Urinary IncontinenceNCT07576205
Effects of Paula Exercises and Tibial Nerve Stimulation in Stress Urinary Incontinence
A study testing Paula Exercises and Tibial Nerve Stimulation in people with Urinary Incontinence, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to compare the combined effects of Paula method \& tibial nerve stimulation on incontinence, pelvic floor muscles strength, sexual function and quality of life in stress urinary incontinence Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Paula Exercises and Tibial Nerve Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Multiparous women (≥2 full-term vaginal deliveries)
- Clinical diagnosis of stress urinary incontinence (confirmed by cough stress test)
- Duration of symptoms ≥3 months
- Ability to correctly perform pelvic floor contractions (confirmed by digital examination)
Who cannot join
- Neurological disorders (e.g., multiple sclerosis, spinal cord injury)
- Mixed or urge urinary incontinence as the predominant type
- Previous pelvic surgery or incontinence-related procedures within the past year
- Current pregnancy or <6 months postpartum
- Pelvic organ prolapse beyond stage II (POP-Q system)
- Current use of other incontinence therapies (e.g., medication, PTNS, PFMT)
Show all 11Show fewer
- Diagnosed malignancy
- Diagnosed psychiatric disorder
- Pregnancy
- Diagnosed dermatological condition
- Participants who are currently enrolled in other clinical trials to avoid potential confounding factors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Arshian Hussnain Medical Clinic
Lahore, Punjab Province, 6400
sobia ghafoor, MSPT-OM, 0309 4384971, Sobia.physio@gmail.com
Fizza Tahir, MSPT(WH)
About this study
Official title: Combine Effects of Paula Exercises and Tibial Nerve Stimulation on Incontinence, Pelvic Floor Muscles Strength, Sexual Function and Quality of Life in Stress Urinary Incontinence
The aim of this study is to compare the combined effects of Paula method \& tibial nerve stimulation on incontinence, pelvic floor muscles strength, sexual function and quality of life in stress urinary incontinence
Read the detailed description
This study will be randomized controlled trial and will be conducted in Arshian Hussnain Medical Clinic and at Marie Stopes Society. Non probability convenience sampling technique will be used and 56 participants will be recruited in study after randomization. Inclusion criteria will be females aged 30-45 years, multiparous women (≥2 full-term vaginal delivery). Exclusion criteria will be Neurological disorders, pregnancy and dermatological conditions .The subjects will be divided into two groups. Group A will receive Paula exercise and Tibial nerve stimulation. Group B will receive only Paula exercises. Both groups will receive baseline treatment which will include pelvic floor muscle contractions. The total duration of treatment will be 8 weeks and there will be 2 sessions each week. Outcomes assessed will be urinary function, pelvic floor muscles strength, sexual function \& quality of life. Outcomes will be assessed using validated tools such as the IIQ-7, Modified Oxford Scale, FSFI, and SF-36. After data collection, it will be analyzed by using SPSS version 21.
- Conditions
- Urinary Incontinence
- Being tested
- Paula Exercises, Tibial Nerve Stimulation
- Keywords
- Tibial Nerve, Incontinence, Pelvic Floor, Quality of life, Female, Stress Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paula ExercisesOther
- Frequency: 2 sessions per week
- Session Duration: 20 minutes
- Repeated voluntary contractions of eye muscles (e.g., squinting) and mouth muscles (e.g., puckering lips), abdominal contractions followed by pelvic contractions.
- Controlled breathing and postural awareness
- Each type of contraction repeated 10-15 times per session
- 30-second rest between sets, total 20 sets
- Duration:8 weeks
Tibial Nerve StimulationOther
- Frequency: 20 Hz
- Pulse Width: 200 microseconds
- Intensity: Adjusted to elicit mild toe flexion ,0 to 10 mA
- Session Duration: 20 minutes
- Frequency: 2 sessions per week
- Total Duration:8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Paula Exercises & Tibial Nerve Stimulation | Experimental | Paula exercises involve contracting circular muscles of the body (especially facial muscles like the orbicularis oris and orbicularis oculi) to stimulate pelvic floor activity indirectly and for tibial stimulation Transcutaneous (TTNS) approach will be used Receives: Other: Paula Exercises; Other: Tibial Nerve Stimulation |
| Paula Exercises | Active comparator | Paula exercises involve contracting circular muscles of the body (especially facial muscles like the orbicularis oris and orbicularis oculi) to stimulate pelvic floor activity indirectly Receives: Other: Paula Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence Impact Questionnaire IIQ 7:
The Incontinence Impact Questionnaire (IIQ-7) is a brief, 7-item instrument used to assess the impact of urinary incontinence on a woman's quality of life.
Measured: 8th week
Modified Oxford Scale
The Modified Oxford Scale is a clinical tool used to assess the strength of pelvic floor muscles through vaginal or rectal examination. It uses a 6-point scale (0 to 5), where 0 indicates no contraction and 5 represents a strong contraction. A Cronbach's alpha is not typically reported for this scale because it is based on a single-item, ordinal rating by a clinician, rather than a multi-item questionnaire
Measured: 8th week
Female Sexual Function Index FSFI
The Female Sexual Function Index (FSFI) is a 19-item self-report questionnaire designed to assess six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain is scored individually and contributes to a total score that reflects overall sexual function, with higher scores indicating better function
Measured: 8th week
SF 36
The Short Form-36 Health Survey (SF-36) is a widely used 36-item questionnaire designed to measure health-related quality of life across eight domainsThese domains contribute to two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sobia ghafoor, MSPT-OM, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576205
- Sponsor's protocol ID
- REC/RCR & AHS/25/0502
- Status last verified
- Sep 2026
- First submitted
- 4 May 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang X, Wang X, Gao Z, Li L, Lin H, Wang H, Zhou H, Tian D, Zhang Q, Shen J. The Anatomical Pathogenesis of Stress Urinary Incontinence in Women. Medicina (Kaunas). 2022 Dec 20;59(1):5. doi: 10.3390/medicina59010005.
PubMed 36676629Mushtaq S. EFFICACY OF EXERCISE-BASED TECHNIQUES TO TREAT STRESS URINARY INCONTINENCE IN FEMALES EXCEPT FOR KEGELS TECHNIQUE: A NARRATIVE REVIEW OF THE LATEST EVIDENCE. Pakistan Journal of Rehabilitation. 2024;13(1):17-29.
Aliyu SU, Hanif SM, Lawal IU. Effect of Paula exercise method on functional outcomes of women with post fistula repair incontinence: a protocol for randomized controlled trial. BMC Womens Health. 2021 Mar 9;21(1):101. doi: 10.1186/s12905-021-01249-w.
PubMed 33750376Lee UJ, MacDiarmid S, Matthews CA, Gillespie E, Peters KM. Tibial Nerve Stimulation for Urge Urinary Incontinence and Overactive Bladder: Narrative Review of Randomized Controlled Trials and Applicability to Implantable Devices. Adv Ther. 2024 Jul;41(7):2635-2654. doi: 10.1007/s12325-024-02864-3. Epub 2024 May 15.
PubMed 38748331Al-Danakh A, Safi M, Alradhi M, Almoiliqy M, Chen Q, Al-Nusaif M, Yang X, Al-Dherasi A, Zhu X, Yang D. Posterior Tibial Nerve Stimulation for Overactive Bladder: Mechanism, Classification, and Management Outlines. Parkinsons Dis. 2022 Mar 16;2022:2700227. doi: 10.1155/2022/2700227. eCollection 2022.
PubMed 35400016
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combine Effects of Paula Exercises and Tibial Nerve Stimulation on Incontinence, Pelvic Floor Muscles Strength, Sexual Function and Quality of Life in Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07576205
- Acronym / sponsor ID
- REC/RCR & AHS/25/0502
- Conditions
- Urinary Incontinence
- Keywords
- Tibial Nerve, Incontinence, Pelvic Floor, Quality of life, Female, Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the combined effects of Paula method \& tibial nerve stimulation on incontinence, pelvic floor muscles strength, sexual function and quality of life in stress urinary incontinence
Detailed description
This study will be randomized controlled trial and will be conducted in Arshian Hussnain Medical Clinic and at Marie Stopes Society. Non probability convenience sampling technique will be used and 56 participants will be recruited in study after randomization. Inclusion criteria will be females aged 30-45 years, multiparous women (≥2 full-term vaginal delivery). Exclusion criteria will be Neurological disorders, pregnancy and dermatological conditions .The subjects will be divided into two groups. Group A will receive Paula exercise and Tibial nerve stimulation. Group B will receive only Paula exercises. Both groups will receive baseline treatment which will include pelvic floor muscle contractions. The total duration of treatment will be 8 weeks and there will be 2 sessions each week. Outcomes assessed will be urinary function, pelvic floor muscles strength, sexual function \& quality of life. Outcomes will be assessed using validated tools such as the IIQ-7, Modified Oxford Scale, FSFI, and SF-36. After data collection, it will be analyzed by using SPSS version 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paula Exercises & Tibial Nerve Stimulation | Experimental | Other: Paula Exercises, Other: Tibial Nerve StimulationPaula exercises involve contracting circular muscles of the body (especially facial muscles like the orbicularis oris and orbicularis oculi) to stimulate pelvic floor activity indirectly and for tibial stimulation Transcutaneous (TTNS) approach will be used |
| Paula Exercises | Active comparator | Other: Paula ExercisesPaula exercises involve contracting circular muscles of the body (especially facial muscles like the orbicularis oris and orbicularis oculi) to stimulate pelvic floor activity indirectly |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Multiparous women (≥2 full-term vaginal deliveries)
- Clinical diagnosis of stress urinary incontinence (confirmed by cough stress test)
- Duration of symptoms ≥3 months
- Ability to correctly perform pelvic floor contractions (confirmed by digital examination)
Key exclusion criteria (11 listed)
- Neurological disorders (e.g., multiple sclerosis, spinal cord injury)
- Mixed or urge urinary incontinence as the predominant type
- Previous pelvic surgery or incontinence-related procedures within the past year
- Current pregnancy or <6 months postpartum
- Pelvic organ prolapse beyond stage II (POP-Q system)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paula Exercises* Frequency: 2 sessions per week * Session Duration: 20 minutes * Repeated voluntary contractions of eye muscles (e.g., squinting) and mouth muscles (e.g., puckering lips), abdominal contractions followed by pelvic contractions. * Controlled breathing and postural awareness * Each type of contraction repeated 10-15 times per session * 30-second rest between sets, total 20 sets * Duration:8 weeks | Other | Paula Exercises, Paula Exercises & Tibial Nerve Stimulation |
| Tibial Nerve Stimulation* Frequency: 20 Hz * Pulse Width: 200 microseconds * Intensity: Adjusted to elicit mild toe flexion ,0 to 10 mA * Session Duration: 20 minutes * Frequency: 2 sessions per week * Total Duration:8 weeks | Other | Paula Exercises & Tibial Nerve Stimulation |
Primary outcome
Incontinence Impact Questionnaire IIQ 7:
Time frame: 8th week
The Incontinence Impact Questionnaire (IIQ-7) is a brief, 7-item instrument used to assess the impact of urinary incontinence on a woman's quality of life.
Modified Oxford Scale
Time frame: 8th week
The Modified Oxford Scale is a clinical tool used to assess the strength of pelvic floor muscles through vaginal or rectal examination. It uses a 6-point scale (0 to 5), where 0 indicates no contraction and 5 represents a strong contraction. A Cronbach's alpha is not typically reported for this scale because it is based on a single-item, ordinal rating by a clinician, rather than a multi-item questionnaire
Female Sexual Function Index FSFI
Time frame: 8th week
The Female Sexual Function Index (FSFI) is a 19-item self-report questionnaire designed to assess six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain is scored individually and contributes to a total score that reflects overall sexual function, with higher scores indicating better function
SF 36
Time frame: 8th week
The Short Form-36 Health Survey (SF-36) is a widely used 36-item questionnaire designed to measure health-related quality of life across eight domainsThese domains contribute to two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 36676629Yang X, Wang X, Gao Z, Li L, Lin H, Wang H, Zhou H, Tian D, Zhang Q, Shen J. The Anatomical Pathogenesis of Stress Urinary Incontinence in Women. Medicina (Kaunas). 2022 Dec 20;59(1):5. doi: 10.3390/medicina59010005.
- BackgroundMushtaq S. EFFICACY OF EXERCISE-BASED TECHNIQUES TO TREAT STRESS URINARY INCONTINENCE IN FEMALES EXCEPT FOR KEGELS TECHNIQUE: A NARRATIVE REVIEW OF THE LATEST EVIDENCE. Pakistan Journal of Rehabilitation. 2024;13(1):17-29.
- Background: PubMed 33750376Aliyu SU, Hanif SM, Lawal IU. Effect of Paula exercise method on functional outcomes of women with post fistula repair incontinence: a protocol for randomized controlled trial. BMC Womens Health. 2021 Mar 9;21(1):101. doi: 10.1186/s12905-021-01249-w.
- Background: PubMed 38748331Lee UJ, MacDiarmid S, Matthews CA, Gillespie E, Peters KM. Tibial Nerve Stimulation for Urge Urinary Incontinence and Overactive Bladder: Narrative Review of Randomized Controlled Trials and Applicability to Implantable Devices. Adv Ther. 2024 Jul;41(7):2635-2654. doi: 10.1007/s12325-024-02864-3. Epub 2024 May 15.
- Background: PubMed 35400016Al-Danakh A, Safi M, Alradhi M, Almoiliqy M, Chen Q, Al-Nusaif M, Yang X, Al-Dherasi A, Zhu X, Yang D. Posterior Tibial Nerve Stimulation for Overactive Bladder: Mechanism, Classification, and Management Outlines. Parkinsons Dis. 2022 Mar 16;2022:2700227. doi: 10.1155/2022/2700227. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
sobia ghafoor, MSPT-OM principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paula Exercises and Tibial Nerve Stimulation in people with Urinary Incontinence, run by Riphah International University at 1 site 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact imran amjad (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence Impact Questionnaire IIQ 7: (time frame: 8th week). 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 NCT07576205, which also lists 5 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 24 Sep 2026.