Effect of Diaphragmatic Training on Urgency Urinary Incontinence in Postmenopausal Women

NCT ID: NCT06521008

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-06-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Urge Incontinence Urinary Incontinence Postmenopausal Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single blinded randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

anti muscarinic drugs

Intervention Type DRUG

a selective anti muscarinic drugs (5-10mg) once per day for 12 weeks.

Instructions including bladder training

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

anti muscarinic drugs

Intervention Type DRUG

a selective anti muscarinic drugs (5-10mg) once per day for 12 weeks.

Instructions including bladder training

Intervention Type OTHER

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.

pelvic floor muscle training (PFMT)

Intervention Type OTHER

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.

abdominal exercise

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

anti muscarinic drugs

Intervention Type DRUG

a selective anti muscarinic drugs (5-10mg) once per day for 12 weeks.

Instructions including bladder training

Intervention Type OTHER

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.

Diaphragmatic Training

Intervention Type OTHER

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.

Interventions

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anti muscarinic drugs

a selective anti muscarinic drugs (5-10mg) once per day for 12 weeks.

Intervention Type DRUG

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sandy Samir Hassan Darweesh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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OM El Masreen General Hospital

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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sandy PHD

Identifier Type: -

Identifier Source: org_study_id

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