Knack Technique in Post-menopausal Women With Stress Urinary Incontinence

Urinary Incontinence,Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05751213
• Other study ID #: REC/RCR & AHS/23/0506
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

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)
• 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

Locations

Country	Name	City	State
Pakistan	Shalamar Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Alves FK, Riccetto C, Adami DB, Marques J, Pereira LC, Palma P, Botelho S. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas. 2015 Jun;81(2):300-5. doi: 10.1016/j.maturitas.2015.03.006. Epub 2015 Mar 14. — View Citation

Bertotto A, Schvartzman R, Uchoa S, Wender MCO. Effect of electromyographic biofeedback as an add-on to pelvic floor muscle exercises on neuromuscular outcomes and quality of life in postmenopausal women with stress urinary incontinence: A randomized controlled trial. Neurourol Urodyn. 2017 Nov;36(8):2142-2147. doi: 10.1002/nau.23258. Epub 2017 May 16. — View Citation

Bo K. Physiotherapy management of urinary incontinence in females. J Physiother. 2020 Jul;66(3):147-154. doi: 10.1016/j.jphys.2020.06.011. Epub 2020 Jul 21. No abstract available. — View Citation

Fitz FF, Gimenez MM, de Azevedo Ferreira L, Matias MMP, Bortolini MAT, Castro RA. Effects of voluntary pre-contraction of the pelvic floor muscles (the Knack) on female stress urinary incontinence-a study protocol for a RCT. Trials. 2021 Jul 23;22(1):484. doi: 10.1186/s13063-021-05440-0. — View Citation

Kolodynska G, Zalewski M, Rozek-Piechura K. Urinary incontinence in postmenopausal women - causes, symptoms, treatment. Prz Menopauzalny. 2019 Apr;18(1):46-50. doi: 10.5114/pm.2019.84157. Epub 2019 Apr 9. — View Citation

Tosun OC, Solmaz U, Ekin A, Tosun G, Gezer C, Ergenoglu AM, Yeniel AO, Mat E, Malkoc M, Askar N. Assessment of the effect of pelvic floor exercises on pelvic floor muscle strength using ultrasonography in patients with urinary incontinence: a prospective randomized controlled trial. J Phys Ther Sci. 2016 Jan;28(2):360-5. doi: 10.1589/jpts.28.360. Epub 2016 Feb 29. — View Citation

Tugtepe H, Thomas DT, Ergun R, Kalyoncu A, Kaynak A, Kastarli C, Dagli TE. The effectiveness of transcutaneous electrical neural stimulation therapy in patients with urinary incontinence resistant to initial medical treatment or biofeedback. J Pediatr Urol. 2015 Jun;11(3):137.e1-5. doi: 10.1016/j.jpurol.2014.10.016. Epub 2015 Mar 12. — View Citation

Yates A. Female pelvic floor 2: assessment and rehabilitation. Nursing Times 2019b. 2019;115(6):30-3

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 DAY BLADDER DIARY	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	PERFECT SCHEME	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
Secondary	THE INCONTINENCE QUALITY OF LIFE QUESTIONNAIRE (I-QOL)	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