Clinical trial NCT03911362: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Pelvic Floor Disorders
Keywords: Lumbopelvic Stabilisation Exercises
Pelvic Floor Exercises
Stress Urinary Incontinence
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 2
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 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
timeFrame: six month
measure: 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
timeFrame: six month
measure: 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
timeFrame: six month
Secondary outcomes:
measure: 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
timeFrame: six month
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Meryem Kurek EKEN
Study officials:
affiliation: Adnan Menderes University Obstetric Clinic
name: Meryem Kürek Eken, Associate
role: STUDY_DIRECTOR
References: