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Completed

NCT Number: NCT07421531

Effects of Pilates With and Without Voluntary Pelvic Floor Muscle Contraction Compared to Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence

This assessor-blinded randomized controlled trial aims to compare the effectiveness of three exercise programs for the treatment of stress urinary incontinence (SUI) in women: (1) Pilates without voluntary pelvic floor muscle contraction, (2) Pilates combined with voluntary pelvic floor muscle contraction, and (3) isolated pelvic floor muscle training (PFMT).

Seventy-eight women aged over 18 years with self-reported SUI are randomly allocated into three parallel groups. Interventions last 6 weeks, with two sessions per week (12 sessions).

The primary outcome is the change in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) score from baseline to post-intervention. Secondary outcomes include urinary frequency and leakage episodes (72-hour bladder diary), pelvic floor muscle strength (Modified Oxford Scale), endurance, rapid contractions, and vaginal squeeze pressure measured by perineal manometry (Peritron).

The hypothesis is that Pilates combined with voluntary pelvic floor muscle contraction will be superior to Pilates alone and comparable or superior to isolated PFMT.

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Key information

Conditions

Stress Urinary Incontinence (SUI) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Uberlandia

Uberlândia, Minas Gerais, 30400-678, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women ≥18 years
  • Self-reported stress urinary incontinence
  • Positive response to stress-related leakage question

Exclusion criteria

  • Inability to read/respond to questionnaires
  • Urinary tract infection within last 2 weeks
  • Current smoking
  • Previous pelvic surgery (except cesarean section)
  • Previous pelvic radiotherapy
  • Neurological disease
  • Pelvic floor muscle strength grade 0-1 (Modified Oxford Scale)
  • Pregnancy or <3 months postpartum

Treatment and study plan

Pelvic Floor Muscle training

Other

Supervised isolated pelvic floor muscle exercises performed in supine, sitting, and standing positions, including sustained and rapid contractions, twice weekly for 12 sessions.

Pilates exercise program

Other

12-session supervised Pilates program including mat and apparatus exercises (Reformer, Chair, Cadillac), performed twice weekly. Abdominal activation during expiration is required, without voluntary pelvic floor muscle contraction instruction.

Pilates With Voluntary Pelvic Floor Muscle Contraction

Other

Same 12-session supervised Pilates protocol, with simultaneous voluntary pelvic floor muscle contraction during each expiratory phase.

Primary outcomes

  1. Change in International Consultation on Incontinence (ICIQ-SF) total score

    Time frame: Baseline and 6 weeks

    Difference in total score from baseline to post-intervention. Higher scores indicate worse urinary incontinence impact.

Secondary outcomes

  1. Change in urinary leakage episodes (72-hour bladder diary)

    Time frame: Baseline and 6 weeks

    Change from baseline to 12 weeks in the number of urinary leakage episodes recorded in a 72-hour bladder diary. Higher values indicate worse symptom severity.

  2. Change in Pelvic Floor Muscle Strength (Modified Oxford Scale, 0-5)

    Time frame: baseline and 6 weeks

    Change from baseline to12 session in pelvic floor muscle strength measured using the Modified Oxford Scale (0 = no contraction; 5 = strong contraction with lift toward the pubic symphysis). Higher scores indicate greater muscle strength.

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Pilates, Pilates Combined With Voluntary Pelvic Floor Muscle Contraction, and Isolated Pelvic Floor Muscle Training for the Treatment of Stress Urinary Incontinence in Women

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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