Effectiveness of Pelvic Floor Muscle Rehabilitation Combined With Desmopressin in Children With Primary Monosymptomatic Nocturnal Enuresis

Condition(s) studied

Investigational drug(s) / intervention(s)

Structured pelvic floor rehabilitation: The classic DDVAP therapy will be administered by the pediatric urologist. The classic urotherapy training recommended for enuresis will be provided by the physiotherapist. In addition, structured pelvic floor muscle rehabilitation (SPFMR) will be provided by the physiotherapist for 10 weeks. Each session is planned to last approximately 60 minutes. SPFMR will include multiple interventions combined. Below is information about the brief interventions. * Diaphragmatic Breathing Training * Pelvic Floor Training with Biofeedback * Core Stabilization Exercises * Squat Exercises * External Rotator Strengthing * Adductor Strengthing * Balance Training * Home Exercises

Study summary

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.

Eligibility

Primary outcome measure(s)

• The Nighttime Bedwetting Diary — 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.).

Trial sites (2)

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