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

January 10, 2024 updated by: Nuriye BUYUKTAS, Izmir Bakircay University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Nilüfer
      • Bursa, Nilüfer, Turkey, 16130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Constipation Severity
Time Frame: Before treatment, end of the second week, end of the fourth week
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life due to Constipation
Time Frame: Before treatment, end of the second week, end of the fourth week
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
Time Frame: Before treatment, end of the second week, end of the fourth week
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
Time Frame: Before treatment and end of the fourth week
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
Time Frame: Before treatment, end of the second week, end of the fourth week
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The impact of Dyssynergic Defecation on other pelvic floor disorders
Time Frame: Before treatment, end of the second week, end of the fourth week
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Bakircay University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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