An interventional study of Reverse Kegel exercise and Postisometric Relaxation Technique in Constipation - Functional, Pelvic Floor Disorders and Pelvic Floor Dyssynergia, sponsored by Izmir Bakircay University. Not yet recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by Izmir Bakircay University · Not applicable, Interventional, and Treatment
Among 30 studies in Pelvic Floor Disorders with a site in Turkey — 5 open to participants now, 6 under way, 1 of them phase 3. Pelvic Floor Disorders · Turkey.
Among the 30 studies in Pelvic Floor Disorders with a site in Turkey, this one is the 9th largest by planned enrollment of the 21 interventional ones, is one of 6 that started in 2024, is one of 20 with no phase, and was the 16th registered.
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
This study's planned enrollment of 42 is below the median of 63 across 148 interventional studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →5 of the 30 studies in Pelvic Floor Disorders with a site in Turkey are open now, in 1 country. Each count lists the studies.
Of the 27 Pelvic Floor Disorders studies recruiting now, 17 (63%) set no upper age limit and 10 (37%) stop at 75 or younger; 0 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 55 Years · female · no healthy volunteers.
The full table on the hub →30 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 6 started in 2024.
Median enrollment 40 across the 21 interventional studies, 94 across the 9 observational. Of the 20 that completed or were terminated, 0 (0%) have results posted.
None of the 30 has an industry lead sponsor. The 10 most frequent:
Izmir Bakircay University is the lead sponsor of 75 studies on the registry; 18 are open to participants now.
Izmir Bakircay University has 1 study filed under Pelvic Floor Disorders — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 30 studies in Pelvic Floor Disorders with a site in Turkey, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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 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.
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.
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.
Time frame: Before treatment, end of the second week, end of the fourth week
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before treatment, end of the second week, end of the fourth week
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.
Time frame: Before treatment, end of the second week, end of the fourth week
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2024; primary completion for Oct 2024, 9 months later.
Of 101 non-industry interventional studies with no phase under Pelvic Floor Disorders, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 9 months is below that.
Counting every sponsor, half of 107 studies reached it within 16 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Izmir Bakircay University