Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Constipation treatment has been found to ameliorate symptoms in some patients with nocturnal enuresis (bed wetting at night). This study aims to explore if treatment of patients without overt constipation (As defined by the ROME III criteria) will also respond to stool softening and GI behavioral therapy with reduction of their urinary tract symptoms when added to standard urotherapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Urotherapy vs. Urotherapy With Constipation Treatment for Children With Lower Urinary Tract Dysfunction

NCT02336906

Diurnal Enuresis

WITHDRAWN PHASE4

Posterior Tibial Nerve Stimulation for Children With Pelvic Floor Dyssynergia

NCT06528470

Constipation Fecal Incontinence in Children Pelvic Floor Dyssynergia

RECRUITING NA

Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study

NCT03477812

Nocturnal Enuresis Polysomnography

UNKNOWN

The Role of Timed Awakening in Treatment of Enuresis

NCT06586476

Nocturnal Enuresis Voiding Dysfunction

NOT_YET_RECRUITING NA

Transcutaneous Electric Nerve Stimulation (TENS) for the Treatment of Nocturnal Enuresis in Children

NCT02900495

Nocturnal Enuresis Bedwetting

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nocturnal Enuresis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Urotherapy + Constipation Treatment

This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction.

Group Type ACTIVE_COMPARATOR

Polyethylene glycol 3350

Intervention Type DRUG

Patients will initially receive three days of high dose PEG3350 treatment (1.5gr/kg up to 100gr maximum) and then will be stepped down to 0.8gr/kg subsequently and tapered accoriding to stool consistency and frequency.

Constipation behavioral therapy

Intervention Type BEHAVIORAL

Patients in the active group will receive dietary instruction as to fiber content, as well as behavioral therapy including active sitting on the toilet to attempt defaction following meals.

Urotherapy

Intervention Type BEHAVIORAL

Patients will be guided for appropriate drinking and toilet habits, and will start with timed voiding.

Urothearpy alone

This group will receive standard behavioral urotherapy alone

Group Type OTHER

Urotherapy

Intervention Type BEHAVIORAL

Patients will be guided for appropriate drinking and toilet habits, and will start with timed voiding.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polyethylene glycol 3350

Patients will initially receive three days of high dose PEG3350 treatment (1.5gr/kg up to 100gr maximum) and then will be stepped down to 0.8gr/kg subsequently and tapered accoriding to stool consistency and frequency.

Intervention Type DRUG

Constipation behavioral therapy

Patients in the active group will receive dietary instruction as to fiber content, as well as behavioral therapy including active sitting on the toilet to attempt defaction following meals.

Intervention Type BEHAVIORAL

Urotherapy

Patients will be guided for appropriate drinking and toilet habits, and will start with timed voiding.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Normalax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged 5-17 years at time of signing of informed consent.
2. MNE as defined by ≥3 wet nights/week without daytime incontinence
3. Do not meet Rome III criteria for functional constipation

Exclusion Criteria

1. Inability to provide signed informed consent.
2. Inability to comply with the study protocol.
3. Neurogenic bladder
4. Attention Deficit Disorder (ADD or ADHD) on medical treatment.
5. Known significant sacral, perineal, or other congenital or surgical defect.
6. Known orthopedic/neurological disease which may affect urinary continence, cause constipation, or affect reading of abdominal x-rays. (e.g. spastic cerebral palsy, severe scoliosis)
7. Patient taking medicinal drugs which can cause urinary incontinence or constipation.

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No