Effects of Paula Exercises and Tibial Nerve Stimulation in Stress Urinary Incontinence

NCT07576205 | Recruiting

• 1 other identifier: REC/RCR & AHS/25/0502
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Urinary Incontinence

Keywords

Tibial Nerve; Incontinence; Pelvic Floor; Quality of life; Female; Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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

  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).

  8th week

Study Arms (2)

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

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

Other: Paula Exercises

Interventions

Paula Exercises OTHER

* 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

Paula Exercises; Paula Exercises & Tibial Nerve Stimulation

Tibial Nerve Stimulation OTHER

* 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

Paula Exercises & Tibial Nerve Stimulation

Eligibility Criteria

• Age: 30 Years - 45 Years
• Gender Eligibility Details: postpartum Stress Urinary Incontinence
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• Diagnosed malignancy
• Diagnosed psychiatric disorder
• Pregnancy
• Diagnosed dermatological condition
• Participants who are currently enrolled in other clinical trials to avoid potential confounding factors.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Arshian Hussnain Medical Clinic

Lahore, Punjab Province, 6400, Pakistan

RECRUITING

Related Publications (5)

• Yang X, Wang X, Gao Z, Li L, Lin H, Wang H, et al. The Anatomical Pathogenesis of Stress Urinary Incontinence in Women. Medicina. 2023;59(1):5.

  BACKGROUND

• Mushtaq 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

• 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 Women's Health. 2021;21(1):101.

  BACKGROUND

• Lee 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. Advances in Therapy. 2024;41(7):2635-54.

  BACKGROUND

• Al-Danakh A, Safi M, Alradhi M, Almoiliqy M, Chen Q, Al-Nusaif M, et al. Posterior tibial nerve stimulation for overactive bladder: mechanism, classification, and management outlines. Parkinson's Disease. 2022;2022(1):2700227.

  BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

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

Study Officials

• sobia ghafoor, MSPT-OM

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad

CONTACT

03324390125; imran.amjad@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

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)