Mean Number Of Wet Nights Research Articles

Desmopressin in combination with anticholinergic agents in the treatment of nocturnal enuresis: a systematic review and meta-analysis.

The desmopressin combined with anticholinergic agents for the treatment of nocturnal enuresis (NE) remains controversial. This meta-analysis assesses the efficacy and safety of desmopressin compared with desmopressin plus anticholinergic agents for the treatment of NE. We searched MEDLINE, Embase, and Cochrane Controlled Trials Register databases for RCTs published for the treatment of NE. Systematic review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-analyses. This meta-analysis used RevMan v.5.1.0 to analyze data. Eight studies involving 600 patients (293 in the combination group and 307 in the desmopressin group) contained meaningful data. The results were as follows: after one month of treatment, compared with the desmopressin monotherapy group, the combination group was significantly better in treating NE in FR (full responders, P = 0.003), FR + PR (partial responders) (P < 0.0001), and the mean number of wet nights (P = 0.004); also, the combination group had a better effect in FR (P < 0.00001), FR + PR (P = 0.02) and the mean number of wet nights (P = 0.04) after 3 months' treatment. For side effects, combination therapy does not cause more adverse events in treating NE (P = 0.42). This study elucidates that desmopressin combined with the anticholinergic agent was demonstrated to be more effective in treating NE than desmopressin monotherapy, and the anticholinergic agent does not increase the risk of adverse events (AEs).

Comparison of desmopressin, alarm, desmopressin plus alarm, and desmopressin plus anticholinergic agents in the management of paediatric monosymptomatic nocturnal enuresis: a network meta‐analysis

To assess the efficacy of desmopressin, alarm, desmopressin plus alarm, and desmopressin plus anticholinergic agent (AA) therapy in the management of paediatric monosymptomatic nocturnal enuresis (MNE) using a network meta-analysis. We searched the electronic databases PubMed, Cochrane Library, EMBASE and Web of Science from inception to 1 March 2018. Randomized controlled trials (RCTs) that compared desmopressin, alarm, desmopressin plus alarm, and desmopressin plus AAs were identified. The network meta-analysis was conducted with software R 3.3.2 and STATA 14.0. Eighteen RCTs with a total of 1 649 participants were included. The meta-analysis results showed that complete response (CR) and success rates with desmopressin plus AAs were higher than with desmopressin or alarm monotherapy. Success rates for desmopressin plus alarm therapy were higher than for alarm monotherapy. No obvious difference was observed between desmopressin plus AAs and desmopressin plus alarm therapy with regard to CR rate and success rate. The relapse rate with alarm monotherapy was much lower than with desmopressin monotherapy. Adverse events seemed to be infrequently and tolerable for all treatments. The ranking probability results were as follows: desmopressin plus AA ranked first for the outcomes of CR and success, desmopressin plus alarm therapy ranked first for mean number of wet nights per week, and alarm therapy had the lowest relapse rate. The network meta-analysis showed that desmopressin had similar efficacy to alarm therapy but a higher relapse rate. Desmopressin plus AA therapy was associated with better efficacy than and a similar relapse rate to desmopressin monotherapy. Desmopressin plus alarm therapy was similar to both desmopressin and alarm monotherapy in efficacy. All treatments, including desmopressin plus AAwere associated with tolerable adverse events; however, additional high-quality studies are needed for further evaluation of these treatments.

Desmopressin plus anticholinergic agent in the treatment of nocturnal enuresis: A meta-analysis.

The present study aimed to evaluate the clinical efficacy and safety of combination therapy comprising desmopressin plus anticholinergic agent compared with desmopressin alone for children with nocturnal enuresis (NE). A meta-analysis of 8 eligible studies was performed to analyze the effects of desmopressin plus anticholinergic agent combination therapy and desmopressin monotherapy in the treatment of NE in children. The overall odds ratio (OR) or standardized mean difference (SMD) and 95% confidence interval were calculated for full responders (FR), partial responders (PR), non-responders (NR), the change in the mean number of wet nights and adverse events. Following 1 month of treatment, efficacy analysis yielded an OR of 3.736, which suggested that the proportion of FR for patients treated with the combination therapy was higher than that for patients treated with monotherapy. Analysis of the change in the mean number of wet nights yielded an SMD of 0.719, which indicated that the change in the mean number of wet nights in the patients treated with combination therapy was greater than that in the patients treated with monotherapy. Following 3 months of treatment, the OR calculated for FR plus PR compared with NR was 2.857, indicating that the proportion of FR and PR was elevated by the combination therapy compared with desmopressin alone. The OR for adverse events was 4.074, which suggested that the combination therapy did not lead to more adverse events in the treatment of NE. Therefore, the present meta-analysis suggests that, compared with desmopressin monotherapy, a combination therapy comprising desmopressin and anticholinergic agent is more effective with equivalent safety for children with NE.

Evaluation of the effect of 3-month bladder basic advice in children with monosymptomatic nocturnal enuresis

Advice (BBA) into the standards of patients' care in both monosymptomatic and non-monosymptomatic nocturnal enuresis. Although the idea of this recommendation was clear and reflects clinical experience, duration and efficacy have not been definitely established. Recent data have demonstrated the lack of efficacy of BBA and a fierce discussion has ensued. The present study was aimed to assess the efficacy of BBA in a group of previously untreated children with primary monosymptomatic nocturnal enuresis (MNE). The study was a prospective interventional multicenter trial in a cohort of previously untreated MNE patients. Forty-nine children (36 males, 13 females, mean age 7.2 years) were included in the analysis. The treatment efficacy was assessed at the 30th, 60th, and 90th days of BBA. We discovered that the mean number of wet nights decreased significantly (p<0.001) only after 3 months of BBA from 8.9 to 5.9 episodes every 2 weeks. BBA was fully successful in 2% o the children after 30 day, 12% after 60 days, and 18% after 90 days (Figure). Partial response (by ICCS) was assessed for 8%, 20%, and 34% of the patients. We noted a relatively high rate of non-responders that decreased from 90% to 47% after 90 days. We detected no differences in BBA efficacy between children with night-time polyuria or decreased maximal voided volume. A lower number of wet nights initially predicted the response to the BBA. Our study confirmed rather limited efficacy of BBA, similarly to previous observations, but provided more information on isolated MNE, because of a more specific study group and longer period of observation. The limitation of the study was lack of randomization. Our study revealed that in treatment-naïve children with monosymptomatic enuresis basic bladder training had a low (18%) and late effect, mostly pronounced after the third month of therapy. It seems that only if the patient presents with a favorable profile of bedwetting, occasionally and with a high maximum voided volume, it is worth maintaining BBA for a longer period of up to 3 months before initiating second-line therapy. In an unfavorable initial profile desmopressin or an alarm may be introduced much earlier.

Efficacy of alarm intervention in primary monosymptomatic nocturnal enuresis in children

Background: Enuresis affects about 15 to 20% of five year old children, and even up to 2% of young adults. The various treatment modalities used are behavioural therapy, alarm intervention and pharmacological therapy. Current evidences suggest that alarm intervention is preferable to other modalities of treatment. So a study was done to assess the efficacy of alarm interventions in primary monosymptomatic nocturnal enuresis in children. Methods: A prospective study was done on children aged between 5-18 years with primary monosymptomatic nocturnal enuresis on a total of 62 children. An enuresis diary was maintained by parents. All children received alarm intervention for 12 weeks. A child remaining dry for two consecutive weeks was taken as a success. The subjects were followed up for 12 weeks, two or more wet night in 2 weeks period were taken as relapse. If child failed to become dry after 12 weeks of alarm intervention, intervention was continued for maximum of 6 months or till he became dry. Results: Out of 62 children, majority were males and in the age group of 5-7 years. Family history of enuresis was present in 30.65% of children. A total of 74.19 % of subjects achieved dryness while failures were 25.8% and relapse was seen in 23.91 % during follow up. Significant improvement was noticed as early as 2 months after alarm intervention (p 0.00499) but maximum improvement was seen after 5 months (20 week). On follow up 23.91 % children had relapsed but the frequency of wet nights among these also was significantly low (mean wet nights 0.08/week). Even among failures there was a significant decrease in mean number of wet nights (from 4.24 wet nights/week to 1.85 wet nights/week). Conclusions: Alarm treatment was an effective intervention for management of primary monosymptomatic nocturnal enuresis with high success and low relapse rate.

Efficacy of transcutaneous interferential electrical stimulation in treatment of children with primary nocturnal enuresis: a randomized clinical trial.

Electrical stimulation has been used as an alternative therapy for adult urinary syndromes and for children with constipation. We have evaluated the safety and efficacy of interferential (IF) electrical stimulation in children with nocturnal enuresis (NE). This was a randomized clinical trial in which 54 children (23 girls, 31 boys) aged 6-14 years with primary NE were recruited and randomly divided into two groups. Children in the control group underwent standard urotherapy only (hydration, scheduled voiding, toilet training, diet), whereas children in the IF group (cases) were treated with standard urotherapy + 15 sessions of IF electrical stimulation for 20 min twice per week. An improvement score was calculated to identify relative decrease in wet nights after the treatment for each child. All children were followed for 1 year. Overall, 15/27 (55.5%) and 6/27 (22%) of children in the IF and control groups responded to treatment at the 1-year follow-up (P = 0.01). The mean number of wet nights per week in the control and IF groups decreased from 5.4 ± 2 and 5.7 ± 2 to 3.3 ± 3 and 1.1 ± 2, respectively, at first evaluation (P = 0.003). The mean improvement score in the IF group was significantly higher than that of the control group after 1 year (78 vs. 46%, respectively; P = 0.004). Interferential therapy can be applied as a safe, effective and well-tolerable alternative therapy in the treatment of children with NE.

Why does Adenotonsillectomy Not Correct Enuresis in All Children with Sleep Disordered Breathing?

We analyzed the outcome of nocturnal enuresis after adenotonsillectomy in children with sleep disordered breathing. We also evaluated differences in demographic, clinical, laboratory and polysomnography parameters between responders and nonresponders after adenotonsillectomy. We prospectively evaluated children 5 to 18 years old diagnosed with sleep disordered breathing (snoring or obstructive sleep apnea syndrome) on polysomnography and monosymptomatic primary nocturnal enuresis requiring adenotonsillectomy to release upper airway obstruction. Plasma antidiuretic hormone and brain natriuretic peptide were measured preoperatively and 1 month postoperatively. Sleep studies were done in 46 children and 32 also underwent blood testing preoperatively and postoperatively. Mean ± SD patient age was 8.79 ± 2.41 years and the mean number of wet nights weekly was 6.39 ± 1.26. Polysomnography revealed obstructive sleep apnea syndrome in 71.7% of patients and snoring in 28.3%. After adenotonsillectomy 43.5% of patients became dry. Preoperative polysomnography findings indicated that responders, who were dry, had significantly more arousals and obstructive apnea episodes but fewer awakenings than nonresponders, who were wet. Significant increases in plasma antidiuretic hormone and significant decreases in plasma brain natriuretic peptide were seen in all children with no difference between responders and nonresponders. No difference between the groups was noted in age, gender, race, body mass index, constipation, preoperative number of wet nights weekly or type of sleep disordered breathing. Nocturnal enuresis resolved after adenotonsillectomy in almost half of the children with sleep disordered breathing. Those who became dry had more frequent arousal episodes caused by apnea events than those who remained wet.

Long-term desmopressin response in primary nocturnal enuresis: open-label, multinational study

Primary nocturnal enuresis (PNE) is a distressing condition, particularly in severe cases (> or = 3 wet nights/week). A prevalent pathophysiological mechanism, especially in monosymptomatic PNE (PMNE), is commonly believed to be an insufficient increase in night-time release of antidiuretic hormone. Desmopressin, a synthetic analogue of antidiuretic hormone, has been shown to reduce the number of wet nights experienced by PMNE patients in several controlled trials. This study was performed to evaluate desmopressin treatment in the real-life clinical setting and was a large-scale, 6-month investigation of efficacy and safety in patients with severe PNE. Predictive factors for desmopressin response were also evaluated. A total of 744 children aged 5 years and above from four countries were involved in the study. At baseline, patients had a median of 6 wet nights/week; at 6 months, 41% of patients had experienced > or = 50% reduction in the mean number of wet nights. Long-term desmopressin treatment was consistently well-tolerated across all ages, with 5% of patients experiencing any treatment-related adverse events. The strength of treatment response was associated with nocturnal diuresis (p < 0.0001) and age (p = 0.0167) in logistic regression analyses. Compliance and dosage were also associated with response and more patients experienced > or = 50% reduction in wet nights after 6 months' treatment than earlier in the study, suggesting the value of persistent treatment. This study shows that long-term desmopressin treatment in the clinical setting is effective and well-tolerated in PNE patients of 5 years and upwards. Early improvements in bedwetting of any appreciable magnitude may be rewarding, may facilitate compliance and enable good long-term response.

A Randomized, Placebo-Controlled, Exploratory Trial of Ibuprofen and Pseudoephedrine in the Treatment of Primary Nocturnal Enuresis in Children

This exploratory randomized, double-blind, double-dummy, placebo-controlled trial of 14 days duration conducted in 22 primary care practices in the United States was used to compare the efficacy of ibuprofen and pseudoephedrine, administered alone or in combination, to placebo for the treatment of primary nocturnal enuresis (PNE) in children aged 6 to 11 years. Ibuprofen (IBU) and pseudoephedrine (PSE) are not approved for the treatment of PNE. Three hundred eighteen children with PNE were enrolled. Eligible children had >or= 8 wet nights during a 14-day baseline. Each child was randomly assigned to 1 of 4 treatment groups: IBU 12.5 mg/kg and PSE HCl 15 or 30 mg (depending on weight) (n = 82), IBU 12.5 mg/kg (n = 78), PSE HCl 15 or 30 mg (n = 76), or placebo (n = 82). Treatment was administered orally at bedtime for 14 days. Caregivers recorded whether the child was wet or dry each night in a daily diary. Children in the IBU alone and IBU and PSE combined groups had greater mean reductions from baseline in the number of wet nights (primary end point) compared to children receiving placebo (-2.9, -2.9, and -1.4, respectively, P < .005); PSE alone (-1.8) was not significantly different from placebo. Children in these groups also had greater mean percentage reductions in the number of wet nights compared to placebo-treated children (26%, 28%, and 12%, respectively). Although not always statistically significant, secondary end points improved in the IBU alone and IBU and PSE combined treatment groups, which included decreases in mean number of wet nights and decreases in the number and percentage of children with >or= 50%, 40%, 30%, or 25% reductions in number of wet nights. Children responding to treatment had larger mean bladder capacities and larger mean percentage of predicted bladder capacities than children who did not respond in each treatment group. No significant differences in adverse events were found among treatment groups. In conclusion, in this exploratory study in children aged 6 through 11 years, IBU provided a beneficial effect in the treatment of PNE compared to placebo, whereas PSE did not. The addition of PSE to IBU did not enhance or diminish the efficacy of IBU. All treatments were well tolerated.

Combination Therapy With Desmopressin and an Anticholinergic Medication for Nonresponders to Desmopressin for Monosymptomatic Nocturnal Enuresis: A Randomized, Double-Blind, Placebo-Controlled Trial

Desmopressin is an approved medical therapy for the treatment of monosymptomatic primary nocturnal enuresis. In cases of limited response to desmopressin, we have added anticholinergic therapy to desmopressin (combination therapy). To evaluate this treatment strategy, we examined the efficacy of combination therapy for primary nocturnal enuresis in desmopressin-nonresponders. Only patients with primary nocturnal enuresis refractory to the maximal dosage of desmopressin were enrolled. Children with lower urinary tract symptoms or bowel dysfunction were excluded, on the basis of a 3-day, 24-hour, frequency-volume chart and elimination record. Children continued to take desmopressin and were assigned randomly, in a double-blind manner, to receive either extended-release anticholinergic medication or placebo. Patients were reassessed after 1 month of therapy, with a 1-week nocturnal record. Forty-one desmopressin-nonresponders were enrolled, and 7 patients were excluded because of noncompliance. The treatment groups were equally matched with respect to age, gender, functional bladder capacity, and number of wet nights per week. After 1 month of treatment, there was a significant reduction in the mean number of wet nights in the combination therapy group, compared with the placebo group. With a generalized estimating equation approach, there was a significant 66% decrease in the risk of a wet episode, compared with the placebo group. This study represents the first prospective, placebo-controlled trial examining the effect of desmopressin in combination with long-acting, anticholinergic, bladder-relaxing therapy for monosymptomatic primary nocturnal enuresis.

The efficacy of the addition of short-term desmopressin to alarm therapy in the treatment of primary nocturnal enuresis

The purpose was to evaluate the efficacy of the addition of short-term desmopressin to enuretic alarm in patients with primary monosymptomatic nocturnal enuresis (PMNE). A total of 58 [corrected] children with PMNE were included in this study. The patients were randomized into two groups. In group 1 (n=30), the patients were given 6 weeks of additional oral desmopressin to 12 weeks of enuretic alarm therapy, as a single dose of 0.2 mg at the first 3 weeks and 0.4 mg at the following 3 weeks. In group 2 (n=28), the patients were given 12 weeks of enuretic alarm therapy alone. According to the number of wet nights after 12 weeks of treatment, the patients were defined as complete responders (dry or more than 75% reduction in wet nights), partial responders (50 to 75% reduction) and non-responders (less than 50% reduction). Relapse was defined as the reappearance of >1 wet night per week for complete responders and >50% increase in pre-treatment wetting frequency for partial responders, and all these patients were called relapsers. The mean number of wet nights after 3 and 6 weeks treatment was significantly lower in group 1 compared to group 2. However, there was no significant difference between the groups regarding the mean number of wet nights after 12 and 24 weeks of treatment. There was no significant difference between the groups regarding the number of responders, partial responders, non-responders and relapsers. In the group with additional desmopressin therapy given, the number of patients who abandoned therapy was lower than the alarm therapy alone group, but it was not statistically significant. Our data showed that the addition of short-term desmopressin to alarm therapy was more effective only in the period when it was given, and it did not change the response to alarm therapy in the long term.

Homotoxicological remedies versus desmopressin versus placebo in the treatment of enuresis: a randomised, double-blind, controlled trial

The aim of this trial was to compare the safety and efficacy of homotoxicological remedies versus placebo and versus desmopressin (dDAVP) in the treatment of monosymptomatic nocturnal enuresis (MNE). We conducted a randomised, double-blind, double-dummy, controlled trial in which 151 children with MNE were randomly assigned to receive oral homotoxicological remedies (n = 50), dDAVP (n = 50) or placebo (n = 51). The primary outcomes were: the reduction of wet nights per week after 3 months of therapy; the evaluation of the numbers and percentages of non-responders and responders; the number of children relapsing after initial response and the number of children attaining 14 consecutive dry nights during the treatment. The secondary outcome was the detection of adverse effects. Baseline clinical characteristics were similar in the three groups of patients. After the 3 months of therapy there was a significant difference between the three groups (P < 0.001) in the mean number of wet nights per week. The daily dose of dDAVP produced a statistically significant decrease (62.9%) in wet nights compared to placebo (2.4%) (P < 0.001) and compared to homotoxicological remedies (30.0%) (P < 0.001). There was a significant decrease in wet nights among the group treated with homotoxicological medications if compared with placebo (P < 0.001). The full response achieved with homotoxicological remedies (20%) was superior if compared with placebo (0%) (P < 0.001). Homotoxicology was superior to placebo (P < 0.001) with regard to the number of children attaining 14 consecutive dry nights during treatment. Our study demonstrates that homotoxicology is safe and effective when compared with placebo, even if it is significantly less effective than dDAVP in this clinical condition.

DIURETIC TREATMENT OF NOCTURNAL ENURESIS: PRELIMINARY RESULTS OF AN OPEN PILOT STUDY

Since antidiuretic treatment with desmopressin in the evening has proven effective against enuresis, it would not be surprising if diuretic treatment in the afternoon would have similar effects. We are currently testing this in an open pilot investigation. A total of 33 children including 12 girls with a mean age +/-SD of 7.6 +/- 2.3 years with monosymptomatic enuresis were recruited from an outpatient primary care setting. Wet and dry nights were recorded for 2 weeks without medication, 2 weeks with 0.4 mg desmopressin orally at night and 2 weeks with 1 mg/kg furosemide 4 to 5 hours before bedtime. The mean number of wet nights +/-SD during the 3 periods was 10.2 +/- 3.0, 6.7 +/- 4.7 and 7.8 +/- 4.5, respectively. The effects of desmopressin and of furosemide were statistically significant (p <0.0001 and p = 0.001), although the 2 treatments did not differ (p = 0.08). Only 6 children had a complete response (ie greater than 90% reduction in wet nights) to desmopressin and 5 responded to furosemide. Interestingly, 2 children had a clearly better response on furosemide than on desmopressin. The treatment of enuresis with diuretic medication in the afternoon may be beneficial but needs to be tested in randomized controlled trials.

Effectiveness of alpha1-adrenergic blockers in boys with low urinary flow rate and urinary incontinence.

Although alpha blockers have been shown to be effective in treating various types of neuropathic voiding dysfunction in children, the effectiveness of alpha(1) blockers in treating neurologically intact children with voiding dysfunction remains unclear. We investigated the effectiveness of treatment with alpha(1)-adrenergic blockade in boys with low uroflow rate and urinary incontinence. The alpha(1) blocker doxazosin (0.5 to 1.0 mg daily) was administered to 16 boys (mean age, 8.9 +/- 3.4 years) with maximum uroflow rate (Qmax) < 15 mL/s and urinary incontinence. Uroflowmetry and postvoid residual volumes were checked before and 4 weeks after doxazosin treatment. After discontinuation of doxazosin for 2 weeks, videourodynamics and cystoscopy were done in 12 of the 16 boys. Improvement of uroflow was arbitrarily defined as an increase of Qmax >/= 2.5 mL/s. Complete improvement of incontinence was defined as > 90% and partial improvement as 50 to 90% reduction of incontinence episodes. Successful treatment was defined as improvement in uroflow and partial or complete improvement of urinary incontinence. Blood pressure, first-dose phenomenon, and adverse effects were monitored at each visit. Mean medication and follow-up periods were 24.5 weeks and 33.1 weeks, respectively. Improvement of uroflow was noted in 10 patients (63%). Qmax increased from 12.3 +/- 1.3 mL/s to 16.3 +/- 4.1 mL/s (p = 0.001). Complete and partial improvement of incontinence was noted in 7 and 3 patients, respectively. The mean number of wet nights per week decreased from 4.9 +/- 2.3 to 2.2 +/- 2.5 (p < 0.001). Successful treatment was noted in 8 boys (50%), including 3 of 5 boys with primary bladder neck obstruction, 3 of 4 boys with dysfunctional voiding, and 2 of 4 boys with neuropathic voiding dysfunction of unclassified etiology. There were no significant adverse effects. Decreases of systolic and diastolic blood pressure were negligible. alpha(1) Blockade is effective in the treatment of boys with low uroflow rate and incontinence.

Efficacy and safety during long‐term treatment f primary monosymptomatic nocturnal enuresis with desmopressin

The Swedish Enuresis Trial (SWEET) was conducted to evaluate the long‐term safety and efficacy of intranasal desmopressin treatment in children with primary, monosymptomatic nocturnal enuresis (PMNE). The study had an open, multicentre design and comprised a 4‐wk observation period, a 6‐wk dose titration period (with 20‐40 μg desmopressin) and a 1‐y, long‐term treatment period. A treatment‐free week was introduced every 3 mo to identify dry patients. In total, 399 children aged 6‐12 y with PMNE were recruited. Of these, 245 patients (61%) experienced ≥ 50% reduction in the number of wet nights during the last 4 wk of dose titration compared with the observation period. These responders entered the long‐term phase of the trial. The mean number of wet nights per week decreased from a median of 5.3 (range 1.3‐7.0) during the observation period to a median of 0.8 (range 0.0‐5.0) during the last 3‐mo period. Seventy‐seven children became dry, 63 (83%) within 6 mo of treatment initiation. The percentage of children who became dry was similar in all age groups. Significantly fewer children in the lowest age group were defined as responders (52%; 95% CI 45, 59) among the 6‐7‐y‐olds compared to 65% (56, 74) and 81% (72, 90) in the two older age groups. Desmopressin was well tolerated. No serious drug‐related adverse events were recorded and no clinical symptoms of hyponatraemia were reported. The SWEET trial has demonstrated that desmopressin is both safe and effective for the long‐term treatment of PMNE, with a significant therapeutic effect also in children of 6–7 y of age.

Oral Desmopressin: A Randomized Double-Blind Placebo Controlled Study of Effectiveness in Children With Primary Nocturnal Enuresis

Purpose Desmopressin nasal spray has proved to be efficacious treatment of primary nocturnal enuresis. Oral desmopressin tablets would be a more easily used, convenient vehicle for our patients and their parents. We evaluated the effectiveness of oral desmopressin in decreasing the number of wet nights in patients with primary nocturnal enuresis. Materials and Methods We performed a double-blind, placebo controlled, parallel group trial of oral desmopressin in 141 children 5 to 17 years old with documented primary nocturnal enuresis at 14 sites. Patients were screened for number of wet nights for 2 weeks before study entry. A minimum of 3 wet nights weekly for 2 consecutive weeks was required for study entry. Patients were randomized to receive 200, 400 or 600 mcg. desmopressin or placebo before bedtime. Fluids were restricted 2 hours before bedtime based on body weight. The primary efficacy variable was mean decrease in the number of wet nights recorded during the last 2-week treatment period. The percentage of responding patients and mean decrease from baseline in number of wet nights at 2, 4 and 6 weeks were also assessed. Results The decrease in wet nights was 9, 20, 30 and 36% for placebo, and 200, 400, and 600 mcg. desmopressin orally per day, respectively. The 600 mcg. dose of oral desmopressin daily was statistically significantly different (p <0.05) from placebo in decreasing wet nights. A complete or near complete response (0 to 2 wet nights) was noted in 3, 18, 33 and 24% of the patients who received placebo, and 200, 400 and 600 mcg. oral desmopressin daily, respectively. The 400 and 600 mcg. treatment groups were statistically significantly different (p <0.05) from placebo. A less than 50% decrease in wet nights was noted in 83, 79, 64 and 61% of the patients who received placebo, and 200, 400 and 600 mcg. oral desmopressin daily, respectively. Oral desmopressin exhibited a dose response in the treatment of primary nocturnal enuresis. The linear trend for the decrease in wet nights was statistically significant (p <0.05). Conclusions A dose of 600 mcg. oral desmopressin daily significantly decreased the mean number of wet nights when administered for 6 weeks. A higher dose may be necessary for an improved response.