Holep SurgeryNCT07719036
The Effect of Pelvic Muscle Exercises on Urinary Incontinence in Patients Undergoing HoLEP Surgery.
A study testing pelvic exercise group in people with Holep Surgery and Pelvic Floor Exercises, run by Atlas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Holep Surgery, Pelvic Floor Exercises, Urinary Incontinence
- What is being tested?
- pelvic exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2025to 30 Jul 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have undergone HOLEP surgery, who can speak and understand Turkish, Patients without visual, hearing, speech, or mental problems.
Who cannot join
- Patients who develop postoperative complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Pelvic Muscle Exercises on Urinary Incontinence in Patients Undergoing HoLEP Surgery: A Randomized Controlled Trial.
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
- Being tested
- pelvic exercise group
- Keywords
- HoLEP surgery,, pelvic floor exercises.
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic exercise groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: pelvic exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The ICIQSF was used to assess individuals' urinary incontinence complaints and quality of life. The ICIQ-SF was developed by Avery et al. to assess urinary incontinence complaints and the impact of urinary incontinence on quality of life (Avery et al., 2004). Internal consistency measurements showed that the ICIQ is highly reliable, provides consistent, stable, and reproducible data; and that the scale has a high level of sensitivity, reliability, and validity. The scale, consisting of four dimensions, questions the frequency of urinary incontinence in the first dimension, the amount of urine leaked in the second dimension, the impact of urinary incontinence on daily life in the third dimension, and when the person leaks urine in the fourth dimension. The first three dimensions are included in the scoring, while the responses to the fourth dimension, which is not included in the scoring, are used to determine the type of urinary incontinence. The ICIQ score is obtained by summing the
Measured: Patients are contacted weekly during the first month after discharge, and once each month during the 2nd and 3rd months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start18 Aug 2025
- Primary completion17 Jul 2026
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Holep SurgeryStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagla Toprak, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719036
- Sponsor's protocol ID
- 28.07.2025
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Pelvic Muscle Exercises on Urinary Incontinence in Patients Undergoing HoLEP Surgery: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07719036
- Acronym / sponsor ID
- 28.07.2025
- Conditions
- Holep Surgery, Pelvic Floor Exercises, Urinary Incontinence
- Keywords
- HoLEP surgery,, pelvic floor exercises.
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 17 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 22 Jul 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –no action was taken |
| Pelvic exercise group | Other | Other: pelvic exercise groupThe 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. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have undergone HOLEP surgery, who can speak and understand Turkish, Patients without visual, hearing, speech, or mental problems.
Key exclusion criteria (1 listed)
- Patients who develop postoperative complications
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 |
|---|---|---|
| pelvic exercise groupThe 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 |
Primary outcome
Urinary incontinence severity index
Time frame: Weekly during the first month after discharge, and once each month during the 2nd and 3rd months.
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.
1 secondary outcome
International Urinary Incontinence Questionnaire-Short Form (ICIQ SF)
Time frame: Patients are contacted weekly during the first month after discharge, and once each month during the 2nd and 3rd months.
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 22 Jul 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic exercise group in people with Holep Surgery and Pelvic Floor Exercises, run by Atlas University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary incontinence severity index (time frame: Weekly during the first month after discharge, and once each month during the 2nd and 3rd months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2026.