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Effects of Connective Tissue Massage in Women With Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03695692
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Overactive Bladder Behavioral: pelvic floor exercise and connective tissue massage Behavioral: pelvic floor exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assistant Professor, Physioterapist, PhD
Actual Study Start Date : May 2, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Connective tissue massage group
Pelvic floor exercises and connective tissue massage have been applied
Behavioral: pelvic floor exercise and connective tissue massage
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

Experimental: Control group
Pelvic floor exercises alone have been applied
Behavioral: pelvic floor exercise
The exercise program is performed every day for 6 weeks




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. urgency complaint assessed with The patient's Perception of Intensity of Urgency Scale [ Time Frame: Change from baseline urgency complaints at 6 weeks ]
    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.

  2. quality of life assessed with King's Health Questionnaire (KHQ) [ Time Frame: Change from baseline quality of life at 6 weeks ]
    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.

  3. pelvic floor muscle strength measured with perineometer [ Time Frame: Change from baseline pelvic floor muscle strength at 6 weeks ]
    change in pelvic floor muscle strength as measued with perineometer

  4. 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 ]
    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.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 65 years of age,
  • having overactive bladder
  • being volunteer

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695692


Contacts
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Contact: Seyda TOPRAK CELENAY +90-534-041-3986 sydtoprak@hotmail.com
Contact: Yasemin KARAASLAN +90 535 845 9625 ptyasemindeveci@gmail.com

Locations
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Turkey
Ankara Yildirim Beyazit University Recruiting
Ankara, Turkey
Contact: Yasemin KARAASLAN    +90 535 845 96 25    ptyasemindeveci@gmail.com   
Contact: Faruk Kucukdurmaz         
Sponsors and Collaborators
Seyda TOPRAK CELENAY
Investigators
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Principal Investigator: Seyda TOPRAK CELENAY Ankara Yildirim Beyazıt University
Study Chair: Yasemin Karaaslan Beykent University
Study Chair: Faruk Kucukdurmaz Kahramanmaras Sutcu Imam University
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Responsible Party: Seyda TOPRAK CELENAY, Assistant Professor, Ataturk Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03695692    
Other Study ID Numbers: 2018/07-01
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms