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

Sponsor

Indonesia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05304312

Collaborator

(none)

170

Enrollment

Location

Arms

27.3

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: Kegel Exercises guidebook	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Participant)

Masking Description:

Participants that received the book (intervention) is followed up with different days and different hospitals with patients that were not receiving any book (control)

Primary Purpose:

Treatment

Official Title:

The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women by Increasing the Adherence

Actual Study Start Date :

Sep 21, 2020

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Women with Kegel Exercises book 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 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
No Intervention: Women without Kegel Exercises book 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

Arm

Intervention/Treatment

Experimental: Women with Kegel Exercises book

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

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

No Intervention: Women without Kegel Exercises book

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

Outcome Measures

Primary Outcome Measures

Compliance [up to 12 weeks]
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
Treatment Success [up to 12 weeks]
Decrease of symptoms based on UDI-6
Treatment Success [up to 12 weeks]
Decrease of symptoms based on IIQ-7
Treatment Success [up to 12 weeks]
Decrease of symptoms based on 1-hour pad test

Secondary Outcome Measures

Improvement of Pelvic floor muscle strength [up to 12 weeks]
measuring the pelvic floor muscle tone at rest and maximum squeeze (min 0) and a higher score means higher muscle tone produced

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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