Preoperative Pelvic Floor Muscle Training in Female Urinary Incontinence

NCT06957795 | Recruiting

• 1 other identifier: 2025-184
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Women; Urinary Incontinence (UI); Pelvic Floor Muscle Training; Preoperative Period

Outcome Measures

Primary Outcomes (5)

• Change in Symptoms

  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.

  Before treatment, after treatment (end of 6 weeks)

• Change in Pelvic Floor Muscle Function

  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).

  Before treatment, after treatment (end of 6 weeks)

• Change in Pelvic Floor Muscle Contraction

  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.

  Before treatment, after treatment (end of 6 weeks)

• Change in Incontinence Severity

  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.

  Before treatment, after treatment (end of 6 weeks)

• Change in Pelvic Floor Health Knowledge

  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.

  Before treatment, after treatment (end of 6 weeks)

Study Arms (2)

Control group

NO INTERVENTION

The patients in the control group will receive only pelvic floor knowledge and awareness training. Brief training on the functions and anatomy of the pelvic floor muscles and the function of the exercises performed, and will be taught how to contract their pelvic floor muscles. In the 6th week, all patients will be called for a final check-up and all the evaluations re-made.

Exercise group

EXPERIMENTAL

Exercise group first receive brief training on the functions and anatomy of the pelvic floor muscles and the function of the exercises performed, and will be taught how to contract their pelvic floor muscles. In addition to this training, patients in exercise group will be taught pelvic floor exercises targeting the fast (tap) and slow twitch fibers (elevator) of the pelvic floor. The patients will do the exercises as a home program, and they will be called for an interim check-up in the 2nd week to check whether they are doing the exercises correctly and ensure their progress in the program. In the 6th week, all patients will be called for a final check-up and all the evaluations re-made.

Other: Intensive Pelvic Floor Exercise Program

Interventions

Intensive Pelvic Floor Exercise Program OTHER

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.

Exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a woman between the ages of 18-65
• Being diagnosed with SUI or SUI-predominant mixed type urinary incontinence by an obstetrician-gynecologist
• Having active pelvic floor muscle contraction
• No genital anatomical abnormality
• Being able to understand and follow verbal and written instructions
• The patient was referred to physiotherapy at least 6 weeks before the planned surgery date
• Patients performed 75% or more of the given exercises (categorized as adequate compliance)

You may not qualify if:

• Not volunteering to participate
• Being pregnant
• Having had previous pelvic floor surgery
• Having received previous pelvic floor physiotherapy
• Having a vaginal or urinary infection
• Being unable to tolerate pelvic floor muscle function measurement
• Having a neuromuscular or neurological disease that may affect muscle function

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gülhane Education and Research Hospital, Department of Obstetrics and Gynecology

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 5, 2025
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

TU (1)