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

NCT07186985 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-09-22

No results posted yet for this study

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. 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.

Conditions

  • Stress Urinary Incontinence (SUI)
  • Postmenopausal Women

Interventions

COMBINATION_PRODUCT

Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy

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

DRUG

Vaginal estrogen

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.

Sponsors & Collaborators

  • Hanoi Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-02-28
Completion
2027-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07186985 on ClinicalTrials.gov