Effect of Diaphragmatic Training on Urgency Urinary Incontinence in Postmenopausal Women

NCT06521008 | Completed DMC

• 1 other identifier: sandy PHD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urge Incontinence; Urinary Incontinence; Postmenopausal Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• assessing the change in weight and height

  up to 12 weeks

• assessing the change in bladder ascending movement

  up to 12 weeks

• assessing the change in Urinary function

  up to 12 weeks

• assessing the change in body mass index

  up to 12 weeks

Study Arms (3)

Selctive drugs

EXPERIMENTAL

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; Other: Instructions including bladder training

Pelvic floor and abdominal strengthening

EXPERIMENTAL

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; Other: Instructions including bladder training; Other: pelvic floor muscle training (PFMT); Other: abdominal exercise

diaphragmatic training

EXPERIMENTAL

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; Other: Instructions including bladder training; Other: Diaphragmatic Training

Interventions

anti muscarinic drugs DRUG

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

Pelvic floor and abdominal strengthening; Selctive drugs; diaphragmatic training

Instructions including bladder training 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; Selctive drugs; diaphragmatic training

pelvic floor muscle training (PFMT) 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.

Pelvic floor and abdominal strengthening

abdominal exercise 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.

Pelvic floor and abdominal strengthening

Diaphragmatic Training 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.

diaphragmatic training

Eligibility Criteria

• Age: 55 Years - 65 Years
• Gender Eligibility Details: Postmenopausal women suffer from Urgency urinary incontinence
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

OM El Masreen General Hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; 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

Study Design

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

Model Details: single blinded randomized controlled trial

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 25, 2024
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

EG (1)