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NCT07329218

Effect of Pelvic Floor Stretching on Pelvic Floor Myofascial Pain and Quality of Life in Postmenopausal Female

Completed NA Last updated 9 January 2026
What this trial tests

NA trial testing Kegel Exercise in Pelvic Floor Myofascial Pain in 60 participants. Completed in 14 April 2025.

Timeline
14 January 2025
Primary endpoint
10 March 2025
14 April 2025

Quick facts

Lead sponsorDelta University for Science and Technology
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment60
Start date14 January 2025
Primary completion10 March 2025
Estimated completion14 April 2025
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Delta University for Science and Technology

Who can join

Adults 45 to 55, female only, with Pelvic Floor Myofascial Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Menopause, also known as the climacteric, is the time when menstrual periods permanently stop, marking the end of reproduction, it typically occurs between the ages of 45 and 55, although the exact timing can vary, menopause is usually a natural change related to a decrease in circulating blood estrogen levels \[1\]. In the years before menopause, a woman's periods typically become irregular, which means that periods may be longer or shorter in duration or be lighter or heavier in the amount of flow. During this time, women often experience hot flashes; these typically last from 30 seconds to ten minutes and may be associated with shivering, night sweats, and reddening of the skin, while other symptoms may include vaginal dryness, trouble sleeping, and mood changes, the severity of symptoms varies between women \[2\]. Female pelvic floor muscles form a diaphragm that spans the entire pelvic cavity. They consist of the fibers of the coccygeus and the levator ani muscles, together with their fascia, the pelvic floor muscles provide support for the urethra, the vagina, and the rectum and constrict the urethral, vaginal, and anal orifices. Alterations in the composition of the pelvic floor muscles at menopause appear to affect their properties and, thereby, their ability to function adequately. This can lead to an increased prevalence in urinary incontinence and other lower urinary tract dysfunction, pelvic organ prolapses, and genitourinary syndrome of menopause \[3\]. During the menopausal transition, there is a substantial decrease in the number of ovarian follicles and numerous hormonal changes are observed. The first endocrine signal of the menopausal transition is a significant increase in follicle-stimulating hormone (FSH) levels. An important increase in FSH levels and a considerable decrease in estrogen and inhibin A concentrations are observed in the late stage of the menopausal transition. However, a 50% increase in FSH levels and a 50% decrease in estrogen concentrations are observed in the final postmenopausal period, these hormonal changes can directly affect pelvic floor muscle mass. After menopause, cross sectional areas of muscle mass decrease by 0.6% every year. Noncontractile muscle tissue mass (intramuscular fat mass) in postmenopausal women is two times greater that than in young women. The ratio of connective tissues to muscle fibrils in the urethral stricture and pelvic floor muscles decreases with age \[4\]. Non-surgical treatment of pelvic floor dysfunction mainly consists of manual approach, stimulation or relaxation techniques. Trigger points can be treated with local massage and stretching of the PFM. Using post isometric contraction techniques might help to give better stretching abilities of muscles \[8\]. In addition to manual manipulation, modalities such as electrostimulation, biofeedback, and vaginal dilators or vaginal weighted cones can be used to help with isolation of pelvic floor musculature and improve contraction. Electrical stimulation provides a small electrical current to contract the pelvic floor and assist the patient in isolation of the proper muscles. Biofeedback uses a vaginal or rectal pressure sensor to provide an audible and/or visual feedback of the strength of the muscle contraction. A vaginal weighted cone is inserted into the vagina and held in place by pelvic muscle contractions during activity Subjects and methods This study was a randomized controlled study. All procedures used in the study were compliant with the Declaration of Helsinki, which regulates research involving human subjects. Registration Clinical Trial Registration database (?) and approval from the Faculty of Physical Therapy, Delta University's institutional review board (F.P.T 250740). This study was carried out at an outpatient clinic at the Faculty of Physical Therapy, Delta University for Science and Technology, Egypt. The registration and recruitment of individuals and follow-up procedures were done from January 2025 to April 2025. Subjects: The patients were included in this study had these criteria: Females diagnosed with postmenopausal chronic pelvic pain between age group 45-55 years.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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