Telerehabilitation Versus Supervised Pelvic Floor Muscle Training in Urinary Incontinence

NCT ID: NCT07151170

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-07-31

Brief Summary

Urinary Incontinence (UI) is a prevalent condition impacting women across all age groups, varing in both severity and type. Urinary Incontinence affects 25%-45% of women worldwide. A systematic review explains that menopause-driven estrogen decline leads to atrophy of pelvic floor muscles (PFM). The goal of this randomized controlled trial is to compare the effects of telerehabilitation-based pelvic floor muscle training with a supervised face-to-face pelvic floor muscle training program in improving urinary incontinence symptoms, pelvic floor muscle funtion and quality of life (QoL) in postmenopausal women. Participnts will be randomly assigned to one of the two groups, and both will receive an identical standardized pelvic floor muscle training protocol. The results of this clinical trial will help evaluate how telerehabilitation can provide support for postmenopausal women with urinary incontinence and improve health outcomes.

Detailed Description

Urinary incontinence (UI) is common among postmenopausal women and is characterized by involuntary urine leakage, leading to physical, psychological, and social challenges. Its prevalence increases after menopause due to hormonal changes, along with loss of connective tissue and muscle fiber degradation. This results in reduced maximal voluntary contraction and diminished coordination, contributing to increased UI risk in postmenopausal women. Postmenopausal women with UI present significantly increased pelvic floor muscle (PFM) stiffness both at rest and during contraction, signalling structural deterioration. Therefore this increased stiffness, linked to tissue atrophy, compromises muscle contraction and is closely associated with reduced urethral support. Systematic reviews highlight that postmenopausal women often are marginalized or grouped with wider age ranges, limiting the significance of outcomes to this specific demographic. Therefore adequately powered randomized controlled trails directly comparing Tele-rehabilitation and supervised Pelvic floor muscle training (PFMT) in postmenopausal women are limited. PFMT is the first-line conservative treatment recommended by international guidelines. Traditionally, PFMT is delivered in supervised, in-person sessions with a physiotherapist; however, hurdles such as mobility issues, transportation costs can reduce access to supervised sessions. Tele-rehabilitation may overcome these barriers by offering flexible and home-based treatment. Tele-rehabilitation, using secure video conferencing to deliver PFMT in real time, may improve accessibility, adherence, and convenience. Hence evaluating the effectiveness and acceptability of remote PFMT in postmenopausal women is both timely and clinically important. This study will provide stronger statistical power to address the existing evidence gap and contribute to the growing field of digital physiotherapy by providing valuable evidence evaluating whether Tele-rehabilitation can serve as an effective and feasible alternative to face-to-face intervention for managing urinary incontinence in postmenopausal women, thereby improving women's health outcomes and quality of life.

Conditions

Urinary Incontinence; Urinary Incontinence,Stress; Urinary Incontinence, Urge; Postmenopausal Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telerehabilitation Pelvic Floor Muscle Taining (TR-PFMT) Group

This group will receive a 6-week standardized Pelvic Floor Muscle Training program (18 sessions, 2/week, 60 min) delivered online by a physiotherapist. The program includes patient education on pelvic floor anatomy, bladder habits, and lifestyle advice, along with diaphragmatic breathing, pelvic mobility, and progressive strengthening of phasic and tonic Pelvic Floor Muscle fibers in multiple positions. Home exercises are prescribed with gradual progression, and participants submit weekly exercise diaries for monitoring and motivation.

Group Type: EXPERIMENTAL

Telerehabilitation Pelvic Floor Muscle Training (TR-PFMT) Group

Intervention Type: OTHER

The program will be delivered online in small groups by a physiotherapist. The program includes diaphragmatic breathing, pelvic mobility (pelvic tilts, hip circles, cat-cow), stretching (butterfly, child pose, deep squat), and progressive strengthening of phasic and tonic fibers through stationary PFMT (10-sec moderate-hold + 3 quick flicks, 8 sets in weeks 1-3, 10 sets in weeks 4-6, 10-sec rest) and home-based PFMT (10 fast contractions and 10 moderate-hold contractions, 2 sets in weeks 1-2 with weekly set increases, 10-sec rest), performed in prone lying, supine hook-lying, butterfly, sitting, and standing positions. All sessions will be recorded, and participants will submit weekly exercise diaries.

Supervised Pelvic Floor Muscle Training (S-PFMT) Group

In the supervised group, the protocol will be delivered by a physiotherapist in a clinical environment by face-to-face. The same standardized Pelvic Floor Muscle Training protocol will be monitored exactly the same as TR-PFMT.

Group Type: ACTIVE_COMPARATOR

Supervised Pelvic Floor Muscle Training (S-PFMT) Group

Intervention Type: OTHER

In the supervised group, the protocol will be delivered by a physiotherapist in a clinical environment by face-to-face. The standardized Pelvic Floor Muscle Training protocol will be monitored exactly the same as Telerehabilitation group (TR-PFMT).

Interventions

Telerehabilitation Pelvic Floor Muscle Training (TR-PFMT) Group

The program will be delivered online in small groups by a physiotherapist. The program includes diaphragmatic breathing, pelvic mobility (pelvic tilts, hip circles, cat-cow), stretching (butterfly, child pose, deep squat), and progressive strengthening of phasic and tonic fibers through stationary PFMT (10-sec moderate-hold + 3 quick flicks, 8 sets in weeks 1-3, 10 sets in weeks 4-6, 10-sec rest) and home-based PFMT (10 fast contractions and 10 moderate-hold contractions, 2 sets in weeks 1-2 with weekly set increases, 10-sec rest), performed in prone lying, supine hook-lying, butterfly, sitting, and standing positions. All sessions will be recorded, and participants will submit weekly exercise diaries.

Intervention Type: OTHER

Supervised Pelvic Floor Muscle Training (S-PFMT) Group

In the supervised group, the protocol will be delivered by a physiotherapist in a clinical environment by face-to-face. The standardized Pelvic Floor Muscle Training protocol will be monitored exactly the same as Telerehabilitation group (TR-PFMT).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Postmenopausal women between the ages of 45-65.
• Postmenopausal status, defined as absence of menstruation for more than 12 months.
• Experiencing symptomatic urinary incontinence, indicated by a Questionnaire for Urinary Incontinence Diagnosis (QUID) score greater than "0".
• Able to comprehend and accurately respond to the questionnaire (i.e., no language barriers) and reading and writing Urdu language.
• Free from any physical or psychological conditions that could hinder participation in the study.
• Participants must have access to both the internet and a mobile phone/laptop
• Signing the informed consent form.

Exclusion Criteria

• Women with cognitive impairments, neurological disorders, pelvic malignancies.
• Individuals with a history of intra-abdominal and pelvic surgery or radiation therapy.
• Presence of active urinary tract/vaginal infection
• Presence of incontinence except stress and urge urinary incontinence (e.g. overflow incontinence or dribbling urine after urination)
• Presence of voiding dysfunction (e.g. incomplete voiding, intermittent urination or delay in starting to urinate)
• Women with contraindications to pelvic floor muscle training (e.g., pelvic pain resulting from endometriosis, coccydynia or anismus, unexplained vaginal bleeding and anal fissure).
• Women aged over 65 years
• Body mass index ≥ 27.4 kg/m²
• Currently undergoing hormone therapy
• Lack of pelvic floor muscle contraction ability (pelvic floor muscle strength <2 according to the Modified Oxford Scale)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huma Riaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University, Islamabad, Pakistan

Locations

Riphah International Hospital

Islamabad, Islamabad, Pakistan

Pakistan Railway Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Huma Riaz, PhD

Role: CONTACT

huma.riaz@riphah.edu.pk

+923215242874

Facility Contacts

Dr Ammara Malik

Role: primary

ammara.malik@riphah.edu.pk

+923145326065

Dr Ansa Rida Azam

Role: primary

ansa.rida@riphah.edu.pk

+923379878043

References

Le Berre M, Filiatrault J, Reichetzer B, Dumoulin C. Group-Based Pelvic Floor Telerehabilitation to Treat Urinary Incontinence in Older Women: A Feasibility Study. Int J Environ Res Public Health. 2023 May 11;20(10):5791. doi: 10.3390/ijerph20105791.

Reference Type: BACKGROUND

PMID: 37239520 (View on PubMed)

Lin KY, Chen CY, Wu PC, Huang MH, Ou YC, Kao YL, Lin KH. The feasibility and effects of a telehealth-delivered physical therapy program for postmenopausal women with urinary incontinence: A pilot mixed-methods study. Maturitas. 2025 Jun;197:108376. doi: 10.1016/j.maturitas.2025.108376. Epub 2025 Apr 23.

Reference Type: BACKGROUND

PMID: 40286562 (View on PubMed)

Parra NS, Jaramillo AP, Zambrano J, Segovia D, Castells J, Revilla JC. The Effectiveness of Pelvic Floor Muscle Exercise in Urinary Incontinence: A Systematic Literature Review and Meta-Analysis. Cureus. 2023 Sep 11;15(9):e45011. doi: 10.7759/cureus.45011. eCollection 2023 Sep.

Reference Type: BACKGROUND

PMID: 37720131 (View on PubMed)

Other Identifiers

Aliza Tahir

Identifier Type: -

Identifier Source: org_study_id