Effects of Connective Tissue Massage in Women With Overactive Bladder

NCT03695692 | Unknown

• 1 other identifier: 2018/07-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline bladder symptoms at 6 weeks

Secondary Outcomes (4)

• urgency complaint assessed with The patient's Perception of Intensity of Urgency Scale

  Change from baseline urgency complaints at 6 weeks

• quality of life assessed with King's Health Questionnaire (KHQ)

  Change from baseline quality of life at 6 weeks

• pelvic floor muscle strength measured with perineometer

  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

  Change from baseline diurnal urinary frequency, nocturia, maximum urinary volume, the number of urinary leakage and pad changes at 6 weeks

Study Arms (2)

Connective tissue massage group

EXPERIMENTAL

Pelvic floor exercises and connective tissue massage have been applied

Behavioral: pelvic floor exercise and connective tissue massage

Control group

EXPERIMENTAL

Pelvic floor exercises alone have been applied

Behavioral: pelvic floor exercise

Interventions

pelvic floor exercise and connective tissue massage BEHAVIORAL

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

Connective tissue massage group

pelvic floor exercise BEHAVIORAL

The exercise program is performed every day for 6 weeks

Control group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seyda TOPRAK CELENAY: lead

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seyda TOPRAK CELENAY

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

• Yasemin Karaaslan

  Beykent University

  STUDY CHAIR

• Faruk Kucukdurmaz

  Kahramanmaras Sutcu Imam University

  STUDY CHAIR

Central Study Contacts

Seyda TOPRAK CELENAY

CONTACT

+90-534-041-3986; sydtoprak@hotmail.com

Yasemin KARAASLAN

CONTACT

+90 535 845 9625; ptyasemindeveci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: May 2, 2018
• Primary Completion: April 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 4, 2018

Record last verified: 2018-10

Locations

TU (1)