Actively Recruiting

Phase Not Applicable
Age: 7Years - 13Years
All Genders
NCT06883851

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

Led by Bahçeşehir University · Updated on 2025-03-19

40

Participants Needed

2

Research Sites

128 weeks

Total Duration

On this page

Sponsors

B

Bahçeşehir University

Lead Sponsor

P

Private Selcuk Sılay Pediatric Urology Clinic

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 7Years - 13Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Being between 7 and 13 years old
  • Diagnosed with primary monosymptomatic nocturnal enuresis by a pediatric urology department within the last 6 months
  • No urinary tract infection confirmed by laboratory tests
  • Able to communicate in Turkish and no mental deficit
  • No diagnosed psychiatric problems
  • Willingness of the child and family to participate in the study
Not Eligible

You will not qualify if you...

  • Orthopedic conditions preventing evaluation
  • Anatomical anomalies in the urinary system
  • History of urinary system surgery
  • Neurological disorders
  • Mental retardation
  • History of orthopedic surgery affecting pelvic or lower extremity integrity
  • Received pelvic floor muscle rehabilitation in the last 6 months
  • Used nighttime alarm therapy in the last 6 months
  • Received any treatment for enuresis in the last 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Private Selcuk Silay Pediatric Urology Clinic

Istanbul, Beşiktaş, Turkey (Türkiye), 34349

Actively Recruiting

2

Medipol Acıbadem Region Hospital

Istanbul, Kadıkoy, Turkey (Türkiye), 34718

Not Yet Recruiting

Loading map...

Research Team

A

Aygul Koseoglu Kurt, Ph.D. (c), PT

CONTACT

P

Pelin Pisirici, Assist. Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here