An interventional study of Pelvic Floor Muscle Training and Abdominal Training and Pelvic Floor Muscle Training in Stress Urinary Incontinence and Pelvic Floor Muscle Weakness, sponsored by Trakya University. Completed. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2018-01-17.
Sponsored by Trakya University · Not applicable, Interventional, and Supportive care
The aim of this study was to investigate the effectiveness of pelvic floor muscle and abdominal training in reproductive-age patients with stress urinary incontinence.
This prospective randomized controlled design study included 64 female patients aged 18-49 years with stress urinary incontinence. The patients were divided into 2 groups (32 PFMT "Pelvic Floor Muscle Training" and 32 PFMT+AT "Abdominal Training") by computer-based randomization. The stress urinary incontinence type was assessed by a stress test, and the pelvic floor muscle strength was measured with a home biofeedback device. Voiding functions were assessed by a 3-day voiding diary and uroflowmetric test. The UDI-6 scale was used to assess the urinary symptoms, and the IIQ-7 scale was used to assess the quality of life. The follow-up measurements of both groups were obtained in the 0th, 4th, and 8th weeks.
The aim of this study was to investigate the effectiveness of pelvic floor muscle and abdominal training in reproductive-age patients with stress urinary incontinence.
This prospective randomized controlled design study included 64 female patients aged 18-49 years with stress urinary incontinence. The patients were divided into 2 groups (32 PFMT "Pelvic Floor Muscle Training" and 32 PFMT+AT "Abdominal Training") by computer-based randomization. The stress urinary incontinence type was assessed by a stress test, and the pelvic floor muscle strength was measured with a home biofeedback device. Voiding functions were assessed by a 3-day voiding diary and uroflowmetric test. The UDI-6 scale was used to assess the urinary symptoms, and the IIQ-7 scale was used to assess the quality of life. The follow-up measurements of both groups were obtained in the 0th, 4th, and 8th weeks.
Participation of 29 patients from each group in the study was determined as sufficient to test the two-way hypothesis, with an effect size of 0.75, with an alpha level of 0.05, and with a power of 80%. However, 32 patients from each group were included as a precaution against possible missing data.
These women were randomly divided into the PFMT+AT (n=32) and PFMT (n=32) groups using a computer based randomization scheme. The data were collected from both groups at the 0th, 4th, and 8th weeks.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's enrollment of 64 is close to the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Trakya University is the lead sponsor of 155 studies on the registry; 15 are open to participants now.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pelvic Floor Muscle Training and Abdominal Training
Other: Pelvic Floor Muscle Training and Abdominal Training
Pelvic Floor Muscle Training
Other: Pelvic Floor Muscle Training
Pelvic Floor Muscle Training + Abdominal Training program was used in the study. The follow-up measurements of the PFMT+AT group were obtained in the 0th, 4th, and 8th weeks.
Pelvic Floor Muscle Training program was used in the study. The follow-up measurements of the PFMT group were obtained in the 0th, 4th, and 8th weeks.
Change from baseline pelvic floor muscle strength at 8 weeks
Pelvic floor muscle strength was measured using a perineometry device
Time frame: 0th, 4th, and 8th weeks.
Change from baseline UDI-6 score at 8 weeks
Urinary symptoms were measured using the Urinary Distress Inventory (UDI-6)
Time frame: 0th, 4th, and 8th weeks.
Change from baseline IIQ-7 score at 8 weeks
Urinary symptoms were measured using the Incontinence Impact Questionnaire (IIQ-7),
Time frame: 0th, 4th, and 8th weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2016 to primary completion in Mar 2017, 6 months.
Of 225 non-industry interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 6 months is below that.
Counting every sponsor, half of 266 studies reached it within 19 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Urinary Incontinence, Stress →