Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
ID06957795

Investigation of the Preoperative Effectiveness of Intensive Pelvic Floor Muscle Training in Women With Urinary Incontinence: a Randomized Controlled Trial

Led by Gulhane School of Medicine · Updated on 2025-05-08

60

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pelvic floor muscles support pelvic organs and help control urination and bowel movements. Weakness in these muscles can cause problems like pelvic organ prolapse, urinary incontinence (UI), and sexual or anorectal disorders. Stress urinary incontinence (SUI), the most common type among women, occurs when urine leaks during activities that increase pressure in the abdomen. Risk factors include being female, aging, obesity, smoking, chronic constipation, past gynecological surgeries, and childbirth. This research aims to evaluate how effective intensive pelvic floor muscle training (PFMT) is before surgery in women with SUI, to guide better pelvic rehabilitation and possibly reduce the need for surgery.

CONDITIONS

Brief Title

Preoperative Pelvic Floor Muscle Training in Female Urinary Incontinence

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Woman aged 18 to 65 years
  • Diagnosed with stress urinary incontinence or stress-predominant mixed urinary incontinence by an obstetrician-gynecologist
  • Able to actively contract pelvic floor muscles
  • No genital anatomical abnormalities
  • Able to understand and follow verbal and written instructions
  • Referred to physiotherapy at least 6 weeks before planned surgery
  • Completed at least 75% of the assigned exercises (adequate compliance)
Not Eligible

You will not qualify if you...

  • Not willing to participate
  • Pregnant
  • Previous pelvic floor surgery
  • Previous pelvic floor physiotherapy
  • Current vaginal or urinary infection
  • Unable to tolerate pelvic floor muscle function measurement
  • Neuromuscular or neurological disease affecting muscle function

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants receive pelvic floor knowledge and awareness training. Those in the exercise group also perform an intensive pelvic floor exercise program at home for 6 weeks, targeting fast and slow twitch pelvic floor muscle fibers. The exercise group has an interim check-up in the 2nd week to monitor progress.

1 to 2 visits (in-person)

Follow-up

Duration - 1 day

Participants return for a final check-up at the end of the 6-week period to evaluate changes in symptoms, pelvic floor muscle function, muscle contraction, incontinence severity, and pelvic floor health knowledge.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Gülhane Education and Research Hospital, Department of Obstetrics and Gynecology

Ankara, Turkey (Türkiye)

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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