Pelvic Floor Muscle Exercise and Progressive Muscle Relaxation for Stress Urinary Incontinence

NCT07762391 | Completed

• 1 other identifier: KMU-SUI-RCT-2025-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Stress urinary incontinence (SUI) is a common condition in women that causes involuntary urine leakage during activities such as coughing, sneezing, laughing, or exercising. This condition can negatively affect physical, emotional, and social well-being and reduce overall comfort. Pelvic floor muscle exercise (PFME) is the recommended first-line conservative treatment for SUI, while progressive muscle relaxation (PMR) may help reduce muscle tension and improve psychological well-being. However, the combined effects of these two interventions on comfort have not been well studied. This randomized controlled trial aims to compare the effects of PFME, PMR, their combined application, and routine care on comfort in women with stress urinary incontinence. Participants will be randomly assigned to one of four study groups and followed for six weeks. Comfort will be assessed at baseline and at Weeks 2, 4, and 6 using a validated questionnaire. The findings are expected to provide evidence for improving conservative treatment strategies and enhancing patient-centered care for women with stress urinary incontinence.

Conditions

Stress Urinary Incontinence (SUI)

Keywords

Progressive Muscle Relaxation; Pelvic Floor Muscle Exercise; Comfort; Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Change in Comfort Level

  To evaluate the effect of pelvic floor muscle exercises, progressive muscle relaxation exercises, and their combined application on comfort levels in women with stress urinary incontinence. Comfort level was assessed using the Urinary Incontinence and Frequency Comfort Questionnaire (UIFCQ).

  Baseline, Week 2, Week 4, and Week 6

Study Arms (4)

Pelvic Floor Muscle Exercise (PFME)

EXPERIMENTAL

Pelvic Floor Muscle Exercise (PFME)

Behavioral: Pelvic Floor Muscle Exercise

Progressive Muscle Relaxation (PMR)

EXPERIMENTAL

Progressive Muscle Relaxation (PMR)

Behavioral: Progressive Muscle Relaxation (PMR)

Combined PFME + PMR

EXPERIMENTAL

Combined PFME + PMR

Behavioral: Combined Pelvic Floor Muscle Exercise and Progressive Muscle Relaxation

Routine Care (Control)

NO INTERVENTION

Routine Care (Control)

Interventions

Pelvic Floor Muscle Exercise BEHAVIORAL

Participants received a standardized pelvic floor muscle exercise (PFME) program delivered individually by a Physical Medicine and Rehabilitation specialist. During the initial 40-minute face-to-face session, participants received education on pelvic floor anatomy, urinary continence mechanisms, identification of the correct pelvic floor muscles, and proper exercise techniques. Participants were instructed to perform slow maximal voluntary contractions of the pelvic floor muscles with progressive contraction duration (3-10 seconds) followed by equal periods of relaxation. The home-based exercise program consisted of three sets of ten contractions performed daily for six weeks. Participants received an educational booklet, an exercise diary, and weekly telephone follow-up to monitor adherence and reinforce compliance.

Pelvic Floor Muscle Exercise (PFME)

Progressive Muscle Relaxation (PMR) BEHAVIORAL

articipants received progressive muscle relaxation (PMR) training based on Jacobson's relaxation technique. The intervention was introduced during an individual face-to-face session conducted by a Physical Medicine and Rehabilitation specialist. Participants were instructed to sequentially contract and relax major muscle groups while practicing slow diaphragmatic breathing to reduce muscle tension and promote physical and psychological relaxation. The standardized home-based PMR program was performed once daily for approximately 20-30 minutes over a six-week period. Participants were provided with written instructions and received weekly telephone follow-up to encourage adherence.

Progressive Muscle Relaxation (PMR)

Combined Pelvic Floor Muscle Exercise and Progressive Muscle Relaxation BEHAVIORAL

Participants received both the standardized pelvic floor muscle exercise (PFME) program and the progressive muscle relaxation (PMR) program throughout the six-week intervention period. PFME and PMR were introduced during individualized face-to-face training sessions by a Physical Medicine and Rehabilitation specialist. Participants were instructed to perform both interventions daily according to the standardized protocols. Weekly telephone follow-up, an exercise diary, and reminder messages were used to support adherence and ensure consistency of the combined intervention.

Combined PFME + PMR

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: Only female participants are eligible to participate in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged 45-55 years Diagnosis of stress urinary incontinence Turkish-speaking Literate Access to the internet Access to a smartphone No active urinary tract infection Not pregnant No neurological or cognitive disorder

You may not qualify if:

• Previous participation in pelvic floor muscle exercise (PFME) or progressive muscle relaxation (PMR) training programs.
• Withdrawal from the study after enrollment.

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

Karaman Eğitim ve Araştırma Hastanesi

Karaman, Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label trial because the nature of the exercise interventions did not permit blinding of participants or intervention providers. Outcome assessments were performed using standardized procedures to ensure consistency across all study groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study was designed as a prospective, single-center, four-arm, parallel-group randomized controlled trial. Eligible women with stress urinary incontinence were randomly assigned in a 1:1:1:1 ratio to one of four study groups: (1) Pelvic Floor Muscle Exercise (PFME), (2) Progressive Muscle Relaxation (PMR), (3) Combined PFME and PMR, or (4) Routine Care (Control). Participants remained in their allocated intervention group throughout the six-week intervention period. Outcome assessments were performed at baseline and at Weeks 2, 4, and 6. Owing to the nature of the interventions, participant and therapist blinding was not feasible; however, outcome assessments were conducted using standardized procedures, and statistical analyses were performed by an investigator blinded to group allocation.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 13, 2026
• Study Start: June 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)