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NCT Number: NCT07186985

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

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.

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Key information

Conditions

Stress Urinary Incontinence (SUI) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Postmenopausal Women Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Patients previously treated for stress urinary incontinence (SUI) (surgery, medications, exercises).
  • Patients with severe heart disease, coronary artery disease, or myocardial ischemia.
  • Patients with pelvic organ prolapse stage III or higher, unexplained vaginal bleeding, confirmed or suspected breast cancer, or vaginitis.
  • Presence of premalignant factors or suspected steroid-dependent cancers such as endometrial carcinoma.
  • History of or current hepatic tumors, or progressive liver or biliary disease.
  • Coagulation/thrombotic disorders, or a history of thromboembolism or stroke.
  • Severe hypertriglyceridemia.
  • Hypersensitivity to any component of vaginally administered estrogen products.
  • The patient or family members are unable to use a smartphone (Android or iOS) to participate in the monitoring program.
  • The patient does not agree to participate in the study.

Treatment and study plan

Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy

Combination Product

Group 1:

  • Patients were instructed to identify and sense their pelvic floor muscles and to perform contraction-hold-relaxation exercises.
  • Exercises were performed at a frequency of 8 sets per session, 3 sessions per week, progressing from the supine position (month 1), to sitting (month 2), and to standing (month 3). Training was monitored by an electronic diary app. (Appendix)
  • Six individual 45-minute intervention sessions at the center using biofeedback, under the supervision of a physical therapy technician. (Appendix)
  • The training program consisted of two parts: resistance training and pre-contraction training (the Knack technique). (Appendix)
  • Patients were prescribed and instructed to use 0.5 mg vaginal estrogen for 6 months according to the following regimen:
  • First 4 weeks: insert one 0.5 mg tablet nightly at bedtime.
  • Next 20 weeks: insert one 0.5 mg tablet at bedtime twice weekly, with 2-3 days between doses

Vaginal estrogen

Drug

Patients were prescribed and instructed to use 0.5 mg vaginal estrogen for 6 months according to the following regimen:

First 4 weeks: insert one 0.5 mg tablet nightly at bedtime. Next 20 weeks: insert one 0.5 mg tablet at bedtime twice weekly, with 2-3 days between doses.

Primary outcomes

  1. Changes from baseline at 3 and 6 months in One-hour Pad test

    Time frame: At baseline, 3 months, and 6 months

    One-hour pad test: A noninvasive method that measures the amount of urine leakage collected in an absorbent pad. Standardized by the International Continence Society (ICS), it quantifies leakage during everyday activities, measured in grams (g)

Secondary outcomes

  1. Changes from baseline at 3 and 6 months in Patient Global Impression of Improvement (PGI-I scale)

    Time frame: At baseline, 3 months, and 6 months

    Patient Global Impression of Improvement (PGI-I): Assesses the degree of improvement in urinary incontinence after treatment based on the patient's perception. The scale ranges from "very much better" to "very much worse"

  2. Changes from baseline at 3 and 6 months in International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF scale)

    Time frame: At baseline, 3 months, and 6 months

    International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF scale): Assesses the severity of urinary incontinence and its impact on quality of life, with scores from 0 to 21. Higher scores indicate more severe incontinence

  3. Changes from baseline at 3 and 6 months in Oxford Scale

    Time frame: At baseline, 3 months, and 6 months

    Oxford Scale: Assesses pelvic floor muscle strength, ranging from 0 (no contraction) to 5 (strong contraction)

  4. Changes from baseline at 3 and 6 months in Pelvic floor ultrasound assessment

    Time frame: At baseline, 3 months, and 6 months

    Bladder neck displacement during pelvic floor muscle contraction on ultrasound: Measurement of bladder neck displacement during pelvic floor muscle contraction, in millimeters (mm)

  5. Changes from baseline at 3 and 6 months in Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol scale)

    Time frame: At baseline, 3 months, and 6 months

    Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol scale): Assesses with a total score from 19 to 76 (higher scores reflect worse quality of life)

  6. Changes from baseline at 3 and 6 months in total serum estradiol concentration

    Time frame: At baseline, 3 months, and 6 months

    The concentration of estradiol in serum in all forms, measured in pg/mL

Study contacts

Contact information is provided by the study sponsor or research team.

Du Nguyen Quang

CONTACT

[email protected]

+84 337828793

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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