Nocturnal EnuresisNCT05617664
Mirabegron 25 mg for Treatment of Primary Nocturnal Enuresis
A study testing desmopressin 120 mcg oral tablets, Mirabegron 25 MG Oral Tablet, Extended Release and behavioral therapy alone in people with Nocturnal Enuresis, run by Benha University at 1 site in Egypt.
Trial summary
Investigators will study the efficacy and safety of mirabegron25 in treatment of primary nocturnal enuresis in comparison to oral desmopressin 120 mcg and behavioral therapy Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- desmopressin 120 mcg oral tablets, Mirabegron 25 MG Oral Tablet, Extended Release and behavioral therapy alone
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Nov 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- primary nocturnal enuresis,
- negligible daytime wetting,
- wet at least 4 times over 4 weeks
- normal clinical examination with no neurological or urological cause for the enuresis
Who cannot join
- secondary enuresis, polysymptomatic
- neurologic bladder, neurological disorders,
- urinary incontinence disorders
- previous anti NE drugs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Benha University Hospitals
Banhā, Qaliopia, 13518
hosam abu el-nasr, MD, 01286296939 ext. 002, hosamabuelnasr@gmail.com
About this study
Official title: Is Mirabegron 25 mg Safe and Effective in Treatment of Primary Nocturnal Enuresis as Regard Oral Desmopressin 120 mcg?
Investigators will study the efficacy and safety of mirabegron25 in treatment of primary nocturnal enuresis in comparison to oral desmopressin 120 mcg and behavioral therapy
Read the detailed description
No doubt that nocturnal enuresis is one of the commonest types of urinary incontinence which affect children and always run in family . Nocturnal enuresis occurs at the age of 5 years with leakage of urine involuntarily during sleep for two times or more per week in three consecutive months not due to congenital or acquired cause. Nocturnal enuresis can be categorized into primary or secondary depending on occurrence of bed dryness for more than six months or not .
Nocturnal enuresis affects 15% to 20 % of children at five years old mainly due to delay of bladder development and function more in male children with presence of family history in half of cases but 15% of children with enuresis recover spontaneously every year .
limitation of fluid intake, urotherapy and bedwetting alarms are non-pharmacological treatments of nocturnal enuresis while the mostly used drugs for treatment of NE are tricyclic antidepressants(Imipramine®) an arginine vasopressin analog (Desmopressin®) and anticholinergic drugs . Enuresis alarms have pitfalls which disgust a lot of patients as skin irritation, sleep disturbances of other family members and failure to wake the child so that about 30% of patients stop its usage .
Desmopressin is approved as a first-line drug therapy for nocturnal enuresis , but a lot of series declared that monotherapy with desmopressin has little efficacy in treating patients which have bladder storage dysfunction furthermore, high recurrence rate after treatment cessation .
The International Children's Continence Society (ICCS) recommended combination therapy for treatment of primary nocturnal enuresis after failure of first line therapy with desmopressin or enuresis alarms . As regard anticholinergic drugs, oxybutynin was firstly prescribed then tolterodine with less side effects and lately solifenacin . Cognitive impairment as a neurological side effect was authenticated for oxybutynin and other side effects (e.g. headache, dry mouth, behavior change, flushed cheeks, constipation, and blurred vision) were unbearable to many children and impulsed them to stop treatment early .
Mirabegron, a b3-adrenoceptor (b3-AR) agonist was the answer to the question about a drug that can relax detrusor muscle and increasing bladder capacity without the limitations of anti-cholinergic drugs. Mirabegron is the first b3-AR agonist to be prescribed clinically for OAB symptoms in adults and showed promising outcomes . while it is not licensed to be used in children with overactive bladder, some early reports declared its efficacy and tolerability in children .
So investigators will study the efficacy and safety of mirabegron in treatment of primary nocturnal enuresis
- Conditions
- Nocturnal Enuresis
- Being tested
- desmopressin 120 mcg oral tablets, Mirabegron 25 MG Oral Tablet, Extended Release, behavioral therapy alone
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desmopressin 120 mcg oral tabletsDrug
treatment for three months then will stop
Mirabegron 25 MG Oral Tablet, Extended ReleaseDrug
treatment for three months then will stop
behavioral therapy aloneBehavioural
no medications will be given to the patient
| Study group | Role | What they receive |
|---|---|---|
| patients with primary nocturnal enuresis will be followed up with behavioral therapy alone. | Placebo comparator | Not described Receives: Behavioral: behavioral therapy alone |
| patients with primary nocturnal enuresis will take desmopressin 120 mcg oral tablets. | Active comparator | Not described Receives: Drug: desmopressin 120 mcg oral tablets |
| patients with PNE will take mirabegron 25 mg oral tablets. | Active comparator | Not described Receives: Drug: Mirabegron 25 MG Oral Tablet, Extended Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
nocturnal enuresis improvement rate
decrease number of nights or absent nights the patient get wet
Measured: four months
Secondary outcomes (1)
side effects of drugs used
appearance of any side effect of desmopressin or mirabegron
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start23 Nov 2022
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Abu El-nasr, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617664
- Sponsor's protocol ID
- treatment of primary nocturnal
- Status last verified
- Aug 2023
- First submitted
- 8 Nov 2022
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bayne AP, Skoog SJ. Nocturnal enuresis: an approach to assessment and treatment. Pediatr Rev. 2014 Aug;35(8):327-34; quiz 335. doi: 10.1542/pir.35-8-327.
PubMed 25086164Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A, Martin NE. Urodynamics and safety of the beta(3)-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. J Urol. 2013 Oct;190(4):1320-7. doi: 10.1016/j.juro.2013.05.062. Epub 2013 May 30.
PubMed 23727415Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, Stolzel M, Martin N, Gunther A, Van Kerrebroeck P. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the beta(3) adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013 Aug;82(2):313-20. doi: 10.1016/j.urology.2013.02.077. Epub 2013 Jun 13.
PubMed 23769122Blais AS, Nadeau G, Moore K, Genois L, Bolduc S. Prospective Pilot Study of Mirabegron in Pediatric Patients with Overactive Bladder. Eur Urol. 2016 Jul;70(1):9-13. doi: 10.1016/j.eururo.2016.02.007. Epub 2016 Feb 11.
PubMed 26876327Park JS, Lee YS, Lee CN, Kim SH, Kim SW, Han SW. Efficacy and safety of mirabegron, a beta3-adrenoceptor agonist, for treating neurogenic bladder in pediatric patients with spina bifida: a retrospective pilot study. World J Urol. 2019 Aug;37(8):1665-1670. doi: 10.1007/s00345-018-2576-0. Epub 2018 Dec 3.
PubMed 30511212Vande Walle J, Rittig S, Bauer S, Eggert P, Marschall-Kehrel D, Tekgul S; American Academy of Pediatrics; European Society for Paediatric Urology; European Society for Paediatric Nephrology; International Children's Continence Society. Practical consensus guidelines for the management of enuresis. Eur J Pediatr. 2012 Jun;171(6):971-83. doi: 10.1007/s00431-012-1687-7. Epub 2012 Feb 24.
PubMed 22362256Neveus T, Fonseca E, Franco I, Kawauchi A, Kovacevic L, Nieuwhof-Leppink A, Raes A, Tekgul S, Yang SS, Rittig S. Management and treatment of nocturnal enuresis-an updated standardization document from the International Children's Continence Society. J Pediatr Urol. 2020 Feb;16(1):10-19. doi: 10.1016/j.jpurol.2019.12.020. Epub 2020 Jan 30.
PubMed 32278657
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Mirabegron 25 mg Safe and Effective in Treatment of Primary Nocturnal Enuresis as Regard Oral Desmopressin 120 mcg?
- ClinicalTrials.gov ID
- NCT05617664
- Acronym / sponsor ID
- treatment of primary nocturnal
- Conditions
- Nocturnal Enuresis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will study the efficacy and safety of mirabegron25 in treatment of primary nocturnal enuresis in comparison to oral desmopressin 120 mcg and behavioral therapy
Detailed description
No doubt that nocturnal enuresis is one of the commonest types of urinary incontinence which affect children and always run in family . Nocturnal enuresis occurs at the age of 5 years with leakage of urine involuntarily during sleep for two times or more per week in three consecutive months not due to congenital or acquired cause. Nocturnal enuresis can be categorized into primary or secondary depending on occurrence of bed dryness for more than six months or not .
Nocturnal enuresis affects 15% to 20 % of children at five years old mainly due to delay of bladder development and function more in male children with presence of family history in half of cases but 15% of children with enuresis recover spontaneously every year .
limitation of fluid intake, urotherapy and bedwetting alarms are non-pharmacological treatments of nocturnal enuresis while the mostly used drugs for treatment of NE are tricyclic antidepressants(Imipramine®) an arginine vasopressin analog (Desmopressin®) and anticholinergic drugs . Enuresis alarms have pitfalls which disgust a lot of patients as skin irritation, sleep disturbances of other family members and failure to wake the child so that about 30% of patients stop its usage .
Desmopressin is approved as a first-line drug therapy for nocturnal enuresis , but a lot of series declared that monotherapy with desmopressin has little efficacy in treating patients which have bladder storage dysfunction furthermore, high recurrence rate after treatment cessation .
The International Children's Continence Society (ICCS) recommended combination therapy for treatment of primary nocturnal enuresis after failure of first line therapy with desmopressin or enuresis alarms . As regard anticholinergic drugs, oxybutynin was firstly prescribed then tolterodine with less side effects and lately solifenacin . Cognitive impairment as a neurological side effect was authenticated for oxybutynin and other side effects (e.g. headache, dry mouth, behavior change, flushed cheeks, constipation, and blurred vision) were unbearable to many children and impulsed them to stop treatment early .
Mirabegron, a b3-adrenoceptor (b3-AR) agonist was the answer to the question about a drug that can relax detrusor muscle and increasing bladder capacity without the limitations of anti-cholinergic drugs. Mirabegron is the first b3-AR agonist to be prescribed clinically for OAB symptoms in adults and showed promising outcomes . while it is not licensed to be used in children with overactive bladder, some early reports declared its efficacy and tolerability in children .
So investigators will study the efficacy and safety of mirabegron in treatment of primary nocturnal enuresis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with primary nocturnal enuresis will be followed up with behavioral therapy alone. | Placebo comparator | Behavioral: behavioral therapy alone |
| patients with primary nocturnal enuresis will take desmopressin 120 mcg oral tablets. | Active comparator | Drug: desmopressin 120 mcg oral tablets |
| patients with PNE will take mirabegron 25 mg oral tablets. | Active comparator | Drug: Mirabegron 25 MG Oral Tablet, Extended Release |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- primary nocturnal enuresis,
- negligible daytime wetting,
- wet at least 4 times over 4 weeks
- normal clinical examination with no neurological or urological cause for the enuresis
Key exclusion criteria (4 listed)
- secondary enuresis, polysymptomatic
- neurologic bladder, neurological disorders,
- urinary incontinence disorders
- previous anti NE drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| desmopressin 120 mcg oral tabletstreatment for three months then will stop | Drug | patients with primary nocturnal enuresis will take desmopressin 120 mcg oral tablets. |
| Mirabegron 25 MG Oral Tablet, Extended Releasetreatment for three months then will stop | Drug | patients with PNE will take mirabegron 25 mg oral tablets. |
| behavioral therapy aloneno medications will be given to the patient | Behavioural | patients with primary nocturnal enuresis will be followed up with behavioral therapy alone. |
Primary outcome
nocturnal enuresis improvement rate
Time frame: four months
decrease number of nights or absent nights the patient get wet
1 secondary outcome
side effects of drugs used
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Results publication: PubMed 25086164Bayne AP, Skoog SJ. Nocturnal enuresis: an approach to assessment and treatment. Pediatr Rev. 2014 Aug;35(8):327-34; quiz 335. doi: 10.1542/pir.35-8-327.
- Results publication: PubMed 23727415Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A, Martin NE. Urodynamics and safety of the beta(3)-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. J Urol. 2013 Oct;190(4):1320-7. doi: 10.1016/j.juro.2013.05.062. Epub 2013 May 30.
- Results publication: PubMed 23769122Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, Stolzel M, Martin N, Gunther A, Van Kerrebroeck P. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the beta(3) adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013 Aug;82(2):313-20. doi: 10.1016/j.urology.2013.02.077. Epub 2013 Jun 13.
- Results publication: PubMed 26876327Blais AS, Nadeau G, Moore K, Genois L, Bolduc S. Prospective Pilot Study of Mirabegron in Pediatric Patients with Overactive Bladder. Eur Urol. 2016 Jul;70(1):9-13. doi: 10.1016/j.eururo.2016.02.007. Epub 2016 Feb 11.
- Results publication: PubMed 30511212Park JS, Lee YS, Lee CN, Kim SH, Kim SW, Han SW. Efficacy and safety of mirabegron, a beta3-adrenoceptor agonist, for treating neurogenic bladder in pediatric patients with spina bifida: a retrospective pilot study. World J Urol. 2019 Aug;37(8):1665-1670. doi: 10.1007/s00345-018-2576-0. Epub 2018 Dec 3.
- Results publication: PubMed 22362256Vande Walle J, Rittig S, Bauer S, Eggert P, Marschall-Kehrel D, Tekgul S; American Academy of Pediatrics; European Society for Paediatric Urology; European Society for Paediatric Nephrology; International Children's Continence Society. Practical consensus guidelines for the management of enuresis. Eur J Pediatr. 2012 Jun;171(6):971-83. doi: 10.1007/s00431-012-1687-7. Epub 2012 Feb 24.
- Results publication: PubMed 32278657Neveus T, Fonseca E, Franco I, Kawauchi A, Kovacevic L, Nieuwhof-Leppink A, Raes A, Tekgul S, Yang SS, Rittig S. Management and treatment of nocturnal enuresis-an updated standardization document from the International Children's Continence Society. J Pediatr Urol. 2020 Feb;16(1):10-19. doi: 10.1016/j.jpurol.2019.12.020. Epub 2020 Jan 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing desmopressin 120 mcg oral tablets, Mirabegron 25 MG Oral Tablet, Extended Release and behavioral therapy alone in people with Nocturnal Enuresis, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hosam abu el-nasr, MD (01286296939 ext. 002, hosamabuelnasr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nocturnal enuresis improvement rate (time frame: four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05617664, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.