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Urinary IncontinenceNCT07151170

Telerehabilitation Versus Supervised Pelvic Floor Muscle Training in Urinary Incontinence

A study testing Telerehabilitation Pelvic Floor Muscle Training (TR-PFMT) Group and Supervised Pelvic Floor Muscle Training (S-PFMT) Group in people with Urinary Incontinence and Urinary Incontinence,Stress, run by Riphah International University at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 45 to 65 years, women only
What is being tested?
Telerehabilitation Pelvic Floor Muscle Training (TR-PFMT) Group and Supervised Pelvic Floor Muscle Training (S-PFMT) Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesPakistan
Study dates
1 Feb 2026to 31 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 10Show fewer
  • 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 locations and contacts

2 sites in 1 country.

Pakistan2 sites
  • Riphah International Hospital

    Islamabad, Islamabad, 44000

  • Pakistan Railway Hospital

    Rawalpindi, Punjab Province, 40100

Other trials in Pakistan

About this study

Official title: Telerehabilitation Versus Supervised Pelvic Floor Muscle Training in Postmenopausal Women With Urinary Incontinence

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.

Being tested
Telerehabilitation Pelvic Floor Muscle Training (TR-PFMT) Group, Supervised Pelvic Floor Muscle Training (S-PFMT) Group
Keywords
Pelvic Floor Muscle Training, Telerehabilitation, Supervised Exercise, Postmenopausal Women, Urinary Incontinence
Medical subject headings
Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telerehabilitation Pelvic Floor Muscle Training (TR-PFMT) GroupOther

    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) GroupOther

    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).

Study groups in NCT07151170
Study groupRoleWhat they receive
Telerehabilitation Pelvic Floor Muscle Taining (TR-PFMT) GroupExperimentalThis 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.
Receives: Other: Telerehabilitation Pelvic Floor Muscle Training (TR-PFMT) Group
Supervised Pelvic Floor Muscle Training (S-PFMT) GroupActive comparatorIn 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.
Receives: Other: Supervised Pelvic Floor Muscle Training (S-PFMT) Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2025
  2. Study start1 Feb 2026
  3. Primary completion31 Jul 2026
  4. Study completion31 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
There will be comparison between the two groups, experimental and control.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07151170
Sponsor's protocol ID
Aliza Tahir
Status last verified
Aug 2026
First submitted
24 Aug 2025
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation Pelvic Floor Muscle Training (TR-PFMT) Group and Supervised Pelvic Floor Muscle Training (S-PFMT) Group in people with Urinary Incontinence and Urinary Incontinence,Stress, run by Riphah International University at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score (time frame: Baseline and 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07151170, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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