CClinicalTrials.gg
CompletedNCT07151170Updated Aug 26, 2026

Telerehabilitation Versus Supervised Pelvic Floor Muscle Training in Urinary Incontinence

An interventional study of Telerehabilitation Pelvic Floor Muscle Training (TR-PFMT) Group and Supervised Pelvic Floor Muscle Training (S-PFMT) Group in Urinary Incontinence, Urinary Incontinence,Stress and Urinary Incontinence, Urge, sponsored by Riphah International University. Completed at 2 sites in Pakistan. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Urinary Incontinence
  • Urinary Incontinence,Stress
  • Urinary Incontinence, Urge
  • Postmenopausal Symptoms

Keywords

  • Pelvic Floor Muscle Training
  • Telerehabilitation
  • Supervised Exercise
  • Postmenopausal Women
  • Urinary Incontinence
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 54 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    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.

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

  • Active comparator
    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.

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

Interventions

  • OtherTelerehabilitation 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.

  • OtherSupervised 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).

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline and 6 weeks

  2. 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.

    Time frame: Baseline and 6 weeks

  3. 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.

    Time frame: Baseline and 6 weeks

  4. 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.

    Time frame: Baseline and 6 weeks

07

Study locations

2 sites
  • Riphah International Hospital
    Islamabad, Islamabad 44000, Pakistan
  • Pakistan Railway Hospital
    Rawalpindi, Punjab Province 40100, Pakistan
08

References and documents

Publications

  • 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. PubMed 37239520 ↗
  • 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. PubMed 40286562 ↗
  • 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. PubMed 37720131 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07151170
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Sep 3, 2025
Start date
Feb 1, 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026
Last update
Aug 26, 2026

Study contacts

Huma Riaz, PhD
principal investigator · Riphah International University, Islamabad, Pakistan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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