Knack Technique in Post-menopausal Women With Stress Urinary Incontinence

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05751213

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the Effects of pelvic floor muscle exercise with and without Knack Technique in post-menopausal women with stress urinary incontinence

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence,Stress	Other: knack technique. Other: pelvic floor muscle exercises	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Pelvic Floor Muscle Exercises With and Without Knack Technique in Post-menopausal Women With Stress Urinary Incontinence

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: knack technique. pelvic floor muscle exercises with knack technique.	Other: knack technique. It consists of 11 patients who will receive pelvic floor muscle exercise and knack technique at outpatient clinic and at home. 8 maximum voluntary contractions of pelvic floor muscles in supine sustained for 6s with a resting interval twice as long between contractions, followed by 3 fast contractions. 3 times per day. 3 days per week at home for 3 months. 3 exercises in supine position. 8 repetitions of each exercise 3times per day , 3 days per week. . Orientation to perform the knack during activities of daily life. The knack consists of voluntary pelvic floor muscles contraction before and during activities that increase abdominal pressure. The exercise will be performed in the supine (first month), sitting (second month), and standing (third month) positions twice a month for 3 months at outpatient clinic. (6 outpatient sessions) Other: pelvic floor muscle exercises It consists of 11 patients who will receive pelvic floor muscle exercises at the outpatient and at home. 8 maximum voluntary contractions of pelvic floor muscles in supine position sustained for 6s with a resting interval twice as long between contractions followed by 3 fast contractions. 3 times per day , 3 days per week at home for 3 months. Two sessions per month at outpatient clinic for 3 months
Active Comparator: pelvic floor muscle exercises pelvic floor muscle exercises	Other: pelvic floor muscle exercises It consists of 11 patients who will receive pelvic floor muscle exercises at the outpatient and at home. 8 maximum voluntary contractions of pelvic floor muscles in supine position sustained for 6s with a resting interval twice as long between contractions followed by 3 fast contractions. 3 times per day , 3 days per week at home for 3 months. Two sessions per month at outpatient clinic for 3 months

Arm

Intervention/Treatment

Experimental: knack technique.

pelvic floor muscle exercises with knack technique.

Other: knack technique.

It consists of 11 patients who will receive pelvic floor muscle exercise and knack technique at outpatient clinic and at home. 8 maximum voluntary contractions of pelvic floor muscles in supine sustained for 6s with a resting interval twice as long between contractions, followed by 3 fast contractions. 3 times per day. 3 days per week at home for 3 months. 3 exercises in supine position. 8 repetitions of each exercise 3times per day , 3 days per week. . Orientation to perform the knack during activities of daily life. The knack consists of voluntary pelvic floor muscles contraction before and during activities that increase abdominal pressure. The exercise will be performed in the supine (first month), sitting (second month), and standing (third month) positions twice a month for 3 months at outpatient clinic. (6 outpatient sessions)

Other: pelvic floor muscle exercises

It consists of 11 patients who will receive pelvic floor muscle exercises at the outpatient and at home. 8 maximum voluntary contractions of pelvic floor muscles in supine position sustained for 6s with a resting interval twice as long between contractions followed by 3 fast contractions. 3 times per day , 3 days per week at home for 3 months. Two sessions per month at outpatient clinic for 3 months

Active Comparator: pelvic floor muscle exercises

pelvic floor muscle exercises

Other: pelvic floor muscle exercises

Outcome Measures

Primary Outcome Measures

3 DAY BLADDER DIARY [12th week]
It is a validated instrument which assesses day time and night time urine leakage episodes during consecutive 3 days. IN column indicates how much you drink and when you drink. OUT column indicates how much urine you pass when you go to toilet. Every time you leak put a cross in OUT column. When you go to bed put a line on the chart next to time. This can tell how many times you have to get up to pass urine.

Secondary Outcome Measures

PERFECT SCHEME [12th week]
The perfect scheme has demonstrated reliability and validity as an assessment tool. Pelvic floor muscles will be assessed by two finger vaginal palpation. The examiner will place fingers at vaginal introitus at about 4cm and the function will be assessed by PERFECT scheme. Modified oxford grading scale (scores of 0-5) will assess the pelvic floor muscle strength.
THE INCONTINENCE QUALITY OF LIFE QUESTIONNAIRE (I-QOL) [12th week]
The incontinence quality of life questionnaire is a valid instrument for measuring quality of life. The incontinence quality of life questionnaire assesses the impact of stress urinary incontinence on quality of life. The limitations in human behavior, psychosocial impact and social embarrassment is evaluated by I-QOL

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Post-menopausal women
Multiparous women
Previous history of vaginal deliveries
Women with mild to moderate stress or mixed incontinence (with predominance of SUI) via the 3 incontinence questions (3IQ)
Able to have a gynecological examination

Exclusion Criteria:

Symptoms of overactive bladder alone
Previous participation in a pelvic floor re-education program and/or previous pelvic floor surgery or currently receiving other treatment for urinary incontinence.
Loss of stools or mucus
Active urinary or vaginal infection in the past 3 months