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

NCT07762391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-13

No results posted yet for this study

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)

Interventions

BEHAVIORAL

Pelvic Floor Muscle Exercise

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.

BEHAVIORAL

Progressive Muscle Relaxation (PMR)

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.

BEHAVIORAL

Combined Pelvic Floor Muscle Exercise and Progressive Muscle Relaxation

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.

Sponsors & Collaborators

  • Karamanoğlu Mehmetbey University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-05-01
Completion
2026-05-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07762391 on ClinicalTrials.gov