Effect of Different Pelvic Floor Loading Techniques on Women With Stress Urinary Incontinence

The purpose of this study is to compare the effects of different pelvic floor loading techniques (graduated positions versus graduated weights) on women with stress urinary incontinence.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Other: Graduated loading positions; Other: Graduated Vaginal Weights (Vaginal Cones)

Detailed Description

Stress incontinence results from an inability of the urethra to provide adequate resistance to the flow of urine with increased abdominal pressures. From a pathophysiologic perspective, stress incontinence may result from a lack of mechanical urethral support, resulting in urethral hypermobility and/or poor coaptation of the urethral tissues. Normally, forces that occur during the Valsalva maneuver are transmitted to the proximal urethra, resulting in compression of the urethra against the anterior vaginal wall; this process is disrupted in the setting of stress incontinence with urethral hypermobility.

The pelvic floor muscles (PFMs), including the levator ani muscle (LAMs), coccygeus, perineal muscles, striated urethral sphincter (SUS), and external anal sphincter, form the base of the abdomino-pelvic cavity and contribute to the support of the pelvic contents and continence control. The LAMs are considered a functional unit that provides support to the pelvic organs in the transverse plane (lifting) and compresses the urethra against the anterior vagina in the mid-sagittal plane (squeezing). Damage to or dysfunction of the LAMs is thought to be a contributor to stress urinary incontinence (SUI).

PFM-training, the most commonly used physical therapy treatment for women with SUI, is effective and therefore recommended as a first-line therapy.

According to traditional recommendations for PFM training programs, it is important to consider a gradual progression in the difficulty of the exercises, starting with less demanding positions (supine, standing, or side plank) and progressing to more complex challenges (quadruped hold, plank, and squat).

Vaginal Weights may be an effective training aid for women with mild to moderate stress incontinence, particularly in the absence of severe pelvic organ prolapse. They also may be useful for pelvic floor strengthening during the immediate postpartum period, as a behavioral program for continence maintenance, and for self-management programs.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba Al-Bahrawy, Master; Phone Number: 01003717687; Email: hebabahrwy@gmail.com
• Study Contact Backup: Name: Doaa Osman, As professor; Phone Number: 01115792245; Email: Doaa.osman@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Heba Allah Abdel salam Al-Bahrawy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All women are suffering from Stress urinary incontinence.
• Their age will range from 30-40 years.
• Their body mass index will range from 25-30 kg/m2.
• They are multiparous women (2-3 times).

Exclusion Criteria:

• Patient with denervated pelvic floor muscle, urinary tract infection, severe prolapse of pelvic organs, fibroid uterus, or intrauterine devices.
• Renal disease, pulmonary illness, chronic cough, and constipation.
• Underwent surgery for stress urinary incontinence.
• Other types of urinary incontinence (e.g., urge incontinence and mixed incontinence).
• Diabetic patients.
• Patient with anatomic changes (ectopic ureter, genito-urinary fistula)
• Patient with knee or back symptoms (Osteoarthritis or lumbar disc).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pelvic floor exercises with graduated loading positions group; The participants will perform pelvic floor exercises with graduated loading positions, 3 sessions per week, for 12 weeks.	Other: Graduated loading positions; The participants will be instructed to perform and repeat each exercise 10 times to build core muscle strength. They will then maintain the position comfortably for 1-5 minutes without engaging the pelvic floor muscles. Afterward, they will begin pelvic floor muscle exercises from each position, including quick flicks, slow contractions, and sustained contractions. The maintenance time will be gradually increased. Each position will be performed under both stable and unstable conditions: (i) Stable side-lying position, with lateral support of the body on the floor (ii) Unstable side-lying position, side plank. (iii) Stable quadruped, with support of the knees on the floor. (iv) Unstable quadruped, off-knees quadruped hold. (v) Stable standing, with support of the back against the wall. (vi) Unstable standing, without support. (vii) Stable squat, or wall squat with back supported against the wall. (viii) Unstable squat, parallel squat
Experimental: Pelvic floor exercises with graduated vaginal weights group; The participants will perform pelvic floor exercises with graduated vaginal weights, 3 sessions per week, for 12 weeks.	Other: Graduated Vaginal Weights (Vaginal Cones); The participants will perform pelvic floor exercises using graduated vaginal weights (cones). The vaginal cone is inserted into the vagina, and pelvic muscle contractions are used to hold it in place during a standing position. The procedure will begin with the lightest cone (white), in a position preferred by each patient. After inserting the vaginal cone, the pelvic muscles will contract for around 2 seconds to hold the cone in place. Initially, contractions of a few seconds will be repeated 10 times, with rest periods of 5-10 seconds between each contraction. As the patient progresses, the contraction duration will gradually increase. To determine when to move to the next cone with a heavier weight, the following exercises will be performed: walking for at least one minute, going up and down the stairs, jumping on the spot for at least thirty seconds, coughing 10 to 15 times, and washing hands under cold water for one minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pelvic floor muscle strength	The Kegel perineometer will be used to assess pelvic floor muscle strength. It provides an indirect measure of strength generated via a change in pressure within a balloon connected to a pressure sensor. A vaginal probe designed to detect pressure changes is inserted within the vaginal canal, as first developed by Kegel. This pressure change reflects muscular force, as the largest change from resting pressure to peak pressure recorded during the contraction. it can also measure the endurance by recording repeated and sustained contractions, which reflect the overall muscular capability of both slow and fast-twitch fiber activity. The Perineometer is considered a highly reproducible and reliable tool, showing the pressure (in millimeters of mercury) as a measure of PFM strength. Vaginal squeeze pressure that is normally around 40 to 60 mmHg.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of urethral angle (α)	Ultrasonography is a reliable, non-invasive, and comfortable method that provides dynamic evaluation in the examination of urethral mobility. Transperineal ultrasonography has also been introduced to evaluate the mobility of the bladder neck and proximal urethra by measuring the urethral angle, the angle between the proximal urethra axis and the long axis of the symphysis pubis (α angle) during rest comfortably filled bladder. Patients will be asked to fully strain by verbally directing to push and cough, and the maximum Valsalva image will be obtained with the help of cine-loop function, and the new angle will be measured. The differences of angles at rest and strain (rotation angles) will be recorded as the urethral angle (α).	3 months
Assessment of stress urinary incontinence Severity	Urinary Incontinence Severity Index will be used to assess stress urinary incontinence severity. It is a valid questionnaire consisting of two questions that determine an overall score by multiplying the frequency of urinary incontinence and the quantity of urine leakage. The severity will be categorized as mild (1-2), moderate (3-6), severe (8-9), and extremely severe (12).	3 months
Assessment of stress urinary incontinence Impact on Quality of Life	International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) will be used to assess quality of life(QoL). This is a simple and brief self-administered questionnaire consisting of six questions. The first two questions address demographic variables, while the next four questions focus on the frequency, amount of leakage, and overall impact on QOL. Additionally, a non-scored item assesses the type of incontinence. Scoring will range from 0 to 21, with higher scores indicating increased severity	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: khadyga Abdul Aziz, Professor, Cairo University; Study Director: Hossam Kamel, Professor, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: P.T.REC/012/006107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No