search
Back to results

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

Primary Purpose

Stress Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Kegel Exercises guidebook
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Kegel Exercises, Compliance, Stress Urinary Incontinence, Pelvic Floor Muscle Traning, IIQ-7, UDI-6, Adherence, Perineometry

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Cipto Mangunkusumo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Women with Kegel Exercises book

Women without Kegel Exercises book

Arm 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.

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

Outcomes

Primary Outcome Measures

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
Treatment Success
Decrease of symptoms based on UDI-6
Treatment Success
Decrease of symptoms based on IIQ-7
Treatment Success
Decrease of symptoms based on 1-hour pad test

Secondary Outcome Measures

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

Full Information

First Posted
January 26, 2022
Last Updated
March 21, 2022
Sponsor
Indonesia University
search

1. Study Identification

Unique Protocol Identification Number
NCT05304312
Brief Title
The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women
Acronym
ROSEBOOK-SUI
Official Title
The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women by Increasing the Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Kegel Exercises, Compliance, Stress Urinary Incontinence, Pelvic Floor Muscle Traning, IIQ-7, UDI-6, Adherence, Perineometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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)
Allocation
Non-Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women with Kegel Exercises book
Arm Type
Experimental
Arm 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.
Arm Title
Women without Kegel Exercises book
Arm Type
No Intervention
Arm 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
Intervention Type
Device
Intervention Name(s)
Kegel Exercises guidebook
Intervention Description
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
Primary Outcome Measure Information:
Title
Compliance
Description
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
Title
Treatment Success
Description
Decrease of symptoms based on UDI-6
Time Frame
up to 12 weeks
Title
Treatment Success
Description
Decrease of symptoms based on IIQ-7
Time Frame
up to 12 weeks
Title
Treatment Success
Description
Decrease of symptoms based on 1-hour pad test
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Improvement of Pelvic floor muscle strength
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Surahman Hakim, Urogynecologist
Phone
+62 82112643676
Email
omanobg@yahoo.co.id
First Name & Middle Initial & Last Name or Official Title & Degree
Gita Nurul Hidayah, Urogynecologist
Phone
+6281221708758
Email
nh_gita@yahoo.com
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surahman Hakim
Phone
+62 821-1264-3676
Email
surahmantap@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20025020
Citation
Abrams P, Andersson KE, Birder L, Brubaker L, Cardozo L, Chapple C, Cottenden A, Davila W, de Ridder D, Dmochowski R, Drake M, Dubeau C, Fry C, Hanno P, Smith JH, Herschorn S, Hosker G, Kelleher C, Koelbl H, Khoury S, Madoff R, Milsom I, Moore K, Newman D, Nitti V, Norton C, Nygaard I, Payne C, Smith A, Staskin D, Tekgul S, Thuroff J, Tubaro A, Vodusek D, Wein A, Wyndaele JJ; Members of Committees; Fourth International Consultation on Incontinence. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn. 2010;29(1):213-40. doi: 10.1002/nau.20870. No abstract available.
Results Reference
background
PubMed Identifier
1586224
Citation
Rivas Alonso A, Franquet Casas T, Arellano Atienza P, Berdusan Sanchez M. [Wunderlich disease. First manifestation of a renal adenocarcinoma]. Arch Esp Urol. 1992 Jan-Feb;45(1):73-5. Spanish.
Results Reference
background
PubMed Identifier
31167796
Citation
Imamura M, Hudson J, Wallace SA, MacLennan G, Shimonovich M, Omar MI, Javanbakht M, Moloney E, Becker F, Ternent L, Montgomery I, Mackie P, Saraswat L, Monga A, Vale L, Craig D, Brazzelli M. Surgical interventions for women with stress urinary incontinence: systematic review and network meta-analysis of randomised controlled trials. BMJ. 2019 Jun 5;365:l1842. doi: 10.1136/bmj.l1842.
Results Reference
background
PubMed Identifier
15014933
Citation
Bo K. Pelvic floor muscle training is effective in treatment of female stress urinary incontinence, but how does it work? Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):76-84. doi: 10.1007/s00192-004-1125-0. Epub 2004 Jan 24.
Results Reference
background
PubMed Identifier
23431210
Citation
Borello-France D, Burgio KL, Goode PS, Ye W, Weidner AC, Lukacz ES, Jelovsek JE, Bradley CS, Schaffer J, Hsu Y, Kenton K, Spino C; Pelvic Floor Disorders Network. Adherence to behavioral interventions for stress incontinence: rates, barriers, and predictors. Phys Ther. 2013 Jun;93(6):757-73. doi: 10.2522/ptj.20120072. Epub 2013 Feb 21.
Results Reference
background
PubMed Identifier
20179901
Citation
Felicissimo MF, Carneiro MM, Saleme CS, Pinto RZ, da Fonseca AM, da Silva-Filho AL. Intensive supervised versus unsupervised pelvic floor muscle training for the treatment of stress urinary incontinence: a randomized comparative trial. Int Urogynecol J. 2010 Jul;21(7):835-40. doi: 10.1007/s00192-010-1125-1. Epub 2010 Feb 24.
Results Reference
background
PubMed Identifier
27611958
Citation
Asklund I, Nystrom E, Sjostrom M, Umefjord G, Stenlund H, Samuelsson E. Mobile app for treatment of stress urinary incontinence: A randomized controlled trial. Neurourol Urodyn. 2017 Jun;36(5):1369-1376. doi: 10.1002/nau.23116. Epub 2016 Sep 9.
Results Reference
background

Learn more about this trial

The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women

We'll reach out to this number within 24 hrs