The Effect of Pelvic Floor Muscle Training in Functional Constipation

NCT07603414 | Active Not Recruiting

• 1 other identifier: 2026/05
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Biofeedback; pelvic floor; chronic constipation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  initially, 4th week, 8th week

• Electromyographic (EMG) Measurement

  EMG 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.

  initially, 4th week, 8th week

• Bristol Stool Scale

  Stool consistency will be assessed using the Bristol Stool Scale. Types 1 and 2 are considered firm or lumpy stools, while types 6 and 7 are considered loose or watery stools.

  initially, 4th week,8th week

Study Arms (2)

control

ACTIVE COMPARATOR

The control group receives diaphragmatic breathing exercises and lifestyle modification training.

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.

Other: Lifestyle change training; Other: Diaphragmatic Breathing Exercise; Other: Pelvic Floor Muscle Training

Interventions

Lifestyle change training OTHER

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.

control; pelvic floor muscle training

Diaphragmatic Breathing Exercise OTHER

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.

control; pelvic floor muscle training

Pelvic Floor Muscle Training OTHER

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.

pelvic floor muscle training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Selin Koşan: lead

Study Sites (1)

Ege University

Izmir, Bornova, 35080, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: December 22, 2025
• Primary Completion: May 22, 2026
• Study Completion (Estimated): July 22, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)