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

NCT05304312 | Unknown

• 1 other identifier: 20-09-1140
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

Kegel Exercises; Compliance; Stress Urinary Incontinence; Pelvic Floor Muscle Traning; IIQ-7; UDI-6; Adherence; Perineometry

Outcome Measures

Primary Outcomes (4)

• 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

  up to 12 weeks

• Treatment Success

  Decrease of symptoms based on UDI-6

  up to 12 weeks

• Treatment Success

  Decrease of symptoms based on IIQ-7

  up to 12 weeks

• Treatment Success

  Decrease of symptoms based on 1-hour pad test

  up to 12 weeks

Secondary Outcomes (1)

• Improvement of Pelvic floor muscle strength

  up to 12 weeks

Study Arms (2)

Women with Kegel Exercises book

EXPERIMENTAL

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

Women without Kegel Exercises book

NO INTERVENTION

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

Interventions

Kegel Exercises guidebook DEVICE

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

Women with Kegel Exercises book

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

Related Publications (7)

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  PMID: 20025020 BACKGROUND

• 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.

  PMID: 1586224 BACKGROUND

• 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.

  PMID: 31167796 BACKGROUND

• 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.

  PMID: 15014933 BACKGROUND

• 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.

  PMID: 23431210 BACKGROUND

• 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.

  PMID: 20179901 BACKGROUND

• 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.

  PMID: 27611958 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress; Patient Compliance

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Surahman Hakim, Urogynecologist

CONTACT

+62 82112643676; omanobg@yahoo.co.id

Gita Nurul Hidayah, Urogynecologist

CONTACT

+6281221708758; nh_gita@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants that received the book (intervention) is followed up with different days and different hospitals with patients that were not receiving any book (control)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Urogynecology Department

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 31, 2022
• Study Start: September 21, 2020
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)