The Effect of Training Based on the Transtheoretical Model on Pelvic Floor Muscle Strength

The Effect of Transtheoretical Model-Based Training on Pelvic Floor Muscle Strength in Women: Creating an Application-Oriented Training Model

The study was designed to evaluate the effect of training based on the transtheoretical model on pelvic floor muscle strength in women.

The study was designed as a randomized controlled single-blind experimental study with pre-test and post-test measurements and will be conducted with sexually active women aged 18 and over who meet the inclusion criteria and who applied to the Sevgi Family Health Center No. 13 in Gaziemir District, Izmir Province.

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvic Floor Awareness
• Intervention / Treatment: Other: Not providing training; Other: TRAINING BASED ON THE TRANSTEOROTİK MODEL

Detailed Description

The pelvic floor is a complex anatomical structure composed of nerve, muscle, fascia, and connective tissue components. Working in conjunction with other muscles associated with the pelvic girdle, the pelvic floor is a vital component responsible for stabilizing the entire body. The primary functions of the pelvic floor and its components include providing support to intra-abdominal structures such as the bladder, urethra, prostate, vagina, uterus, anus, and rectum; supporting continence by enabling the voluntary initiation and cessation of urination and defecation, thus preventing incontinence; preventing pelvic organ prolapse; playing an active role during childbirth; and maintaining sexual function .

Pelvic floor dysfunction (PFD) manifests with various complex symptoms such as urinary incontinence (UI), pelvic organ prolapse (POP), fecal incontinence (FI), sexual problems, and chronic pelvic pain, alongside damage, weakening, and impairment of the pelvic floor's function and morphological structure. affecting women's daily activities, psychosocial status, and overall health perception . Pelvic floor dysfunction is a common problem worldwide, occurring at rates ranging from 1.9% to 46.5%, and is underdiagnosed. In Turkey, the prevalence of pelvic organ prolapse is 30-50%, urinary incontinence is 26.3-71.5%, and fecal/anal incontinence is reported in the literature as 2-3%. it is reported that this rate increases with age, exceeding 10%, and that the rate of sexual dysfunction in women ranges from 20% to 73% stated in their article that approximately 10% of women face pelvic floor problems requiring surgery . Although it varies between countries and societies, the prevalence of pelvic floor dysfunction in women generally ranges between 20-40% .These rates indicate that pelvic floor dysfunction is a significant public health issue.

The treatment and care interventions for pelvic floor dysfunction are a preventive health service that healthcare professionals, particularly midwives in primary healthcare institutions, should prioritize. Providing education on pelvic floor strengthening is important both in preventing misconceptions and in increasing women's knowledge and awareness levels.

A systematic review conducted to determine the effectiveness of health promotion interventions based on behavioral change models for modifying lifestyle factors (physical activity, diet, alcohol, and smoking) in adults receiving primary health care found that the Transtheoretical Model was the most frequently used intervention for these purposes. The Transtheoretical Model was developed by Prochaska and Diclemente to guide individuals in accepting problematic behaviors in their lives and changing these behaviors with positive expectations and desire. This model aims to change the individual's behavior intentionally. It is recommended that the Transtheoretical Model be used to facilitate individuals' adaptation to lifestyle changes and to provide effective education also stated in their studies that care provided in conjunction with pelvic floor training prevents pelvic floor dysfunction and improves quality of life .

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Sexually active women aged 18-65
• Women who volunteered to participate in the study

Exclusion Criteria:

Those with a perinometer measurement result of 2

• Pregnant women
• Those who have undergone pelvic floor muscle training in the last two years
• Those with conditions that prevent them from performing Pelvic Floor Muscle Exercises
• Those who use a mobile application for Pelvic Floor Muscle Exercises
• Those with Pelvic Floor Dysfunction
• Those who are unable to perform the Pelvic Floor exercise program -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Other: TRAINING BASED ON THE TRANSTEOROTİK MODEL; Women in the intervention group will receive awareness training on pelvic floor muscle exercises based on the transtheoretical model. This training includes a brochure and a seminar program prepared according to the transtheoretical model. A monthly exercise schedule will be provided to the women in this group to support them in performing pelvic floor muscle exercises.
Placebo Comparator: Control Group; Group not receiving training	Other: Not providing training; Once the data collection phase of the study is complete, women in the control group will also be given a detailed explanation of pelvic floor muscle exercises based on the transtheoretical model and awareness training, and will be provided with a brochure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pelvic floor muscle activity (Microvolts µV)	The maximum voluntary contraction (MVC) and average contraction of the pelvic floor muscles will be measured using a surface EMG biofeedback device.Higher values indicate improved muscle activation and strength.	Baseline (week 0) and Post-intervention( week 8)

Collaborators and Investigators

• Sponsor: Aynur Erçek Karci

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Transtheoretical Model; Pelvic Floor Exercises; Health Education, Quality of Life
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Adherence Interventions; Medication Adherence; Health Education
• Other Study ID Numbers: 26-1T/83

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data that underlie the results reported in this article (text, tables,figures and appendices) will be shared
• IPD Sharing Time Frame: Beginning 6 months after publication. Ending 36 months after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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