NCT07004738

Brief Summary

The study will be conducted on 40 women between the ages of 20-40 who volunteer to participate in the study. All participants will be selected from individuals who have been diagnosed with pelvic floor dysfunction and have no history of pelvic surgery. Pelvic floor dysfunction will be diagnosed by an Obstetrics and Gynecology Specialist. Participants will be divided into two groups as the Pelvic floor exercise group and the control group.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

May 26, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 26, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

May 26, 2025

Last Update Submit

May 26, 2025

Conditions

Keywords

pelvic floor exercisesrectus abdominis muscle thicknessresidual bladder

Outcome Measures

Primary Outcomes (2)

  • Ultrasound Measurements

    Ultrasound measurements will be performed at two points: at baseline (before the exercise program) and after 6 weeks of intervention. A high-resolution ultrasound device will be used to measure the thickness and cross-sectional area of the rectus abdominis muscle at rest.

    20 minutes

  • The residual bladder volume measurement

    The residual bladder volume immediately after voiding will also be measured by ultrasonography to assess bladder control.A normal post-void residual volume is between 50 mL (milliliters) and 100 mL.

    20 minutes

Study Arms (2)

Pelvic floor exercise group

EXPERIMENTAL

Participants will be instructed to perform daily pelvic floor exercises under the guidance of a physical therapist specializing in pelvic health. The exercises focus on isolated pelvic muscle contractions and core muscle engagement. The exercises will be performed 3 times per day for 6 weeks.

Other: Pelvic floor exercises

Control Group

OTHER

Women in this group who have been diagnosed with pelvic floor dysfunction will not be given any exercises. Women will continue their routine lives and their evaluations will be made.

Other: Control group

Interventions

The bladder should be emptied before the exercise. In order to correctly identify the pelvic floor muscles, it is necessary to initially try to hold urine while emptying the bladder. If the result is successful, it means that the correct muscles have contracted. During the learning phase, the exercise can be done in a supine position with the legs bent at the knees or in a sitting position. Initially, the pelvic floor muscles should be contracted for 5 seconds by pulling them inward as if stopping the passage of urine or gas, and then rested for 5 seconds.

Pelvic floor exercise group

Women in this group who have been diagnosed with pelvic floor dysfunction will not be given any exercises. Women will continue their routine lives and their evaluations will be made.

Control Group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe gender eligibility is based on self-representation of gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • were being between 20-40 years of age,
  • having pelvic floor dysfunction,
  • not having any problems that would prevent performing pelvic floor exercises

You may not qualify if:

  • previous pelvic surgery
  • active urinary tract infections
  • neurological conditions affecting bladder control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Wang X, Li H, Luan B, Han R, Lun W. Dynamic Evaluation of the Rectus Abdominis Muscle before and after Delivery by Ultrasonography. Evid Based Complement Alternat Med. 2022 Aug 26;2022:9751136. doi: 10.1155/2022/9751136. eCollection 2022.

Related Links

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • MERVE YILMAZ MENEK, Assoc. Prof.

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 26, 2025

First Posted

June 4, 2025

Study Start

May 26, 2025

Primary Completion

July 30, 2025

Study Completion

September 30, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

IPD will be shared where necessary.

Locations