Stress Urinary IncontinenceNCT07661264
Effect of Different Pelvic Floor Loading Techniques on Women With Stress Urinary Incontinence
A study testing Graduated loading positions and Graduated Vaginal Weights (Vaginal Cones) in people with Stress Urinary Incontinence, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Graduated loading positions and Graduated Vaginal Weights (Vaginal Cones)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Graduated loading positions, Graduated Vaginal Weights (Vaginal Cones)
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graduated loading positionsOther
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Graduated Vaginal Weights (Vaginal Cones) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startJun 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Allah Abd-El-Salam Al-Bahrawy, Cairo University
- Investigators
- Hossam Kamel, Professor, Study director, Al-Azhar Universitykhadyga Abdul Aziz, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661264
- Sponsor's protocol ID
- P.T.REC/012/006107
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Pelvic Floor Loading Techniques on Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07661264
- Acronym / sponsor ID
- P.T.REC/012/006107
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor exercises with graduated loading positions group | Experimental | Other: Graduated loading positionsThe participants will perform pelvic floor exercises with graduated loading positions, 3 sessions per week, for 12 weeks. |
| Pelvic floor exercises with graduated vaginal weights group | Experimental | Device: Graduated Vaginal Weights (Vaginal Cones)The participants will perform pelvic floor exercises with graduated vaginal weights, 3 sessions per week, for 12 weeks. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graduated loading positionsThe 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 | Other | Pelvic floor exercises with graduated loading positions group |
| 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. | Device | Pelvic floor exercises with graduated vaginal weights group |
Primary outcome
Assessment of pelvic floor muscle strength
Time frame: 3 months
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 secondary outcomes
Measurement of urethral angle (α)
Time frame: 3 months
Assessment of stress urinary incontinence Severity
Time frame: 3 months
Assessment of stress urinary incontinence Impact on Quality of Life
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hossam Kamel, Professor study director
Al-Azhar University
khadyga Abdul Aziz, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graduated loading positions and Graduated Vaginal Weights (Vaginal Cones) in people with Stress Urinary Incontinence, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heba Al-Bahrawy, Master (01003717687, hebabahrwy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pelvic floor muscle strength (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.