NCT04428853

Brief Summary

the study is aimed to identify the feasibility, safety, and efficacy of iyengar Yoga therapy in the management of stress urinary incontinence among young female

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

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

First Submitted

Initial submission to the registry

June 10, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

April 13, 2022

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

June 10, 2020

Last Update Submit

April 12, 2022

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (9)

  • pelvic muscle strength (Pre treatment)

    Perineometer is used to to assess pelvic muscle strength

    baseline

  • pelvic muscle strength (Post treatment)

    Perineometer is used to to assess pelvic muscle strength

    4th week after intervention

  • pelvic muscle strength (Post treatment)

    Perineometer is used to to assess pelvic muscle strength

    8th week after intervention

  • quantity of urine leakage (Pre treatment)

    1-hour pad test is used to measure the quantity of urine leakage

    baseline

  • quantity of urine leakage (Post treatment)

    1-hour pad test is used to measure the quantity of urine leakage

    4th week after intervention

  • quantity of urine leakage (Post treatment)

    1-hour pad test is used to measure the quantity of urine leakage

    8th week after intervention

  • Quality of life (Pre treatment)

    International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe

    baseline

  • Quality of life (Post treatment)

    International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe

    4th week after intervention

  • Quality of life (Post treatment)

    International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe

    8th week after intervention

Study Arms (1)

exercise

EXPERIMENTAL

A schedule has designed by the researcher for group yoga therapy of the participant twice a week, each session lasting for 75- minutes for the duration of 8 weeks

Behavioral: iyengar yoga

Interventions

iyengar yogaBEHAVIORAL

different yoga postures including warm up, cool down and meditation that incorporate 75 minutes of training

exercise

Eligibility Criteria

Age17 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Married Females of age 17-40 year
  • Diagnosed Cases of Stress Urinary Incontinence due to pelvic floor muscle weakness

You may not qualify if:

  • Current Urinary Tract Infection (UTI) or hematuria
  • Pregnancy
  • On pharmacological treatment of SUI
  • Any red flags

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziauddin university

Karachi, Sindh, 74000, Pakistan

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

  • sadia shafaq

    Ziauddin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 11, 2020

Study Start

August 15, 2020

Primary Completion

March 15, 2021

Study Completion

June 30, 2021

Last Updated

April 13, 2022

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)