NocturiaNCT05222477
Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes
A study testing pelvic floor exercise and Abdominal muscles exercise in people with Nocturia and Sleep Deprivation, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Nocturia, Sleep Deprivation
- What is being tested?
- pelvic floor exercise and Abdominal muscles exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pelvic Floor Versus 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.
Read the detailed description
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.
- Conditions
- Nocturia, Sleep Deprivation
- Being tested
- pelvic floor exercise, Abdominal muscles exercise
- Keywords
- nocturia, sleep deprivation, sleep quality, type 2 diabetes mellitus
- Medical subject headings
- Nocturia, Sleep Deprivation, Sleep Initiation and Maintenance Disorders, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor exerciseBehavioural
pelvic floor exercises(intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week
Abdominal muscles exerciseBehavioural
abdominal exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor group | Active comparator | pelvic floor exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week Receives: Behavioral: pelvic floor exercise |
| Abdominal group | Active comparator | Abdominal exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week Receives: Behavioral: Abdominal muscles exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of voids
Number of times that the patient go for toilet per night for urination
Measured: 6 weeks
Sleep quality (0 is best, 3 is worst)
data about sleep from Pittsburgh sleep quality index questionnaire
Measured: 6 weeks
Secondary outcomes (1)
Abdominal and pelvic floor muscle electrical activity
Data described by the electromyograph (EMG)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start15 Nov 2021
- Primary completion15 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Hady Atef Labib, Cairo University
- Investigators
- Hady Atef, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222477
- Sponsor's protocol ID
- NSQ
- Status last verified
- Apr 2023
- First submitted
- 10 Jan 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are planning to share the IPD on publication
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic Floor Versus Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05222477
- Acronym / sponsor ID
- NSQ
- Conditions
- Nocturia, Sleep Deprivation
- Keywords
- nocturia, sleep deprivation, sleep quality, type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor group | Active comparator | Behavioral: pelvic floor exercisepelvic floor exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week |
| Abdominal group | Active comparator | Behavioral: Abdominal muscles exerciseAbdominal exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvic floor exercisepelvic floor exercises(intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week | Behavioural | Pelvic floor group |
| Abdominal muscles exerciseabdominal exercises (intervention) will be applied for patients with nocturia and type 2 DM for 6 weeks, 3 times/week | Behavioural | Abdominal group |
Primary outcome
Number of voids
Time frame: 6 weeks
Number of times that the patient go for toilet per night for urination
Sleep quality (0 is best, 3 is worst)
Time frame: 6 weeks
data about sleep from Pittsburgh sleep quality index questionnaire
1 secondary outcome
Abdominal and pelvic floor muscle electrical activity
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Yes. We are planning to share the IPD on publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hady Atef, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic floor exercise and Abdominal muscles exercise in people with Nocturia and Sleep Deprivation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of voids (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.