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

March 21, 2022 updated by: Surahman Hakim, Indonesia University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Surahman Hakim, Urogynecologist
  • Phone Number: +62 82112643676
  • Email: omanobg@yahoo.co.id

Study Contact Backup

  • Name: Gita Nurul Hidayah, Urogynecologist
  • Phone Number: +6281221708758
  • Email: nh_gita@yahoo.com

Study Locations

  • Indonesia
    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 10430
        • Recruiting
        • Cipto Mangunkusumo hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: 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
up to 12 weeks
Treatment Success
Time Frame: up to 12 weeks
Decrease of symptoms based on UDI-6
up to 12 weeks
Treatment Success
Time Frame: up to 12 weeks
Decrease of symptoms based on IIQ-7
up to 12 weeks
Treatment Success
Time Frame: up to 12 weeks
Decrease of symptoms based on 1-hour pad test
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of Pelvic floor muscle strength
Time Frame: 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
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 21, 2020

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (ACTUAL)

March 31, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-09-1140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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