Telerehabilitation Versus Supervised Pelvic Floor Muscle Training in Urinary Incontinence

Riphah International University

Status: Not yet enrolling

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

Treatments: Other: Supervised Pelvic Floor Muscle Training (S-PFMT) Group; Other: Telerehabilitation Pelvic Floor Muscle Training (TR-PFMT) Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07151170

Aliza Tahir

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

54 participants in 2 patient groups

Telerehabilitation Pelvic Floor Muscle Taining (TR-PFMT) Group

Experimental group

Description:

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.

Treatment:

Other: Telerehabilitation Pelvic Floor Muscle Training (TR-PFMT) Group

Supervised Pelvic Floor Muscle Training (S-PFMT) Group

Active Comparator group

Description:

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.

Treatment:

Other: Supervised Pelvic Floor Muscle Training (S-PFMT) Group