BLADDER AND BOWEL DYSFUNCTIONNCT05779709
Reformer Pilates Exerises in Bladder and Bowel Dysfunction
A study testing exercise and Urotherapy in people with BLADDER AND BOWEL DYSFUNCTION, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- BLADDER AND BOWEL DYSFUNCTION
- What is being tested?
- exercise and Urotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Apr 2021to 7 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children between ages 5-18,
- Diagnosed with bladder and bowel dysfunction without any neurological abnormalities
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Reformer Pilates Exercises on Symptoms and Quality of Life in Children With Bladder and Bowel Dysfunction
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.
Read the detailed description
Bladder and bowel dysfunction (BBD) describes the urinary tract symptoms associated with bowel complaints. BBD symptoms are thought to represent 40% of pediatric urology consultations. In children who do not have any neurological or physiological problems, micturition and defecation occur with the coordinated work of the involuntary bladder and bowel, voluntary contracting external urethral sphincter and external anorectal sphincter. For normal micturition and defecation, the pelvic floor muscles must be able to relax properly. This relaxation may not be achieved even in children with no neurological or physiological problems.
Urotherapy and pharmacological treatments are used in conservative BBD treatment. 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. 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. It includes exercises that can work the pelvic floor muscles (PFMs), while avoiding intense abdominal contractions, holding breath, or straining that can create increased pressure on the pelvic floor.
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. Such exercises are known to have an important role related to continence, maintenance of intra-abdominal pressure and respiratory mechanics.
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 literature. 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.
- Conditions
- BLADDER AND BOWEL DYSFUNCTION
- Being tested
- exercise, Urotherapy
- Keywords
- Reformer, Pilates, Urotherapy, Quality of life, Bladder and bowel dysfunction
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
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.
UrotherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: exercise; Other: Urotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start19 Apr 2021
- Primary completion20 May 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for BLADDER AND BOWEL DYSFUNCTIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Usgu, Hasan Kalyoncu University
- Investigators
- Yavuz Yakut, Study chair, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779709
- Sponsor's protocol ID
- 2021/051
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30316317Wennergren 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.
PubMed 1947848Berry A. Helping children with dysfunctional voiding. Urol Nurs. 2005 Jun;25(3):193-200; quiz 201.
PubMed 16050350Ladi-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.
PubMed 32717244Lausen 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.
PubMed 29329567Pedriali 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.
PubMed 25809925Kaya 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.
PubMed 29306236Akbal 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.
PubMed 15711352Bower 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.
PubMed 18947606
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Reformer Pilates Exercises on Symptoms and Quality of Life in Children With Bladder and Bowel Dysfunction
- ClinicalTrials.gov ID
- NCT05779709
- Acronym / sponsor ID
- 2021/051
- Conditions
- BLADDER AND BOWEL DYSFUNCTION
- Keywords
- Reformer, Pilates, Urotherapy, Quality of life, Bladder and bowel dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bladder and bowel dysfunction (BBD) describes the urinary tract symptoms associated with bowel complaints. BBD symptoms are thought to represent 40% of pediatric urology consultations. In children who do not have any neurological or physiological problems, micturition and defecation occur with the coordinated work of the involuntary bladder and bowel, voluntary contracting external urethral sphincter and external anorectal sphincter. For normal micturition and defecation, the pelvic floor muscles must be able to relax properly. This relaxation may not be achieved even in children with no neurological or physiological problems.
Urotherapy and pharmacological treatments are used in conservative BBD treatment. 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. 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. It includes exercises that can work the pelvic floor muscles (PFMs), while avoiding intense abdominal contractions, holding breath, or straining that can create increased pressure on the pelvic floor.
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. Such exercises are known to have an important role related to continence, maintenance of intra-abdominal pressure and respiratory mechanics.
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 literature. 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Urotherapy group | Experimental | Other: UrotherapyThe 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 |
| Reformer pilates group | Experimental | Other: exercise, Other: UrotherapyThe 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children between ages 5-18,
- Diagnosed with bladder and bowel dysfunction without any neurological abnormalities
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseReformer 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. | Other | Reformer pilates group |
| UrotherapyUrotherapy 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 | Other | Reformer pilates group, Urotherapy group |
Primary outcome
Voiding Disorders Symptom Scoring
Time frame: 8 weeks
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.
Bladder and Bowel Dysfunction Questionnaire
Time frame: 8 weeks
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.
Pediatric İncontinence Questionnaire
Time frame: 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 30316317Aguiar 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.
- Background: PubMed 1947848Wennergren 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.
- Background: PubMed 16050350Berry A. Helping children with dysfunctional voiding. Urol Nurs. 2005 Jun;25(3):193-200; quiz 201.
- Background: PubMed 32717244Ladi-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.
- Background: PubMed 29329567Lausen 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.
- Background: PubMed 25809925Pedriali 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.
- Background: PubMed 29306236Kaya 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.
- Background: PubMed 15711352Akbal 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.
- Background: PubMed 18947606Bower 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yavuz Yakut study chair
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and Urotherapy in people with BLADDER AND BOWEL DYSFUNCTION, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voiding Disorders Symptom Scoring (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05779709, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.