Stress Urinary Incontinence (SUI)NCT07186985
The Effectiveness of Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy in Postmenopausal Women With Stress Urinary Incontinence
A study testing Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy and Vaginal estrogen in people with Stress Urinary Incontinence (SUI) and Postmenopausal Women, run by Hanoi Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI), Postmenopausal Women
- What is being tested?
- Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy and Vaginal estrogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 28 Feb 2027
- Phase
- Interventional
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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?
Read more
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.
- Being tested
- Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy, Vaginal estrogen
- Keywords
- stress urinary incontinence (SUI), postmenopausal women, Pelvic Floor Muscle Training, Vaginal Oestrogen, Pelvic floor rehabilitation
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Pelvic Floor Muscle Training and Vaginal Oestrogen TherapyCombination 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 estrogenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| combination of PFMT and vaginal estrogen. | Experimental | Patients were treated with a combination of a pelvic floor rehabilitation program and 0.5 mg vaginal estrogen. Receives: Combination Product: Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy |
| vaginal estrogen | Active comparator | Patients were treated with 0.5 mg topical vaginal estrogen Receives: Drug: Vaginal estrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline at 3 and 6 months in One-hour Pad test
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)
Measured: At baseline, 3 months, and 6 months
Secondary outcomes (6)
Changes from baseline at 3 and 6 months in Patient Global Impression of Improvement (PGI-I scale)
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"
Measured: At baseline, 3 months, and 6 months
Changes from baseline at 3 and 6 months in International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF scale)
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
Measured: At baseline, 3 months, and 6 months
Changes from baseline at 3 and 6 months in Oxford Scale
Oxford Scale: Assesses pelvic floor muscle strength, ranging from 0 (no contraction) to 5 (strong contraction)
Measured: At baseline, 3 months, and 6 months
Changes from baseline at 3 and 6 months in Pelvic floor ultrasound assessment
Bladder neck displacement during pelvic floor muscle contraction on ultrasound: Measurement of bladder neck displacement during pelvic floor muscle contraction, in millimeters (mm)
Measured: At baseline, 3 months, and 6 months
Changes from baseline at 3 and 6 months in Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol scale)
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)
Measured: At baseline, 3 months, and 6 months
Changes from baseline at 3 and 6 months in total serum estradiol concentration
The concentration of estradiol in serum in all forms, measured in pg/mL
Measured: At baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Quang Du, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186985
- Sponsor's protocol ID
- HMUIRB1843
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No