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

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

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: Paula Exercises; Other: Tibial Nerve Stimulation

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 Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: imran amjad; Phone Number: 03324390125; Email: imran.amjad@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 6400
      • Recruiting
      • Arshian Hussnain Medical Clinic
      • Contact: sobia ghafoor, MSPT-OM; Phone Number: 0309 4384971; Email: Sobia.physio@gmail.com
      • Principal Investigator: Fizza Tahir, MSPT(WH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paula Exercises & Tibial Nerve Stimulation; 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; 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: 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
Active Comparator: Paula Exercises; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: sobia ghafoor, MSPT-OM, Riphah International University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Incontinence; Female; Stress Urinary Incontinence; Pelvic Floor; Tibial Nerve
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: REC/RCR & AHS/25/0502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No