NCT07037160

Brief Summary

The objective of the study will be to assess the efficacy of foam rolling alone and combination treatment of foam rolling and Kegel exercises in alleviating urinary incontinence among postpartum women with diastasis recti. The data will be collected from 60 enrolled postpartum females with diastasis recti to evaluate the effectiveness of foam rolling alone compared to foam rolling and Kegel exercises in improving urinary incontinence. The data will be collected using urogenital distress inventory (UDI).

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 17, 2025

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Urogenital Distress Inventory (UDI-6)

    The Urogenital Distress Inventory (UDI-6) is a questionnaire used to assess the impact of urinary symptoms on a woman's quality of life. It consists of six questions, each with four possible responses ranging from "not at all" to "greatly," and the responses are scored from 0 to 3 respectively. The scores for each question are summed, and then the total is multiplied by 33.3 to scale the score to a range of 0-100. Higher scores indicate a greater degree of distress caused by urinary symptoms

    6 Month

Study Arms (2)

Kegel exercises

EXPERIMENTAL
Combination Product: Kegel exercises

Kegel exercises with Foam Rolling

EXPERIMENTAL
Combination Product: Kegel exercises with Foam Rolling

Interventions

Kegel exercisesCOMBINATION_PRODUCT

Kegel exercises, also known as pelvic floor exercises, involve contracting and relaxing the muscles of the pelvic floor to strengthen them. These exercises can help improve urinary and fecal continence, potentially enhance sexual function, and are recommended for both men and women.

Kegel exercises

Foam rolling can be a helpful tool to prepare for or complement Kegel exercises by releasing tension in surrounding muscles and improving overall pelvic floor function. Foam rolling can help address tight muscles in the hips and lower back that can contribute to pelvic floor dysfunction. By releasing these tight areas, foam rolling can allow for better engagement and control of the pelvic floor muscles during Kegel exercises.

Kegel exercises with Foam Rolling

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females with age 20 to 35 years
  • Females with vaginal delivery
  • Non obese females
  • Females diagnosed with diastasis recti and urinary incontinence

You may not qualify if:

  • Females with mental disorders
  • Females who take di-uretic medications
  • Females with malignant tumors
  • Patients with urinary tract infection
  • Patients with a history of pelvic surgery
  • Patients with cognitive dysfunction
  • Female with gynecological conditions or diseases that may affect the investigation results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Superior University

Lahore, Punjab Province, Pakistan

Location

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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

March 4, 2025

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations