Overactive BladderNCT06662565
Effect of Pelvic Floor Down-training on Women With Idiopathic Overactive Bladder
A study testing Behavioral modification and Pelvic floor down-training in people with Overactive Bladder, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of pelvic floor down-training on women with idiopathic overactive bladder Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Behavioral modification and Pelvic floor down-training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Oct 2024to 15 Mar 2025
- 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 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Multiparous woman with idiopathic OAB (2-3 times) who diagnosed by physician and confirmed by the urodynamic study.
- Woman with high rectal resting tone measured by pressure biofeedback.
- Woman diagnosed with constipation according to the Rome IV criteria and Bristol score.
- Ages ranging from 30 to 45 years.
- BMI from 25-29.9 Kg/m2
Who cannot join
- Women will be excluded from the study if they have:
- Severe OAB as measured by the overactive bladder symptom score for severity
- Postmenopausal women (a point in time 12 months after a woman's last period.)
- Any abnormalities around the bladder, such as bladder cancer, bladder calculus, interstitial cystitis, or endometriosis.
- Untreated urinary tract infections.
- Psychological or mental health problems.
Show all 9Show fewer
- Pregnancy and lactation
- A history of previous pelvic surgery.
- Are receiving any pharmacological treatment at the time of the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to investigate the effect of pelvic floor down-training on women with idiopathic overactive bladder
Read the detailed description
The relationship between overactive bladder (OAB), constipation, and overactive pelvic floor muscles is complex and interrelated. OAB increases the likelihood of overactive pelvic floor muscles, and conversely, hyperactive pelvic floor muscles can exacerbate OAB symptoms. Non-relaxing pelvic floor dysfunction often presents with urinary symptoms, including increased frequency, hesitancy, urgency, dysuria, bladder pain, and occasionally urge incontinence Pelvic floor down-training exercises targeting the rectum provide a safe, conservative way to manage constipation, which may in turn help relieve OAB. Unlike medications or surgery; these exercises are generally safe and easy to incorporate into daily life. However, more studies are needed to evaluate their effectiveness, especially for treating idiopathic OAB in women. Filling this research gap will provide clearer clinical guidance on managing the interplay between OAB, constipation, and pelvic floor hyperactivity. So this study will be the first to investigate the effect of pelvic floor down-training on symptoms of idiopathic OAB in women.
- Conditions
- Overactive Bladder
- Being tested
- Behavioral modification, Pelvic floor down-training
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral modificationBehavioural
It includes:
.- Reducing or eliminating smoking and carbonated drinks.
- Weight loss in overweight or obese individuals.
- Caffeine Reduction: Limiting caffeine intake, especially for those consuming at least 400 mg per day.
- Consume Adequate Water: 6 to 8 glasses of water per day.
- Refrain from consuming fluids 2 to 3 hours before bedtime.
- Identify Bladder Irritants: such as sugar substitutes, citrus fruits, and tomato.
- Increasing fiber intake like fruits, and vegetables to reduce constipation with adequate hydration to make stools softer and easier to pass
Pelvic floor down-trainingOther
Pelvic floor down training exercises aimed at promoting relaxation and deconditioning of the pelvic floor muscles (PFM). It will be practiced three sessions per week for 8 weeks.
Biofeedback-Assisted pelvic floor down-training:
Procedure:
- Rectal biofeedback will be inserted.
- The therapist asks the woman to focus on consciously relaxing and releasing the PFM after each contraction or exercise while watching biofeedback screen.
- Then, breathe deeply and fully into her abdomen, allowing her pelvic floor to naturally relax and lengthen.
- And to incorporate relaxation techniques such as visualization, or progressive muscle relaxation to promote overall muscle relaxation and reduce PFM tension.
- Exercises are typically repeated around 10-20 times per session. This number can vary depending on the patient's condition and tolerance, as well as the therapist's assessment and treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral modification group | Active comparator | They will be treated with behavioral modification for 8 weeks. Receives: Behavioral: Behavioral modification |
| Pelvic floor down training and behavioral modification group | Experimental | They will be treated with the same behavioral modification plus pelvic floor down training three times per week for 24 sessions for 8 weeks. Receives: Behavioral: Behavioral modification; Other: Pelvic floor down-training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectal resting pressure
Biofeedback with intra-rectal probe (Myo200 manometer produced by Gymna. Bilzen. Belgium) will be used to measure rectal resting pressure before and after treatment for all women in both groups. Resting pressure is a good reflection of internal anal sphincter tone. The high resting pressure measures indicate pelvic floor hypertonicity which can indicate the presence of constipation.
Measured: 8 weeks
Rectal bearing pressure
Biofeedback with intra-rectal probe (Myo200 manometer produced by Gymna. Bilzen. Belgium) will be used to measure rectal pressure during the bear-down maneuver before and after treatment for all women in both groups. the high pressure is an indicative of obstructed defecation.
Measured: 8 weeks
Overactive Bladder Symptom Score (OABSS):
It will be used for assessing the severity of bladder symptoms before and after treatment for all women in both groups. The OABSS is validated, correlates well with other measures, and has high reliability. it measures the severity of overactive bladder symptoms like daytime frequency, nocturia, urgency, and urge incontinence. After the patient finishes the questionnaire, it will be collected for scoring, with each symptom scored separately and a total score calculated. The general score will be classified into three severity categories based on the total score: mild (0-5), moderate (6-11), and severe (12-20).
Measured: 8 weeks
Assessment of overactive bladder symptoms
The Overactive Bladder Assessment Tool (OAB-BAT) evaluates bladder symptoms before and after treatment for all women in both groups. The OAB-BAT demonstrates strong construct validity and high reliability. It assesses frequency, urgency, and incontinence. It consists of 5 questions ranging from 0 to 5 for each. the higher scores indicating more severe symptoms.
Measured: 8 weeks
Assessment of quality of life
The Overactive Bladder Assessment Tool (OAB-BAT) evaluates the quality of life of women with overactive bladder before and after treatment in both groups. The OAB-BAT demonstrates strong construct validity and high reliability. It consists of 6 questions ranging from 0 to 5 for each. the higher scores indicate poor quality of life.
Measured: 8 weeks
Constipation scoring system
It is a questionnaire designed to evaluate the severity of constipation and has the advantage of not requiring digital rectal examination. It is valid and reliable and has a score ranging from 0 (minimum) and 30 (maximum), the higher the score, the more the severity of constipation symptoms.
Measured: 8 weeks
Five-item score for obstructed defecation syndrome (ODS-S)
The questionnaire consists of 5 items: excessive straining, incomplete rectal evacuation, use of enemas and/or laxatives, vaginal-anal-perineal digitations, and abdominal discomfort and/or pain. Each item was graded from 0 to 5 with a score ranging from 0 (no symptoms) to 20 (very severe symptoms).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start31 Oct 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayatullah Farouk Abdelfattah Ahmed, Cairo University
- Investigators
- Amira N. Abdel Latif, PHD, Study director, Cairo UniversityDoaa A. Osman, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662565
- Sponsor's protocol ID
- P.T.REC/012/005319
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2024
- Last updated
- 29 Oct 2024
- 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 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic Floor Down-training on Women With Idiopathic Overactive Bladder
- ClinicalTrials.gov ID
- NCT06662565
- Acronym / sponsor ID
- P.T.REC/012/005319
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 31 Oct 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 29 Oct 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.
This study will be conducted to investigate the effect of pelvic floor down-training on women with idiopathic overactive bladder
Detailed description
The relationship between overactive bladder (OAB), constipation, and overactive pelvic floor muscles is complex and interrelated. OAB increases the likelihood of overactive pelvic floor muscles, and conversely, hyperactive pelvic floor muscles can exacerbate OAB symptoms. Non-relaxing pelvic floor dysfunction often presents with urinary symptoms, including increased frequency, hesitancy, urgency, dysuria, bladder pain, and occasionally urge incontinence Pelvic floor down-training exercises targeting the rectum provide a safe, conservative way to manage constipation, which may in turn help relieve OAB. Unlike medications or surgery; these exercises are generally safe and easy to incorporate into daily life. However, more studies are needed to evaluate their effectiveness, especially for treating idiopathic OAB in women. Filling this research gap will provide clearer clinical guidance on managing the interplay between OAB, constipation, and pelvic floor hyperactivity. So this study will be the first to investigate the effect of pelvic floor down-training on symptoms of idiopathic OAB in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral modification group | Active comparator | Behavioral: Behavioral modificationThey will be treated with behavioral modification for 8 weeks. |
| Pelvic floor down training and behavioral modification group | Experimental | Behavioral: Behavioral modification, Other: Pelvic floor down-trainingThey will be treated with the same behavioral modification plus pelvic floor down training three times per week for 24 sessions for 8 weeks. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Multiparous woman with idiopathic OAB (2-3 times) who diagnosed by physician and confirmed by the urodynamic study.
- Woman with high rectal resting tone measured by pressure biofeedback.
- Woman diagnosed with constipation according to the Rome IV criteria and Bristol score.
- Ages ranging from 30 to 45 years.
- BMI from 25-29.9 Kg/m2
Key exclusion criteria (9 listed)
- Severe OAB as measured by the overactive bladder symptom score for severity
- Postmenopausal women (a point in time 12 months after a woman's last period.)
- Any abnormalities around the bladder, such as bladder cancer, bladder calculus, interstitial cystitis, or endometriosis.
- Untreated urinary tract infections.
- Psychological or mental health problems.
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 |
|---|---|---|
| Behavioral modificationIt includes: .- Reducing or eliminating smoking and carbonated drinks. * Weight loss in overweight or obese individuals. * Caffeine Reduction: Limiting caffeine intake, especially for those consuming at least 400 mg per day. * Consume Adequate Water: 6 to 8 glasses of water per day. * Refrain from consuming fluids 2 to 3 hours before bedtime. * Identify Bladder Irritants: such as sugar substitutes, citrus fruits, and tomato. * Increasing fiber intake like fruits, and vegetables to reduce constipation with adequate hydration to make stools softer and easier to pass | Behavioural | Behavioral modification group, Pelvic floor down training and behavioral modification group |
| Pelvic floor down-trainingPelvic floor down training exercises aimed at promoting relaxation and deconditioning of the pelvic floor muscles (PFM). It will be practiced three sessions per week for 8 weeks. Biofeedback-Assisted pelvic floor down-training: Procedure: * Rectal biofeedback will be inserted. * The therapist asks the woman to focus on consciously relaxing and releasing the PFM after each contraction or exercise while watching biofeedback screen. * Then, breathe deeply and fully into her abdomen, allowing her pelvic floor to naturally relax and lengthen. * And to incorporate relaxation techniques such as visualization, or progressive muscle relaxation to promote overall muscle relaxation and reduce PFM tension. * Exercises are typically repeated around 10-20 times per session. This number can vary depending on the patient's condition and tolerance, as well as the therapist's assessment and treatment plan. | Other | Pelvic floor down training and behavioral modification group |
Primary outcome
Rectal resting pressure
Time frame: 8 weeks
Biofeedback with intra-rectal probe (Myo200 manometer produced by Gymna. Bilzen. Belgium) will be used to measure rectal resting pressure before and after treatment for all women in both groups. Resting pressure is a good reflection of internal anal sphincter tone. The high resting pressure measures indicate pelvic floor hypertonicity which can indicate the presence of constipation.
Rectal bearing pressure
Time frame: 8 weeks
Biofeedback with intra-rectal probe (Myo200 manometer produced by Gymna. Bilzen. Belgium) will be used to measure rectal pressure during the bear-down maneuver before and after treatment for all women in both groups. the high pressure is an indicative of obstructed defecation.
Overactive Bladder Symptom Score (OABSS):
Time frame: 8 weeks
It will be used for assessing the severity of bladder symptoms before and after treatment for all women in both groups. The OABSS is validated, correlates well with other measures, and has high reliability. it measures the severity of overactive bladder symptoms like daytime frequency, nocturia, urgency, and urge incontinence. After the patient finishes the questionnaire, it will be collected for scoring, with each symptom scored separately and a total score calculated. The general score will be classified into three severity categories based on the total score: mild (0-5), moderate (6-11), and severe (12-20).
Assessment of overactive bladder symptoms
Time frame: 8 weeks
The Overactive Bladder Assessment Tool (OAB-BAT) evaluates bladder symptoms before and after treatment for all women in both groups. The OAB-BAT demonstrates strong construct validity and high reliability. It assesses frequency, urgency, and incontinence. It consists of 5 questions ranging from 0 to 5 for each. the higher scores indicating more severe symptoms.
Assessment of quality of life
Time frame: 8 weeks
The Overactive Bladder Assessment Tool (OAB-BAT) evaluates the quality of life of women with overactive bladder before and after treatment in both groups. The OAB-BAT demonstrates strong construct validity and high reliability. It consists of 6 questions ranging from 0 to 5 for each. the higher scores indicate poor quality of life.
Constipation scoring system
Time frame: 8 weeks
It is a questionnaire designed to evaluate the severity of constipation and has the advantage of not requiring digital rectal examination. It is valid and reliable and has a score ranging from 0 (minimum) and 30 (maximum), the higher the score, the more the severity of constipation symptoms.
Five-item score for obstructed defecation syndrome (ODS-S)
Time frame: 8 weeks
The questionnaire consists of 5 items: excessive straining, incomplete rectal evacuation, use of enemas and/or laxatives, vaginal-anal-perineal digitations, and abdominal discomfort and/or pain. Each item was graded from 0 to 5 with a score ranging from 0 (no symptoms) to 20 (very severe symptoms).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 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.
Amira N. Abdel Latif, PHD study director
Cairo University
Doaa A. Osman, 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 Behavioral modification and Pelvic floor down-training in people with Overactive Bladder, 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: status not confirmed, as of the sponsor's last update on 29 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayatullah F. Abdel Fattah, Master (+201114310845, Aya.farouk121@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rectal resting pressure (time frame: 8 weeks). The study lists 7 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 29 Oct 2024.