Effect of Diaphragmatic Training on Urgency Urinary Incontinence in Postmenopausal Women

Not Applicable

Completed

• Conditions: Urge Incontinence; Urinary Incontinence; Postmenopausal Disorder
• Interventions: Drug: anti muscarinic drugs; Other: Instructions including bladder training; Other: pelvic floor muscle training (PFMT); Other: Diaphragmatic Training; Other: abdominal exercise

• Registration Number: NCT06521008
• Lead Sponsor: Cairo University

Brief Summary

The purpose of this study was to determine the effect of diaphragmatic training on urgency urinary incontinence in postmenopausal women.

Detailed Description

Urgency urinary incontinence affects 9-13% of women, increasing with age and impacting daily activities, quality of life, depression, and social isolation. It is a significant source of dependency among the elderly and a factor in nursing home admissions. Untreated incontinence can lead to falls, infections, and loss of independence. Conservative management is the first-line therapy, but pelvic floor muscle training is a potential treatment method. This study aims to evaluate the effectiveness of diaphragmatic training on urinary incontinence in postmenopausal women.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2023-12-01
• Study Completion: 2024-06-01
• Study First Submitted: 2024-06-30
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Postmenopausal women suffer from UUI.
• They will be multipara more than 1.
• Their age will range from 55-65 years old.
• Their body mass index (BMI) will range from 25-29.9 kg/m2..
• They will experience menopause at least for 3 years.

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Exclusion Criteria

• Urinary tract infection
• Previous surgery for urinary incontinence
• Upper motor neuron diseases
• History of genito-urinary cancer
• Previous pelvic irradiation
• Pure stress urinary incontinence
• Genital prolapse
• Diabetes mellitus
• Pace maker

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic floor and abdominal strengthening	anti muscarinic drugs	consists of 20 women. They will receive the same treatment in group (A), pelvic floor muscle training (PFMT) and abdominal strengthening 3 sessions/week for 12 weeks.
Pelvic floor and abdominal strengthening	pelvic floor muscle training (PFMT)	consists of 20 women. They will receive the same treatment in group (A), pelvic floor muscle training (PFMT) and abdominal strengthening 3 sessions/week for 12 weeks.
diaphragmatic training	anti muscarinic drugs	consists of 20 women. They will receive the same treatment in group (B), in addition to diaphragmatic training 3 sessions/week for 12 weeks.
diaphragmatic training	Instructions including bladder training	consists of 20 women. They will receive the same treatment in group (B), in addition to diaphragmatic training 3 sessions/week for 12 weeks.
Pelvic floor and abdominal strengthening	Instructions including bladder training	consists of 20 women. They will receive the same treatment in group (A), pelvic floor muscle training (PFMT) and abdominal strengthening 3 sessions/week for 12 weeks.
Selctive drugs	Instructions including bladder training	consists of 20 women. They will receive selective anti Muscarinic drugs (5-10 mg) once per day for 12 weeks and instructions including bladder retraining.
diaphragmatic training	Diaphragmatic Training	consists of 20 women. They will receive the same treatment in group (B), in addition to diaphragmatic training 3 sessions/week for 12 weeks.
Selctive drugs	anti muscarinic drugs	consists of 20 women. They will receive selective anti Muscarinic drugs (5-10 mg) once per day for 12 weeks and instructions including bladder retraining.
Pelvic floor and abdominal strengthening	abdominal exercise	consists of 20 women. They will receive the same treatment in group (A), pelvic floor muscle training (PFMT) and abdominal strengthening 3 sessions/week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
assessing the change in Urodynamics (first desire to void)	up to 12 weeks	The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of volume at first desire to void, for each woman in all groups. The urodynamic method is a reliable and mandatory method for diagnosing and treating UUI symptoms, as relying solely on urinary symptoms may lead to under-diagnosis of detrusor overactivity.
assessing the change in Urodynamics (first sensation of bladder filling)	up to 12 weeks	The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of first sensation of bladder filling, for each woman in all groups.
assessing the change in Urodynamics (maximum bladder capacity)	up to 12 weeks	The study used a double-lumen cytometry catheter to diagnose involuntary detrusor contractions in women. The catheter measured the change in urodynamics in form of maximum bladder capacity, for each woman in all groups.

Secondary Outcome Measures

Name	Time	Method
assessing the change in weight and height	up to 12 weeks	The study utilized a weight-height scale to measure weight and height for women in all groups (A, B \& C) and to calculate BMI before and after treatment.
assessing the change in bladder ascending movement	up to 12 weeks	Transvaginal ultrasound assessment of bladder and urethra was conducted in the midsagittal plane, determining posterior urethro vesical angle.
assessing the change in Urinary function	up to 12 weeks	The study uses a self-administered questionnaire to assess urinary function in women in different groups (A, B, and C) at the start and end of the study course. The questionnaire consists of 21 items, each with its own Likert rating scale structure. Each woman is instructed and given appropriate time to answer.
assessing the change in body mass index	up to 12 weeks	The study utilized a weight-height scale to measure to calculate BMI before and after treatment.

Trial Locations

Locations (1)

OM El Masreen General Hospital; 🇪🇬 Giza, Egypt