Urge IncontinenceNCT06521008
Effect of Diaphragmatic Training on Urgency Urinary Incontinence in Postmenopausal Women
A study testing anti muscarinic drugs, Instructions including bladder training and pelvic floor muscle training (PFMT) in people with Urge Incontinence and Urinary Incontinence, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study was to determine the effect of diaphragmatic training on urgency urinary incontinence in postmenopausal women. Read more about this study
- Who is it for?
- Ages 55 to 65 years, women only
- Conditions the study is for
- Urge Incontinence, Urinary Incontinence, Postmenopausal Disorder
- What is being tested?
- anti muscarinic drugs, Instructions including bladder training and pelvic floor muscle training (PFMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women suffer from UUI.
- They will be multipara more than 1.
- Their age will range from 55-65 years old.
- Their body mass index (BMI) will range from 25-29.9 kg/m2..
- They will experience menopause at least for 3 years.
Who cannot join
- Urinary tract infection
- Previous surgery for urinary incontinence
- Upper motor neuron diseases
- History of genito-urinary cancer
- Previous pelvic irradiation
- Pure stress urinary incontinence
Show all 9Show fewer
- Genital prolapse
- Diabetes mellitus
- Pace maker
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to determine the effect of diaphragmatic training on urgency urinary incontinence in postmenopausal women.
Read the detailed description
Urgency urinary incontinence affects 9-13% of women, increasing with age and impacting daily activities, quality of life, depression, and social isolation. It is a significant source of dependency among the elderly and a factor in nursing home admissions. Untreated incontinence can lead to falls, infections, and loss of independence. Conservative management is the first-line therapy, but pelvic floor muscle training is a potential treatment method. This study aims to evaluate the effectiveness of diaphragmatic training on urinary incontinence in postmenopausal women.
- Being tested
- anti muscarinic drugs, Instructions including bladder training, pelvic floor muscle training (PFMT), abdominal exercise, Diaphragmatic Training
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti muscarinic drugsDrug
a selective anti muscarinic drugs (5-10mg) once per day for 12 weeks.
Instructions including bladder trainingOther
The program teaches women skills and strategies to prevent incontinence, including bladder irritants like caffeine and discussing bowel habits to prevent constipation. It also teaches them how to respond adaptively to urgency, such as pause, sit down, relax, and contract pelvic muscles to diminish urgency and prevent urine loss. Once urgency subsides, they can proceed to the toilet at a normal pace. The program emphasizes the importance of educating patients about bladder irritants and bowel habits.
pelvic floor muscle training (PFMT)Other
The training program teaches bladder control through contracting the striated skeletal pelvic floor muscles (PFM). The women are instructed to empty their bladder, lie in a lithotomy position, and tighten their pelvic floor muscles. The duration of contraction and repetitions is gradually increased, totaling 20-30 minutes. The program is 3 sessions per week under supervision for 12 weeks, and each woman is instructed to perform exercises at home until they can do 300 contractions per day.
abdominal exerciseOther
Women will engage in transverse abdominis exercises, focusing on drawing the lower abdominal wall towards the spine and pressing the lumbar region downward, repeated for 15 minutes per session, three times per week.
Diaphragmatic TrainingOther
The therapist will instruct each woman to lie on her back with knees bent, place one hand on her upper chest and the other on her belly. They will breathe in slowly, tighten abdominal muscles, and exhale through pursed lips. Expiration should be relaxed and lightly controlled, and not forceful. Expiration should not be prolonged, and the woman should not initiate inspiration with accessory muscles or upper chest. The session will be repeated 3-4 times, lasting 5-10 minutes, and repeated three times per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Selctive drugs | Experimental | consists of 20 women. They will receive selective anti Muscarinic drugs (5-10 mg) once per day for 12 weeks and instructions including bladder retraining. Receives: Drug: anti muscarinic drugs; Other: Instructions including bladder training |
| Pelvic floor and abdominal strengthening | Experimental | consists of 20 women. They will receive the same treatment in group (A), pelvic floor muscle training (PFMT) and abdominal strengthening 3 sessions/week for 12 weeks. Receives: Drug: anti muscarinic drugs; Other: Instructions including bladder training; Other: pelvic floor muscle training (PFMT); Other: abdominal exercise |
| diaphragmatic training | Experimental | consists of 20 women. They will receive the same treatment in group (B), in addition to diaphragmatic training 3 sessions/week for 12 weeks. Receives: Drug: anti muscarinic drugs; Other: Instructions including bladder training; Other: Diaphragmatic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing the change in Urodynamics (first desire to void)
The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of volume at first desire to void, for each woman in all groups. The urodynamic method is a reliable and mandatory method for diagnosing and treating UUI symptoms, as relying solely on urinary symptoms may lead to under-diagnosis of detrusor overactivity.
Measured: up to 12 weeks
assessing the change in Urodynamics (first sensation of bladder filling)
The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of first sensation of bladder filling, for each woman in all groups.
Measured: up to 12 weeks
assessing the change in Urodynamics (maximum bladder capacity)
The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of maximum bladder capacity, for each woman in all groups.
Measured: up to 12 weeks
Secondary outcomes (4)
assessing the change in weight and height
The study utilized a weight-height scale to measure weight and height for women in all groups (A, B \& C) and to calculate BMI before and after treatment.
Measured: up to 12 weeks
assessing the change in bladder ascending movement
Transvaginal ultrasound assessment of bladder and urethra was conducted in the midsagittal plane, determining posterior urethro vesical angle.
Measured: up to 12 weeks
assessing the change in Urinary function
The study uses a self-administered questionnaire to assess urinary function in women in different groups (A, B, and C) at the start and end of the study course. The questionnaire consists of 21 items, each with its own Likert rating scale structure. Each woman is instructed and given appropriate time to answer.
Measured: up to 12 weeks
assessing the change in body mass index
The study utilized a weight-height scale to measure to calculate BMI before and after treatment.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Jul 2023
- Primary completion1 Dec 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urge 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
- Model description
- single blinded randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandy Samir Hassan Darweesh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521008
- Sponsor's protocol ID
- sandy PHD
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diaphragmatic Training on Urgency Urinary Incontinence in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06521008
- Acronym / sponsor ID
- sandy PHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 25 Jul 2024 (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 was to determine the effect of diaphragmatic training on urgency urinary incontinence in postmenopausal women.
Detailed description
Urgency urinary incontinence affects 9-13% of women, increasing with age and impacting daily activities, quality of life, depression, and social isolation. It is a significant source of dependency among the elderly and a factor in nursing home admissions. Untreated incontinence can lead to falls, infections, and loss of independence. Conservative management is the first-line therapy, but pelvic floor muscle training is a potential treatment method. This study aims to evaluate the effectiveness of diaphragmatic training on urinary incontinence in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- single blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Selctive drugs | Experimental | Drug: anti muscarinic drugs, Other: Instructions including bladder trainingconsists of 20 women. They will receive selective anti Muscarinic drugs (5-10 mg) once per day for 12 weeks and instructions including bladder retraining. |
| Pelvic floor and abdominal strengthening | Experimental | Drug: anti muscarinic drugs, Other: Instructions including bladder training, Other: pelvic floor muscle training (PFMT), Other: abdominal exerciseconsists of 20 women. They will receive the same treatment in group (A), pelvic floor muscle training (PFMT) and abdominal strengthening 3 sessions/week for 12 weeks. |
| diaphragmatic training | Experimental | Drug: anti muscarinic drugs, Other: Instructions including bladder training, Other: Diaphragmatic Trainingconsists of 20 women. They will receive the same treatment in group (B), in addition to diaphragmatic training 3 sessions/week for 12 weeks. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women suffer from UUI.
- They will be multipara more than 1.
- Their age will range from 55-65 years old.
- Their body mass index (BMI) will range from 25-29.9 kg/m2..
- They will experience menopause at least for 3 years.
Key exclusion criteria (9 listed)
- Urinary tract infection
- Previous surgery for urinary incontinence
- Upper motor neuron diseases
- History of genito-urinary cancer
- Previous pelvic irradiation
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 |
|---|---|---|
| anti muscarinic drugsa selective anti muscarinic drugs (5-10mg) once per day for 12 weeks. | Drug | Pelvic floor and abdominal strengthening, Selctive drugs, diaphragmatic training |
| Instructions including bladder trainingThe program teaches women skills and strategies to prevent incontinence, including bladder irritants like caffeine and discussing bowel habits to prevent constipation. It also teaches them how to respond adaptively to urgency, such as pause, sit down, relax, and contract pelvic muscles to diminish urgency and prevent urine loss. Once urgency subsides, they can proceed to the toilet at a normal pace. The program emphasizes the importance of educating patients about bladder irritants and bowel habits. | Other | Pelvic floor and abdominal strengthening, Selctive drugs, diaphragmatic training |
| pelvic floor muscle training (PFMT)The training program teaches bladder control through contracting the striated skeletal pelvic floor muscles (PFM). The women are instructed to empty their bladder, lie in a lithotomy position, and tighten their pelvic floor muscles. The duration of contraction and repetitions is gradually increased, totaling 20-30 minutes. The program is 3 sessions per week under supervision for 12 weeks, and each woman is instructed to perform exercises at home until they can do 300 contractions per day. | Other | Pelvic floor and abdominal strengthening |
| abdominal exerciseWomen will engage in transverse abdominis exercises, focusing on drawing the lower abdominal wall towards the spine and pressing the lumbar region downward, repeated for 15 minutes per session, three times per week. | Other | Pelvic floor and abdominal strengthening |
| Diaphragmatic TrainingThe therapist will instruct each woman to lie on her back with knees bent, place one hand on her upper chest and the other on her belly. They will breathe in slowly, tighten abdominal muscles, and exhale through pursed lips. Expiration should be relaxed and lightly controlled, and not forceful. Expiration should not be prolonged, and the woman should not initiate inspiration with accessory muscles or upper chest. The session will be repeated 3-4 times, lasting 5-10 minutes, and repeated three times per week for 12 weeks. | Other | diaphragmatic training |
Primary outcome
assessing the change in Urodynamics (first desire to void)
Time frame: up to 12 weeks
The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of volume at first desire to void, for each woman in all groups. The urodynamic method is a reliable and mandatory method for diagnosing and treating UUI symptoms, as relying solely on urinary symptoms may lead to under-diagnosis of detrusor overactivity.
assessing the change in Urodynamics (first sensation of bladder filling)
Time frame: up to 12 weeks
The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of first sensation of bladder filling, for each woman in all groups.
assessing the change in Urodynamics (maximum bladder capacity)
Time frame: up to 12 weeks
The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of maximum bladder capacity, for each woman in all groups.
4 secondary outcomes
assessing the change in weight and height
Time frame: up to 12 weeks
assessing the change in bladder ascending movement
Time frame: up to 12 weeks
assessing the change in Urinary function
Time frame: up to 12 weeks
assessing the change in body mass index
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti muscarinic drugs, Instructions including bladder training and pelvic floor muscle training (PFMT) in people with Urge Incontinence and 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 25 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessing the change in Urodynamics (first desire to void) (time frame: up to 12 weeks). The study lists 3 primary outcomes in all. 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 25 Jul 2024.