Treatment of a child with daytime urinary incontinence.
Margaret Reilly, Yves Homsy
https://pubmed.ncbi.nlm.nih.gov/18480719Actively Recruiting
Phase Not Applicable
Age: 7Years - 13Years
All Genders
ID06883851
Evaluating the Efficacy of Structured Pelvic Floor Muscle Rehabilitation Combined With Desmopressin in the Management of Primary Monosymptomatic Nocturnal Enuresis in Children
Led by Bahçeşehir University · Updated on 2025-03-19
40
Participants Needed
2
Research Sites
24 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
Researchers are investigating the effects of Structured Pelvic Floor Muscle Rehabilitation (SPFMR) combined with desmopressin acetate (DDAVP) treatment in children aged 7 to 13 with Primary Monosymptomatic Nocturnal Enuresis (PMNE), a condition characterized by bedwetting without daytime urinary symptoms. This randomized controlled trial aims to determine if adding SPFMR can reduce the frequency and severity of bedwetting episodes and lower relapse rates during both short- and long-term follow-ups compared to DDAVP treatment alone. The study has two groups: one receiving only DDAVP and urotherapy training as prescribed by a pediatric urologist, and the other receiving DDAVP plus 10 weeks of structured pelvic floor muscle rehabilitation sessions led by a physiotherapist. The rehabilitation includes diaphragmatic breathing, biofeedback-assisted pelvic floor training, core stabilization and squat exercises, strengthening of specific muscles, balance training, and home exercises. Each rehabilitation session lasts about 60 minutes, with home exercises performed three times weekly. Participants will keep diaries documenting bedwetting frequency and severity and undergo assessments such as uroflowmetry, post-void residual measurement, bladder diaries, and pelvic floor muscle activation evaluations at baseline and several follow-up points. Researchers will monitor treatment responses and relapse rates over time. The study follows ethical guidelines, requires parental consent, and expects to conclude in 2027.
CONDITIONS
Brief 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
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 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 will not qualify if you...
- 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 pelvic floor muscle 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 10 weeks
Participants receive treatment for primary monosymptomatic nocturnal enuresis. This includes the standard DDAVP therapy prescribed by a pediatric urologist and urotherapy training. Participants in the structured pelvic floor muscle rehabilitation group also attend 10 weeks of structured pelvic floor muscle rehabilitation sessions, which include diaphragmatic breathing, biofeedback-assisted pelvic floor training, core stabilization, squat exercises, strengthening, balance training, and home exercises.
Weekly visits for 10 weeks
Follow-up
Duration - 6 weeks
Participants are monitored after treatment to assess the frequency and severity of enuresis episodes and relapse rates.
Visits at Week 12 and Week 16 after baseline
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
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Research Team
A
Aygul Koseoglu Kurt, Ph.D. (c), PT
P
Pelin Pisirici, Assist. Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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