Clinical trial NCT05751213: Knack Technique in Post-menopausal Women With Stress Urinary Incontinence
Official title: Effects of Pelvic Floor Muscle Exercises With and Without Knack Technique in Post-menopausal Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence,Stress
Keywords: exercise
pelvic floor
post menopause
urinary incontinence
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 22
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 3 DAY BLADDER DIARY
timeFrame: 12th week
Secondary outcomes:
measure: PERFECT SCHEME
timeFrame: 12th week
measure: THE INCONTINENCE QUALITY OF LIFE QUESTIONNAIRE (I-QOL)
timeFrame: 12th week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shalamar Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: hina gul gul, MSOMPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.
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.
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.
citation: Yates A. Female pelvic floor 2: assessment and rehabilitation. Nursing Times 2019b. 2019;115(6):30-3