Overactive BladderNCT03695692
Effects of Connective Tissue Massage in Women With Overactive Bladder
A study testing pelvic floor exercise and connective tissue massage and pelvic floor exercise in people with Overactive Bladder, run by Seyda TOPRAK CELENAY at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the effects of pelvic floor muscle trainig with connective tissue massage and only pelvic floor muscle training in women with overactive bladder Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- pelvic floor exercise and connective tissue massage and pelvic floor exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2018to Oct 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age,
- having overactive bladder
- being volunteer
Who cannot join
- being in the period of pregnancy or breastfeeding,
- having an accompanying neurological disease, presence of a mental issue that would prevent cooperation in examinations and/or implementations, history of acute infectionor presence of a malignce
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yildirim Beyazit University
Ankara
Yasemin KARAASLAN, +90 535 845 96 25, ptyasemindeveci@gmail.com
Faruk Kucukdurmaz
About this study
Official title: Assistant Professor, Physioterapist, PhD
The aim of this study was to compare the effects of pelvic floor muscle trainig with connective tissue massage and only pelvic floor muscle training in women with overactive bladder
- Conditions
- Overactive Bladder
- Being tested
- pelvic floor exercise and connective tissue massage, pelvic floor exercise
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor exercise and connective tissue massageBehavioural
Pelvic floor exercises with connective tissue massage will be performed.The massage program is carried out for 18 sessions, 3 days/week in 6 weeks. The exercise program is performed every day for 6 weeks
pelvic floor exerciseBehavioural
The exercise program is performed every day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue massage group | Experimental | Pelvic floor exercises and connective tissue massage have been applied Receives: Behavioral: pelvic floor exercise and connective tissue massage |
| Control group | Experimental | Pelvic floor exercises alone have been applied Receives: Behavioral: pelvic floor exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
overactive bladder symptoms measured by Overactive Bladder Questionnaire_V8
Overactive Bladder Questionnaire_V8 assessing severity of overactive bladder symptoms will be used. This scale includes items on urgency, incontinence, nocturia and voiding frequency, as defined by the International Continence Society, referring to the previous four weeks. The final score is the sum of the partial scores obtained for each of the eight questions, ranging from 0 to 40. Patients with a final score of eight or more are considered as having Overactive Bladder symptoms.
Measured: Change from baseline bladder symptoms at 6 weeks
Secondary outcomes (4)
urgency complaint assessed with The patient's Perception of Intensity of Urgency Scale
The patient's Perception of Intensity of Urgency Scale assessing urgency complaints will be used. This scale is scored on 0 and 4 points (the best score is '0' and the worst score is '4') based on urgency complaints. Higher scores indicate more severe urgency complaints.
Measured: Change from baseline urgency complaints at 6 weeks
quality of life assessed with King's Health Questionnaire (KHQ)
King's Health Questionnaire assessing quality of life related to urinary problems will be used. This questionnaire consists of two parts and 32 items. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with UI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains.
Measured: Change from baseline quality of life at 6 weeks
pelvic floor muscle strength measured with perineometer
change in pelvic floor muscle strength as measued with perineometer
Measured: Change from baseline pelvic floor muscle strength at 6 weeks
diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes measured with voiding dairy
Patients will be also instructed to keep voiding diary for three days. In this diary, diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes will be recorded.
Measured: Change from baseline diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start2 May 2018
- Primary completionApr 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seyda TOPRAK CELENAY
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
- Investigators
- Seyda TOPRAK CELENAY, Principal investigator, Ankara Yildirim Beyazıt UniversityYasemin Karaaslan, Study chair, Beykent UniversityFaruk Kucukdurmaz, Study chair, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695692
- Sponsor's protocol ID
- 2018/07-01
- Status last verified
- Oct 2018
- First submitted
- 2 Oct 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Professor, Physioterapist, PhD
- ClinicalTrials.gov ID
- NCT03695692
- Acronym / sponsor ID
- 2018/07-01
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seyda TOPRAK CELENAYUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 4 Oct 2018 (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 aim of this study was to compare the effects of pelvic floor muscle trainig with connective tissue massage and only pelvic floor muscle training in women with overactive bladder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective tissue massage group | Experimental | Behavioral: pelvic floor exercise and connective tissue massagePelvic floor exercises and connective tissue massage have been applied |
| Control group | Experimental | Behavioral: pelvic floor exercisePelvic floor exercises alone have been applied |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years of age,
- having overactive bladder
- being volunteer
Key exclusion criteria (2 listed)
- being in the period of pregnancy or breastfeeding,
- having an accompanying neurological disease, presence of a mental issue that would prevent cooperation in examinations and/or implementations, history of acute infectionor presence of a malignce
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 |
|---|---|---|
| pelvic floor exercise and connective tissue massagePelvic floor exercises with connective tissue massage will be performed.The massage program is carried out for 18 sessions, 3 days/week in 6 weeks. The exercise program is performed every day for 6 weeks | Behavioural | Connective tissue massage group |
| pelvic floor exerciseThe exercise program is performed every day for 6 weeks | Behavioural | Control group |
Primary outcome
overactive bladder symptoms measured by Overactive Bladder Questionnaire_V8
Time frame: Change from baseline bladder symptoms at 6 weeks
Overactive Bladder Questionnaire_V8 assessing severity of overactive bladder symptoms will be used. This scale includes items on urgency, incontinence, nocturia and voiding frequency, as defined by the International Continence Society, referring to the previous four weeks. The final score is the sum of the partial scores obtained for each of the eight questions, ranging from 0 to 40. Patients with a final score of eight or more are considered as having Overactive Bladder symptoms.
4 secondary outcomes
urgency complaint assessed with The patient's Perception of Intensity of Urgency Scale
Time frame: Change from baseline urgency complaints at 6 weeks
quality of life assessed with King's Health Questionnaire (KHQ)
Time frame: Change from baseline quality of life at 6 weeks
pelvic floor muscle strength measured with perineometer
Time frame: Change from baseline pelvic floor muscle strength at 6 weeks
diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes measured with voiding dairy
Time frame: Change from baseline diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
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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.
Seyda TOPRAK CELENAY principal investigator
Ankara Yildirim Beyazıt University
Yasemin Karaaslan study chair
Beykent University
Faruk Kucukdurmaz study chair
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic floor exercise and connective tissue massage and pelvic floor exercise in people with Overactive Bladder, run by Seyda TOPRAK CELENAY 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 3 inclusion and 2 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 4 Oct 2018. 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?
Contact Seyda TOPRAK CELENAY (+90-534-041-3986, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overactive bladder symptoms measured by Overactive Bladder Questionnaire_V8 (time frame: Change from baseline bladder symptoms at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2018.