The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women (ROSEBOOK-SUI)

University of Indonesia (UI)

Status: Unknown

Conditions: Stress Urinary Incontinence

Treatments: Device: Kegel Exercises guidebook

Study type: Interventional

Funder types: Other

Identifiers

NCT05304312

20-09-1140

Details and patient eligibility

About

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.

Full 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

Enrollment: 170 estimated patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Women with Kegel Exercises book

Experimental group

Description:

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.

Treatment:

Device: Kegel Exercises guidebook

Women without Kegel Exercises book

No Intervention group

Description:

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