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

Not Applicable

Not yet recruiting

• Conditions: Overactive Bladder

• Registration Number: NCT06662565
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-26
• Study First Submitted QC: 2024-10-26
• Last Update Submitted: 2024-10-26
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Study Start: 2024-10-31
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rectal resting pressure	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	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):	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	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	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	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)	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).

Trial Locations

Locations (1)

Ayatullah Farouk Abdel Fattah; 🇪🇬 Cairo, Egypt