CompletedNot Applicable

Efficacy of Li-SWT on Persistent Storage Symptoms After Transurethral Surgery for BPO

Egypt132 participantsStarted 2020-07-04

Plain-language summary

comparing the outcome of low-intensity shock wave therapy (Li-SWT) versus solifenacin on persistent storage symptoms after transurethral surgery for benign prostatic obstruction (BPO)

Who can participate

Age range

50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Ability to give informed consent and reply to questionnaires.
. Average urgency episodes per 24 hrs ≥ 1 and average daytime frequency ≥ 8 during the baseline 3-day voiding diary.
. Relief of BOO as proved by non-invasive uroflowmetry, pressure flow study (PFS) or urethrocystoscopy.

Exclusion criteria

. Untreated UTI.
. BOO such as bladder neck contracture (BNC), residual obstructing adenoma or urethral stricture.
. Neurogenic lower urinary tract dysfunction (LUTD).
. Uncontrolled diabetes mellitus.
. Depression or any psychogenic disorders.
. Prior radiation therapy to the pelvic area.
. History of prostate cancer, bladder tumor or intravesical Bacillus Calmette Guerin (BCG) therapy.
. Poor coagulopathy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The percent change in overactive bladder symptoms score (OABSS)

Timeframe: approximately 20 months

Percent of responders

Timeframe: approximately 20 months

The numerical change in overactive bladder symptoms score (OABSS)

Timeframe: approximately 2 years.

3-day voiding diary

Timeframe: approximately 2 years.

Incidence of adverse events associated with treatment

Timeframe: approximately 18 months

Trial details

NCT IDNCT04437108

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-12

View on ClinicalTrials.gov More Overactive Bladder trials

Who can participate

Age range

50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Ability to give informed consent and reply to questionnaires.
. Average urgency episodes per 24 hrs ≥ 1 and average daytime frequency ≥ 8 during the baseline 3-day voiding diary.
. Relief of BOO as proved by non-invasive uroflowmetry, pressure flow study (PFS) or urethrocystoscopy.

Exclusion criteria

. Untreated UTI.
. BOO such as bladder neck contracture (BNC), residual obstructing adenoma or urethral stricture.
. Neurogenic lower urinary tract dysfunction (LUTD).
. Uncontrolled diabetes mellitus.
. Depression or any psychogenic disorders.
. Prior radiation therapy to the pelvic area.
. History of prostate cancer, bladder tumor or intravesical Bacillus Calmette Guerin (BCG) therapy.
. Poor coagulopathy.

What they're measuring

The percent change in overactive bladder symptoms score (OABSS)

Timeframe: approximately 20 months

Percent of responders

Timeframe: approximately 20 months

The numerical change in overactive bladder symptoms score (OABSS)

Timeframe: approximately 2 years.

3-day voiding diary

Timeframe: approximately 2 years.

Incidence of adverse events associated with treatment

Timeframe: approximately 18 months