NCT06715813

Brief Summary

SUI stands for stress urinary incontinence. A common condition seen among multiparous women associated with physical strain like bending, coughing, sneezing that put strain on the pelvic floor muscles.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 28, 2024

Last Update Submit

November 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • stress urinary incontinence

    SUI will be measured using Michigan incontinence index

    8 weeks

Study Arms (2)

pelvic floor strengthening group

ACTIVE COMPARATOR

Group A that is the control group will includes pelvic floor strengthening exercises. given three times a week on alternate days and session will be given for 4 weeks (protocol) and the retention effect will be given for 8 weeks. Each session will be performed at a moderate intensity , indicated by sustained contractions for 5 seconds initially and then progresively increased to 10 seconds overtime. pelvic floor strengtheing exercises includes : 1. breathing exercises, 2. kegels exercises 3. bridging exercises 4. squatting 5. Elevator exercises

Procedure: pelvic floor strengthening

PFMS + Transversus abdominal strengthening

EXPERIMENTAL

group B includes interventional group which includes core stabilization exercises for 2 weeks like stomach hallowing , dead bugs and pelvic tilt exercises and after 2 weeks dead bug progression, planks and pelvic floor strengthening exercises.

Procedure: pelvic floor strengtheningProcedure: Transversus abdominal strengthening

Interventions

pelvic floor strengthening exercises includes : 1. breathing exercises, 2. kegels exercises 3. bridging exercises 4. squatting 5. Elevator exercises

PFMS + Transversus abdominal strengtheningpelvic floor strengthening group

core stabilization exercises for 2 weeks like stomach hallowing , dead bugs and pelvic tilt exercises and after 2 weeks dead bug progression, planks

PFMS + Transversus abdominal strengthening

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAge group: multiparous women ( 30-50 yrs)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age group: multiparous women ( 30-50 yrs)
  • females only
  • all modes of delivery of childbirth
  • diagnosed cases of SUI from fauji foundation hospital.
  • patient without any medical contraindications and limitations (Sign and Symptoms of SUI)
  • accordances with the michigan incontinence index

You may not qualify if:

  • pregnancy or recent childbirth
  • any history of pelvic organ prolapse or surgical intervention
  • metabolic diseases, uncontrolled hypertension as well as neurological intervention
  • any kind of malignancy in lower abdomen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 460000, 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having two groups. One group will receive SNAGs and the second will receive Sternocleidomastoid Release along with SNAGS. Both groups will be recruited concurrently.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 4, 2024

Study Start

June 10, 2024

Primary Completion

November 10, 2024

Study Completion

December 30, 2024

Last Updated

December 4, 2024

Record last verified: 2024-11

Locations