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

NCT06883851 | Recruiting DMC

• 1 other identifier: E-10840098-202.3.02-6971
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Primary Nocturnal Enuresis; Nocturnal Enuresis in Children

Keywords

biofeedback; core stabilization; exercise; urinary incontinence; management; treatment; enuresis; pelvic floor rehabilitation; desmopressin

Outcome Measures

Primary Outcomes (1)

• The Nighttime Bedwetting Diary

  The diary records dry and wet nights, the amount of bedwetting, bedtime, and wake-up time. The nighttime bedwetting diary will be completed one week before treatment initiation, during the treatment period (10 weeks), and throughout the follow-up phase for both groups. Data will be shared weekly with the researchers, either face-to-face or via phone (WhatsApp, email, etc.).

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

Secondary Outcomes (4)

• Uroflowmetry Test

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

• Post-Void Residual (PVR) Assessment

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

• Bladder Diary

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

• Pelvic Floor Muscle Activation Measurement

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

Study Arms (2)

Control Group (CG)

NO INTERVENTION

The group that will receive first-line treatment, consisting of classic DDVAP treatment with evidence level A and urotherapy training, will be included in the treatment of PMNE. The DDVAP dosage will be determined and prescribed by the pediatric urologist. Only these treatments will be applied, and no pelvic floor rehabilitation will be implemented.

Structered Pelvic Floor Muscle Rehabilitation Group (SPFMRG)

EXPERIMENTAL

This group will receive, in addition to the DDVAP therapy prescribed by the pediatric urologist and urotherapy training, 10 weeks of structured pelvic floor muscle rehabilitation sessions.

Other: Structured pelvic floor rehabilitation

Interventions

Structured pelvic floor rehabilitation OTHER

The classic DDVAP therapy will be administered by the pediatric urologist. The classic urotherapy training recommended for enuresis will be provided by the physiotherapist. In addition, structured pelvic floor muscle rehabilitation (SPFMR) will be provided by the physiotherapist for 10 weeks. Each session is planned to last approximately 60 minutes. SPFMR will include multiple interventions combined. Below is information about the brief interventions. * Diaphragmatic Breathing Training * Pelvic Floor Training with Biofeedback * Core Stabilization Exercises * Squat Exercises * External Rotator Strengthing * Adductor Strengthing * Balance Training * Home Exercises

Structered Pelvic Floor Muscle Rehabilitation Group (SPFMRG)

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Bahçeşehir University: lead
• Private Selcuk Sılay Pediatric Urology Clinic: collaborator
• Medipol Acıbadem Regional Hospital: collaborator

Study Sites (2)

Private Selcuk Silay Pediatric Urology Clinic

Istanbul, Beşiktaş, 34349, Turkey (Türkiye)

RECRUITING

Medipol Acıbadem Region Hospital

Istanbul, Kadıkoy, 34718, Turkey (Türkiye)

NOT YET RECRUITING

Related Publications (16)

• Reilly M, Homsy Y. Treatment of a child with daytime urinary incontinence. Pediatr Phys Ther. 2008 Summer;20(2):185-93. doi: 10.1097/PEP.0b013e318171fb8d.

  PMID: 18480719 RESULT

• Kim DH, An DH, Yoo WG. Effects of 4 weeks of dynamic neuromuscular stabilization training on balance and gait performance in an adolescent with spastic hemiparetic cerebral palsy. J Phys Ther Sci. 2017 Oct;29(10):1881-1882. doi: 10.1589/jpts.29.1881. Epub 2017 Oct 21.

  PMID: 29184312 RESULT

• Bo K. Pelvic floor muscle training is effective in treatment of female stress urinary incontinence, but how does it work? Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):76-84. doi: 10.1007/s00192-004-1125-0. Epub 2004 Jan 24.

  PMID: 15014933 RESULT

• Ladi-Seyedian SS, Sharifi-Rad L, Nabavizadeh B, Kajbafzadeh AM. Traditional Biofeedback vs. Pelvic Floor Physical Therapy-Is One Clearly Superior? Curr Urol Rep. 2019 May 30;20(7):38. doi: 10.1007/s11934-019-0901-9.

  PMID: 31147796 RESULT

• Wagner B, Steiner M, Huber DFX, Crevenna R. The effect of biofeedback interventions on pain, overall symptoms, quality of life and physiological parameters in patients with pelvic pain : A systematic review. Wien Klin Wochenschr. 2022 Jan;134(Suppl 1):11-48. doi: 10.1007/s00508-021-01827-w. Epub 2021 Mar 22.

  PMID: 33751183 RESULT

• Hodges, P., R. Sapsford, and H. Pengel, Feedforward activity of the pelvic floor muscles precedes rapid upper limb movements. 2002.

  RESULT

• Campos RM, Lucio AC, Lopes MHBM, Hacad CR, Perissinotto MCR, Glazer HI, D'Ancona CAL. Pelvic floor muscle training alone or in combination with oxybutynin in treatment of nonmonosymptomatic enuresis. A randomized controlled trial with 2-year follow up. Einstein (Sao Paulo). 2019 Jun 27;17(3):eAO4602. doi: 10.31744/einstein_journal/2019AO4602.

  PMID: 31271608 RESULT

• Ma Y, Liu X, Shen Y. Effect of traditional Chinese and Western medicine on nocturnal enuresis in children and indicators of treatment success: Randomized controlled trial. Pediatr Int. 2017 Nov;59(11):1183-1188. doi: 10.1111/ped.13417.

  PMID: 28891253 RESULT

• Vesna ZD, Milica L, Stankovic I, Marina V, Andjelka S. The evaluation of combined standard urotherapy, abdominal and pelvic floor retraining in children with dysfunctional voiding. J Pediatr Urol. 2011 Jun;7(3):336-41. doi: 10.1016/j.jpurol.2011.02.028. Epub 2011 Apr 27.

  PMID: 21527231 RESULT

• Hamano S, Yamanishi T, Igarashi T, Ito H, Murakami S. Functional bladder capacity as predictor of response to desmopressin and retention control training in monosymptomatic nocturnal enuresis. Eur Urol. 2000 Jun;37(6):718-22. doi: 10.1159/000020224.

  PMID: 10828674 RESULT

• Shah, V., T. PalEkar, and P. GuruPraSad, Surface Electromyography of Perianal Muscles in Children with and without Enuresis: A Cross-sectional Study. JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH, 2022. 16(1): p. SC01-SC03.

  RESULT

• Abd El-Moghny, S.M., et al., Pelvic Floor Muscles Activity Deviation from the Normal among Children with Primary Monosymptomatic Nocturnal Enuresis. 2019.

  RESULT

• Haid B, Tekgul S. Primary and Secondary Enuresis: Pathophysiology, Diagnosis, and Treatment. Eur Urol Focus. 2017 Apr;3(2-3):198-206. doi: 10.1016/j.euf.2017.08.010. Epub 2017 Sep 6.

  PMID: 28888814 RESULT

• Neveus T. Pathogenesis of enuresis: Towards a new understanding. Int J Urol. 2017 Mar;24(3):174-182. doi: 10.1111/iju.13310. Epub 2017 Feb 16.

  PMID: 28208214 RESULT

• Kawauchi A, Tanaka Y, Naito Y, Yamao Y, Ukimura O, Yoneda K, Mizutani Y, Miki T. Bladder capacity at the time of enuresis. Urology. 2003 May;61(5):1016-8. doi: 10.1016/s0090-4295(02)02515-3.

  PMID: 12736027 RESULT

• Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Walle JV, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society. Neurourol Urodyn. 2016 Apr;35(4):471-81. doi: 10.1002/nau.22751. Epub 2015 Mar 14.

  PMID: 25772695 RESULT

MeSH Terms

Conditions

Motor Activity; Urinary Incontinence; Enuresis

Condition Hierarchy (Ancestors)

Behavior; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Elimination Disorders; Mental Disorders

Study Officials

• Pelin Pisirici, Assist. Prof.

  Bahçeşehir University

  STUDY DIRECTOR

• Mesrur Selcuk Silay, Prof. Dr.

  Medipol University

  STUDY CHAIR

• Aygul Koseoglu Kurt, Ph.D. (c)

  Bahçeşehir University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+90 544 477 0157; aygulkoseoglu@gmail.com

Pelin Pisirici, Assist. Prof.

CONTACT

+90 212 381 9198; pelin.pisirici@hes.bau.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The children included in the study will be randomized into two groups: the control group (CG) and the Structured Pelvic Floor Muscle Rehabilitation Group (SPFMRG), following the completion of evaluations by the pediatric urologist. The participants will be randomly assigned to groups using the website https://www.randomizer.org/.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Children aged 7 to 13 years, diagnosed with PMNE and meeting the inclusion criteria, will be included in the study. The sample size for the study will be determined after data collection from a pilot study involving ten participants.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 19, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): March 11, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)