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

NCT06662565 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005319
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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).

  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.

  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.

  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.

  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).

  8 weeks

Study Arms (2)

Behavioral modification group

ACTIVE COMPARATOR

They will be treated with behavioral modification for 8 weeks.

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.

Behavioral: Behavioral modification; Other: Pelvic floor down-training

Interventions

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

Behavioral modification group; Pelvic floor down training and behavioral modification group

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.

Pelvic floor down training and behavioral modification group

Eligibility Criteria

• Age: 30 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ayatullah Farouk Abdel Fattah

Cairo, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Amira N. Abdel Latif, PHD

  Cairo University

  STUDY DIRECTOR

• Doaa A. Osman, professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Ayatullah F. Abdel Fattah, Master

CONTACT

+201114310845; Aya.farouk121@gmail.com

Samer S. Mahmoud, PHD

CONTACT

+201000908851; Samermorsy1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: October 29, 2024
• Study Start: October 31, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 15, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

EG (1)