Overactive Bladder Syndrome (OABS)OABS/BT/PFETNCT06209333

Effect of BT and PFET on Urinary Symptoms and Quality of Life in Patients With OABS

A study testing Standard Patient Education, bladder training and pelvic floor exercise in people with Overactive Bladder Syndrome (OABS), run by Hacettepe University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The aim of this study was to examine the effects of bladder training and pelvic floor exercise training programs given in addition to Botulinum Toxin-A (BTx-A) application on urinary symptoms and quality of life in patients with Overactive Bladder Syndrome (AAMS) who do not respond to conservative treatments. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder Syndrome (OABS)
What is being tested?: Standard Patient Education, bladder training and pelvic floor exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Oct 2023to 15 Oct 2024
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

over the age of 18 (those with a Mini Mental Test score of 24 and above for individuals over the age of 65),
Who has Non-Neurogenic Overactive Bladder Syndrome,
Patients who received Routine Botulinum Toxin-A administration because they did not respond to conservative treatment,
Patients who volunteer to participate in the study will be included.

Who cannot join

Patients with Neurogenic Overactive Bladder Syndrome,
Pregnant Women,
Lack of cooperation in evaluation and/or treatment and lack of literacy status,
Patients with urogynocological/anatomical abnormalities,
Patients receiving pelvic radiation therapy,
Patients with psychiatric or neurogenic disorders and
Patients who have not given consent to the study and do not have an informed consent form (BGOF).

Trial locations and contacts

1 site in 1 country.

Ceren Gursen, associate professor contact

+905380644120

cerengursen@yahoo.com

Turkey (Türkiye)1 site, 1 recruiting

Aslı Aslan
Ankara, 06100
Aslı Aslan, +905072831519, asliiiiaslan@outlook.com
Naside Mangır
Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Bladder Training and Pelvic Floor Exercise Training on Urinary Symptoms and Quality of Life in Patients With Overactive Bladder Syndrome

Individuals who meet the criteria for inclusion in the study and agree to participate in the study will be divided into 2 separate research branches.The patients to be included in the study will be divided into two groups as "Group 1=Botox + physiotherapy " or "Group 2=Botox group ". In addition to the BTx-A application, bladder training and pelvic floor exercise training will be applied to patients in the first group, while standard patient training will be provided to patients in the second group.

Severity of urinary symptoms, quality of life and subjective perception of improvement Before BTx-A application, 2 weeks and 12 weeks after BTX-A application, International Incontinence Consultation Questionnaire - Women's Lower Urinary Tract Symptoms (ICIQ-FLUTS), 1-hour ped test, International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS) and Global Perception of Improvement will be evaluated.

Conditions: Overactive Bladder Syndrome (OABS)
Being tested: Standard Patient Education, bladder training, pelvic floor exercise
Keywords: pelvic floor exercise, bladder training, standard patient education, botulinum toxin-A, BTx-A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard Patient EducationOther
Standard Patient Education will take approximately 20 minutes. Within the scope of standard patient education, some recommendations will be made to the patient to lose weight, drink sufficient water, avoid consuming caffeinated foods and beverages, acidic/carbonated or alcoholic beverages, spicy/acidic foods, and quit smoking. Patients will be evaluated on the day they receive standard patient training (before receiving this training) and 10 weeks after the training.
bladder trainingOther
Interval urination in bladder training in bladder training will be determined according to the bladder diaries filled in by the patients. If the patient is able to do it, bladder education will be improved by increasing the interval urination in bladder training. A total of 5 sessions of bladder training will be applied to patients, the first session of which will be face-to-face. Within the scope of Bladder Training, the patient will be given information about bladder, pelvic floor, incontinence and relaxation techniques. The patient will be asked to fill out a 3-day bladder diary before starting bladder training, and an appropriate progressive timed voiding program will be drawn according to the bladder diaries, and the patient will be given a training brochure to implement this program.
pelvic floor exerciseOther
This training will take between 45 and 60 minutes.Within the scope of exercise training, patients will be taught 3 types of contractions: maximal (fast), slow and submaximal contractions. The patient will be asked to continue the maximum and submaximal contraction for 1-2 seconds, and to continue the Deceleration contraction for 3-10 seconds. These contractions will be performed in different positions such as supine, lying on the side, sitting, crawling, squatting and standing, specifically for the pelvic floor November muscle strength of the patient. These exercises will be performed every day and each type of contraction (maximal, slow and submaximal contraction) will be performed 8-12 repetitions, 3 sets per day. Progress will be achieved with follow-ups.

Study groups in NCT06209333
Study group	Role	What they receive
pelvic physiotherapy	Experimental	Not described Receives: Other: bladder training; Other: pelvic floor exercise
standard patient education	Active comparator	Not described Receives: Other: Standard Patient Education

What is being measured

The primary outcome is the main question the study is designed to answer.

International Incontinence Consultation Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
Storage symptoms are scored as 0-16 points, urination symptoms are scored as 0-12, incontinence symptoms are scored as 0-20 points.
The effect of the patient's symptoms on their daily activities has 5 options, including "0-Never", "4-Always".The highest possible score is 48. A higher score means a worse outcome.
Measured: the change in the symptoms of the lower urinary tract from the beginning to the end of 12 weeks and the effects of symptoms on quality of life
International Incontinence Consultation Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
This scale aims to evaluate male lower urinary tract symptoms in the last 4 weeks and the effects of symptoms on quality of life with 13 questions.
The effect of the patient's symptoms on their daily activities has 5 options, including "0-Never", "4-Always".The highest possible score is 52. A higher score means a worse outcome.
Measured: the change in the symptoms of the lower urinary tract from the beginning to the end of 12 weeks and the effects of symptoms on quality of life

Secondary outcomes (7)

International Incontinence Consultation Bladder Diary (ICIQ-Bladder Diary):
ICIQ-Bladder Diary is a volume-frequency chart that allows patients to record the frequency of urination, the volume of mixing and fluid intake (quantity, duration and type), bladder sensation and pad use at each time.
Measured: change in the severity of urinary incontinence from the beginning to the end of 12 weeks
1-Hour Ped Test
Just before this test, the patient is asked to empty his bladder and put the pad, the weight of which is known in advance, in his clothes.
Then, the patient is asked to do 500 mL of oral hydration while sitting for 15 minutes. the time is completed with other activities.
1. the pad is taken from the patient per minute. During this time, the weight difference on the pad is measured and the test is interpreted according to the difference.
Measured: change in the severity of urinary incontinence from the beginning to the end of 12 weeks
International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS):
Quality of life will be evaluated by the International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS). This scale consists of 20 questions that evaluate different sub-areas of quality of life (work life, daily life, travel and sexuality).The highest possible score is 76. A higher score means a worse outcome.
Measured: Change in quality of life from baseline at 12 weeks
Global Perception of Improvement Scale
The Global Perception of Improvement Scale, the perception of changes in patients' complaints related to overactive bladder symptoms after the study compared to the beginning of the study, will be evaluated by the Global Perception of Improvement Scale, which is a 7-item scale (1-I am much better, 7-much worse). A higher score means a worse outcome.
Measured: Change from baseline patient global change at 12 weeks
Compliance with Standard Patient Education
It will be evaluated with a Visual Analog Scale. The Visual Analog Scale (VAS) is a horizontal line of 0-10 cm that expresses that it does not fit education at all at one end and that it adapts to patient education to the maximum extent at the other end. A higher score means better fit.
Measured: compliance with Standard Patient Education at the end of 12 weeks
Compliance with Bladder Training
It will be evaluated with a Visual Analog Scale. 12. at the end of the week, they will be asked to mark on the VAS how much they have implemented this training throughout the study.
Measured: Compliance with Bladder Training at the end of 12 weeks
Compliance with Pelvic Floor Exercise Training
It will be evaluated with exercise diaries.
Measured: Compliance with Pelvic Floor Exercise Training at the end of 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202315 Oct 2024

First posted17 Jan 2024
Study start15 Oct 2023
Primary completion15 Oct 2024 (estimated)
Study completion15 Oct 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Overactive Bladder Syndrome (OABS)Studies of the same condition, open and under way.
More trials run by Hacettepe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06209333
Sponsor's protocol ID: KA-23003
Acronym: OABS/BT/PFET
Status last verified: Jan 2024
First submitted: 18 Sep 2023
Last updated: 17 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

The Overactive Bladder: From Basic Science to Clinical Management Consensus Conference. Proceedings. London, England, June 29, 1997. Urology. 1997 Dec;50(6A Suppl):1-114. No abstract available.
PubMed 9446279
Orasanu B, Mahajan ST. The use of botulinum toxin for the treatment of overactive bladder syndrome. Indian J Urol. 2013 Jan;29(1):2-11. doi: 10.4103/0970-1591.109975.
PubMed 23671356
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
PubMed 12559262
Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
PubMed 12794644
Mertoglu O, Ucer O, Ceylan Y, Bozkurt O, Gunlusoy B, Albaz AC, Demir O; Aegean Study Group of Society of Urological Surgery. Reliability and Validity of the Turkish Language Version of the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms. Int Neurourol J. 2016 Jun;20(2):159-63. doi: 10.5213/inj.1630460.230. Epub 2016 Jun 24.
PubMed 27377949
Shen L, Hou L, Li B, Jin X, Han F, Wang Y. Translation of the ICIQ-bladder diary and its validation among Chinese females with lower urinary tract symptoms. Int Urogynecol J. 2020 Dec;31(12):2535-2542. doi: 10.1007/s00192-020-04339-9. Epub 2020 May 28.
PubMed 32468173
Castellani D, Saldutto P, Galica V, Pace G, Biferi D, Paradiso Galatioto G, Vicentini C. Low-Dose Intravaginal Estriol and Pelvic Floor Rehabilitation in Post-Menopausal Stress Urinary Incontinence. Urol Int. 2015;95(4):417-21. doi: 10.1159/000381989. Epub 2015 May 30.
PubMed 26043913
Ptak M, Ciecwiez S, Brodowska A, Starczewski A, Nawrocka-Rutkowska J, Diaz-Mohedo E, Rotter I. The Effect of Pelvic Floor Muscles Exercise on Quality of Life in Women with Stress Urinary Incontinence and Its Relationship with Vaginal Deliveries: A Randomized Trial. Biomed Res Int. 2019 Jan 6;2019:5321864. doi: 10.1155/2019/5321864. eCollection 2019.
PubMed 30723739

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Bladder Training and Pelvic Floor Exercise Training on Urinary Symptoms and Quality of Life in Patients With Overactive Bladder Syndrome
ClinicalTrials.gov ID: NCT06209333
Acronym / sponsor ID: OABS/BT/PFET / KA-23003
Conditions: Overactive Bladder Syndrome (OABS)
Keywords: pelvic floor exercise, bladder training, standard patient education, botulinum toxin-A, BTx-A
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Hacettepe UniversityUniversity, hospital or other
Study start: 15 Oct 2023 (actual)
Primary completion: 15 Oct 2024 (estimated)
Study completion: 15 Oct 2024 (estimated)
First posted: 17 Jan 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
pelvic physiotherapy	Experimental	Other: bladder training, Other: pelvic floor exercise
standard patient education	Active comparator	Other: Standard Patient Education

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

over the age of 18 (those with a Mini Mental Test score of 24 and above for individuals over the age of 65),
Who has Non-Neurogenic Overactive Bladder Syndrome,
Patients who received Routine Botulinum Toxin-A administration because they did not respond to conservative treatment,
Patients who volunteer to participate in the study will be included.

Key exclusion criteria (7 listed)

Patients with Neurogenic Overactive Bladder Syndrome,
Pregnant Women,
Lack of cooperation in evaluation and/or treatment and lack of literacy status,
Patients with urogynocological/anatomical abnormalities,
Patients receiving pelvic radiation therapy,

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
Standard Patient EducationStandard Patient Education will take approximately 20 minutes. Within the scope of standard patient education, some recommendations will be made to the patient to lose weight, drink sufficient water, avoid consuming caffeinated foods and beverages, acidic/carbonated or alcoholic beverages, spicy/acidic foods, and quit smoking. Patients will be evaluated on the day they receive standard patient training (before receiving this training) and 10 weeks after the training.	Other	standard patient education
bladder trainingInterval urination in bladder training in bladder training will be determined according to the bladder diaries filled in by the patients. If the patient is able to do it, bladder education will be improved by increasing the interval urination in bladder training. A total of 5 sessions of bladder training will be applied to patients, the first session of which will be face-to-face. Within the scope of Bladder Training, the patient will be given information about bladder, pelvic floor, incontinence and relaxation techniques. The patient will be asked to fill out a 3-day bladder diary before starting bladder training, and an appropriate progressive timed voiding program will be drawn according to the bladder diaries, and the patient will be given a training brochure to implement this program.	Other	pelvic physiotherapy
pelvic floor exerciseThis training will take between 45 and 60 minutes.Within the scope of exercise training, patients will be taught 3 types of contractions: maximal (fast), slow and submaximal contractions. The patient will be asked to continue the maximum and submaximal contraction for 1-2 seconds, and to continue the Deceleration contraction for 3-10 seconds. These contractions will be performed in different positions such as supine, lying on the side, sitting, crawling, squatting and standing, specifically for the pelvic floor November muscle strength of the patient. These exercises will be performed every day and each type of contraction (maximal, slow and submaximal contraction) will be performed 8-12 repetitions, 3 sets per day. Progress will be achieved with follow-ups.	Other	pelvic physiotherapy

Primary outcome

International Incontinence Consultation Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
Time frame: the change in the symptoms of the lower urinary tract from the beginning to the end of 12 weeks and the effects of symptoms on quality of life
Storage symptoms are scored as 0-16 points, urination symptoms are scored as 0-12, incontinence symptoms are scored as 0-20 points. The effect of the patient's symptoms on their daily activities has 5 options, including "0-Never", "4-Always".The highest possible score is 48. A higher score means a worse outcome.
International Incontinence Consultation Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
Time frame: the change in the symptoms of the lower urinary tract from the beginning to the end of 12 weeks and the effects of symptoms on quality of life
This scale aims to evaluate male lower urinary tract symptoms in the last 4 weeks and the effects of symptoms on quality of life with 13 questions. The effect of the patient's symptoms on their daily activities has 5 options, including "0-Never", "4-Always".The highest possible score is 52. A higher score means a worse outcome.

7 secondary outcomes

International Incontinence Consultation Bladder Diary (ICIQ-Bladder Diary):
Time frame: change in the severity of urinary incontinence from the beginning to the end of 12 weeks
1-Hour Ped Test
Time frame: change in the severity of urinary incontinence from the beginning to the end of 12 weeks
International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS):
Time frame: Change in quality of life from baseline at 12 weeks
Global Perception of Improvement Scale
Time frame: Change from baseline patient global change at 12 weeks
Compliance with Standard Patient Education
Time frame: compliance with Standard Patient Education at the end of 12 weeks
Compliance with Bladder Training
Time frame: Compliance with Bladder Training at the end of 12 weeks
Compliance with Pelvic Floor Exercise Training
Time frame: Compliance with Pelvic Floor Exercise Training at the end of 12 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
Background: PubMed 9446279The Overactive Bladder: From Basic Science to Clinical Management Consensus Conference. Proceedings. London, England, June 29, 1997. Urology. 1997 Dec;50(6A Suppl):1-114. No abstract available.
Background: PubMed 23671356Orasanu B, Mahajan ST. The use of botulinum toxin for the treatment of overactive bladder syndrome. Indian J Urol. 2013 Jan;29(1):2-11. doi: 10.4103/0970-1591.109975.
Background: PubMed 12559262Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
Background: PubMed 12794644Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
Background: PubMed 27377949Mertoglu O, Ucer O, Ceylan Y, Bozkurt O, Gunlusoy B, Albaz AC, Demir O; Aegean Study Group of Society of Urological Surgery. Reliability and Validity of the Turkish Language Version of the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms. Int Neurourol J. 2016 Jun;20(2):159-63. doi: 10.5213/inj.1630460.230. Epub 2016 Jun 24.
Background: PubMed 32468173Shen L, Hou L, Li B, Jin X, Han F, Wang Y. Translation of the ICIQ-bladder diary and its validation among Chinese females with lower urinary tract symptoms. Int Urogynecol J. 2020 Dec;31(12):2535-2542. doi: 10.1007/s00192-020-04339-9. Epub 2020 May 28.
Background: PubMed 26043913Castellani D, Saldutto P, Galica V, Pace G, Biferi D, Paradiso Galatioto G, Vicentini C. Low-Dose Intravaginal Estriol and Pelvic Floor Rehabilitation in Post-Menopausal Stress Urinary Incontinence. Urol Int. 2015;95(4):417-21. doi: 10.1159/000381989. Epub 2015 May 30.
Background: PubMed 30723739Ptak M, Ciecwiez S, Brodowska A, Starczewski A, Nawrocka-Rutkowska J, Diaz-Mohedo E, Rotter I. The Effect of Pelvic Floor Muscles Exercise on Quality of Life in Women with Stress Urinary Incontinence and Its Relationship with Vaginal Deliveries: A Randomized Trial. Biomed Res Int. 2019 Jan 6;2019:5321864. doi: 10.1155/2019/5321864. eCollection 2019.
Individual participant dataSharing planned: No

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.

Ceren Gursen, associate professor contact

+905380644120

cerengursen@yahoo.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standard Patient Education, bladder training and pelvic floor exercise in people with Overactive Bladder Syndrome (OABS), run by Hacettepe 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 4 inclusion and 7 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 17 Jan 2024. 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 Ceren Gursen, associate professor (+905380644120, cerengursen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Incontinence Consultation Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) (time frame: the change in the symptoms of the lower urinary tract from the beginning to the end of 12 weeks and the effects of symptoms on quality of life). The study lists 2 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 NCT06209333, which also lists 8 linked publications.

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 17 Jan 2024.