Clinical trial NCT05549193: The Effects of the Pelvic Floor and Abdominal Muscle Training on Urinary Incontinence
Official title: The Effects of the Pelvic Floor and Abdominal Muscle Training in Urinary Incontinence According to the Severity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Rectus Abdominus
Pelvic Floor Muscle Training
Stress Urinary Incontinence
Quality of Life
Biofeedback
Home Exercises
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The aim of this study is to investigate the effect of incontinence severity on the pelvic floor and abdominal muscle strengthening training in women with stress urinary incontinence (UI). Sixteen patients with stress and mixed UI were included in the study. According to the 24-hour pad test (24hPT), individuals were divided into two groups as group 1 (24hPT 4-20gr, mild group, n: 9) and group 2 (24hPT 21g and above in 24hPT, moderate-severe group, n: 7). Pelvic floor muscle training (PFMT) and abdominal muscle training were applied to the groups for 6 weeks.

PFMT was given as a home-based exercise program to increase pelvic floor muscle (PFM) strength and endurance. Before starting the program, PFM was taught first schematically and then by the biofeedback method. It was ensured that the patient learned the PFM. Fast and slow pelvic floor contractions were taught for both type 1 and type 2 muscle fibres. For slow contractions, it was asked to gradually contract in 5 seconds, 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. Patients were asked to perform 10 slow contractions after every 10 rapid contractions. 10 fast + 10 slow contractions were accepted as 1 set exercise. Subjects were asked to make 10 sets every day for 6 weeks.

Strengthening exercises for transversus abdominus and internal obliques abdominus muscles were given as a home program and the details were written below:

Transversus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically. Fifteen repetitions were carried out; each one consisting of contraction for 10 s followed by relaxation for 20 s. After 15 repetitions, patients rested for 5 min. The sequence was then repeated for two sets of 15 repetitions.

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. After 15 repetitions, patients rested for 5 min. The sequence was then repeated on the other leg.

Urinary incontinence, pelvic floor muscle strength measurement, quality of life, symptom, and the presence of pelvic floor dysfunction were evaluated respectively using 24hPT, Electromyography (EMG) Biofeedback device, King's Health Questionnaire, Urogenital Distress Inventory, and Global Pelvic Floor Bother Questionnaire. Evaluations were performed at the beginning and at the end of the physiotherapy program, and a subjective improvement rate was determined.

Eligibility criteria: Inclusion Criteria:

* Being female,
* Being 18 years of age or older
* Having been diagnosed of SUI and stress-predominant MUI after urodynamic evaluation by the urologist.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Urinary Incontinence Severity
timeFrame: 6 weeks
Secondary outcomes:
measure: Pelvic Floor Muscle Activity
timeFrame: 6 weeks
measure: Abdominal Muscles Strength
timeFrame: 6 weeks
measure: Quality of life about Urinary Incontinence
timeFrame: 6 weeks
measure: Urinary Incontinence Symptom severity
timeFrame: 6 weeks
measure: Existing pelvic floor dysfunction
timeFrame: 6 weeks
measure: Treatment adherence
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References: