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

Primary Purpose

Stress Urinary Incontinence, Pelvic Floor Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lumbopelvic Stabilisation Exercises Group
Pelvic Floor Exercises Group
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress Urinary Incontinence focused on measuring Lumbopelvic Stabilisation Exercises, Pelvic Floor Exercises, Stress Urinary Incontinence

Eligibility Criteria

35 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Meryem Kurek EKEN

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lumbopelvic Stabilisation Exercises

Pelvic Floor Exercises

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 10, 2019
Last Updated
April 9, 2019
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT03911362
Brief Title
A Comparison of Lumbopelvic Stabilisation and Pelvic Floor Exercises on the Stress Incontinence
Official Title
A Comparison of the Effect on Stress Urinary Incontinence of Lumbopelvic Stabilisation Exercises and Pelvic Floor Exercises: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Anticipated)
Study Completion Date
August 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Pelvic Floor Disorders
Keywords
Lumbopelvic Stabilisation Exercises, Pelvic Floor Exercises, Stress Urinary Incontinence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumbopelvic Stabilisation Exercises
Arm Type
Active Comparator
Arm Description
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
Arm Title
Pelvic Floor Exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lumbopelvic Stabilisation Exercises Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic Floor Exercises Group
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
six month
Title
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
Description
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.
Time Frame
six month
Title
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
Description
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.
Time Frame
six month
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
six month

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meryem Kürek Eken, Associate
Organizational Affiliation
Adnan Menderes University Obstetric Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Meryem Kurek EKEN
City
Aydın
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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