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

A Comparison of the Effect on Stress Urinary Incontinence of Lumbopelvic Stabilisation Exercises and Pelvic Floor Exercises: A Randomised Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence; Pelvic Floor Disorders
• Intervention / Treatment: Behavioral: Lumbopelvic Stabilisation Exercises Group; Behavioral: Pelvic Floor Exercises Group

Detailed Description

The females included in the study will be separated into 2 groups in the 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. After a demonstration by the physiotherapist of how both exercises should be performed, the women will be requested to perform the exercises under the supervision of the physiotherapist. 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. The exercises will start as 5 sets of 10 repetitions per day, then each week the number of sets will be increased by 5 to reach 30 sets per day, and the exercises will be continued at this rate of 30 sets per day.

The women who will perform the dynamic 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. Initially the exercise position is held for 5-10 secs with 10 repetitions, and as the program advances the time of holding the position will be extended to 30-45 secs. 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.

The Q-Tip test will be used in the evaluation of uretero vesical junction (UVJ) mobility. A cotton swab lubricated with lidocaine gel will be used in the test. The cotton swab will be placed from the external urethral meatus and will be slowly pushed towards the bladder until resistance is felt. This point where resistance is met will be accepted as the UVJ. During the test, the angle will be measured during maximal strain by drawing the labia to the sides.

The patients diagnosed with stress urinary incontinence and included in the study will be taught the lumbopelvic stabilisation and pelvic floor exercises in the clinic under the guidance of the physiotherapist.

Study procedure:

In literature, the physiological effects of the exercises have been reported to emerge 2 weeks after starting and complaints reduce in 6-8 weeks. Therefore the patients will be instructed to perform the lumbopelvic stabilisation exercises at home, once a day for approximately 30 mins for a period of 10 weeks. Similarly the pelvic flor exercises will be performed for 10 weeks, once a day lasting approximately 30 mins. On 2 days a week, the women in both groups will perform the exercises under the guidance of the physiotherapist in the clinic. In this way, the necessary follow-up will be applied that the women are performing the pelvic flor muscle exercises and the lumbopelvic stabilisation exercises correctly and completely.

• Study Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Aydın, Turkey
    • Meryem Kurek EKEN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Pelvic Floor Trauma
• Lumbar disc hernia
• Pregnancy
• Breast-feeding
• Diabetes mellitus
• Hypertension
• BMI>30 kg/m2
• Chronic obstructive sleep apnea
• Chronic lung disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lumbopelvic Stabilisation Exercises; 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; 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.
Active Comparator: Pelvic Floor Exercises; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Quality of life of women will measure with Incontinence Quality of Life Questionnaire. The degree of quality of life will be measured by change from baseline in Incontinence Quality of Life Questionnaire after the exercises.	six month

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Study Director: Meryem Kürek Eken, Associate, Adnan Menderes University Obstetric Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): July 31, 2019
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: March 10, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Stress Urinary Incontinence; Pelvic Floor Exercises; Lumbopelvic Stabilisation Exercises
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pregnancy Complications; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Pelvic Floor Disorders
• Other Study ID Numbers: 2018/1507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No