Stress Urinary IncontinenceNCT03911362
A Comparison of Lumbopelvic Stabilisation and Pelvic Floor Exercises on the Stress Incontinence
A study testing Lumbopelvic Stabilisation Exercises Group and Pelvic Floor Exercises Group in people with Stress Urinary Incontinence and Pelvic Floor Disorders, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence, Pelvic Floor Disorders
- What is being tested?
- Lumbopelvic Stabilisation Exercises Group and Pelvic Floor Exercises Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Positive cough provocation test (stress test)
- Positive Q-tip test,
- No complaints of constipation
Who cannot join
- Musculoskeletal system disorder
- Neurological dysfunction
- Genital prolapse more then second stage
- Hormone replacement therapy use
- Postmenopausal
- Anticholinergic drug use
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Lumbopelvic Stabilisation Exercises Group, Pelvic Floor Exercises Group
- Keywords
- Lumbopelvic Stabilisation Exercises, Pelvic Floor Exercises, Stress Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Stress, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbopelvic Stabilisation Exercises GroupBehavioural
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.
Pelvic Floor Exercises GroupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Pelvic Floor Exercises Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Dec 2018
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Kurek eken, Aydin Adnan Menderes University
- Investigators
- Meryem Kürek Eken, Associate, Study director, Adnan Menderes University Obstetric Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911362
- Sponsor's protocol ID
- 2018/1507
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effect on Stress Urinary Incontinence of Lumbopelvic Stabilisation Exercises and Pelvic Floor Exercises: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03911362
- Acronym / sponsor ID
- 2018/1507
- Keywords
- Lumbopelvic Stabilisation Exercises, Pelvic Floor Exercises, Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbopelvic Stabilisation Exercises | Active comparator | Behavioral: Lumbopelvic Stabilisation Exercises GroupStarting 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 |
| Pelvic Floor Exercises | Active comparator | Behavioral: Pelvic Floor Exercises GroupThe 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. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Aged ≥ 35 years
- BMI <29 kg/m2
- Are willing to participate in the research
- Premenopausal
- Able to self-report urine loss
Key exclusion criteria (24 listed)
- Musculoskeletal system disorder
- Neurological dysfunction
- Genital prolapse more then second stage
- Hormone replacement therapy use
- Postmenopausal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbopelvic Stabilisation Exercises GroupLumbopelvic 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. | Behavioural | Lumbopelvic Stabilisation Exercises |
| Pelvic Floor Exercises GroupThe 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 | Behavioural | Pelvic Floor Exercises |
Primary outcome
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
Time frame: six month
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
Time frame: six month
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
Time frame: six month
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.
1 secondary outcome
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
Time frame: six month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Derived from this study: PubMed 39704322Hay-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryem Kürek Eken, Associate study director
Adnan Menderes University Obstetric Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbopelvic Stabilisation Exercises Group and Pelvic Floor Exercises Group in people with Stress Urinary Incontinence and Pelvic Floor Disorders, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: six month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03911362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.