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

NCT06215924 | Unknown DMC

• 1 other identifier: Nuriye Büyüktaş
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Constipation - Functional; Pelvic Floor Disorders; Pelvic Floor Dyssynergia

Keywords

dyssynergic defecation; functional constipation; pelvic floor physiotherapy; pelvic health; postisometric relaxation technique

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of Life due to Constipation

  Before treatment, end of the second week, end of the fourth week

• Anal Pain

  Before treatment, end of the second week, end of the fourth week

• Sexual Function

  Before treatment and end of the fourth week

• Function of the pelvic floor muscles

  Before treatment, end of the second week, end of the fourth week

Other Outcomes (1)

• The impact of Dyssynergic Defecation on other pelvic floor disorders

  Before treatment, end of the second week, end of the fourth week

Study Arms (2)

'Reverse Kegel' exercise group

ACTIVE COMPARATOR

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

'Postisometric Relaxation Technique' group

EXPERIMENTAL

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

Interventions

Reverse Kegel exercise OTHER

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.

'Reverse Kegel' exercise group

Postisometric Relaxation Technique OTHER

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.

'Postisometric Relaxation Technique' group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Female aged between 18-55, female with dyssynergic defecation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Nuriye Büyüktaş

Bursa, Nilüfer, 16130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 22, 2024
• Study Start: January 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: December 31, 2024
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

TU (1)