Comparison of Two Different Pelvic Floor Muscle Training Programs in Stress Urinary Incontinence

NCT05293886 | Completed

• 1 other identifier: KA-21107
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Pelvic floor muscle training (PFMT) is indicated as a first-line treatment for stress urinary incontinence. PFMT aims to improve pelvic floor muscle strength, endurance and relaxation ability or a combination of these. PFMT is a structured and customized exercise program. Pelvic floor muscles work in synchronization with many muscles and pelvic floor muscle function is supported by synergistic muscles. Relationships between the functions of pelvic floor muscles and synergistic muscle groups have been reported in the literature. However, studies comparing the efficacy of PFMT and combined training of these muscles are limited and more studies are needed. Therefore the aim of this study is to compare the effects of isolated PFMT and functional PFMT in women with stress urinary incontinence.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Change in Symptom Severity and Impact of Incontinence on Life by International Urinary Incontinence Consultation Questionnaire Short Form

  International Urinary Incontinence Consultation Questionnaire Short Form will be used to evaluate the change in symptom severity and impact of incontinence on life. Score ranges are 1-5 (slight), 6- 2 (moderate), 13-18 (severe) and 19-21 (very severe). Lower scores mean a better outcome for this questionnaire form.

  Change in International Urinary Incontinence Consultation Questionnaire Short Form score from baseline to end of 8th week

Secondary Outcomes (4)

• Incontinence Severity by 1-hour pad test

  Change in incontinence severity from baseline to end of 8th week.

• The Impact of Incontinence on Quality of Life by King Health Questionnaire

  Change in King Health Questionnaire score from baseline to end of 8th week.

• Participant's Perception of Symptom Severity by Patient Global Impression of Severity Scale

  Change in Patient Global Impression of Severity Scale score from baseline to end of 8th week.

• Participant's Perception of Recovery by Patient Global Impression of Change Scale

  Change in Patient Global Impression of Change Scale score from baseline to end of 8th week.

Study Arms (2)

Classical Pelvic Floor Muscle Training

ACTIVE COMPARATOR

In the first 2 weeks of classical pelvic floor muscle training, individuals will perform 3 sets of 10 maximal voluntary pelvic floor muscle contraction exercises and 20 submaximal voluntary pelvic floor muscle contraction exercises per day. In every 2-week control, the number of sets will be increased by one set.

Other: Classical Pelvic Floor Muscle Training

Functional Pelvic Floor Muscle Training

EXPERIMENTAL

Functional pelvic floor muscle training will be started with 3 exercises (toe tap, bridge and clamshall exercises), each exercise will be performed with 1 set and 30 repetitions. In every 2-week control, the number of exercises will be increased by one. Cat-cow exercise will be added at 3-4th weeks, squats will be added at 5-6th weeks, and lunges will be added at 7-8th weeks.

Other: Functional Pelvic Floor Muscle Training

Interventions

Classical Pelvic Floor Muscle Training OTHER

In the first 2 weeks of classical pelvic floor muscle training, individuals will perform 3 sets of 10 maximal voluntary pelvic floor muscle contraction exercises and 20 submaximal voluntary pelvic floor muscle contraction exercises per day. In every 2-week control, the number of sets will be increased by one set.

Classical Pelvic Floor Muscle Training

Functional Pelvic Floor Muscle Training OTHER

Functional pelvic floor muscle training will be started with 3 exercises (toe tap, bridge and clamshall exercises), each exercise will be performed with 1 set and 30 repetitions. In every 2-week control, the number of exercises will be increased by one. Cat-cow exercise will be added at 3-4th weeks, squats will be added at 5-6th weeks, and lunges will be added at 7-8th weeks.

Functional Pelvic Floor Muscle Training

Eligibility Criteria

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

You may qualify if:

• Patients suffering from stress urinary incontinence or SUI predominant Mixed Urinary Incontinence according to the 3 Incontinence Questionnaire (3IQ)
• Body mass index \<35 kg/m²
• Individuals over the age of 18 (with a Mini Mental Test score ≥ 24 for individuals over the age of 65)

You may not qualify if:

• Patients with pure urge incontinence, urge predominant mixed urinary incontinence or neurogenic bladder
• Pregnancy or suspected of pregnancy
• Those who have given birth in the last 1 year
• Being virgin
• Those who have had abdomino-pelvic surgery in the last 6 months, and/or those who have received abdomino-pelvic radiotherapy
• Those with urinary tract infection, recurrent urinary tract infection, diagnosis of interstitial cystitis
• Any orthopedic problem that will hinder exercise
• Patients over 65 years of age with a mini mental test score \< 24
• Patients with Pelvic Organ Prolapse grade ≥ Stage 2
• Those who have received treatment for urinary incontinence in the last 6 months
• Those who have uncontrolled diabetes and hypertension, severe systemic disease
• Those who have a neurological disease that will affect the urinary system
• Those who have started a new drug that will affect bladder functions in the last 1 month
• The strength of the pelvic floor muscles in digital examination is \<2 according to the Modified Oxford Scale score.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Berna Tokmak

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (10)

• Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Neurourol Urodyn. 2017 Feb;36(2):221-244. doi: 10.1002/nau.23107. Epub 2016 Dec 5.

  PMID: 27918122 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.

  PMID: 12794644 BACKGROUND

• Jorgensen L, Lose G, Andersen JT. One-hour pad-weighing test for objective assessment of female urinary incontinence. Obstet Gynecol. 1987 Jan;69(1):39-42.

  PMID: 3796918 BACKGROUND

• Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.

  PMID: 15227649 BACKGROUND

• Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997 Dec;104(12):1374-9. doi: 10.1111/j.1471-0528.1997.tb11006.x.

  PMID: 9422015 BACKGROUND

• Kaya S, Akbayrak T, Toprak Celenay S, Dolgun A, Ekici G, Beksac S. Reliability and validity of the Turkish King's Health Questionnaire in women with urinary incontinence. Int Urogynecol J. 2015 Dec;26(12):1853-9. doi: 10.1007/s00192-015-2786-6. Epub 2015 Jul 26.

  PMID: 26209953 BACKGROUND

• Fischer MC, Huckabay C, Nitti VW. The male perineal sling: assessment and prediction of outcome. J Urol. 2007 Apr;177(4):1414-8. doi: 10.1016/j.juro.2006.11.061.

  PMID: 17382743 BACKGROUND

• Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.

  PMID: 12861145 BACKGROUND

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

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

Study Officials

• Serap Özgül, Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: November 15, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)