Effects of Pelvic Floor Rehab Protocol on Urinary Incontinence

NCT07603388 | Active Not Recruiting

• 1 other identifier: Attiya Azhar
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary incontinence is a serious health issue that deeply affects a person's daily life and overall well-being. The global prevalence of UI is between 5 to 69% during a woman's lifetime, with higher prevalence in older age groups. The goal of this randomized controlled trial is to compare the effects of pregnancy specific pelvic floor rehab protocol with the standard protocol on urinary incontinence. Participants will be randomly assigned to one of the two groups. The results of this trial would be helpful in this way that how Pregnancy specific pelvic floor rehab protocol can provide support for pregnant ladies with urinary incontinence and improve health outcomes.

Conditions

Urinary Incontinence

Keywords

Pregnancy Specific Pelvic Floor Rehab Protocol; Pregnant Women; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Questionnaire for Incontinence Diagnosis

  The Questionnaire for Incontinence Diagnosis is a self-reported screening tool used to identify the presence and type of urinary incontinence, such as stress, urge, or mixed incontinence. It consists of structured questions related to symptom triggers, frequency, and leakage patterns. Each item scores 0 (None of the time), 1 (Rarely), 2 (Once in a while), 3 (Often), 4 (Most of the time) or 5 (All of the time). Responses to items 1, 2 and 3 are summed for the Stress score; and responses to items 4, 5, and 6 are summed for the Urge score.

  4 weeks

Secondary Outcomes (4)

• Incontinence Severity Index

  4 weeks

• International Consultation on Incontinence Questionnaire (ICIQ-UI-SF)

  4 weeks

• Incontinence Impact Questionnaire

  4 weeks

• Patient Global Impression of Improvement Scale

  4 weeks

Study Arms (2)

Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group

EXPERIMENTAL

This pregnancy-specific pelvic floor rehabilitation protocol follows a progressive 4-week plan focused on pelvic floor muscle training, core activation, and functional strengthening. Exercises such as Kegels, abdominal drawing-in, bridging, and clamshells are performed in various positions with controlled breathing. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education.

Other: Pregnancy Specific Pelvic floor rehab protocol (PSPFR) Group

Standard Pelvic floor Rehab Protocol Group

ACTIVE COMPARATOR

This group receives standard protocol for strengthening of pelvic floor to prevent urinary incontinence.

Other: Standard Protocol for Pelvic floor strengthening

Interventions

Pregnancy Specific Pelvic floor rehab protocol (PSPFR) Group OTHER

This pregnancy-specific pelvic floor rehabilitation protocol follows a progressive 4-week plan focused on pelvic floor muscle training, core activation, and functional strengthening. Exercises such as Kegels, abdominal drawing-in, bridging, and clamshells are performed in various positions with controlled breathing. Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education. The instructions of the supervised exercises would be Hold for 2 s in 3 repetitions, 5 seconds rest, 1 minute of rest between each exercise \& 2 sets each. The record of each session will be written in diaries.

Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group

Standard Protocol for Pelvic floor strengthening OTHER

in this group, standard exercises used for strengthening of pelvic floor to prevent urinary incontinence will be implemented.

Standard Pelvic floor Rehab Protocol Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 18-35 yrs.
• Score ≥1 on stress or urge subscale of the Questionnaire for Incontinence Diagnosis
• No participation in a structured pelvic floor rehabilitation program within the last six months.

You may not qualify if:

• Patients with High-risk pregnancy.
• Known neurological disorders.
• History of pelvic surgery.
• ACOG Contraindications for Exercise

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International Hospital

Islamabad, Islamabad, 44000, Pakistan

Location

Related Publications (2)

• Wu Y, Li T, Cai F, Ye X, Xu M. Stable pelvic floor muscle training improves urinary incontinence in women with gestational diabetes mellitus. J Obstet Gynaecol. 2024 Dec;44(1):2420192. doi: 10.1080/01443615.2024.2420192. Epub 2024 Oct 30.

  PMID: 39473377 BACKGROUND

• Kamali S, Ozengin N, Topcuoglu MA. The effect of e-pelvic floor muscle training on symptoms in women with stress urinary incontinence: a randomized controlled trial. Women Health. 2023 Jul 3;63(6):473-483. doi: 10.1080/03630242.2023.2223729. Epub 2023 Jun 14.

  PMID: 37315962 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Population Groups

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Dr Zahra Ijaz

  Riphah International University

  PRINCIPAL INVESTIGATOR

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

Model Details: There will be comparison between experimental group and control group.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: November 1, 2025
• Primary Completion: May 7, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)