Seeing Efficacy of Transvaginal Pelvic Floor Muscle Training in Middle Aged & Elderly Females with Stress Urinary Leakage

Efficacy of Transvaginal Pelvic Floor Muscle Training on Strength & Endurance of Pelvic Floor Muscles & Quality of Life in Peri & Post Menopausal Females with Stress Urinary Incontinence A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/089962

Enrollment

140

Registered

2025-07-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N393- Stress incontinence (female) (male)

Interventions

Intervention1: Transvaginal and Supervised Pelvic Floor Muscle Training.: GROUP A - Intervention Group: Transvaginal Pelvic Floor Muscle Training, given twice a week by digital insertion of Index Fin

Home Program) : GROUP C (ACTIVE CONTROL GROUP): Unsupervised Pelvic Floor Muscle Training (Home Program) Will be taught to patients to perform as home program, Frequency : 2 sessions of 30 minutes dur

Eligibility

Inclusion criteria

Inclusion criteria: 1. Middle aged Peri/ Post Menopausal women (age 44 55 years) with clinical diagnosis of SUI for more than 3 months and/or Mixed UI with predominant SUI symptoms, having sufficient cognitive and physical function to allow them to participate in the program. 2. Min 3 incontinence episodes per week, daytime frequency of less than 8 micturition episodes, nocturia of less than 3 episodes, positive stress test (urine leakage with coughing) 3. A score of 1 - 3 on Oxford scale / PERFECT Scale . 4. Patients with mild to moderate stress urinary incontinence (Garde 1 / Grade2)

Exclusion criteria

Exclusion criteria: 1. Symptoms primarily of urge incontinence 2. Presence of any degree of pelvic organ prolapse above grade 1 3. Cognitive, Neurological, psychiatric and/or physical disorders that could hinder their participation in the assessment & Treatment 4. Use of medications affecting micturition/ presence of current UTI 5. History of surgical or pharmaceutical treatment of SUI, 6. Chronic debilitating disease such as renal failure 7. Patients with oncology treatment. 8. Inability to contract the PFM (grade zero according to the Modified Oxford Grading Scale) 9. Previous pelvic floor surgeries 10. Women with instrumental deliveries/ nulliparous women/ multiparous women with parity above 3 11. Inability to contract the PFMs (grade zero according to the Modified Oxford Grading Scale)

Design outcomes

Primary

Measure	Time frame
1. Strength of Pelvic Floor Muscles 2. Endurance of Pelvic Floor Muscles 3. Number of Fast Twitch Contractions of Pelvic Floor Muscles 4. Number of Full-Strength Repetitions of Pelvic Floor Muscles Contractions Timepoint: 1. Baseline 2. 4 weeks 3. 8 weeks 4. 12 weeks	—

Secondary

Measure	Time frame
Quality Of Life Questionnaire (Incontinence related)Timepoint: 1. Baseline 2. 4 weeks 3. 8 weeks 4. 12 weeks	—

Countries

India

Contacts

Public ContactProf Dr Shagun Aggarwal

School of Allied Health Sciences, Galgotias University

dean.sahs@galgotiasuniversity.edu.in09910259583

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026