Effects of Connective Tissue Massage in Women With Overactive Bladder

• Sponsor: Seyda TOPRAK CELENAY (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03695692
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: Oct 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. overactive bladder symptoms measured by Overactive Bladder Questionnaire_V8 [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 [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) [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara Yildirim Beyazit University	Ankara		Turkey

Sponsors and Collaborators

• Seyda TOPRAK CELENAY

Investigators

• Principal Investigator: Seyda TOPRAK CELENAY, Ankara Yildirim Beyazıt University
• Study Chair: Yasemin Karaaslan, Beykent University
• Study Chair: Faruk Kucukdurmaz, Kahramanmaras Sutcu Imam University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Oct 4, 2018
• Last Update Posted: Oct 4, 2018
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Bladder, Overactive

Study Results

No Results Posted as of Oct 4, 2018