ClinicalTrials.gg
Status unknownNCT06045728Updated Sep 21, 2023

Telerehabilitation for Overactive Bladder Syndrome in Obese Women

An interventional study of Pilates exercises and Mediterranean diet in Overactive Bladder Syndrome, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 35 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
35 Years to 45 Years
Sex
Female
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Study summary

Overactive bladder syndrome(OAB) is a chronic medical condition which has a major influence on the quality of life in a significant amount of the population. The goal of this clinical trial study to identify the effect of telerehabilitation program on overactive bladder symptoms and metabolic health in obese women and to compare between the telerehabilitation group and the control group regarding overactive bladder symptoms and metabolic health in obese women.

Read the detailed description

overactive bladder syndrome occurs globally and affects both genders with studies indicating high prevalence in obese females. Obesity brings with it not only an increased risk of cardiovascular diseases, but also urological dysfunction including overactive bladder. Pilates exercise and diet can be used as ways for controlling overactive bladder symptoms and improving overall health of obese subjects. Integration of telerehabilitation in the clinical practice benefits both providers and patients as well decreasing healthcare costs, so the objective of this study to determine the effect of telerehabilitation on overactive bladder symptoms and metabolic health in obese women through Pilates exercise and Mediterranean diet .

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Conditions studied

  • Overactive Bladder Syndrome
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In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women aged 35-45 years old
  • class I obesity(30-34.9kg/m2)
  • women will be referred by urologist with Presence of overactive bladder symptoms confirmed by overactive bladder questionnaire
  • waist circumference more than 88 cm

Exclusion criteria

Exclusion Criteria:

  • history of surgical treatment of urological disease
  • infection of urinary tract
  • oncological and neurological urinary tract disease,
  • refusal to participate in the study
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    group 1 telerehabilitation group

    subjects in this group will receive telerehabilitation sessions through online video programs (including Pilates exercise and diet) 3 times per week for 12 weeks. Outcome measures will be evaluated at baseline and after 12 weeks

    Other: Pilates exercises · Behavioral: Mediterranean diet

  • Other
    group 2 control group

    subjects in this group will be informed about the importance of Pilates exercise and diet for one session only. subjects will be asked to apply the exercise at home 3 times per week for 12 weeks and diet. Outcome measures will be evaluated at baseline and after 12 weeks

    Other: Pilates exercises · Behavioral: Mediterranean diet

Interventions

  • OtherPilates exercises

    Pilates is a group of low impact muscle exercises that strengthen abdominal muscles, back, hips and pelvic floor muscles. the exercise consists of 10 min warm up, 40 min exercise and 10 min cooling down. the exercises that will be included: spine twist, double leg stretch, double leg circles, side leg circle, curl up, shoulder bridges and pelvic curl.

  • BehavioralMediterranean diet

    it is a type of diet used for obesity management based on high vegetable intake, olive oil as a source of fat, the consumption of grains, legumes, and nuts with high amounts of pulp, low-medium consumption of fish, low consumption of red meat.

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What researchers measure

Primary outcomes

  1. body mass index

    it is calculated by dividing weight in kg on height in m square

    Time frame: at baseline and after 12 weeks of the intervention

  2. waist circumference

    it is an indicator of central obesity with waist circumference more than 88 cm is considered central obesity in females

    Time frame: at baseline and after 12 weeks of the intervention

  3. overactive bladder questionnaire short form

    is a questionnaire that is divided into two sections : symptoms and quality of life. In symptoms section, the higher the scores the more the symptoms that bother the patients. higher scores in quality of life section indicates better quality of life.

    Time frame: at baseline and after 12 weeks of the intervention

  4. patient perception of intensity of urgency scale

    a scale ranges from 0 to 4 that measures the degree of urgency with micturition with higher scores indicate higher perception of urgency

    Time frame: at baseline and after 12 weeks of the intervention

  5. HOMA IR

    The homeostatic model assessment (HOMA IR) is a method used to quantify insulin resistance . derived from the product of the insulin and glucose values divided by a constant.

    Time frame: at baseline and after 12 weeks of the intervention

Secondary outcomes

  1. telehealth usability questionnaire

    a comprehensive questionnaire that covers all usability factors (i.e., usefulness, ease of use, effectiveness, reliability, and satisfaction). It is used with various types of telehealth systems, including the traditional videoconferencing systems, computer-based systems, and the mobile telehealth systems.

    Time frame: after 12 weeks of the intervention

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Study locations

1 of 1 sites recruiting
  • Online Video Programs With Patients Referred From Urologist ( Kasr Eleiny Hospital)
    Giza, Egypt
    Recruiting
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References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2023; primary completion for Dec 2023, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2023
First posted
Sep 21, 2023
StartEst.
Sep 15, 2023
Primary completionEst.
Dec 15, 2023
CompletionEst.
Dec 30, 2023
Last update
Sep 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06045728
Lead sponsor
Cairo University
Responsible party
Salma Ibrahim Abdelmohsen Alghitany (teacher at Faculty of physical therapy Cairo university, Cairo University) — Principal investigator
First posted
Sep 21, 2023
Start date
Sep 15, 2023 (estimated)
Primary completion
Dec 15, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Sep 21, 2023

Study contacts

salma I alghitany, PHD
Contact
fardreams@yahoo.com
01229723881
sandra A girguis, PHD
Contact
sandra_sweety@hotmail.com
0122142663
salma I alghitany, PHD
study director · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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