An interventional study of Kegel Exercises guidebook in Stress Urinary Incontinence, sponsored by Indonesia University. Status unknown at 1 site in Indonesia. Open to female participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
This research aims to evaluate a Kegel Exercises guidebook to treat stress urinary incontinence (SUI) in female patients. The Kegel Exercises guidebook had been made and evaluated before, this was a clinical trial to test out the book in clinical settings. In measuring the effectiveness of the book, the investigators used some examinations and questionnaires such as UDI-6, IIQ-7, perineometer, and 1-hour pad test improvement. Investigators followed up the patient's symptoms subjectively with UDI-6 and IIQ-7 and objectively with a perineometer and 1-hour pad test every four weeks.
This research aims to evaluate the Kegel Exercises guidebook in treating stress urinary incontinence in female patients. The guidebook had been produced through rigorous previous research with many evaluations from many clinicians, urogynecologists, and patients. The editing and evaluation process took some time and before long the guidebook was ready to be tested in the clinical setting.
The Investigators enrolled 85 patients in the intervention group and 85 patients in the control group after population sampling calculation. The patients in the intervention group were supervised by the Kegel guidebook however, the patients in the control group were supervised without the Kegel guidebook. The patients in the intervention group were enrolled from Cipto Mangunkusumo Hospital and YPK Mandiri Hospital. For the control group, the investigators enrolled the patients from Buah Hati Hospital and Fatmawati Hospital. Investigators enrolled the patients from different hospitals to mask the book as the intervention to the patients.
The Kegel regiment the Investigators taught were the same. The exercises consisted of two types of movements that contracted the fast-twitch muscle and the slow-twitch muscle. The Investigators recommended doing the fast repetitions ten times a session and the slow repetitions ten times a session. The patients needed to do three sessions for a day, and every day for a week.
To examine the improvement of the symptoms, the investigators used many parameters such as UDI-6 and IIQ-7 questionnaire, a perineometer, and a 1-hour pad test. The investigators evaluate the parameters before the therapy and followed them every four weeks up until 12 weeks of follow-up. The investigators also count how many kegel exercises they did in four weeks, by checking on their Kegel exercises book or by recalling method in control group
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 170 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
We gave the patient the Kegel Exercises guidebook for them to study, follow, and keep track of their exercise. The Kegel Exercises regiment was 10 each slow and fast-twitch muscle contraction for a session. Three sessions a day needed to be done every day for 12 weeks.
Device: Kegel Exercises guidebook
We did not give the Kegel Exercises guidebook for the patients We taught the same Kegel Exercises regiment that was 10 each slow and fast-twitch muscle contraction for a session. Three sessions a day and needed to be done every day for 12 weeks
The Kegel exercises book is consisted of basic explanation about stress urinary incontinence and Kegel exercises, how to do Kegel exercises, table for them to write how many session they did in a day, and lastly their report progress (UDI-6, IIQ-7, periineometer, and 1-hour pad test) that we updated every four weeks
Compliance
We expect that the patients did a total of 1000 contractions slow and fast twitch muscle. Patients that did less than 1000 contractions a month are classified as non-comply. On the other hand patients who had done 1000 or more contractions were classified as comply
Time frame: up to 12 weeks
Treatment Success
Decrease of symptoms based on UDI-6
Time frame: up to 12 weeks
Treatment Success
Decrease of symptoms based on IIQ-7
Time frame: up to 12 weeks
Treatment Success
Decrease of symptoms based on 1-hour pad test
Time frame: up to 12 weeks
Improvement of Pelvic floor muscle strength
measuring the pelvic floor muscle tone at rest and maximum squeeze (min 0) and a higher score means higher muscle tone produced
Time frame: up to 12 weeks
Plan to share: No
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Indonesia University