The Effects of the Pelvic Floor and Abdominal Muscle Training on Urinary Incontinence
1 other identifier
interventional
16
1 country
1
Brief Summary
To investigate the effects of the pelvic floor and abdominal muscle training on the severity of incontinence in women with stress and mixed urinary incontinence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 12, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedSeptember 23, 2022
September 1, 2022
7 months
September 12, 2022
September 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urinary Incontinence Severity
A 24-hour pad test was used to assess and standardize the severity of UI. The patients were informed before the test. The patients were told to change their pads every 4-6 hours and put the pads in an airtight locked bag to prevent the urine from evaporating. Since the pads should be weighed immediately after the evaluation, they were asked to do the test 1 day before the evaluation. Pads that were used for 24 hours were requested in a mouth-locked bag. 1 unused pad of the same type was requested. Urinary incontinence was determined by measuring the weight of the pad with precision scales (Isolab Laborgerate GMBH, Germany) before and after 24 hours. As a result of the 24-hour pad test, 4-20 grams were defined as mild, 21-74 grams as moderate, and \> 75 grams as severe UI.
6 weeks
Secondary Outcomes (6)
Pelvic Floor Muscle Activity
6 weeks
Abdominal Muscles Strength
6 weeks
Quality of life about Urinary Incontinence
6 weeks
Urinary Incontinence Symptom severity
6 weeks
Existing pelvic floor dysfunction
6 weeks
- +1 more secondary outcomes
Study Arms (1)
Mild and Moderate-Severe Urinary Incontinence Group
EXPERIMENTAL10 sets of pelvic floor muscle training and 2 sets of abdominal muscle strengthening training were given every day for 6 weeks. All analyzes were conducted at the beginning and end of the 6-week training. The same training program was applied to both groups ( Group 1 (mild urinary incontinence) and Group 2 (moderate-severe urinary incontinence), and the effects were compared according to the severity of incontinence.
Interventions
Pelvic Floor Muscle Training: For slow contractions, it was asked to contract in 5 seconds gradually, wait at a maximum of 5 seconds and gradually relax in 5 seconds. For fast contractions, it was asked to contract at a maximum of 2 seconds and then to relax. 10 fast + 10 slow contractions were accepted as 1 set exercise. (10 sets x Every Day x 6 weeks) Transversus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically. 15 repetitions were carried out, each consisting of contraction for 10 s and relaxation for 20 s. 2 sets of 15 repetitions were done. Internal Obliquus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically and then try to touch the furthest point of their legs with their fingertips for 15 repetitions consisting of contraction for 10 s followed by relaxation for 20 s. The sequence was then repeated on the other leg.
Eligibility Criteria
You may qualify if:
- Being female,
- Being 18 years of age or older
- Having been diagnosed of SUI and stress-predominant MUI after urodynamic evaluation by the urologist.
You may not qualify if:
- Currently taking medications for UI,
- Having urinary tract infection,
- Neurological disorders,
- Pelvic organ prolapse stage \>2,
- Pregnancy,
- a mental problem and/or
- been applied prior to physiotherapy for UI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Study Sites (1)
Gazi University
Ankara, 06490, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 12, 2022
First Posted
September 22, 2022
Study Start
November 28, 2018
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
September 23, 2022
Record last verified: 2022-09