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Completed

NCT Number: NCT05222477

Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes

Nocturia is the leading cause of sleep disruption with its subsequent negative impact on general health and QoL for a large proportion of the adult population. Nocturia is prevalent in men and women of all ages but may be particularly bothersome in younger adults, in whom the consequences of sleep disturbance may be more detrimental for daytime functioning and possibly for health and mortality.The underlying causes of nocturia obviously influence the efficacy of different treatment options. Because a major cause of nocturia is overproduction of urine at night, nocturia may not respond to treatments designed to reduce urgency and increase bladder capacity or increase urine flow, such as agents for the management of bladder outlet obstruction.

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Key information

Conditions

Nocturia Diabetes Mellitus Diabetes Mellitus, Type 2 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Lower Urinary Tract Symptoms Mental Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urological Manifestations

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alkasr Alaini hospitals

Cairo, Egypt

About this study

Nocturia may be more than simply a patient inconvenience, in view of its association with increased risk of morbidity and mortality. Clinicians often underestimate the consequences of nocturia, however, and thus fail to perform a thorough evaluation of the condition and its causes. Patients with nocturia deserve full consultation and implementation of an appropriate management strategy to ensure that the specific underlying medical conditions associated with nighttime voiding are addressed. Investigators should help women with nocturia as to improve their sleep. Participants will strengthen their pelvic floor muscles and abdominal muscles to control voiding so their sleep will not disturb to decrease their sufferance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female Patients have had type II diabetes mellitus for more than 5years.
  • HbA1c value from 6.5% to7.5%.
  • Sleep deprivation for more than one month.
  • Medically stable patients
  • Blood glucose level from 130 to 150
  • Patients are not pregnant
  • Body mass index is 25 to 29.9 kg / m

Exclusion criteria

  • Unstable medical condition.
  • On antidepressors or anxiety treatment.
  • With ant musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise.
  • Cushing's disease (hypercortisolism) or Addison's disease (hypocortisolism).

Treatment and study plan

pelvic floor exercise

Behavioral

pelvic floor exercises(intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week

Abdominal muscles exercise

Behavioral

abdominal exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week

Primary outcomes

  1. Number of voids

    Time frame: 6 weeks

    Number of times that the patient go for toilet per night for urination

  2. Sleep quality (0 is best, 3 is worst)

    Time frame: 6 weeks

    data about sleep from Pittsburgh sleep quality index questionnaire

Secondary outcomes

  1. Abdominal and pelvic floor muscle electrical activity

    Time frame: 6 weeks

    Data described by the electromyograph (EMG)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Mansoura University

Registry information

Official study title

Effect of Pelvic Floor Versus Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2022
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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