Trial · Interventional
RecruitingNot applicableRegistry dataThis trial does not test a peptide that PepBank tracks.
Turkey (Türkiye)
1 trial · 1 ongoing
Effectiveness of Pelvic Floor Muscle Rehabilitation Combined With Desmopressin in Children With Primary Monosymptomatic Nocturnal Enuresis
NCT0688385111 Mar 2025 to est. 30 Aug 2027
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The aim of this randomized controlled trial is to evaluate the effects of Structured Pelvic Floor Muscle Rehabilitation (SPFMR) in children with Primary Monosymptomatic Nocturnal Enuresis (PMNE) who are undergoing desmopressin asetat (DDAVP) treatment prescribed by a pediatric urologist. The study aims to investigate whether SPFMR can reduce the frequency and severity of enuresis episodes and whether it can also reduce relapse rates in the short- and long-term follow-up. The main questions the study seeks to answer are: * Does SPFMR reduce the frequency and severity of enuresis episodes in children with PMNE? * Does SPFMR treatment reduce relapse rates in children with PMNE in the long term? Researchers will compare the group receiving SPFMR in addition to DDAVP treatment with a control group receiving only DDAVP treatment. This comparison will help evaluate the effect of SPFMR on the severity of enuresis episodes and relapse rates. Participants will: * Receive DDAVP treatment (SPFMR group and Control group) * Participate in SPFMR sessions ( SPFMR group) * Keep a diary of enuresis frequency and severity * Assess relapse during short- and long-term follow-up The hypotheses of the study are: H0: Adding SPFMR to desmopressin treatment for children with PMNE has no short-term effect on the severity of enuresis episodes. H1: Adding SPFMR to desmopressin treatment for children with PMNE has a short-term effect on the severity of enuresis episodes. H0: Adding SPFMR to desmopressin treatment for children with PMNE has no long-term effect on the severity of enuresis episodes. H2: Adding SPFMR to desmopressin treatment for children with PMNE has a long-term effect on the severity of enuresis episodes.
No intervention
Control Group (CG)
The group that will receive first-line treatment, consisting of classic DDVAP treatment with evidence level A and urotherapy training, will be included in the treatment of PMNE. The DDVAP dosage will be determined and prescribed by the pediatric urologist. Only these treatments will be applied, and no pelvic floor rehabilitation will be implemented.
Experimental
Structered Pelvic Floor Muscle Rehabilitation Group (SPFMRG)
This group will receive, in addition to the DDVAP therapy prescribed by the pediatric urologist and urotherapy training, 10 weeks of structured pelvic floor muscle rehabilitation sessions.
Outcomes the sponsor listed as primary.
The Nighttime Bedwetting Diary
Time frame · baseline; 10th week after baseline; 12th week after baseline and 16th week after baseline
The diary records dry and wet nights, the amount of bedwetting, bedtime, and wake-up time. The nighttime bedwetting diary will be completed one week before treatment initiation, during the treatment period (10 weeks), and throughout the follow-up phase for both groups. Data will be shared weekly with the researchers, either face-to-face or via phone (WhatsApp, email, etc.).
Uroflowmetry Test
Time frame · baseline; 10th week after baseline; 12th week after baseline and 16th week after baseline
During the uroflowmetry evaluation, patients will be asked to urinate into a sensor-equipped uroflowmetry container (MMES ® brand) when they feel the urge to urinate. For children whose feet do not touch the ground, a stool will be used to ensure a proper toilet position. To minimize external factors affecting the urination pattern, it will be ensured that no one else is present in the uroflowmetry room except the patient. The parameters obtained from the measurement will be used to evaluate the voiding phase of the bladder. Flow rate will be recorded. Flow rate is the volume of urine per unit of time, typically expressed in milliliters per second (ml/s).
Post-Void Residual (PVR) Assessment
Time frame · baseline; 10th week after baseline; 12th week after baseline and 16th week after baseline
The Clarius® transabdominal ultrasound device will be used, and measurements will be performed from the suprapubic region. During the measurement, the patient will be positioned in a supine position with knees slightly flexed and supported with a towel beneath. The volume values calculated by the probe in the coronal and sagittal regions in mm³ will be automatically multiplied by the ultrasound system to calculate the residual urine volume in the bladder.
Bladder Diary
Time frame · baseline; 10th week after baseline; 12th week after baseline and 16th week after baseline
The diary will be maintained over a 48-hour period, recording daytime voiding frequency, voided volume, fluid types, and the amounts.
Pelvic Floor Muscle Activation Measurement
Time frame · baseline; 10th week after baseline; 12th week after baseline and 16th week after baseline
After proper placement of the electrodes, PFM activity will be measured using the NeuroTrac Myoplus4 Pro device. The CE certificate and registration of the device with the Ministry of Health are presented. Participants will be asked to perform 5 seconds of maximal contractions of their PFM ("work" phase EMG activity) followed by 5 seconds of relaxation ("rest" phase EMG activity), repeated in succession after resting. The device provides verbal commands of "work" for each contraction and "rest" for each relaxation. The measurement lasts for 55 seconds.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
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Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Clinical trial · 2000
Hamano et al. 2000European urologycited by 30
PMID 10828674DOI 10.1159/000020224PUB-10828674
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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