Pelvic floor muscle rehabilitation with desmopressin for children with bedwetting
Evaluating the Efficacy of Structured Pelvic Floor Muscle Rehabilitation Combined With Desmopressin in the Management of Primary Monosymptomatic Nocturnal Enuresis in Children
This study is testing if combining pelvic floor muscle exercises with a medication can help children aged 7 to 13 who wet the bed at night have fewer accidents and stay dry longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 7 Years to 13 Years |
| Sex | All |
| Sponsor | Bahçeşehir University Academic / other |
| Locations | 2 sites (Istanbul, Beşiktaş and 1 other locations) |
| Trial ID | NCT06883851 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Structured Pelvic Floor Muscle Rehabilitation (SPFMR) combined with desmopressin treatment in children aged 7 to 13 diagnosed with Primary Monosymptomatic Nocturnal Enuresis (PMNE). The study aims to determine if SPFMR can reduce the frequency and severity of bedwetting episodes and lower relapse rates compared to a control group receiving only desmopressin. Participants will undergo a randomized controlled approach to assess the impact of this combined treatment over both short- and long-term follow-ups.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 13 who have been diagnosed with primary monosymptomatic nocturnal enuresis within the last six months.
Not a fit: Patients with neurological disorders, anatomical anomalies in the urinary system, or those who have received other enuresis treatments in the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of bedwetting in children, leading to better quality of life.
How similar studies have performed: While the combination of pelvic floor rehabilitation and desmopressin is a novel approach, similar studies have shown promise in treating nocturnal enuresis with various interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul, Beşiktaş and 1 other locations
- Private Selcuk Silay Pediatric Urology Clinic — Istanbul, Beşiktaş, Turkey (Türkiye) (Recruiting)
- Medipol Acıbadem Region Hospital — Istanbul, Kadıkoy, Turkey (Türkiye) (Not_yet_recruiting)
Study contacts
- Principal investigator: Aygul Koseoglu Kurt, Ph.D. (c) — Bahçeşehir University
- Study coordinator: Aygul Koseoglu Kurt, Ph.D. (c), PT
- Email: aygulkoseoglu@gmail.com
- Phone: +90 544 477 0157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.