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

NCT07661264 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006107
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Measurement of urethral angle (α)

  3 months

• Assessment of stress urinary incontinence Severity

  3 months

• Assessment of stress urinary incontinence Impact on Quality of Life

  3 months

Study Arms (2)

Pelvic floor exercises with graduated loading positions group

EXPERIMENTAL

The participants will perform pelvic floor exercises with graduated loading positions, 3 sessions per week, for 12 weeks.

Other: Graduated loading positions

Pelvic floor exercises with graduated vaginal weights group

EXPERIMENTAL

The participants will perform pelvic floor exercises with graduated vaginal weights, 3 sessions per week, for 12 weeks.

Device: Graduated Vaginal Weights (Vaginal Cones)

Interventions

Graduated loading positions OTHER

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

Pelvic floor exercises with graduated loading positions group

Graduated Vaginal Weights (Vaginal Cones) DEVICE

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.

Pelvic floor exercises with graduated vaginal weights group

Eligibility Criteria

• Age: 30 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Heba Allah Abdel salam Al-Bahrawy

Cairo, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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 Officials

• Hossam Kamel, Professor

  Al-Azhar University

  STUDY DIRECTOR

• khadyga Abdul Aziz, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Heba Al-Bahrawy, Master

CONTACT

01003717687; hebabahrwy@gmail.com

Doaa Osman, As professor

CONTACT

01115792245; Doaa.osman@cu.edu.eg

Study Design

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

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

EG (1)