Defecation DisorderNCT07482696
Electromyographic Biofeedback Therapy in Patients With Dyssynergic Defecation
A study testing Game-Based Electromyographic (EMG) Biofeedback Therapy in people with Defecation Disorder, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on the quality of life and sleep quality of individuals diagnosed with dyssynergic defecation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Defecation Disorder
- What is being tested?
- Game-Based Electromyographic (EMG) Biofeedback Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of dyssynergic defecation was confirmed by anorectal manometry, which demonstrated paradoxical pelvic floor muscle contraction and/or inadequate relaxation during defecation.
- Eligibility for a pelvic floor rehabilitation program was based on a comprehensive evaluation conducted at the Physical Medicine and Rehabilitation Clinic.
- Age between 18 and 70 years.
- A history of chronic constipation lasting at least six months, in accordance with the Rome IV diagnostic criteria.
- Stool consistency was classified as type 1 or type 2 according to the Bristol Stool Scale, indicating a hard stool pattern.
Who cannot join
- Presence of communication barriers that may interfere with participation in the study.
- Cognitive impairment affects the ability to comply with rehabilitation programs or assessments.
- Pregnancy.
- Presence of severe depression and/or anxiety disorder.
- Untreated metabolic or endocrine disorders, including but not limited to diabetes mellitus, hypothyroidism, hypokalemia, and hypercalcemia.
- Use of medications known to cause or exacerbate constipation.
Show all 12Show fewer
- History of spinal, rectal, or pelvic surgery, excluding cholecystectomy, hysterectomy, and appendectomy.
- Presence of colorectal malignancy or inflammatory bowel disease.
- Anorectal malformations or congenital pelvic floor anomalies.
- Spina bifida, spinal cord injury, or neurological disorders, including multiple sclerosis, Parkinson's disease, dementia, or epilepsy.
- Presence of severe cardiac or renal disease.
- Advanced-stage hemorrhoids, anal fissures, or anal fistulas.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University
Kocaeli, Izmit
Feyza Alaoğlu, MD, +90 530 930 32 60, feyzaceyhan96@gmail.com
About this study
Official title: Effects of Game-Based Electromyographic Biofeedback Therapy on Quality of Life and Sleep Quality in Patients With Dyssynergic Defecation
This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on the quality of life and sleep quality of individuals diagnosed with dyssynergic defecation.
Read the detailed description
This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on quality of life, sleep quality, constipation severity, and pelvic floor muscle function in individuals diagnosed with dyssynergic defecation and chronic constipation. Dyssynergic defecation is a common functional defecation disorder and is one of the leading causes of chronic constipation. It is characterized by paradoxical contraction or inadequate relaxation of the pelvic floor muscles and anal sphincters during defecation, resulting in impaired evacuation of the rectum. This condition leads to excessive straining, a sensation of incomplete evacuation, prolonged stool retention, and significant deterioration in quality of life. Epidemiological studies indicate that dyssynergic defecation accounts for a substantial proportion of chronic constipation cases referred to tertiary care centers for treatment. In patients with dyssynergic defecation, pharmacological treatments alone are often insufficient because they do not address the underlying neuromuscular coordination disorder. Therefore, contemporary management strategies emphasize behavioral and rehabilitative interventions aimed at retraining pelvic floor muscle coordination in women with UI. Among these approaches, EMG biofeedback therapy has emerged as one of the most effective and evidence-based treatment modalities for this condition. Previous randomized controlled trials have demonstrated that EMG biofeedback improves defecation dynamics, reduces constipation-related symptoms, and provides sustained benefits compared with conventional treatment. Despite its proven efficacy, conventional EMG biofeedback therapy may be limited by reduced patient motivation, difficulty in understanding abstract muscle activity patterns, and decreased adherence. In recent years, game-based biofeedback systems have been introduced to overcome these limitations by enhancing patient engagement and facilitating the motor learning process. Game-based biofeedback integrates real-time visual feedback with interactive tasks, allowing patients to actively control on-screen elements through appropriate muscle activation and relaxation. This approach supports motor learning principles, promotes neuromuscular adaptation, and may improve treatment compliance in patients. Another important but often overlooked consequence of chronic constipation and dyssynergic defecation is the impaired sleep quality. Persistent abdominal discomfort, bloating, and defecation-related anxiety can negatively affect sleep patterns, leading to fatigue, reduced daytime functioning, and further deterioration in quality of life (QoL). However, limited data are available on the effects of pelvic floor rehabilitation and biofeedback therapy on sleep quality in this patient population. In recent years, increasing attention has been given to the role of objective physiological assessments in evaluating the efficacy of treatments. Anorectal manometry provides quantitative information on anorectal motility and pelvic floor muscle coordination and is considered the gold standard for diagnosing of dyssynergic defecation. The inclusion of objective manometric measurements alongside patient-reported outcomes allows for a comprehensive evaluation of both the clinical and physiological responses to treatment. Therefore, this randomized controlled study aimed to evaluate the short- and mid-term effects of game-based EMG biofeedback therapy, applied in addition to standard pelvic floor rehabilitation, compared with sham EMG biofeedback in individuals with dyssynergic defecation. The primary outcome of this study was the change in quality of life, assessed using the Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaire. Secondary outcomes included sleep quality, constipation severity, defecation patterns, pain intensity, pelvic floor muscle function assessed using surface EMG, and anorectal motility evaluated using anal manometry. By combining subjective clinical scales with objective physiological measurements, this study aimed to provide high-quality evidence regarding the effectiveness of adaptive, game-based EMG biofeedback therapy in the management of dyssynergic defecation. The findings are expected to contribute to the development of patient-centered, motivation-enhancing rehabilitation strategies and support the integration of game-based biofeedback approaches into standard pelvic floor rehabilitation programs.
- Conditions
- Defecation Disorder
- Being tested
- Game-Based Electromyographic (EMG) Biofeedback Therapy, Sham Control
- Keywords
- Dyssynergic Defecation, Electromyographic Biofeedback, Pelvic Floor Rehabilitation, Constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-Based Electromyographic (EMG) Biofeedback TherapyDevice
Game-based biofeedback integrates real-time visual feedback with interactive tasks, allowing patients to actively control on-screen elements through appropriate muscle activation and relaxation. This approach supports motor learning principles, promotes neuromuscular adaptation, and may improve treatment compliance.
Sham ControlDevice
Sham EMG biofeedback therapy will be administered alongside the same standard pelvic floor rehabilitation program with identical session frequency and duration. Surface electrodes will be placed in the same anatomical locations; however, the biofeedback device will operate in demo mode, and visual feedback will not reflect actual muscle activity.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback Group | Experimental | Participants in the experimental group will receive game-based electromyographic (EMG) biofeedback therapy in addition to the standard pelvic floor rehabilitation program. Receives: Device: Game-Based Electromyographic (EMG) Biofeedback Therapy |
| Control Group | Sham comparator | Participants in the control group will receive sham EMG biofeedback therapy alongside the same standard pelvic floor rehabilitation program with identical session frequency and duration. Receives: Device: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Assessment of Constipation-Quality of Life Questionnaire
The Patient Assessment of Constipation-Quality of Life questionnaire is a validated and reliable patient-reported outcome measure developed to assess the impact of chronic constipation on the quality of life. The scale consists of 28 items grouped into four subdomains.
- Physical Discomfort: Assesses constipation-related physical symptoms and bodily discomfort.
- Psychosocial Discomfort: Evaluates the impact of the condition on emotional status, social functioning, and psychological well-being.
- Worries and Concerns: Assesses anxiety, concerns, and illness-related perceptions associated with constipation.
- Satisfaction: Evaluates patients' satisfaction with their current bowel function and treatments.
Each item is scored on a 5-point Likert scale, with higher scores indicating a greater negative impact on the quality of life.
Measured: At baseline, immediately after the intervention, and 2-months after the intervention.
Secondary outcomes (5)
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index is a self-reported questionnaire that assesses sleep quality over 1-month period. The measure consists of 19 individual items, creating seven components that produce one global score, and takes 5-10 minutes to complete. Each item is weighted on a 0-3 interval scale. The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with lower scores denoting healthier sleep quality.
Measured: At baseline, immediately after the intervention, and 2-months after the intervention.
Constipation Severity Instrument
Constipation severity will be evaluated using the Constipation Severity Instrument, which assesses the severity of constipation-related symptoms and their impacts on daily life. It uses a five-point Likert scale (0-4), resulting in a total score from 0-73, where higher scores indicate greater severity.
Measured: At baseline, immediately after the intervention, and 2-months after the intervention.
Bristol Stool Scale
The Bristol Stool Scale categorizes human feces into seven types based on their shape and consistency, ranging from constipation (types 1-2) to diarrhea (types 5-7). This classification facilitates the objective monitoring of changes in bowel habits by assessing stool form and consistency.
Measured: At baseline, immediately after the intervention, and 2-months after the intervention.
Visual Analog Scale
Pain intensity and defecation-related discomfort will be measured using the Visual Analog Scale, a widely used tool for quantifying subjective pain perception. It is resulting in a total score from 0-100 mm, where higher scores indicate severe pain.
Measured: At baseline, immediately after the intervention, and 2-months after the intervention.
Anorectal manometry
Anorectal manometry is considered the gold standard for assessing anorectal function and for objectively monitoring physiological responses to treatment in patients with dyssynergic defecation.
Measured: At baseline, immediately after the intervention, and 2-months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start31 Mar 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Defecation DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Game-based electromyographic (EMG) biofeedback therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Gokbel, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482696
- Sponsor's protocol ID
- 2024-KAEK-02.bI.04
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yamamoto S, Kawamura Y, Yamamoto K, Yamaguchi Y, Tamura Y, Izawa S, Nakagawa H, Wakita Y, Hijikata Y, Ebi M, Funaki Y, Ohashi W, Ogasawara N, Sasaki M, Maekawa M, Kasugai K. Internet Survey of Japanese Patients With Chronic Constipation: Focus on Correlations Between Sleep Quality, Symptom Severity, and Quality of Life. J Neurogastroenterol Motil. 2021 Oct 30;27(4):602-611. doi: 10.5056/jnm20135.
PubMed 34642281Sadeghi A, Akbarpour E, Majidirad F, Bor S, Forootan M, Hadian MR, Adibi P. Dyssynergic Defecation: A Comprehensive Review on Diagnosis and Management. Turk J Gastroenterol. 2023 Mar;34(3):182-195. doi: 10.5152/tjg.2023.22148.
PubMed 36919830Schrader R, Maschuw R. [Reduction of the surface dose of Co 60 rays in a tissue depth of 0 to 3 mm by means of a magnetic field (author's transl)]. Strahlentherapie. 1980 Apr;156(4):257-63. German.
PubMed 7368232Rao SS, Patcharatrakul T. Diagnosis and Treatment of Dyssynergic Defecation. J Neurogastroenterol Motil. 2016 Jul 30;22(3):423-35. doi: 10.5056/jnm16060.
PubMed 27270989Rao SS, Seaton K, Miller M, Brown K, Nygaard I, Stumbo P, Zimmerman B, Schulze K. Randomized controlled trial of biofeedback, sham feedback, and standard therapy for dyssynergic defecation. Clin Gastroenterol Hepatol. 2007 Mar;5(3):331-8. doi: 10.1016/j.cgh.2006.12.023.
PubMed 17368232Simon MA, Bueno AM. Efficacy of Biofeedback Therapy in the Treatment of Dyssynergic Defecation in Community-Dwelling Elderly Women. J Clin Gastroenterol. 2017 Nov/Dec;51(10):e90-e94. doi: 10.1097/MCG.0000000000000794.
PubMed 28059942Chiarioni G, Whitehead WE, Pezza V, Morelli A, Bassotti G. Biofeedback is superior to laxatives for normal transit constipation due to pelvic floor dyssynergia. Gastroenterology. 2006 Mar;130(3):657-64. doi: 10.1053/j.gastro.2005.11.014.
PubMed 16530506Sahin M, Dogan I, Cengiz M, Unal S. The impact of anorectal biofeedback therapy on the quality of life of patients with dyssynergic defecation. Turk J Gastroenterol. 2015 Mar;26(2):140-4. doi: 10.5152/tjg.2015.4689.
PubMed 25835112Ozkutuk N, Eser I, Bor S. Effectiveness of Biofeedback Therapy on Quality of Life in Patients with Dyssynergic Defecation Disorder. Turk J Gastroenterol. 2021 Jan;32(1):22-29. doi: 10.5152/tjg.2020.19678.
PubMed 33893763Heymen S, Scarlett Y, Jones K, Ringel Y, Drossman D, Whitehead WE. Randomized, controlled trial shows biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia-type constipation. Dis Colon Rectum. 2007 Apr;50(4):428-41. doi: 10.1007/s10350-006-0814-9.
PubMed 17294322Rao SS, Valestin J, Brown CK, Zimmerman B, Schulze K. Long-term efficacy of biofeedback therapy for dyssynergic defecation: randomized controlled trial. Am J Gastroenterol. 2010 Apr;105(4):890-6. doi: 10.1038/ajg.2010.53. Epub 2010 Feb 23.
PubMed 20179692Xu Y, Li X, Xia F, Xu F, Chen JDZ. Efficacy of a Modified Training Program of Adaptive Biofeedback Therapy for Dyssynergic Defecation in Patients with Chronic Constipation. Dig Dis Sci. 2022 Apr;67(4):1320-1327. doi: 10.1007/s10620-021-07094-z. Epub 2021 Jun 15.
PubMed 34129127
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Game-Based Electromyographic Biofeedback Therapy on Quality of Life and Sleep Quality in Patients With Dyssynergic Defecation
- ClinicalTrials.gov ID
- NCT07482696
- Acronym / sponsor ID
- 2024-KAEK-02.bI.04
- Conditions
- Defecation Disorder
- Keywords
- Dyssynergic Defecation, Electromyographic Biofeedback, Pelvic Floor Rehabilitation, Constipation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Mar 2026 (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.
This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on the quality of life and sleep quality of individuals diagnosed with dyssynergic defecation.
Detailed description
This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on quality of life, sleep quality, constipation severity, and pelvic floor muscle function in individuals diagnosed with dyssynergic defecation and chronic constipation. Dyssynergic defecation is a common functional defecation disorder and is one of the leading causes of chronic constipation. It is characterized by paradoxical contraction or inadequate relaxation of the pelvic floor muscles and anal sphincters during defecation, resulting in impaired evacuation of the rectum. This condition leads to excessive straining, a sensation of incomplete evacuation, prolonged stool retention, and significant deterioration in quality of life. Epidemiological studies indicate that dyssynergic defecation accounts for a substantial proportion of chronic constipation cases referred to tertiary care centers for treatment. In patients with dyssynergic defecation, pharmacological treatments alone are often insufficient because they do not address the underlying neuromuscular coordination disorder. Therefore, contemporary management strategies emphasize behavioral and rehabilitative interventions aimed at retraining pelvic floor muscle coordination in women with UI. Among these approaches, EMG biofeedback therapy has emerged as one of the most effective and evidence-based treatment modalities for this condition. Previous randomized controlled trials have demonstrated that EMG biofeedback improves defecation dynamics, reduces constipation-related symptoms, and provides sustained benefits compared with conventional treatment. Despite its proven efficacy, conventional EMG biofeedback therapy may be limited by reduced patient motivation, difficulty in understanding abstract muscle activity patterns, and decreased adherence. In recent years, game-based biofeedback systems have been introduced to overcome these limitations by enhancing patient engagement and facilitating the motor learning process. Game-based biofeedback integrates real-time visual feedback with interactive tasks, allowing patients to actively control on-screen elements through appropriate muscle activation and relaxation. This approach supports motor learning principles, promotes neuromuscular adaptation, and may improve treatment compliance in patients. Another important but often overlooked consequence of chronic constipation and dyssynergic defecation is the impaired sleep quality. Persistent abdominal discomfort, bloating, and defecation-related anxiety can negatively affect sleep patterns, leading to fatigue, reduced daytime functioning, and further deterioration in quality of life (QoL). However, limited data are available on the effects of pelvic floor rehabilitation and biofeedback therapy on sleep quality in this patient population. In recent years, increasing attention has been given to the role of objective physiological assessments in evaluating the efficacy of treatments. Anorectal manometry provides quantitative information on anorectal motility and pelvic floor muscle coordination and is considered the gold standard for diagnosing of dyssynergic defecation. The inclusion of objective manometric measurements alongside patient-reported outcomes allows for a comprehensive evaluation of both the clinical and physiological responses to treatment. Therefore, this randomized controlled study aimed to evaluate the short- and mid-term effects of game-based EMG biofeedback therapy, applied in addition to standard pelvic floor rehabilitation, compared with sham EMG biofeedback in individuals with dyssynergic defecation. The primary outcome of this study was the change in quality of life, assessed using the Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaire. Secondary outcomes included sleep quality, constipation severity, defecation patterns, pain intensity, pelvic floor muscle function assessed using surface EMG, and anorectal motility evaluated using anal manometry. By combining subjective clinical scales with objective physiological measurements, this study aimed to provide high-quality evidence regarding the effectiveness of adaptive, game-based EMG biofeedback therapy in the management of dyssynergic defecation. The findings are expected to contribute to the development of patient-centered, motivation-enhancing rehabilitation strategies and support the integration of game-based biofeedback approaches into standard pelvic floor rehabilitation programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Game-based electromyographic (EMG) biofeedback therapy
| Arm | Type | Receives |
|---|---|---|
| Biofeedback Group | Experimental | Device: Game-Based Electromyographic (EMG) Biofeedback TherapyParticipants in the experimental group will receive game-based electromyographic (EMG) biofeedback therapy in addition to the standard pelvic floor rehabilitation program. |
| Control Group | Sham comparator | Device: Sham ControlParticipants in the control group will receive sham EMG biofeedback therapy alongside the same standard pelvic floor rehabilitation program with identical session frequency and duration. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of dyssynergic defecation was confirmed by anorectal manometry, which demonstrated paradoxical pelvic floor muscle contraction and/or inadequate relaxation during defecation.
- Eligibility for a pelvic floor rehabilitation program was based on a comprehensive evaluation conducted at the Physical Medicine and Rehabilitation Clinic.
- Age between 18 and 70 years.
- A history of chronic constipation lasting at least six months, in accordance with the Rome IV diagnostic criteria.
- Stool consistency was classified as type 1 or type 2 according to the Bristol Stool Scale, indicating a hard stool pattern.
Key exclusion criteria (12 listed)
- Presence of communication barriers that may interfere with participation in the study.
- Cognitive impairment affects the ability to comply with rehabilitation programs or assessments.
- Pregnancy.
- Presence of severe depression and/or anxiety disorder.
- Untreated metabolic or endocrine disorders, including but not limited to diabetes mellitus, hypothyroidism, hypokalemia, and hypercalcemia.
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 |
|---|---|---|
| Game-Based Electromyographic (EMG) Biofeedback TherapyGame-based biofeedback integrates real-time visual feedback with interactive tasks, allowing patients to actively control on-screen elements through appropriate muscle activation and relaxation. This approach supports motor learning principles, promotes neuromuscular adaptation, and may improve treatment compliance. | Device | Biofeedback Group |
| Sham ControlSham EMG biofeedback therapy will be administered alongside the same standard pelvic floor rehabilitation program with identical session frequency and duration. Surface electrodes will be placed in the same anatomical locations; however, the biofeedback device will operate in demo mode, and visual feedback will not reflect actual muscle activity. | Device | Control Group |
Primary outcome
Patient Assessment of Constipation-Quality of Life Questionnaire
Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.
The Patient Assessment of Constipation-Quality of Life questionnaire is a validated and reliable patient-reported outcome measure developed to assess the impact of chronic constipation on the quality of life. The scale consists of 28 items grouped into four subdomains. * Physical Discomfort: Assesses constipation-related physical symptoms and bodily discomfort. * Psychosocial Discomfort: Evaluates the impact of the condition on emotional status, social functioning, and psychological well-being. * Worries and Concerns: Assesses anxiety, concerns, and illness-related perceptions associated with constipation. * Satisfaction: Evaluates patients' satisfaction with their current bowel function and treatments. Each item is scored on a 5-point Likert scale, with higher scores indicating a greater negative impact on the quality of life.
5 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.
Constipation Severity Instrument
Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.
Bristol Stool Scale
Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.
Visual Analog Scale
Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.
Anorectal manometry
Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 34642281Yamamoto S, Kawamura Y, Yamamoto K, Yamaguchi Y, Tamura Y, Izawa S, Nakagawa H, Wakita Y, Hijikata Y, Ebi M, Funaki Y, Ohashi W, Ogasawara N, Sasaki M, Maekawa M, Kasugai K. Internet Survey of Japanese Patients With Chronic Constipation: Focus on Correlations Between Sleep Quality, Symptom Severity, and Quality of Life. J Neurogastroenterol Motil. 2021 Oct 30;27(4):602-611. doi: 10.5056/jnm20135.
- Background: PubMed 36919830Sadeghi A, Akbarpour E, Majidirad F, Bor S, Forootan M, Hadian MR, Adibi P. Dyssynergic Defecation: A Comprehensive Review on Diagnosis and Management. Turk J Gastroenterol. 2023 Mar;34(3):182-195. doi: 10.5152/tjg.2023.22148.
- Background: PubMed 7368232Schrader R, Maschuw R. [Reduction of the surface dose of Co 60 rays in a tissue depth of 0 to 3 mm by means of a magnetic field (author's transl)]. Strahlentherapie. 1980 Apr;156(4):257-63. German.
- Background: PubMed 27270989Rao SS, Patcharatrakul T. Diagnosis and Treatment of Dyssynergic Defecation. J Neurogastroenterol Motil. 2016 Jul 30;22(3):423-35. doi: 10.5056/jnm16060.
- Results publication: PubMed 17368232Rao SS, Seaton K, Miller M, Brown K, Nygaard I, Stumbo P, Zimmerman B, Schulze K. Randomized controlled trial of biofeedback, sham feedback, and standard therapy for dyssynergic defecation. Clin Gastroenterol Hepatol. 2007 Mar;5(3):331-8. doi: 10.1016/j.cgh.2006.12.023.
- Results publication: PubMed 28059942Simon MA, Bueno AM. Efficacy of Biofeedback Therapy in the Treatment of Dyssynergic Defecation in Community-Dwelling Elderly Women. J Clin Gastroenterol. 2017 Nov/Dec;51(10):e90-e94. doi: 10.1097/MCG.0000000000000794.
- Results publication: PubMed 16530506Chiarioni G, Whitehead WE, Pezza V, Morelli A, Bassotti G. Biofeedback is superior to laxatives for normal transit constipation due to pelvic floor dyssynergia. Gastroenterology. 2006 Mar;130(3):657-64. doi: 10.1053/j.gastro.2005.11.014.
- Results publication: PubMed 25835112Sahin M, Dogan I, Cengiz M, Unal S. The impact of anorectal biofeedback therapy on the quality of life of patients with dyssynergic defecation. Turk J Gastroenterol. 2015 Mar;26(2):140-4. doi: 10.5152/tjg.2015.4689.
- Results publication: PubMed 33893763Ozkutuk N, Eser I, Bor S. Effectiveness of Biofeedback Therapy on Quality of Life in Patients with Dyssynergic Defecation Disorder. Turk J Gastroenterol. 2021 Jan;32(1):22-29. doi: 10.5152/tjg.2020.19678.
- Results publication: PubMed 17294322Heymen S, Scarlett Y, Jones K, Ringel Y, Drossman D, Whitehead WE. Randomized, controlled trial shows biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia-type constipation. Dis Colon Rectum. 2007 Apr;50(4):428-41. doi: 10.1007/s10350-006-0814-9.
- Results publication: PubMed 20179692Rao SS, Valestin J, Brown CK, Zimmerman B, Schulze K. Long-term efficacy of biofeedback therapy for dyssynergic defecation: randomized controlled trial. Am J Gastroenterol. 2010 Apr;105(4):890-6. doi: 10.1038/ajg.2010.53. Epub 2010 Feb 23.
- Results publication: PubMed 34129127Xu Y, Li X, Xia F, Xu F, Chen JDZ. Efficacy of a Modified Training Program of Adaptive Biofeedback Therapy for Dyssynergic Defecation in Patients with Chronic Constipation. Dig Dis Sci. 2022 Apr;67(4):1320-1327. doi: 10.1007/s10620-021-07094-z. Epub 2021 Jun 15.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game-Based Electromyographic (EMG) Biofeedback Therapy in people with Defecation Disorder, run by Kocaeli 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tugba Gokbel, Assistant Prof, MD (+905442877390, tugbagokbelftr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Assessment of Constipation-Quality of Life Questionnaire (time frame: At baseline, immediately after the intervention, and 2-months after the intervention.). 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 NCT07482696, which also lists 12 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 7 Aug 2026.