NCT05751213

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

February 20, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

exercisepelvic floorpost menopauseurinary incontinence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • PERFECT SCHEME

    12th week

  • THE INCONTINENCE QUALITY OF LIFE QUESTIONNAIRE (I-QOL)

    12th week

Study Arms (2)

knack technique.

EXPERIMENTAL

pelvic floor muscle exercises with knack technique.

Other: knack technique.Other: pelvic floor muscle exercises

pelvic floor muscle exercises

ACTIVE COMPARATOR

pelvic floor muscle exercises

Other: pelvic floor muscle exercises

Interventions

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)

knack technique.

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

knack technique.pelvic floor muscle exercises

Eligibility Criteria

Age50 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspost-menopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalamar Hospital

Lahore, Punjab Province, 05499, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 28508398BACKGROUND
  • 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.

    PMID: 32709588BACKGROUND
  • 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.

    PMID: 31114458BACKGROUND
  • 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.

    PMID: 34301324BACKGROUND
  • 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.

    PMID: 25862491BACKGROUND
  • 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.

    PMID: 27065519BACKGROUND
  • 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.

    PMID: 25824876BACKGROUND
  • Yates A. Female pelvic floor 2: assessment and rehabilitation. Nursing Times 2019b. 2019;115(6):30-3

    BACKGROUND
  • Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

MeSH Terms

Conditions

Urinary Incontinence, StressMotor ActivityUrinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • hina gul gul, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 2, 2023

Study Start

October 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations