NCT04994041

Brief Summary

Stress incontinence is common form of urinary incontinence in females. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. Group A: with pelvic floor muscle strengthening plus adductor is strengthening. Group B: with pelvic floor muscle strengthening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

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

January 10, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

August 5, 2021

Last Update Submit

August 27, 2021

Conditions

Keywords

Urinary Incontinence, Pelvic Floor Exercises

Outcome Measures

Primary Outcomes (2)

  • Urinary Distress Inventory (UDI-6)

    It is 6 point scale No= 0, Not at all= 1, Somewhat= 2, Moderately= 3, Quite a bit= 4. Add all scores and multiply by 6 then multiply by 25 for the scale score The UDI-6 Total Score of 33.33 was determined to be the optimal cutoff for distinguishing between symptomatic and asymptomatic women. For UDI-6 scores more than 33.33 indicate higher distress caused by urinary incontinence symptoms.

    8 weeks

  • The Revised Urinary Incontinence Scale (RUIS)

    It is a 5 point scale with each point contain 3 to 4option. Possible score range of 0 - 16 A score of less than 4 indicates that the patient has no urinary incontinence a score of 4-8 is considered mild. a score of 9-12 is considered moderate. a score of 13 or above is considered severe.

    8 weeks

Study Arms (2)

Pelvic floor muscle plus adductor strengthening

EXPERIMENTAL

pelvic floor muscle plus adductor strengthening

Other: Pelvic floor muscle plus adductor strengthening

Pelvic floor muscle exercises

ACTIVE COMPARATOR

pelvic floor muscle exercises

Other: Pelvic floor muscle exercises

Interventions

20 sessions of pelvic floor muscle strengthening plus adductor is strengthening

Pelvic floor muscle plus adductor strengthening

20 sessions of pelvic floor muscle strengthening

Pelvic floor muscle exercises

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 25-45 years of age
  • Engaged in gym exercises
  • Fulfilling signs and symptoms of stress 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)

Genesis fitness centere

Gujranwala, Punjab Province, 52250, Pakistan

Location

Related Publications (7)

  • 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
  • Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.

    PMID: 28977091BACKGROUND
  • Pizzoferrato AC, Fauconnier A, Fritel X, Bader G, Dompeyre P. Urethral Closure Pressure at Stress: A Predictive Measure for the Diagnosis and Severity of Urinary Incontinence in Women. Int Neurourol J. 2017 Jun;21(2):121-127. doi: 10.5213/inj.1732686.343. Epub 2017 Jun 21.

    PMID: 28673060BACKGROUND
  • de Mattos Lourenco TR, Matsuoka PK, Baracat EC, Haddad JM. Urinary incontinence in female athletes: a systematic review. Int Urogynecol J. 2018 Dec;29(12):1757-1763. doi: 10.1007/s00192-018-3629-z. Epub 2018 Mar 19.

    PMID: 29552736BACKGROUND
  • Diokno AC, Newman DK, Low LK, Griebling TL, Maddens ME, Goode PS, Raghunathan TE, Subak LL, Sampselle CM, Boura JA, Robinson AE, McIntyre D, Burgio KL. Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1333-1341. doi: 10.1001/jamainternmed.2018.3766.

    PMID: 30193294BACKGROUND
  • 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, StressUrinary 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

  • Muhammad Sanaullah, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2021

First Posted

August 6, 2021

Study Start

January 10, 2021

Primary Completion

August 10, 2021

Study Completion

August 10, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations