The Effects of Postisometric Relaxation Technique in Female Patients With Dyssynergic Defecation

Investigation of the Effects of Postisometric Relaxation Technique Applied to Pelvic Floor Muscles on Constipation Severity, Quality of Life, Anal Pain, Muscle Function and Sexual Function in Female Patients With Dyssynergic Defecation

Functional bowel diseases are defined as chronic disorders of the gastrointestinal tract characterized by abdominal pain, bloating, tension and/or defecation abnormalities. Functional bowel diseases are studied under five headings: functional constipation, functional diarrhea, functional abdominal bloating / tightness and unclassifiable functional bowel disorders. Functional constipation is divided into three categories as normal transition-time constipation, slow transition-time constipation and defecation disorders. Defecation disorders occur due to improper use of pelvic floor muscles and anorectal muscles or anatomical abnormalities and account for 1/3 of all constipation. Defecation disorders characterized by excessive straining, incomplete defecation sensation, difficult and painful defecation are defined as narrowing of the fecal exit path due to involuntary pelvic floor contractions or posterior compartment pelvic organ prolapse. Non-pharmacological treatment in the treatment of functional constipation is considered as the first-line treatment and includes information about the nutrition, fiber-liquid consumption, physical activity and toilet training of patients. Biofeedback therapy is often recommended in patients with defecation disorders in the literature, and there are studies showing that it is superior to laxative use and placebo applications in the studies conducted. However, the fact that it is difficult and costly to achieve Biofeedback treatment, the method used allows movement at a certain angle and does not include the stretching method seems to be a disadvantage. Postisometric Relaxation technique is used in cases of pain, muscle spasm and movement limitations. People with defecation disorders experience spasms, pain and movement limitations in the pelvic floor muscles. For this reason, the investigators think that the Postisometric Relaxation technique may be effective in patients with defecation disorders, and it will also provide advantages due to the fact that the method is easily accessible, does not require extra materials and devices, and has a stretching effect. The aim of this study is to investigate the effect of Postisometric Relaxation technique on constipation severity, quality of life, anal pain, muscle function and sexual function in patients with defecation disorder.

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvic Floor Disorders; Constipation - Functional; Pelvic Floor Dyssynergia
• Intervention / Treatment: Other: Reverse Kegel exercise; Other: Postisometric Relaxation Technique

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Nilüfer
    • Bursa, Nilüfer, Turkey, 16130
      • Nuriye Büyüktaş
      • Contact: Nuriye Büyüktaş, MsC; Phone Number: +905339663055; Email: nuriyeozhan@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being the ages between 18-55
• Being a women
• Having been diagnosed with dyssynergic defecation by a physician
• Not using Laxatives

Exclusion Criteria:

• Having undergone anal region surgery in the last 6 months
• Having had Botox in the last 6 months
• Being in the menopause period
• Having been diagnosed with cancer
• Having a mental problem • Having previously received pelvic floor physiotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 'Reverse Kegel' exercise group; In addition to the training given by the physician, patients will be taught the 'Reverse Kegel' exercise. The 'Reverse Kegel' exercise is an exercise that is used to relax the pelvic floor muscles. To practice the exercise, patients will be asked to lie in a supine position with a support under the knees. In this position, patients will be asked to relax the pelvic floor muscles while breathing through their nose, maintain this movement for 5 seconds, and tighten the pelvic floor muscles while exhaling. Patients will be advised to do this exercise for 5 sets, 10 repetitions during the day. On the day of the training, initial evaluations will be made to the patients before the exercise training is given. Evaluations will be repeated at the end of the second and fourth week.	Other: Reverse Kegel exercise; In addition to the training given by the physician, patients will be taught the 'Reverse Kegel' exercise. The 'Reverse Kegel' exercise is an exercise that is used to relax the pelvic floor muscles. To practice the exercise, patients will be asked to lie in a supine position with a support under the knees. In this position, patients will be asked to relax the pelvic floor muscles while breathing through their nose, maintain this movement for 5 seconds, and tighten the pelvic floor muscles while exhaling. Patients will be advised to do this exercise for 5 sets, 10 repetitions during the day. On the day of the training, initial evaluations will be made to the patients before the exercise training is given. Evaluations will be repeated at the end of the second and fourth week.
Experimental: 'Postisometric Relaxation Technique' group; In addition to training given by the physican, internal digital Postisometric Relaxation method will be applied to the patients in this group from the anal region. Application will be made to the muscles where muscle spasm, movement restriction and pain are detected. The patient will be asked to perform a contraction against the digital resistance with maximum force and maintain this contraction for 5 seconds, actively relax after 5 seconds. During relaxation, stretching will be applied for 30 seconds by digitally supporting the movement of the pelvic floor muscles. The process will be performed with 5 repetitions. The application will be made 2 days a week for 4 weeks. On the day of the training, initial evaluations will be made to the patients before the exercise training is given.Evaluations will be repeated at the end of the second and fourth week.	Other: Postisometric Relaxation Technique; In addition to training given by the physican, internal digital Postisometric Relaxation method will be applied to the patients in this group from the anal region. Application will be made to the muscles where muscle spasm, movement restriction and pain are detected. The patient will be asked to perform a contraction against the digital resistance with maximum force and maintain this contraction for 5 seconds, actively relax after 5 seconds. During relaxation, stretching will be applied for 30 seconds by digitally supporting the movement of the pelvic floor muscles. The process will be performed with 5 repetitions. The application will be made 2 days a week for 4 weeks. On the day of the training, initial evaluations will be made to the patients before the exercise training is given.Evaluations will be repeated at the end of the second and fourth week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constipation Severity	The Constipation Severity Scale will be used. It contains a total of 16 questions and is scored between 0-73. High scores indicate that the severity of constipation is excessive.	Before treatment, end of the second week, end of the fourth week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life due to Constipation	The Constipation Quality of life Scale will be used. It contains a total of 28 questions and is scored between 28-140. The high scores obtained from the scale indicate that the quality of life is poor.	Before treatment, end of the second week, end of the fourth week
Anal Pain	The Visual Analog Scale will be used. In this scale, numbered from 0 to 10, 0 refers to the absence of any pain; 10 refers to the most severe pain.	Before treatment, end of the second week, end of the fourth week
Sexual Function	The Female Sexual Function Index will be used. The scale contains a total of 19 questions to evaluate sexual functions in the last 4 weeks and is scored between 0-95. High scores obtained from the scale indicate that sexual function is negatively affected.	Before treatment and end of the fourth week
Function of the pelvic floor muscles	Measurement will be made with a electromyography device (NeuroTrac® MyoPlus Pro). Superficial anal prob will be used. The prob will be inserted rectally to measure the activity of the pelvic floor muscles during contraction and resting. Participants will be asked to contract and relax the pelvic floor muscles for 5 repetitions. The average amount of 5 contraction and relaxation of the measurement will be recorded in micro volts. High resting scores indicate that the pelvic floor muscle can not adequatly relax.	Before treatment, end of the second week, end of the fourth week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The impact of Dyssynergic Defecation on other pelvic floor disorders	The Pelvic Floor Impact Questionnaire will be used. It consists of 21 questions and is scored between 0-300. A high score indicates that the degree of complaint of pelvic floor dysfunction is high.	Before treatment, end of the second week, end of the fourth week

Collaborators and Investigators

• Sponsor: Izmir Bakircay University

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: functional constipation; dyssynergic defecation; pelvic floor physiotherapy; pelvic health; postisometric relaxation technique
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms, Digestive; Dyskinesias; Pregnancy Complications; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Constipation; Ataxia; Pelvic Floor Disorders
• Other Study ID Numbers: Nuriye Büyüktaş

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No