NCT05463172

Brief Summary

Urinary incontinence is common females., it badly affects their performance and result in psychosocial problems in addition to the barriers that already have been resulted from incontinence. This study combines simple regime of hip adductor a strengthening with pelvic floor muscles. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. If this comes out to be effective, this can be great contribution to gym doing females to improve their urinary incontinence related impairments. Woman would be encouraged to continue regular exercise. This will be randomized clinical trial. There are two groups for the compression of adductors strengthening and pelvic floor muscle strengthening. The collected data will be entered in SPSS 20.0, Descriptive and Inferential statists will be applied. Results and conclusion will be drawn.

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 May 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

First Submitted

Initial submission to the registry

April 15, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

April 15, 2022

Last Update Submit

December 7, 2022

Conditions

Keywords

bladder neck mobility

Outcome Measures

Primary Outcomes (3)

  • urinary distress

    Urinary Distress Inventory, Short Form (UDI-6), UDI-6 consists of 6 items: 1-Frequent urination, 2-Leakage related to feeling of urgency, 3-Leakage related to activity, 4-Coughing, or sneezing small amounts of leakage (drops), 5-Difficulty emptying the bladder, and 6-Pain or discomfort in the lower abdominal or genital area

    6 months

  • Cough stress test

    Cough stress test to evaluate urinary incontinence. Leakage of fluid from the urethral meatus coincident with/simultaneous to the cough(s) is considered a positive test.

    6 months

  • Vaginal Ultrasonography

    Bladder neck mobility can be described as a semicircular movement with the tip of the symphysis pubis as the center and a line from the tip to the bladder neck as the radius (BS). Movement can be measured by 2 independent factors: BS distance and size of the angle between the BS line and the midline of the symphysis, at rest, during the Valsalva maneuver and withholding urine. The continent controls were characterized by a 90 degrees angle at rest, a long BS (2.4 cm) and a fixed bladder neck

    6 months

Study Arms (2)

pelvic floor muscles strengthening exercises

EXPERIMENTAL

pelvic floor muscles strengthening exercises

Other: pelvic floor muscles strengthening exercises

abdominal strengthening exercises

EXPERIMENTAL

abdominal strengthening exercises

Other: abdominal strengthening exercises

Interventions

abdominal strengthening exercises

abdominal strengthening exercises

to strengthen pelvic floor muscles

pelvic floor muscles strengthening exercises

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale only
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 25-45 years of age
  • Females with abdominal muscles weakness
  • Females with pelvic floor muscles weakness
  • Females with urinary incontinence

You may not qualify if:

  • Pregnant females
  • Females having any history of trauma
  • Any neurological disorders affecting bowl bladder
  • Any malignancy in lower abdominal area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinah Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

  • Schneeweiss J, Koch M, Umek W. The human urinary microbiome and how it relates to urogynecology. Int Urogynecol J. 2016 Sep;27(9):1307-12. doi: 10.1007/s00192-016-2944-5. Epub 2016 Jan 25.

    PMID: 26811114BACKGROUND
  • Al-Mukhtar Othman J, Akervall S, Milsom I, Gyhagen M. Urinary incontinence in nulliparous women aged 25-64 years: a national survey. Am J Obstet Gynecol. 2017 Feb;216(2):149.e1-149.e11. doi: 10.1016/j.ajog.2016.09.104. Epub 2016 Oct 6.

    PMID: 27720862BACKGROUND
  • 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

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 Symptoms

Study Officials

  • Dr. Rabiya Noor, PhD

    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

April 15, 2022

First Posted

July 18, 2022

Study Start

May 15, 2022

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations