RecruitingNot Applicable

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

Turkey (Türkiye)40 participantsStarted 2025-03-11

Plain-language 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.

Who can participate

Age range

7 Years – 13 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Nighttime Bedwetting Diary

Timeframe: baseline; 10th week after baseline; 12th week after baseline and 16th week after baseline

Trial details

NCT IDNCT06883851

SponsorBahçeşehir University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-11

Contact for this trial

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

+90 544 477 0157 aygulkoseoglu@gmail.com

View on ClinicalTrials.gov More Primary Nocturnal Enuresis trials