Effect of Diaphragmatic Training on Urgency Urinary Incontinence in Postmenopausal Women

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

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • OM El Masreen General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selctive 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.	Drug: anti muscarinic drugs; a selective anti muscarinic drugs (5-10mg) once per day for 12 weeks.; Other: Instructions including bladder training; The program teaches women skills and strategies to prevent incontinence, including bladder irritants like caffeine and discussing bowel habits to prevent constipation. It also teaches them how to respond adaptively to urgency, such as pause, sit down, relax, and contract pelvic muscles to diminish urgency and prevent urine loss. Once urgency subsides, they can proceed to the toilet at a normal pace. The program emphasizes the importance of educating patients about bladder irritants and bowel habits.
Experimental: Pelvic floor and abdominal strengthening; 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.	Drug: anti muscarinic drugs; a selective anti muscarinic drugs (5-10mg) once per day for 12 weeks.; Other: Instructions including bladder training; The program teaches women skills and strategies to prevent incontinence, including bladder irritants like caffeine and discussing bowel habits to prevent constipation. It also teaches them how to respond adaptively to urgency, such as pause, sit down, relax, and contract pelvic muscles to diminish urgency and prevent urine loss. Once urgency subsides, they can proceed to the toilet at a normal pace. The program emphasizes the importance of educating patients about bladder irritants and bowel habits.; Other: pelvic floor muscle training (PFMT); The training program teaches bladder control through contracting the striated skeletal pelvic floor muscles (PFM). The women are instructed to empty their bladder, lie in a lithotomy position, and tighten their pelvic floor muscles. The duration of contraction and repetitions is gradually increased, totaling 20-30 minutes. The program is 3 sessions per week under supervision for 12 weeks, and each woman is instructed to perform exercises at home until they can do 300 contractions per day.; Other: abdominal exercise; Women will engage in transverse abdominis exercises, focusing on drawing the lower abdominal wall towards the spine and pressing the lumbar region downward, repeated for 15 minutes per session, three times per week.
Experimental: 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.	Drug: anti muscarinic drugs; a selective anti muscarinic drugs (5-10mg) once per day for 12 weeks.; Other: Instructions including bladder training; The program teaches women skills and strategies to prevent incontinence, including bladder irritants like caffeine and discussing bowel habits to prevent constipation. It also teaches them how to respond adaptively to urgency, such as pause, sit down, relax, and contract pelvic muscles to diminish urgency and prevent urine loss. Once urgency subsides, they can proceed to the toilet at a normal pace. The program emphasizes the importance of educating patients about bladder irritants and bowel habits.; Other: Diaphragmatic Training; The therapist will instruct each woman to lie on her back with knees bent, place one hand on her upper chest and the other on her belly. They will breathe in slowly, tighten abdominal muscles, and exhale through pursed lips. Expiration should be relaxed and lightly controlled, and not forceful. Expiration should not be prolonged, and the woman should not initiate inspiration with accessory muscles or upper chest. The session will be repeated 3-4 times, lasting 5-10 minutes, and repeated three times per week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessing the change in Urodynamics (first desire to void)	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.	up to 12 weeks
assessing the change in Urodynamics (first sensation of bladder filling)	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.	up to 12 weeks
assessing the change in Urodynamics (maximum bladder capacity)	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.	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessing the change in weight and height	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.	up to 12 weeks
assessing the change in bladder ascending movement	Transvaginal ultrasound assessment of bladder and urethra was conducted in the midsagittal plane, determining posterior urethro vesical angle.	up to 12 weeks
assessing the change in Urinary function	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.	up to 12 weeks
assessing the change in body mass index	The study utilized a weight-height scale to measure to calculate BMI before and after treatment.	up to 12 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Urge; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Antagonists; Muscarinic Antagonists; Cholinergic Agents
• Other Study ID Numbers: sandy PHD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No