Pelvic FloorNCT07603414
The Effect of Pelvic Floor Muscle Training in Functional Constipation
A study testing Lifestyle change training, Diaphragmatic Breathing Exercise and Pelvic Floor Muscle Training in people with Pelvic Floor and Functional Constipation, run by Selin Koşan at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of individualized pelvic floor muscle training on symptoms, core muscle function, and quality of life in patients with functional constipation.The research is being conducted at the Department of Internal Medicine, Gastroenterology Division, Faculty of Medicine, Ege… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pelvic Floor, Functional Constipation, Biofeedback
- What is being tested?
- Lifestyle change training, Diaphragmatic Breathing Exercise and Pelvic Floor Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Dec 2025to 22 Jul 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female cases diagnosed with functional constipation (according to ROMA IV criteria)
- Over 18 years of age and under 70 years of age
- According to ROMA IV criteria:
- Onset of symptoms at least 6 months prior to diagnosis, and experiencing any two or more of the following symptoms in the last 12 weeks (not necessarily consecutive): a) straining during at least 25% of defecations, b) hard stools in at least 25% of defecations, c) feeling of incomplete bowel movements in at least 25% of defecations, d) feeling of anorectal blockage/obstruction in at least 25% of defecations, e) needing to empty the rectum (supporting the pelvic floor muscles), and f) fewer than three bowel movements per week
- Very rare achievement of soft stools without laxative use
- Having insufficient criteria for irritable bowel syndrome,
- Ready to write in Turkish
- Cases who have signed the informed consent form will be included in the study.
Who cannot join
- Patients with secondary constipation (metabolic, endocrine, and neurological)
- Patients with slow transit constipation
- Patients with major orthopedic limitations that may affect the study
- Patients with megacolon, pseudo-obstruction, and severe anorectal disorders (Grade 3-4 hemorrhoidal disease, anal fissure, anal fistula, anorectal abscess, pilonidal sinus, etc.)
- Patients who have undergone pelvic floor surgery, coloproctological surgery, bridileus surgery, or similar major abdominal surgery (excluding appendectomy)
- Patients with drug-induced constipation
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- Patients with any serious systemic disorder including heart, lung, gastrointestinal system, or uncontrolled diabetes mellitus
- Patients with cognitive difficulties that would hinder the conduct of the study (Mini Mental Test score <24)
- Patients with major psychiatric problems that may affect the study
- Pregnant patients will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pelvic Floor Muscle Training on Symptoms, Core Muscle Function, and Quality of Life in Functional Constipation
The aim of this study is to examine the effect of individualized pelvic floor muscle training on symptoms, core muscle function, and quality of life in patients with functional constipation.The research is being conducted at the Department of Internal Medicine, Gastroenterology Division, Faculty of Medicine, Ege University.The study group received diaphragmatic breathing exercises, lifestyle modification training, and individualized pelvic floor muscle training, while the control group received diaphragmatic breathing exercises and lifestyle modification training. These treatments were applied to the patients for 8 weeks. Demographic information was recorded using a data record form. Frequency of bowel movements, stool types and shapes were assessed using the Bristol Stool Scale, muscle function using superficial electromyography (EMG), quality of life using the Constipation Quality of Life Scale, and severity of constipation using the Constipation Severity Scale. All assessments were repeated at weeks 4 and 8.
- Conditions
- Pelvic Floor, Functional Constipation, Biofeedback, Chronic Constipation, Diaphragmatic Breathing
- Being tested
- Lifestyle change training, Diaphragmatic Breathing Exercise, Pelvic Floor Muscle Training
- Keywords
- Biofeedback, pelvic floor, chronic constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle change trainingOther
Patients are advised to increase their physical activity levels. Toilet training includes: not ignoring the urge to defecate, using correct posture during defecation, leaning forward with knees higher than hips when sitting on the toilet, and supporting the feet on a step to correct the anorectal angle. This training is supported by images. They are also instructed to use deep relaxation techniques during defecation, avoid straining, and not stay on the toilet for longer than 10 minutes. Dietary changes include: drinking a warm caffeinated beverage upon waking, having breakfast within an hour of waking, increasing daily fluid intake to 1.5-2 liters, and increasing dietary fiber to 25-30 grams daily, but doing so slowly to prevent abdominal cramps and bloating. Lifestyle changes are monitored daily. Diary entries are requested weekly for 8 weeks via mobile phone application/email.
Diaphragmatic Breathing ExerciseOther
The mechanism of constipation and the purpose of diaphragmatic breathing exercises will be explained to the patients. Patients will be instructed to begin the diaphragmatic breathing exercise in a seated position with one hand on their abdomen and the other on their chest, with their feet 20 cm above the ground. They will then inhale slowly, deeply, and gradually for 6-8 seconds, hold their breath for 10 seconds, and exhale slowly over 6-8 seconds. While inhaling deeply, they will be asked to expand their abdomen by raising their hands from their abdomen while keeping their hands on their chest stationary. Patients will be advised to perform this exercise 3 times a day (especially in the toilet) for 15 breaths each time.
Pelvic Floor Muscle TrainingOther
The functional status of the pelvic floor muscles is determined based on the results obtained from EMG data and the type of Pelvic Floor Muscle Training is determined. PTKE is applied individually, tailored to the functional status of the pelvic floor muscles. Before the exercise, patients are taught correct and effective pelvic floor muscle contraction and relaxation techniques through external palpation of the perineum and abdominal region. Patients are instructed to relax their pelvic floor muscles as if urinating or defecating while inhaling through their nose, feeling the area descend, and to contract their pelvic floor muscles as if holding back urine or stool while exhaling. Relaxing the levator ani muscle durmuscle during straining and proper breathing techniques are re-taught. The duration of pelvic floor muscle training is initially kept short and gradually increased. Under these conditions, sessions are held once a week, lasting approximately 30-45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | The control group receives diaphragmatic breathing exercises and lifestyle modification training. Receives: Other: Lifestyle change training; Other: Diaphragmatic Breathing Exercise |
| pelvic floor muscle training | Experimental | The functional status of the pelvic floor muscles is determined based on the results obtained from EMG data and the type of Pelvic Floor Muscle Training is determined. PTKE is applied individually, tailored to the functional status of the pelvic floor muscles. Before the exercise, patients are taught correct and effective pelvic floor muscle contraction and relaxation techniques through external palpation of the perineum and abdominal region. Patients are instructed to relax their pelvic floor muscles as if urinating or defecating while inhaling through their nose, feeling the area descend, and to contract their pelvic floor muscles as if holding back urine or stool while exhaling. Relaxing the levator ani muscle durmuscle during straining and proper breathing techniques are re-taught. The duration of pelvic floor muscle training is initially kept short and gradually increased. Under these conditions, sessions are held once a week, lasting approximately 30-45 minutes. Receives: Other: Lifestyle change training; Other: Diaphragmatic Breathing Exercise; Other: Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Quality of Life Scale
The quality of life of the subjects is measured using the Constipation Quality of Life Scale. It consists of a total of 28 items: "worry/anxiety" (11 items), "physical discomfort" (4 items), "psychosocial discomfort" (8 items), and "satisfaction" (5 items). The scale score ranges from 28 to 140, with a higher score indicating a negative impact on quality of life.
Measured: initially, 4th week, 8th week
Constipation Severity Scale
The severity of constipation will be assessed using the Constipation Severity Scale (CSS). The CSS is a scale designed to determine the frequency, intensity, and difficulty/hardship of bowel movements. It can also be used to measure constipation symptoms. The minimum total score on the scale is "0", and the maximum is "73". Higher scores indicate greater severity of constipation symptoms.
Measured: initially, 4th week, 8th week
Electromyographic (EMG) Measurement
Electromyographic measurement will be used to record the bioelectrical activity generated by the internal oblique abdominals, transversus abdominis, and levator ani muscles in µV. First, patients will be asked to relax all their muscles when given the command "relax," to contract their muscles as strongly as possible when given the command "muscle," and to initiate defecation as if using a toilet when given the command "strain." Patients will be asked not to contract their abdominal, gluteal, and adductor muscles during each assessment.
Measured: initially, 4th week, 8th week
Bristol Stool Form Scale
Stool consistency will be assessed using the Bristol Stool Form Scale. The scale is scored from 1 to 7, with lower scores indicating harder stools and higher scores indicating looser or watery stools. Types 1-2 represent hard/lumpy stools associated with constipation, whereas types 6-7 indicate loose/watery stools associated with diarrhea. Higher scores indicate worse stool consistency outcomes.
Measured: initially, 4th week,8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start22 Dec 2025
- Primary completion22 May 2026 (estimated)
- Study completion22 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FloorStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selin Koşan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Selin Koşan, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603414
- Sponsor's protocol ID
- 2026/05
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Muscle Training on Symptoms, Core Muscle Function, and Quality of Life in Functional Constipation
- ClinicalTrials.gov ID
- NCT07603414
- Acronym / sponsor ID
- 2026/05
- Conditions
- Pelvic Floor, Functional Constipation, Biofeedback, Chronic Constipation, Diaphragmatic Breathing
- Keywords
- Biofeedback, pelvic floor, chronic constipation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Selin KoşanUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 22 May 2026 (estimated)
- Study completion
- 22 Jul 2026 (estimated)
- First posted
- 22 May 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.
The aim of this study is to examine the effect of individualized pelvic floor muscle training on symptoms, core muscle function, and quality of life in patients with functional constipation.The research is being conducted at the Department of Internal Medicine, Gastroenterology Division, Faculty of Medicine, Ege University.The study group received diaphragmatic breathing exercises, lifestyle modification training, and individualized pelvic floor muscle training, while the control group received diaphragmatic breathing exercises and lifestyle modification training. These treatments were applied to the patients for 8 weeks. Demographic information was recorded using a data record form. Frequency of bowel movements, stool types and shapes were assessed using the Bristol Stool Scale, muscle function using superficial electromyography (EMG), quality of life using the Constipation Quality of Life Scale, and severity of constipation using the Constipation Severity Scale. All assessments were repeated at weeks 4 and 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: Lifestyle change training, Other: Diaphragmatic Breathing ExerciseThe control group receives diaphragmatic breathing exercises and lifestyle modification training. |
| pelvic floor muscle training | Experimental | Other: Lifestyle change training, Other: Diaphragmatic Breathing Exercise, Other: Pelvic Floor Muscle TrainingThe functional status of the pelvic floor muscles is determined based on the results obtained from EMG data and the type of Pelvic Floor Muscle Training is determined. PTKE is applied individually, tailored to the functional status of the pelvic floor muscles. Before the exercise, patients are taught correct and effective pelvic floor muscle contraction and relaxation techniques through external palpation of the perineum and abdominal region. Patients are instructed to relax their pelvic floor muscles as if urinating or defecating while inhaling through their nose, feeling the area descend, and to contract their pelvic floor muscles as if holding back urine or stool while exhaling. Relaxing the levator ani muscle durmuscle during straining and proper breathing techniques are re-taught. The duration of pelvic floor muscle training is initially kept short and gradually increased. Under these conditions, sessions are held once a week, lasting approximately 30-45 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female cases diagnosed with functional constipation (according to ROMA IV criteria)
- Over 18 years of age and under 70 years of age
- According to ROMA IV criteria:
- Onset of symptoms at least 6 months prior to diagnosis, and experiencing any two or more of the following symptoms in the last 12 weeks (not necessarily consecutive): a) straining during at least 25% of defecations, b) hard stools in at least 25% of defecations, c) feeling of incomplete bowel movements in at least 25% of defecations, d) feeling of anorectal blockage/obstruction in at least 25% of defecations, e) needing to empty the rectum (supporting the pelvic floor muscles), and f) fewer than three bowel movements per week
- Very rare achievement of soft stools without laxative use
Key exclusion criteria (10 listed)
- Patients with secondary constipation (metabolic, endocrine, and neurological)
- Patients with slow transit constipation
- Patients with major orthopedic limitations that may affect the study
- Patients with megacolon, pseudo-obstruction, and severe anorectal disorders (Grade 3-4 hemorrhoidal disease, anal fissure, anal fistula, anorectal abscess, pilonidal sinus, etc.)
- Patients who have undergone pelvic floor surgery, coloproctological surgery, bridileus surgery, or similar major abdominal surgery (excluding appendectomy)
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 |
|---|---|---|
| Lifestyle change trainingPatients are advised to increase their physical activity levels. Toilet training includes: not ignoring the urge to defecate, using correct posture during defecation, leaning forward with knees higher than hips when sitting on the toilet, and supporting the feet on a step to correct the anorectal angle. This training is supported by images. They are also instructed to use deep relaxation techniques during defecation, avoid straining, and not stay on the toilet for longer than 10 minutes. Dietary changes include: drinking a warm caffeinated beverage upon waking, having breakfast within an hour of waking, increasing daily fluid intake to 1.5-2 liters, and increasing dietary fiber to 25-30 grams daily, but doing so slowly to prevent abdominal cramps and bloating. Lifestyle changes are monitored daily. Diary entries are requested weekly for 8 weeks via mobile phone application/email. | Other | control, pelvic floor muscle training |
| Diaphragmatic Breathing ExerciseThe mechanism of constipation and the purpose of diaphragmatic breathing exercises will be explained to the patients. Patients will be instructed to begin the diaphragmatic breathing exercise in a seated position with one hand on their abdomen and the other on their chest, with their feet 20 cm above the ground. They will then inhale slowly, deeply, and gradually for 6-8 seconds, hold their breath for 10 seconds, and exhale slowly over 6-8 seconds. While inhaling deeply, they will be asked to expand their abdomen by raising their hands from their abdomen while keeping their hands on their chest stationary. Patients will be advised to perform this exercise 3 times a day (especially in the toilet) for 15 breaths each time. | Other | control, pelvic floor muscle training |
| Pelvic Floor Muscle TrainingThe functional status of the pelvic floor muscles is determined based on the results obtained from EMG data and the type of Pelvic Floor Muscle Training is determined. PTKE is applied individually, tailored to the functional status of the pelvic floor muscles. Before the exercise, patients are taught correct and effective pelvic floor muscle contraction and relaxation techniques through external palpation of the perineum and abdominal region. Patients are instructed to relax their pelvic floor muscles as if urinating or defecating while inhaling through their nose, feeling the area descend, and to contract their pelvic floor muscles as if holding back urine or stool while exhaling. Relaxing the levator ani muscle durmuscle during straining and proper breathing techniques are re-taught. The duration of pelvic floor muscle training is initially kept short and gradually increased. Under these conditions, sessions are held once a week, lasting approximately 30-45 minutes. | Other | pelvic floor muscle training |
Primary outcome
Constipation Quality of Life Scale
Time frame: initially, 4th week, 8th week
The quality of life of the subjects is measured using the Constipation Quality of Life Scale. It consists of a total of 28 items: "worry/anxiety" (11 items), "physical discomfort" (4 items), "psychosocial discomfort" (8 items), and "satisfaction" (5 items). The scale score ranges from 28 to 140, with a higher score indicating a negative impact on quality of life.
Constipation Severity Scale
Time frame: initially, 4th week, 8th week
The severity of constipation will be assessed using the Constipation Severity Scale (CSS). The CSS is a scale designed to determine the frequency, intensity, and difficulty/hardship of bowel movements. It can also be used to measure constipation symptoms. The minimum total score on the scale is "0", and the maximum is "73". Higher scores indicate greater severity of constipation symptoms.
Electromyographic (EMG) Measurement
Time frame: initially, 4th week, 8th week
Electromyographic measurement will be used to record the bioelectrical activity generated by the internal oblique abdominals, transversus abdominis, and levator ani muscles in µV. First, patients will be asked to relax all their muscles when given the command "relax," to contract their muscles as strongly as possible when given the command "muscle," and to initiate defecation as if using a toilet when given the command "strain." Patients will be asked not to contract their abdominal, gluteal, and adductor muscles during each assessment.
Bristol Stool Form Scale
Time frame: initially, 4th week,8th week
Stool consistency will be assessed using the Bristol Stool Form Scale. The scale is scored from 1 to 7, with lower scores indicating harder stools and higher scores indicating looser or watery stools. Types 1-2 represent hard/lumpy stools associated with constipation, whereas types 6-7 indicate loose/watery stools associated with diarrhea. Higher scores indicate worse stool consistency outcomes.
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 29 May 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle change training, Diaphragmatic Breathing Exercise and Pelvic Floor Muscle Training in people with Pelvic Floor and Functional Constipation, run by Selin Koşan 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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 29 May 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. 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?
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?
Constipation Quality of Life Scale (time frame: initially, 4th week, 8th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026.