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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence (SUI)
• Intervention / Treatment: Other: Pelvic Floor Muscle Training; Other: Pilates Exercise Program; Other: Pilates With Voluntary Pelvic Floor Muscle Contraction

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Uberlândia, Minas Gerais, Brazil, 30400-678
      • Federal University of Uberlândia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 - Pelvic floor muscle training; Intervention: Behavioral: Pelvic Floor Muscle Training Participants perform isolated pelvic floor muscle exercises in supine, sitting, and standing positions, including sustained and rapid contractions, twice weekly for 12 session. Stretching and mobility exercises are performed during rest intervals.	Other: Pelvic Floor Muscle Training; Supervised isolated pelvic floor muscle exercises performed in supine, sitting, and standing positions, including sustained and rapid contractions, twice weekly for 12 sessions.
Experimental: Arm 2 - Pilates group; Intervention: Other: Pilates Exercise Program Participants perform mat and equipment-based Pilates exercises (Reformer, Chair, Cadillac) for 6 weeks, twice weekly - 12 session. Exercises are performed in three progressive phases (8-10-12 repetitions, 3 sets). Abdominal contraction is requested during expiration to activate the "powerhouse," without voluntary pelvic floor muscle contraction instruction.	Other: Pilates Exercise Program; 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.
Experimental: Arm 3 - Pilates + pelvic floor contraction; Intervention: Other: Pilates With Voluntary Pelvic Floor Muscle Contraction Same protocol as the Pilates group; however, participants are instructed to perform simultaneous voluntary pelvic floor muscle contraction during each expiratory phase.	Other: Pilates With Voluntary Pelvic Floor Muscle Contraction; Same 12-session supervised Pilates protocol, with simultaneous voluntary pelvic floor muscle contraction during each expiratory phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in International Consultation on Incontinence (ICIQ-SF) total score	Difference in total score from baseline to post-intervention. Higher scores indicate worse urinary incontinence impact.	Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in urinary leakage episodes (72-hour bladder diary)	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.	Baseline and 6 weeks
Change in Pelvic Floor Muscle Strength (Modified Oxford Scale, 0-5)	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.	baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): November 29, 2025
• Study Completion (Actual): November 29, 2025

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: 88644825.5.0000.5152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in publications, including baseline characteristics and outcome measures. Study protocol and statistical analysis plan will be avalilable. Data will be available upon reasonable request to the principal investigator and after approval by the institutional ethics committee.
• IPD Sharing Time Frame: Beginning 6 months after publication and ending 5 years after publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No