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

Recruiting now · Not applicable

Conditions studied: Primary Nocturnal Enuresis, Nocturnal Enuresis in Children

In brief

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.

Key facts

Study ID

NCT06883851

Run by

Bahçeşehir University

People needed

40

Starts

2025-03-11

Expected to finish

2027-08-30

Last updated by the study team

2025-03-19

Who can join

Age: 7 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Being between 7 and 13 years old
• Diagnosed with primary MNE by a pediatric urology department within the last 6 months
• No urinary tract infection verified by laboratory tests
• Ability to communicate in Turkish and absence of mental deficit
• No diagnosed psychiatric problems
• Willingness to participate in the study (child and family)

You may not qualify if…

• Presence of orthopedic conditions preventing evaluation
• Anatomical anomalies in the urinary system
• History of urinary system surgery
• Neurological disorders
• Presence of mental retardation
• History of orthopedic surgery that could alter pelvic or lower extremity integrity
• Receiving PFM rehabilitation in the last 6 months
• Using nighttime alarm therapy in the last 6 months
• Receiving any treatment for enuresis in the last 6 months

Where it is running

• Private Selcuk Silay Pediatric Urology Clinic — Istanbul, Beşiktaş, Turkey (Türkiye) (enrolling)
• Medipol Acıbadem Region Hospital — Istanbul, Kadıkoy, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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