A Comparison of Lumbopelvic Stabilisation and Pelvic Floor Exercises on the Stress Incontinence

NCT03911362 | Unknown DMC

• 1 other identifier: 2018/1507
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The patients diagnosed with stress urinary incontinence and included in the study. According to randomisation plan one group will be instructed by a physiotherapist to perform pelvic flor exercises and the other group will be instructed by the same physiotherapist to perform dynamic lumbopelvic stabilisation exercises.Throughout the study, the women will be followed up to ensure the exercises are performed. The exercises will be applied for approximately 30 mins once a day for a period of 10 weeks.

Conditions

Stress Urinary Incontinence; Pelvic Floor Disorders

Keywords

Lumbopelvic Stabilisation Exercises; Pelvic Floor Exercises; Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (3)

• The primer outcome of the study was to investigate the effects of lumbopelvic stabilisation exercises and pelvic floor exercises on the severity of incontinence in women with a diagnosis of stress urinary incontinence

  The severity of incontinence at before and after the exercises (total exercise duration is 10 weeks) will measure with Urogenital Distress Inventory. The change from baseline in Urogenital Distress Inventory after the exercises intervention will be measured by decrease on the severity of incontinence.

  six month

• The other primer outcome of the study was to lumbopelvic stabilisation exercises and pelvic floor exercises on the severity of incontinence in women with a diagnosis of stress urinary incontinence

  The severity of incontinence at before and after the exercises (total exercise duration is 10 weeks) will measure with Incontinence Impact Questionnaire. The change from baseline in Incontinence Impact Questionnaire after the exercises intervention will be measured by decrease on the severity of incontinence.

  six month

• The another primer outcome of the study was to investigate the effects of lumbopelvic stabilisation exercises and pelvic floor exercises on the amount of urinary output in women with a diagnosis of stress urinary incontinence

  The amount of urinary output and urine leakage in women during five days before exercises and five days after exercises (total exercise duration is 10 weeks) will Bladder Diary with measure. The amount of urinary output and urine leakage before and after exercises will be measured by decrease in urination of frequency and urine leakage at Bladder Diary.

  six month

Secondary Outcomes (1)

• The seconder outcome of the study was to investigate the effects of lumbopelvic stabilisation exercise and pelvic floor exercise on the degree of quality of life in women with a diagnosis of stress urinary incontinence

  six month

Study Arms (2)

Lumbopelvic Stabilisation Exercises

ACTIVE COMPARATOR

Starting with co-contraction of the transversus abdominis (TA) muscle and other muscles together with diaphragm breathing, and continuing the exercises with upper and lower extremity movements together with TA and multifidus contraction

Behavioral: Lumbopelvic Stabilisation Exercises Group

Pelvic Floor Exercises

ACTIVE COMPARATOR

The pelvic flor exercise will be in the form of contraction-release for rapidly contracting muscle fibres and for slowly contracting muscle fibres,slow contraction by counting to ten hold for a count of ten, then gradually relax by counting to ten.

Behavioral: Pelvic Floor Exercises Group

Interventions

Lumbopelvic Stabilisation Exercises Group BEHAVIORAL

Lumbopelvic stabilisation exercises will be taught the basic movement, starting with co-contraction of the transversus abdominis (TA) muscle and other muscles together with diaphragm breathing, and continuing the exercises with upper and lower extremity movements together with TA and multifidus contraction.

Lumbopelvic Stabilisation Exercises

Pelvic Floor Exercises Group BEHAVIORAL

The pelvic flor exercise will be in the form of contraction-release for rapidly contracting muscle fibres, and for slowly contracting muscle fibres, slow contraction by counting to ten, hold for a count of ten, then gradually relax by counting to ten

Pelvic Floor Exercises

Eligibility Criteria

• Age: 35 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged ≥ 35 years
• BMI \<29 kg/m2
• Are willing to participate in the research
• Premenopausal
• Able to self-report urine loss
• Educational level of at least primary school
• Positive cough provocation test (stress test)
• Positive Q-tip test,
• No complaints of constipation

You may not qualify if:

• Musculoskeletal system disorder
• Neurological dysfunction
• Genital prolapse more then second stage
• Hormone replacement therapy use
• Postmenopausal
• Anticholinergic drug use
• Urge and mixed incontinence
• Diuretic drug use
• Antidepressant drugs use
• Caffeine intake of \>4 cups/day
• Diabetes insipidus
• Urinary infection
• Vaginal infection
• History of urinary or genital surgery
• Malignancy

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Meryem Kurek EKEN

Aydin, Turkey (Türkiye)

Location

Related Publications (1)

• 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; Pelvic Floor Disorders

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; Pregnancy Complications

Study Officials

• Meryem Kürek Eken, Associate

  Adnan Menderes University Obstetric Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: April 11, 2019
• Study Start: December 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: August 31, 2019
• Last Updated: April 11, 2019

Record last verified: 2019-03

Locations

TU (1)