Effect of Pelvic Floor Down-training on Women With Idiopathic Overactive Bladder

NCT ID: NCT06662565

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-03-15

Brief Summary

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavioral modification group

They will be treated with behavioral modification for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Behavioral modification

Intervention Type: BEHAVIORAL

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 training and behavioral modification group

They will be treated with the same behavioral modification plus pelvic floor down training three times per week for 24 sessions for 8 weeks.

Group Type: EXPERIMENTAL

Behavioral modification

Intervention Type: BEHAVIORAL

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-training

Intervention Type: OTHER

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.

Interventions

Behavioral modification

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

Intervention Type: BEHAVIORAL

Pelvic floor down-training

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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.
• Pregnancy and lactation
• A history of previous pelvic surgery.
• Are receiving any pharmacological treatment at the time of the study.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ayatullah Farouk Abdelfattah Ahmed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amira N. Abdel Latif, PHD

Role: STUDY_DIRECTOR

Cairo University

Doaa A. Osman, professor

Role: STUDY_CHAIR

Cairo University

Locations

Ayatullah Farouk Abdel Fattah

Cairo, , Egypt

Countries

Egypt

Central Contacts

Ayatullah F. Abdel Fattah, Master

Role: CONTACT

Aya.farouk121@gmail.com

+201114310845

Samer S. Mahmoud, PHD

Role: CONTACT

Samermorsy1@gmail.com

+201000908851

Other Identifiers

P.T.REC/012/005319

Identifier Type: -

Identifier Source: org_study_id