Preoperative Pelvic Floor Muscle Training in Female Urinary Incontinence

Condition(s) studied

Investigational drug(s) / intervention(s)

Intensive Pelvic Floor Exercise Program: Intensive pelvic floor exercise program targeting the fast (tap) and slow twitch fibers (elevator) of the pelvic floor. The tap exercise will be performed by instructing the patient to quickly contract and release the pelvic floor muscles. For the elevator exercise, the patient will be asked to contract the pelvic floor muscles for 5 seconds and hold them for 5 seconds and then slowly relax them within 5 seconds. Patients will do the exercises as a home program. The exercise program will last for 6 weeks. One set of exercise will be counted as 10 taps and 10 elevator. In the first week, patients will be asked to do 5 sets of exercises per day and the number of sets will be increased by five for 6 weeks.

Study summary

Pelvic floor muscles (PFM) play a crucial role in supporting pelvic organs and maintaining continence. Weakness in these muscles can lead to dysfunctions such as pelvic organ prolapse, urinary incontinence (UI), and sexual or anorectal disorders. UI, defined as the involuntary loss of urine, is common globally and classified as stress, urge, or mixed incontinence. Stress urinary incontinence (SUI) - the most prevalent type among women - occurs during activities that increase intra-abdominal pressure. Risk factors include female sex, aging, obesity, smoking, chronic constipation, previous gynecological surgeries, and childbirth. Treatment options for SUI include conservative and surgical methods. Pelvic floor training (PFT), first described by Arnold Kegel in 1948, is a conservative approach that strengthens PFM and alleviates symptoms. Although surgery is often used for SUI, with over 200 procedures described, this study aims to evaluate the preoperative effectiveness of intensive PFT in women with SUI. It will assess changes in muscle function and symptoms before surgery, guiding pelvic rehabilitation strategies to potentially reduce surgical burden and improve outcomes.

Eligibility

Primary outcome measure(s)

• Change in Symptoms — Before treatment, after treatment (end of 6 weeks)
  The severity of the symptoms of the patients will be evaluated with the Global Pelvic Floor Disorder Questionnaire measures the symptoms of stress urinary incontinence, urge urinary incontinence, frequent and sudden urination, difficulty urinating, pelvic organ prolapse, fecal incontinence, dyspareunia and obstructive defecation due to pelvic floor dysfunction and the discomfort felt from these symptoms. The scale consists of a total of 9 questions. The subjects were rated as "yes" or "no" (0) according to whether they had the complaint or not, and if they answered yes, they were rated as "not at all" (1), "very little" (2), "a little" (3), "quite a bit" (4), "a lot" (5). Each question was given a score between 1 and 5. The scoring system gives the same weight to each question. The total score is between 0 and 45. In order to score between 0 and 100, the average of the total score was taken and multiplied by 20. A high score indicates that the complaint is severe.
• Change in Pelvic Floor Muscle Function — Before treatment, after treatment (end of 6 weeks)
  Change in pelvic floor muscle function of the patients will be evaluated with Modified Oxford grading system, a method frequently used in the clinic, will be used to evaluate pelvic floor muscle strength. While the patient is in the lithotomy position, two fingers will be placed in the vagina by an experienced physiotherapist. During this time, the patient will be asked to squeeze the muscles around the vagina as hard as she can. Contraction degree According to the Modified Oxford Scale, 0: No contraction, 1: Minimal contraction (able to hold the fingers for less than 1 second), 2: Weak contraction (no elevation of the fingers and able to hold for 1-3 seconds), 3: Moderate contraction (fingers are elevated to the posterior vaginal wall, can hold for 4-6 seconds), 4: Good contraction (Therapist's fingers are elevated to the posterior vaginal wall).
• Change in Pelvic Floor Muscle Contraction — Before treatment, after treatment (end of 6 weeks)
  Pelvic floor muscle strength and endurance will be assessed using vaginal perineometry (Peritron™; Cardio-Design, Australia). The patient will lie on her back with hips and knees flexed and feet on the bed. She will be instructed not to hold her breath, not to contract abdominal, hip, or leg muscles, not to strain outward, take a deep breath, or move her pelvis during contraction. After confirming proper technique, the perineometer sensor will be inserted vaginally. The patient will be asked to contract and sustain the contraction of her pelvic floor muscles as long as possible, then relax without bearing down. Resting pressure, peak contraction pressure, and contraction duration (in seconds) will be recorded. Each measurement will be repeated three times, and average values will be used for analysis.
• Change in Incontinence Severity — Before treatment, after treatment (end of 6 weeks)
  The incontinence severity assessment of the participants was made with the Incontinence Severity Index. Scale consists of two sub-items. These are determined as 'How often do you leak urine?', 'How much urine do you leak each time?' The score is obtained by multiplying the numbers of the questions in both items. The score will be determined by grouping them as 1-2 mild, 3-6 moderate, 8-9 severe, and 12 very severe.
• Change in Pelvic Floor Health Knowledge — Before treatment, after treatment (end of 6 weeks)
  Pelvic Floor Health Knowledge Test was developed in Turkish and its reliability and validity have been demonstrated. Pelvic Floor Health Knowledge Test is given as "No" and "I don't know". Each correct answer is given "1" point, while incorrectly answered or unknown items are given "0" points, and as the score increases, it is an indication that the level of knowledge is high.

Trial sites (1)

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