Knack Technique in Post-menopausal Women With Stress Urinary Incontinence

March 4, 2024 updated by: Riphah International University

Effects of Pelvic Floor Muscle Exercises With and Without 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 05499
        • Shalamar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12th week
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
12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: hina gul gul, MSOMPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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