To evaluate the effect of pelvic floor muscle training with the "Knack" technique in women with stress urinary incontinence - Randomized Study

Compare pelvic floor muscle training with “Knack” contraction

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-9mh6p6

Enrollment

Unknown

Registered

2020-07-27

Start date

2018-10-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence,Stress

Interventions

Women with a medical diagnosis of stress urinary incontinence are invited to participate in the study. In total there will be 98 women, with 48 on each arm. After the evaluation with pad test, flowmet

Procedure/surgery

Q65.060

A01.923.600.600

H02.010.625

G11.427.494

F01.145.632

Eligibility

Sex/Gender

Female

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Women with 18 years old and under 85 years old;diagnosis with stress urinary incontinence; referred for evaluation and treatment at the Urinary Dysfunctions Clinic Urology Discipline - UNIFESP;who agree to participate in the study and sign the free consent form and enlightened.

Exclusion criteria

Exclusion criteria: Women diagnosed with overactive bladder;pregnant woman;neurological disease;with severe cognitive impairment;psychiatric diagnoses;urethral vesicle fistula;stage III prolapse;renal and bladder stones;urethral cysts and diverticula;bladder cancer.

Design outcomes

Primary

Measure	Time frame
In the primary endpoint, it is expected that both therapies will show good results in the treatment of stress urinary incontinence. The results will be evaluated with the questionnaires, the pad test and the satisfaction of these women	—

Secondary

Measure	Time frame
As a secondary outcome, it is expected to analyze the quality of life of these women during treatment. To assess these variables, the quality of life questionnaire is required, which will be the World Health Organization Quality of Life instrument shortened and validated in Portuguese, with a scale from 0% to 100%, so the higher the score, the better the quality of life of these women.;As a secondary outcome, it is expected to analyze the adherence of these women during treatment. To evaluate the adherence of these women to treatment, the exercise diary is delivered, according to the filling, 0% to 100% is scored. Descriptive analyzes will be performed, using mean, standard deviation, percentile, minimum and maximum values, later statistical tests such as “t-stundent” will be used to compare the pre and post treatment moments and ANOVA for analysis between groups, the 95% confidence interval will be used.	—

Measure

Time frame

As a secondary outcome, it is expected to analyze the quality of life of these women during treatment. To assess these variables, the quality of life questionnaire is required, which will be the World Health Organization Quality of Life instrument shortened and validated in Portuguese, with a scale from 0% to 100%, so the higher the score, the better the quality of life of these women.;As a secondary outcome, it is expected to analyze the adherence of these women during treatment. To evaluate the adherence of these women to treatment, the exercise diary is delivered, according to the filling, 0% to 100% is scored. Descriptive analyzes will be performed, using mean, standard deviation, percentile, minimum and maximum values, later statistical tests such as “t-stundent” will be used to compare the pre and post treatment moments and ANOVA for analysis between groups, the 95% confidence interval will be used.

—

Countries

Brazil

Contacts

Public ContactMaira Santos

Universidade Federal de São Paulo

maira.oshiro@gmail.com+55-(11)-55764517

Outcome results

None listed

Source: REBEC (via WHO ICTRP)