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NCT Number: NCT06662565

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

This study will be conducted to investigate the effect of pelvic floor down-training on women with idiopathic overactive bladder

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ayatullah Farouk Abdel Fattah

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral modification

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ayatullah F. Abdel Fattah, Master

CONTACT

[email protected]

+201114310845

Samer S. Mahmoud, PHD

CONTACT

[email protected]

+201000908851

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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