on placebo. RESULTS: There was a higher mean (sd) incidence of periods with no leakage in the first 4 h on desmopressin, at 62 (35)%, than on placebo, at 48 (40)%, and during the first 8 h, at 55 (37)% vs 40 (41)%. There was also a higher frequency of dry days on desmopressin than on placebo; 36% of patients had no leakage on virtually all treatment days (6 or 7) for 4 h after dosing. At 4-8 h the incidence of periods with no leakage on desmopressin was 68 (35)% vs 63 (41)% on placebo, and thereafter the incidence was similar. The time from dosing to first incontinence episode was longer on desmopressin, at 6.3 (2.5) h, vs 5.2 (3.3) h, whilst the volume leaked per incontinence episode was lower on desmopressin than placebo. The total volume voided was consistently lower on desmopressin, at 1180 (58) mL vs 1375 (57) mL, over the 24-h period after administration. There were no serious or severe adverse events reported. Seven women (11%) withdrew from the study, of whom five did not attend for the final visit and two (3%) because of mild adverse events. CONCLUSIONS: The results of this exploratory study suggest that desmopressin is an effective and safe treatment in women with daytime urinary incontinence, and allows them to choose when they need treatment, thus improving motivation, which may aid compliance with therapy.