The Effectiveness of Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy in Postmenopausal Women With Stress Urinary Incontinence

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorHanoi Medical University

About this trial

The objective of this clinical trial is to investigate whether the combination of pelvic floor muscle training (PFMT) and topical estrogen is more effective in treating stress urinary incontinence (SUI) in postmenopausal women compared to topical estrogen alone. The trial will also analyze factors related to the outcomes of the combined therapy. The key questions this trial aims to answer are:

* Does the combination of PFMT and topical estrogen improve symptoms of stress urinary incontinence in postmenopausal women better than topical estrogen alone? * Which factors are associated with the effectiveness of the combined therapy?

Researchers will compare the group receiving the combined therapy (pelvic floor muscle training plus topical estrogen) with the group receiving topical estrogen alone to determine whether adding PFMT to estrogen therapy provides additional treatment benefits for SUI in postmenopausal women.

Participants will:

\- Be randomly assigned to one of two groups:

Group 1: Undergo a pelvic floor muscle training (PFMT) program combined with topical estrogen therapy (e.g., vaginal cream/application,...).

Group 2: Receive topical estrogen therapy alone (e.g., vaginal cream/application,...).

* Follow the assigned intervention protocol for a specified duration. * Attend regular clinic visits for clinical examinations, assessment of incontinence severity, and related measurements. * Monitor and record their incontinence symptoms and the frequency of urine leakage during daily activities.

Eligibility criteria

Qualifiers

Patients diagnosed with stress urinary incontinence.

Women who have been naturally postmenopausal for at least 1 year or are postmenopausal due to bilateral oophorectomy (surgical removal of both ovaries).

Have had sexual intercourse to ensure feasibility of urogenital tract examination and assessment.

Patients who consent to participate in the study and comply with the treatment protocol, including performing pelvic floor muscle training (PFMT) and completing topical vaginal estrogen therapy.

Disqualifiers

Patients with concomitant neurological disorders, urinary tract infections, prior pelvic radiotherapy, or congenital malformations of the lower urinary tract.

Genitourinary malformations or fistulas causing continuous urinary incontinence.

Genitourinary cancers or tumors of the urinary tract.

History of spinal cord injury or central nervous system injury affecting the centers that control urination.

Trial design

Treatments tested in this trial

  • Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy
  • Vaginal estrogen

Treatment groups

115 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators