Telerehabilitation Versus Supervised Pelvic Floor Muscle Training in Urinary Incontinence

NCT07151170 | Not Yet Recruiting

• 1 other identifier: Aliza Tahir
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Pelvic Floor Muscle Training; Telerehabilitation; Supervised Exercise; Postmenopausal Women; Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

• Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score

  The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a valid, widely used tool to assess urinary incontinence (UI) symptoms, severity and its impact on quality of life. It has three scored items (leakage frequency, amount, and interference) and one unscored diagnostic item identifying possible causes or situations of leakage (e.g., coughing, sneezing, exertion). Scores range from 0-21, with higher scores showing greater severity: slight (1-5), moderate (6-12), severe (13-18), very severe (19-21)

  Baseline and 6 weeks

• Change in pelvic floor muscle strength using the Modified Oxford Scale

  The Modified Oxford Scale is a validated grading system used to assess pelvic floor muscle strength through vaginal palpation. It ranges from 0 to 5. The Modified Oxford Scale developed by Laycock is scored as, a score of 0: indicates no contraction, 1: a slight flicker, 2: a weak squeeze, 3: a moderate contraction with some lift, 4: a good contraction with resistance, and 5: a strong contraction with firm resistance and lift. Higher grades indicate stronger pelvic floor muscles.

  Baseline and 6 weeks

• Change in Urinary Impact Questionnaire short form (UIQ-7) score

  The Urinary Impact Questionnaire short form (UIQ-7) is a validated self-report tool. The UIQ-7 consists of 7 items assessing how urinary incontinence affects daily activities, emotional health, and social interactions. Each item is scored from 0 (not at all) to 3 (greatly), giving a total score of 0-21, with higher scores indicating greater negative impact.

  Baseline and 6 weeks

• Change in Incontinence Impact Questionnaire, Short Form (IIQ-7) score

  The IIQ-7 emphasises the functional impact of incontinence, comprising 7 items that evaluate the influence of incontinence on physical activity, travel, social relationships, and emotional health. Each response is scored 0-3, resulting in a total score of 0-21, where higher scores indicate a more severe impact on quality of life.

  Baseline and 6 weeks

Study Arms (2)

Telerehabilitation Pelvic Floor Muscle Taining (TR-PFMT) Group

EXPERIMENTAL

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.

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

Supervised Pelvic Floor Muscle Training (S-PFMT) Group

ACTIVE COMPARATOR

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.

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

Interventions

Telerehabilitation Pelvic Floor Muscle Training (TR-PFMT) Group 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.

Telerehabilitation Pelvic Floor Muscle Taining (TR-PFMT) Group

Supervised Pelvic Floor Muscle Training (S-PFMT) Group 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).

Supervised Pelvic Floor Muscle Training (S-PFMT) Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Riphah International Hospital

Islamabad, Islamabad, 44000, Pakistan

Location

Pakistan Railway Hospital

Rawalpindi, Punjab Province, 40100, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 37239520 BACKGROUND

• 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.

  PMID: 40286562 BACKGROUND

• 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.

  PMID: 37720131 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress; Urinary Incontinence, Urge

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Huma Riaz, PhD

  Riphah International University, Islamabad, Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huma Riaz, PhD

CONTACT

+923215242874; huma.riaz@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be comparison between the two groups, experimental and control.

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 3, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)