The Effect of Pelvic Muscle Exercises on Urinary Incontinence in Patients Undergoing HoLEP Surgery.

NCT07719036 | Active Not Recruiting

• 1 other identifier: 28.07.2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patients meeting the eligibility criteria and scheduled for HoLEP surgery will provide written informed consent prior to enrollment. Participants will be randomly assigned to either the intervention or control group. Upon acceptance, baseline demographic and clinical data will be collected. In the intervention group, standardized pelvic floor muscle training (PFMT) will be administered individually the day before surgery. Participants will be instructed to perform slow and rapid pelvic floor muscle contractions. The same supervised exercise protocol will be repeated on days 1 and 2 post-surgery. After discharge, participants will be contacted weekly during the first month and monthly during the second and third months to encourage adherence to PFMT. At the end of the third month post-surgery, urinary incontinence will be assessed using the Severity Index of Urinary Incontinence (ISI) and the International Urinary Incontinence Advisory Questionnaire - Short Form (ICIQ-SF). The control group will receive routine pre- and post-operative care without supervised PFMT and will undergo the same outcome assessments at the third month post-surgery.

Conditions

Holep Surgery; Pelvic Floor Exercises; Urinary Incontinence

Keywords

HoLEP surgery,; pelvic floor exercises.

Outcome Measures

Primary Outcomes (1)

• Urinary incontinence severity index

  The severity of incontinence in individuals was assessed using the Urinary Incontinence Severity Index (ISI). This index consists of 2 items. The first item questions the frequency of urinary incontinence, and the second item questions the amount of urine leaked. The total score is obtained by multiplying the scores from the first and second items and ranges from 1 to 12. A higher score indicates more severe urinary incontinence. The studies conducted show that ISI is a valid measure in assessing the severity of incontinence.

  Weekly during the first month after discharge, and once each month during the 2nd and 3rd months.

Secondary Outcomes (1)

• International Urinary Incontinence Questionnaire-Short Form (ICIQ SF)

  Patients are contacted weekly during the first month after discharge, and once each month during the 2nd and 3rd months.

Study Arms (2)

Control Group

NO INTERVENTION

no action was taken

Pelvic exercise group

OTHER

The individual will be given a position where communication is easy and they feel comfortable. Lie down, sit, or stand with your knees slightly apart. Slowly contract and move your pelvic floor muscles as much as you can. Hold for 5 seconds, then relax. Repeat at least 5 times (slow contractions). Now contract and relax your muscles quickly and tightly. Repeat at least 5 times (fast contractions). Do these two exercises at least 10 times a day, 5 fast and 5 slow. As your muscles get stronger, you will notice that you can hold the contraction for longer than 5 seconds. Each time you can do 5 more contractions without getting tired.

Other: pelvic exercise group

Interventions

pelvic exercise group OTHER

The individual will be given a position where communication is easy and they feel comfortable. Lie down, sit, or stand with your knees slightly apart. Slowly contract and move your pelvic floor muscles as much as you can. Hold for 5 seconds, then relax. Repeat at least 5 times (slow contractions). Now contract and relax your muscles quickly and tightly. Repeat at least 5 times (fast contractions). Do these two exercises at least 10 times a day, 5 fast and 5 slow. As your muscles get stronger, you will notice that you can hold the contraction for longer than 5 seconds. Each time you can do 5 more contractions without getting tired.

Pelvic exercise group

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have undergone HOLEP surgery, who can speak and understand Turkish, Patients without visual, hearing, speech, or mental problems.

You may not qualify if:

• Patients who develop postoperative complications

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Bezmi Alem Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Patients who meet the inclusion criteria and are scheduled to undergo HoLEP surgery will provide written informed consent before enrollment. Participants will be randomly assigned to either the intervention or control group. After admission, baseline demographic and clinical data will be collected. In the intervention group, standardized pelvic floor muscle training (PFMT) will be provided individually on the day before surgery. Participants will be instructed to perform slow and fast pelvic floor muscle contractions. The same supervised exercise protocol will be repeated on postoperative days 1 and 2. After discharge, participants will be contacted weekly during the first month and monthly during the second and third months to encourage adherence to PFMT. At the end of the third postoperative month, urinary incontinence will be assessed using the Incontinence Severity Index (ISI) and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The control group w

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: August 18, 2025
• Primary Completion: July 17, 2026
• Study Completion: July 30, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)