NCT05779709

Brief Summary

Bladder and bowel dysfunction (BBD) describes the urinary tract symptoms associated with bowel complaints. Urotherapy and pharmacological treatments are used in conservative BBD treatment. Pilates is an exercise method that includes a series of movements that both strengthen and increase flexibility of the entire body without focusing on a specific muscle. Reformer pilates is a specific type that provides resistance exercise at certain weights with the pulley system relying basically on the same principles. Pilates exercises provide breathing and activation of the deep stabilizing muscles of the trunk in coordination with the pelvic floor muscles (PFMs). Despite the increasing number of health care professionals using the pilates-based approach in rehabilitation. The pilates-based exercises in rehabilitation is still insufficient in the literature7. To our knowledge, none of studies which were investigated the usefulness of pilates-based exercise principle in children with BBD. This study was aimed to investigate the effect of reformer pilates exercises on bladder and bowel dysfunction symptoms and quality of life in children with bladder and bowel dysfunction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

March 10, 2023

Last Update Submit

March 22, 2023

Conditions

Keywords

ReformerPilatesUrotherapyQuality of lifeBladder and bowel dysfunction

Outcome Measures

Primary Outcomes (3)

  • Voiding Disorders Symptom Scoring

    Voiding disorders symptom scoring was developed by Akbal et al. First, it was formed as an empirical questionnaire consisting of questions about day/night symptoms, micturition, defecation habits and quality of life. Then Akbal et al. excluded the question about quality of life and achieved a 90% rate in the specificity and sensitivity study they conducted for 8.5 points and above. The questionnaire includes 13 questions for symptoms and 1 question for quality of life. The maximum score is 35, the minimum score is 0.

    8 weeks

  • Bladder and Bowel Dysfunction Questionnaire

    The Bladder and Bowel Dysfunction Questionnaire (BBDQ) was used to assess bowel and bladder dysfunctions. Drzewiecki et al. found that this questionnaire was reliable in detecting and evaluating the non-neuropathic pediatric BBDQ. The questionnaire has 14-item and scores for all questions except the first question range from 0 to 4 points, with 0 points indicating no complaints and 4 points indicating the most severe complaints. In the first validation study performed on this questionnaire, 11 points or 52 points were shown as the threshold for BBDQ.

    8 weeks

  • Pediatric İncontinence Questionnaire

    Bower et al. developed the Pediatric İncontinence Questionnaire (PinQ), a cross-cultural tool specific to children with lower urinary tract dysfunction. This instrument has proven to be a reliable and valid tool for measuring the holistic impact of bladder dysfunction in children, and has been recommended for assessing the quality of life in children with urinary incontinence. The questionnaire was also used to measure changes in quality of life during therapy. The PinQ consists of 20 items. Items have five response options following the Likert scale: 0 no, 1 difficult, 2 sometimes, 3 often, and 4 always. The maximum total score is 80 and higher score means a lower quality of life.

    8 weeks

Study Arms (2)

Urotherapy group

EXPERIMENTAL

The purpose of urotherapy education was to teach children to empty the bladder regularly and completely. The standardized urotherapy which included instructions on daily fluid intake of at least 1,200 ml evenly distributed daily as described and voiding at 2-hour intervals until bedtime in which the voiding and defecation positions were taught not to perform avoidance maneuvers. In this training, families were given basic information about the anatomy and physiology of the lower urinary tract (LUT) and anorectum, normal voiding and defecation, fluid consumption and voiding habits of children. The children were allowed to pee whenever they wanted occasionally at any time. Children were also asked to report the number of wet days during 8 weeks

Other: Urotherapy

Reformer pilates group

EXPERIMENTAL

The basic pilates principles were explained to the children. The diaphragmatic breathing, neutral position of the pelvis, centering and pelvic floor control were teached with appropriate language for their age. Verbal help were given to maintain centering during each movement. The exercises (30 min) were started by doing 10 repetitions in combination with diaphragm breathing, and progressed 12 repetitions after 3 weeks, 15 repetitions after 6 weeks (frog series, leg circles series, hundred series, box series, side splits series).İndividual reformer pilates training consisting of 30 minutes two days a week was given to the exercise group by an expert physiotherapist for 8 weeks.

Other: exerciseOther: Urotherapy

Interventions

Reformer pilates is a specific type that provides resistance exercise at certain weights with the pulley system relying basically on the same principles. Pilates exercises provide breathing and activation of the deep stabilizing muscles of the trunk in coordination with the PFMs. It includes exercises that focus on pelvic stability, mobility and body alignment. PFMs activation is carried out simultaneously with the trunk muscles in various positions in coordination with breathing.

Reformer pilates group

Urotherapy includes education of the child and family, diet (adequate fiber and fluid consumption), regular optimal voiding, daily physical activity, teaching normal toilet use, pelvic floor muscle training and relaxation

Reformer pilates groupUrotherapy group

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children between ages 5-18,
  • Diagnosed with bladder and bowel dysfunction without any neurological abnormalities

You may not qualify if:

  • Children with neuropathic or anatomical abnormalities in the urinary tract or gastrointestinal tract, inflammatory bowel disease or any other disorder affecting bladder or bowel function and who requested withdrawal from the study at any stage were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan kalyoncu üniversity

Gaziantep, 27144, Turkey (Türkiye)

Location

Related Publications (9)

  • Aguiar LM, Franco I. Bladder Bowel Dysfunction. Urol Clin North Am. 2018 Nov;45(4):633-640. doi: 10.1016/j.ucl.2018.06.010. Epub 2018 Sep 7.

    PMID: 30316317BACKGROUND
  • Wennergren HM, Oberg BE, Sandstedt P. The importance of leg support for relaxation of the pelvic floor muscles. A surface electromyograph study in healthy girls. Scand J Urol Nephrol. 1991;25(3):205-13. doi: 10.3109/00365599109107948.

    PMID: 1947848BACKGROUND
  • Berry A. Helping children with dysfunctional voiding. Urol Nurs. 2005 Jun;25(3):193-200; quiz 201.

    PMID: 16050350BACKGROUND
  • Ladi-Seyedian SS, Sharifi-Rad L, Kajbafzadeh AM. Management of Bladder Bowel Dysfunction in Children by Pelvic Floor Interferential Electrical Stimulation and Muscle Exercises: A Randomized Clinical Trial. Urology. 2020 Oct;144:182-187. doi: 10.1016/j.urology.2020.07.015. Epub 2020 Jul 25.

    PMID: 32717244BACKGROUND
  • Lausen A, Marsland L, Head S, Jackson J, Lausen B. Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a mixed methods pilot for a randomised controlled trial. BMC Womens Health. 2018 Jan 12;18(1):16. doi: 10.1186/s12905-017-0503-y.

    PMID: 29329567BACKGROUND
  • Pedriali FR, Gomes CS, Soares L, Urbano MR, Moreira EC, Averbeck MA, de Almeida SH. Is pilates as effective as conventional pelvic floor muscle exercises in the conservative treatment of post-prostatectomy urinary incontinence? A randomised controlled trial. Neurourol Urodyn. 2016 Jun;35(5):615-21. doi: 10.1002/nau.22761. Epub 2015 Mar 21.

    PMID: 25809925BACKGROUND
  • Kaya Narter F, Tarhan F, Narter KF, Sabuncu K, Alay Eser R, Akin Y, Ay P. Reliability and validity of the Bladder and Bowel Dysfunction Questionnaireamong Turkish children. Turk J Med Sci. 2017 Dec 19;47(6):1765-1769. doi: 10.3906/sag-1601-122.

    PMID: 29306236BACKGROUND
  • Akbal C, Genc Y, Burgu B, Ozden E, Tekgul S. Dysfunctional voiding and incontinence scoring system: quantitative evaluation of incontinence symptoms in pediatric population. J Urol. 2005 Mar;173(3):969-73. doi: 10.1097/01.ju.0000152183.91888.f6.

    PMID: 15711352BACKGROUND
  • Bower WF, Sit FK, Bluyssen N, Wong EM, Yeung CK. PinQ: a valid, reliable and reproducible quality-of-life measure in children with bladder dysfunction. J Pediatr Urol. 2006 Jun;2(3):185-9. doi: 10.1016/j.jpurol.2005.07.004. Epub 2005 Aug 19.

    PMID: 18947606BACKGROUND

MeSH Terms

Conditions

Intestinal Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yavuz Yakut

    Hasan Kalyoncu University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Children between ages 5-18, who were diagnosed with bladder and bowel dysfunction without any neurological abnormalities were invited. Children with neuropathic or anatomical abnormalities in the urinary tract or gastrointestinal tract, inflammatory bowel disease or any other disorder affecting bladder or bowel function and who requested withdrawal from the study at any stage were excluded. The children who met the inclusion criteria were invited for pre-intervention meeting and assessments. The aim of study and reformer pilates exercise intervention explained parents and children during the meeting. The children and their parents who want to join exercise sessions during the study were assigned in the reformer pilates group and who did not accept to perform reformer pilates exercises were assigned in the urotherapy group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 22, 2023

Study Start

April 19, 2021

Primary Completion

May 20, 2022

Study Completion

July 7, 2022

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations