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

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.

Conditions

• Primary Nocturnal Enuresis
• Nocturnal Enuresis in Children

Interventions

OTHER

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

Sponsors & Collaborators

• Private Selcuk Sılay Pediatric Urology Clinic

  collaborator UNKNOWN

• Medipol Acıbadem Regional Hospital

  collaborator UNKNOWN

• Bahçeşehir University

  lead OTHER

Principal Investigators

• Pelin Pisirici, Assist. Prof. · Bahçeşehir University

• Mesrur Selcuk Silay, Prof. Dr. · Medipol University

• Aygul Koseoglu Kurt, Ph.D. (c) · Bahçeşehir University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-11

Primary Completion

2027-03-11

Completion

2027-08-30

Countries

• Turkey (Türkiye)

Study Locations