Biofeedback for Women With Dyssynergic Defecation (DD)

N/AEnrolling By InvitationNCT07622732

Ahram Canadian University58 enrolled

Overview

This research aimed to compare the effect of Biofeedback (BFB) versus Lifestyle management in form of stretching positions and patient's education position of defecation, in addition to rectal massage, and anal dilators among Dyssynergic Defecation (DD) in Females. It is common and affects up to one half of patients with chronic constipation. This acquired behavioral problem is due to the inability to coordinate the abdominal and pelvic floor muscles to evacuate stools

A randomized controlled trial will be conducted on 58 female participants aged 35-65 years, their BMI 30-34 kg/m2, they are suffering from DD, Diagnostic criteria for functional defecation disorders include those for functional constipation, namely two or more of 6 symptoms present for the last 3 months with an onset more than 6 months in the past; the symptoms are: straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction/blockage, or manual maneuvers to facilitate defecation, or less than 3 bowel movements per week. All the included patients will have selected to be unresponsive to dietary modification, life style modification, and laxatives for a period of at least 3 months. The control Group (n=30), receiving Lifestyle management in form of stretching positions and patient's education position of defecation, in addition to rectal massage, and anal dilators, while the study Group (n=30), receiving the same program in addition to BFB. The Patient will receive consecutive 12 sessions at frequency of 2 sessions per week over a period of 6 weeks. The treatment will have done on outpatient basis. During the session, the patient will be instructed to visualize the monitor (pressure traction) to understand the function of the pelvic floor muscles especially to the responses during anal squeezing and straining. During menstruation, the patient will be temporarily withdrawn from the sessions tell the end of menstruation. Primary Outcome Measures: 1- Resting anal pressure. 2-Maximum straining anal pressure during an attempted defecation (bearing down). Time Frame: the questionnaire will be taken at baseline and after 6 weeks of intervention. Description: These variables will be done by using the EMG Biofeedback device: (Gymna Myo 200). This is the primary test to assess the pressure activity and coordination of the rectal and anal muscles. A small, flexible probe will be inserted into the rectum. The test will measure rectal pressure andanal sphincter pressure changes. In DD, it typically shows inadequate pushing force, paradoxical anal sphincter contraction, or insufficient relaxation. Secondary Outcome Measures: 1-Bristol scale: to assess the consistency of the stool. 2- Functional obstructed defecation severity, Modified obstructed defecation score (MODS). Time Frame: the questionnaire will be taken at baseline and after 6 weeks of intervention. Description: the MODS is a sum of individual scores for 7 symptoms and one score for life style alteration. 3- Digital rectal examination (DRE): Assess resting and squeeze tone of the anal sphincter and puborectalis muscles. It is a crucial, cost-effective screening tool that can be performed in the clinic. Identifying dyssynergia in patients with chronic constipation and detecting normal, but not abnormal, sphincter tone. Time Frame: the questionnaire will be taken at baseline and after 6 weeks of intervention. Description: During an attempted defecation maneuver (bearing down), the examiner will normally feel the anal sphincter relax and the perineum descend. In patients with DD, the examiner will may feel the anal sphincter paradoxically contract (tighten) or fail to relax, along with absent or reduced perineal descent. Digital Rectal Examination This evaluation consisted of 3 steps: (1) inspection of the anus and surrounding tissue, (2) testing of perineal sensation and the anocutaneous reflex; and (3) digital palpation and maneuvers to assess anorectal function. With the patient in the left lateral position, and hips flexed to 90°, the anus and surrounding tissue were inspected in good light to check for skin excoriation, skin tags, anal fissure, scars, or hemorrhoids. The perineal sensation then will be assessed by stroking the skin around the anus in a centripetal fashion in all 4 quadrants by using a stick with a cotton bud. A normal response consisted of a brisk contraction of the perianal skin, the anoderm, and the external anal sphincter. This reflex response is termed the anocutaneous reflex. If there is no response with the soft cotton bud, the opposite (wooden) end will be used to provide a more intense sensation. If a response will be evoked with the wooden end but not with the cotton bud end, the response will be categorized as impaired anocutaneous reflex, and if there is no response with either end, the response will be categorized as absent. Next, digital palpation will be performed by slowly advancing a lubricated and gloved index finger into the rectum. The presence of any tenderness, mass, stricture, or stool, and the consistency of the stool, were noted. The resting sphincter tone will be assessed and categorized as either normal, weak (decreased), or increased. The patient then will be asked to squeeze and to hold the squeeze for as long as possible. The squeeze anal tone will be categorized as normal, weak (decreased), or increased. Next, the examiner placed the left hand over the patient's abdomen to assess the push effort. The patient then will be asked to push and bear down as if to defecate. The push effort, the ability to relax the anal sphincter, and the degree of perineal descent will be noted. Each maneuver will be repeated once or twice to ensure that the patient fully understood and complied with the request, and that the responses will be consistent. A normal response consisted of contraction of abdominal muscles along with relaxation of the external anal sphincter and puborectalis muscle and perineal descent. The presence of any 2 of the following findings will be used to clinically diagnose dyssynergia: the inability to contract the abdominal muscles, inability to relax the anal sphincter, a paradoxical contraction of the anal sphincter, or the absence of perineal descent. The EMG Biofeedback will be performed by using rectal probe and using previously described methodology. Descriptive statistics: In this study, the descriptive statistics (the mean and the standard deviation) and frequency/percentage for categorical data will be calculated for all subjects in the study to determine the homogeneity of the groups. Frequency/percentage for categorical data. Analytical statistics: Data will be analyzed using SPSS. Normality will be assessed using the Shapiro-Wilk test. Baseline comparisons between groups will be performed using independent t-tests or Mann-Whitney U tests as appropriate. A two-way repeated measures ANOVA will be used to evaluate the effects of time (pre- and post-intervention), group (control vs. study), and their interaction on primary and secondary outcomes. For non-normally distributed data, Wilcoxon signed-rank and Mann-Whitney U tests will be applied. A p-value ≤ 0.05 will be considered statistically significant.

Conditions

Dyssenergic Defecation Straining, Hard Stools, Incomplete Evacuation

Interventions

Lifestyle management in form of stretching positions and patient's education position of defecationOTHER

1. Stretching Positions: \*Child's Pose\*\* Reverse Kegel Exercises \*\*\*Supine Piriformis Stretch. 2. Education Defecation Position: patient sit with her knees positioned higher than hips, use a small footstool. Lean forward from the hips and rest your forearms on thighs. 3. Rectal Massage: Using a water-based lubricant and a clean, gloved finger, therapist can gently massage the internal anal sphincter to encourage it to relax. 4. Anal Dilators: patient lie on her side or back with pillows under knees. Apply a generous amount of water-based lubricant to both the dilator and anal area. Ask patient to gently bear down as if passing gas and insert the tip. Pause if she feel the muscle contract or guard, ask her to focus on breathing, and wait for the muscle to soften before inserting it further.Once fully inserted, ask her to breathe in deeply to distend her belly, then exhale while maintaining abdominal distention. Visualize the pelvic floor dropping.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients aged between 35-65 years, their BMI 30-34 kg/m2, they are suffering from DD, have ability to perform BFB, and cooperative and capable of providing informed consent. namely two or more of 6 symptoms present for the last 3 months with an onset more than 6 months in the past; the symptoms are: straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction/blockage, or manual manoeuvres to facilitate defecation, or less than 3 bowel movements per week. All the included patients will have selected to be unresponsive to dietary modification, life style modification, and laxatives for a period of at least 3 months. Exclusion Criteria: * Significant anatomical issues such as a large rectocele, full rectal prolapse, active anal fissures, severe internal anal sphincter injuries, or anorectal neoplasia, history of recent anal region surgery (e.g., within the last 6 months), history of previous gastrointestinal, spinal, or pelvic surgery, neurological diseases that affect bowel function, such as multiple sclerosis, stroke, spinal cord injury, or Parkinson's disease, severe cardiac, renal, or chronic obstructive pulmonary disease (COPD), inflammatory bowel disease (Crohn's disease or ulcerative colitis), diabetes mellitus, or thyroid dysfunction. Use of opioids within a specified recent period (e.g., the previous 2 weeks or not on a stable dose). Use of medications known to cause constipation or interfere with the study, such as certain antidepressants or analgesics. Recent history (e.g., within 6 months) of Botox injections for pelvic floor issues. Pregnancy, Impaired cognition or mental health issues (e.g., severe depression, psychotic disorders, cognitive disability) that would prevent understanding and cooperation with the treatment. Alternating patterns of constipation and diarrhea, which may indicate Irritable Bowel Syndrome (IBS) without a clear constipation subtype.

Locations (1)

Ahram Canadian University

Giza, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

1- Resting anal pressure. 2-Maximum straining anal pressure during an attempted defecation (bearing down).

These variables will be done by using the EMG Biofeedback device: (Gymna Myo 200). This is the primary test to assess the pressure activity and coordination of the rectal and anal muscles. A small, flexible probe will be inserted into the rectum. The test will measure rectal pressure and anal sphincter pressure changes, using Millimeters of mercury (mmHg). In DD, it typically shows inadequate pushing force, paradoxical anal sphincter contraction, or insufficient relaxation.

Time frame: The measurements will be taken at baseline and after 6 weeks of intervention

Secondary Outcomes

1-Bristol scale: to assess the consistency of the stool. 2- Functional obstructed defecation severity, Modified obstructed defecation score (MODS). 3- Digital rectal examination (DRE). 4- Body Mass Index (BMI).

1. Bristol scale: a medical tool that classifies stool into 7 categories based strictly on shape and consistency, consistency by dividing stool forms into three primary types, \*Constipation (Types 1-2),\*\*Ideal/Normal (Types 3-5),\*\*\*Diarrhea (Types 6-7). 2. (MODS):is a sum of individual scores for 7 symptoms and one score for life style alteration. 1. The Renzi (Modified) ODS Score, The 5 Core Items Measured:Each item is typically graded on a 5-point Likert scale from (0) (Never) to (4) (Always). 2. The Longo ODS Score. 3. (DRE): This evaluation consisted of 3 steps: inspection of the anus and surrounding tissue, (2) testing of perineal sensation and the anocutaneous reflex; and (3) digital palpation and maneuvers to assess anorectal function. 4. Weight and Height will be combined to report BMI in kg/m\^2

Time frame: The scale / questionnaire will be taken at baseline and after 6 weeks of intervention.

Data from ClinicalTrials.gov

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