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Completed

NCT Number: NCT05751213

Knack Technique in Post-menopausal Women With Stress Urinary Incontinence

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

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Key information

Conditions

Urinary Incontinence,Stress Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shalamar Hospital

Lahore, Punjab Province, 05499, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

knack technique.

Other

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)

pelvic floor muscle exercises

Other

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

Primary outcomes

  1. 3 DAY BLADDER DIARY

    Time frame: 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 outcomes

  1. PERFECT SCHEME

    Time frame: 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.

  2. THE INCONTINENCE QUALITY OF LIFE QUESTIONNAIRE (I-QOL)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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