NCT05851729

Brief Summary

To study the effects of kegal exercises with and without postural correction on pelvic organ prolapse in primiparous women. Although pregnancy is a physiological process, it is associated with risk factors. These risk factors can put women at risk. One of the most common problems is pelvic floor muscle weakness, and this weakness of pelvic floor muscles causes many other problems, such as pelvic organ prolapse. Normal delivery (vaginal delivery) can cause laxity and weakness of ligaments such as the external urethral and pubourethral. Pelvic organs prolapse severely affects the quality of life of patients. Pelvic organ prolapse appears in women after vaginal delivery. Pelvic muscle training is a conservative treatment for many problems, including pelvic organ prolapse. However, the effects of pelvic floor muscle training for pelvic organ prolapse in primiparous women are controversial. This study is aimed at a systematic review of the effects of pelvic floor muscle training on pelvic organ prolapse in primiparous women.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

March 31, 2023

Last Update Submit

May 9, 2023

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Pelvic Floor Impact Questionnaire. (PFIQ-7)

    The PFIQ is a patient report designed to assess life impact of pelvic floor disorders on women

    1st day

Study Arms (2)

Kegal exercises with postural correction

EXPERIMENTAL
Other: Kegal exercises with postural correction

Kegal exercises without postural correction

EXPERIMENTAL
Other: Kegal exercises without postural correction

Interventions

Kegal exercises with postural correctionOTHER

Kegal exercises with postural correction

Kegal exercises with postural correction
Kegal exercises without postural correctionOTHER

Kegal exercises without postural correction

Kegal exercises without postural correction

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous,Age: 20-40,
  • th to 8th week after delivery,
  • Singleton baby vaginally fully term,
  • Non instrumented birth of child,
  • Grade 1 prolapse (5)

You may not qualify if:

  • Women with Chronic Cough,
  • Constipation,
  • Previous Pelvic surgery,
  • Pelvic malignancy,
  • Genitourinary Infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Hospital

Lahore, Punjab Province, 54660, Pakistan

RECRUITING

Related Publications (2)

  • Sigurdardottir T, Steingrimsdottir T, Geirsson RT, Halldorsson TI, Aspelund T, Bo K. Postpartum pelvic organ prolapse and pelvic floor muscle training: secondary analysis of a randomized controlled trial of primiparous women. Int Urogynecol J. 2023 Jun;34(6):1319-1326. doi: 10.1007/s00192-023-05502-8. Epub 2023 Mar 30.

    PMID: 36995416BACKGROUND

  • Artymuk NV, Khapacheva SY. Device-assisted pelvic floor muscle postpartum exercise programme for the management of pelvic floor dysfunction after delivery. J Matern Fetal Neonatal Med. 2022 Feb;35(3):481-485. doi: 10.1080/14767058.2020.1723541. Epub 2020 Feb 4.

    PMID: 32019378BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Hafiza Mehjabeen, MS(WHPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Misbah Jaffar, MS(WHPT)

CONTACT

03069680832mishijaffar1998@gmail.com

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

March 31, 2023

First Posted

May 10, 2023

Study Start

January 1, 2023

Primary Completion

June 3, 2023

Study Completion

June 3, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)