Clinical trial NCT05304312: The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women
Official title: The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women by Increasing the Adherence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Kegel Exercises
Compliance
Stress Urinary Incontinence
Pelvic Floor Muscle Traning
IIQ-7
UDI-6
Adherence
Perineometry
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 170
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups in which one group will be given a Kegel Exercises guidebook and another group or control will not be given the book. Both groups were equally followed-up for 3 months and examined by UDI-6, IIQ-7, Perineometer, and 1-hour pad test.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Women with Stress Urinary Incontinence
* Good cognitive function (based on Moca-Ina questionnaire \> 26)
* Able to do Kegel Exercises without restrictions
* Signed the informed consent form

Exclusion Criteria:

* Patient that had incontinence surgery before or other incontinence therapy other than Kegel exercises
* Mix urinary incontinence
* abnormal uterine bleeding
* Pelvic organ prolapse \>2 stage
* a severe neurological disorder
* active urinary tract infections
* malignancy on pelvic
* Trauma or radiation therapy on pelvic
* Had other risk factors that may influence persistent high abdominal pressure

Primary outcomes:
measure: Compliance
timeFrame: up to 12 weeks
measure: Treatment Success
timeFrame: up to 12 weeks
measure: Treatment Success
timeFrame: up to 12 weeks
measure: Treatment Success
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Improvement of Pelvic floor muscle strength
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: Jakarta
Study officials:
References:
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