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Pelvic Floor AwarenessNCT07443423

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

A study testing TRAINING BASED ON THE TRANSTEOROTİK MODEL and Not providing training in people with Pelvic Floor Awareness, run by Aynur Erçek Karci.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pelvic Floor Awareness
What is being tested?
TRAINING BASED ON THE TRANSTEOROTİK MODEL and Not providing training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
No sites listed yet
Study dates
1 Mar 2026to 1 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 -

About this study

Official title: 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.

Read the 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 .

Being tested
TRAINING BASED ON THE TRANSTEOROTİK MODEL, Not providing training
Keywords
Pelvic Floor Exercises, Transtheoretical Model, Randomized Controlled Trial, Health Education, Quality of Life
Medical subject headings
Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRAINING BASED ON THE TRANSTEOROTİK MODELOther

    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.

  • Not providing trainingOther

    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.

Study groups in NCT07443423
Study groupRoleWhat they receive
Control GroupPlacebo comparatorGroup not receiving training
Receives: Other: Not providing training
Experimental groupExperimentalNot described
Receives: Other: TRAINING BASED ON THE TRANSTEOROTİK MODEL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (week 0) and Post-intervention( week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07443423
Sponsor's protocol ID
26-1T/83
Status last verified
Feb 2026
First submitted
5 Feb 2026
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data that underlie the results reported in this article (text, tables,figures and appendices) will be shared

Questions about this trial

What is this clinical trial studying?

A study testing TRAINING BASED ON THE TRANSTEOROTİK MODEL and Not providing training in people with Pelvic Floor Awareness, run by Aynur Erçek Karci.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pelvic floor muscle activity (Microvolts µV) (time frame: Baseline (week 0) and Post-intervention( week 8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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