ClinicalTrials.gg
RecruitingNCT07473310Updated Mar 16, 2026

Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women

A Phase 4 interventional study of Low intensity shockwave therapy and Oral Solifenacin succinate 5 mg in Overactive Bladder (OAB) and Urge Incontinence, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Mansoura University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.
Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Urinary Bladder, Overactive with a site in Egypt — 7 open to participants now, 8 under way, 1 of them phase 3. Urinary Bladder, Overactive · Egypt.

Planned enrollment
12th of 21
70 · median 74
Started
2025
with 5 others
Phase 4
5 of 23
2 open now
Registered
20th of 23
by date
Lead sponsor
6 of 23
Mansoura University

Among the 23 studies in Urinary Bladder, Overactive with a site in Egypt, this one is the 12th largest by planned enrollment of the 21 interventional ones that give a count, is one of 6 that started in 2025, is one of 5 in phase 4, and was the 20th registered.

Urinary Bladder, Overactive

858 studies on the registry are indexed under Urinary Bladder, Overactive; 126 are open to participants now.

Browse Urinary Bladder, Overactive studies →

Open to participants now

7 of the 23 studies in Urinary Bladder, Overactive with a site in Egypt are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 73 Urinary Bladder, Overactive studies recruiting now, 44 (60%) set no upper age limit and 15 (21%) stop at 75 or younger; 6 take children under 18; 8 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

Study summary

The goal of this clinical trial is to evaluate the effectiveness and safety of low-intensity shockwave therapy (Li-SWT) for the treatment of overactive bladder (OAB) in adult women.

The main questions this study aims to answer are whether Li-SWT improves overactive bladder symptoms and quality of life, and whether these improvements are sustained over a 12-month follow-up period, compared with standard medical therapy.

Researchers will compare Li-SWT with oral solifenacin succinate, a commonly used antimuscarinic medication for OAB.

Participants will be randomly assigned to receive either Li-SWT once weekly for 8 weeks or solifenacin 5 mg taken orally once daily for 12 months. All participants will complete symptom questionnaires and three-day voiding diaries and will undergo uroflowmetry, post-void residual measurement, and filling cystometry at specified time points during follow-up.

03

Conditions studied

  • Overactive Bladder (OAB)
  • Urge Incontinence

Keywords

  • OAB
  • overactive bladder
  • low intensity shockwave
  • solifenacin
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • OAB symptoms persisting for ≥3 months.
  • OAB Symptom Score (OABSS) ≥7.
  • Ability and willingness to provide

Exclusion criteria

Exclusion Criteria:

  • Active urinary tract infection.
  • Stress urinary incontinence as primary diagnosis.
  • Pelvic organ prolapse stage ≥II.
  • History of pelvic radiation or surgery within 6 months.
  • Use of anticholinergics or β3-agonists for the past 4 weeks who are unwilling to undergo washout.
  • Pregnancy or breast feeding.
  • Neuropathic diseases or psychological disorders.
  • History of urogenital .
  • Uncontrolled DM ( > 6.8)
  • Uncorrected coagulopathy or severe cardiovascular disease.
  • to solifenacin e.g.: closed angle glaucoma)
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    LiSWT group

    Allocated to receive LiSWT

    Other: Low intensity shockwave therapy

  • Active comparator
    Solifenacin Group

    Allocated to receive oral Solifenacin succinate 5 mg

    Drug: Oral Solifenacin succinate 5 mg

Interventions

  • OtherLow intensity shockwave therapy

    Participants will receive Li-SWT which will be applied once weekly for 8 weeks, with a focused shockwave. The bladder will be scanned by US to ensure that t is filled with approximately 50% of the maximum cytometric capacity as measure by baseline cystometry. The patients will be asked to lie flat in a supine position. The device will be operated by a well-trained urologist. A commercially used gel for sonography will be applied to suprapubic region. The applicator will be applied to the S.P region in 3 horizontal sites. 2 cm from each other and 2 fingerbreadths above the pubic bone with 45° tilt. Li-SWT will be applied with energy density of 0.12 mJ/mm² and frequency of 4 pulses/second for a total of 3000 pulses per session (1000 pulses per bladder dome and each lateral wall at 45° tilt).

  • Participants will receive solifenacin succinate 5 orally once daily for 12 months

06

What researchers measure

Primary outcomes

  1. Changes in Overactive Bladder Symptom Score (OABSS) from baseline to different points of follow up

    self administered questionnaire with minimum score of 0 and maximum score of 15, higher score means worse symptoms

    Time frame: Baseline and 3 months

Secondary outcomes

  1. Changes in frequency on three-day urinary diary

    Changes in the mean number of voiding episodes per days as measure by a self administered three-day urinary diary

    Time frame: from baseline to 1, 3, 6,9 and 12 months

  2. Changes in number of urgency episodes on three-day urinary diary

    Changes in the mean number of urgency episodes per day (strong desire to void that cannot be postponed or withheld) as measured by a self administered three-day voiding diary

    Time frame: baseline to 1, 2, 3,6,9 and 12 months

  3. Changes in number of nocturia episodes on three-day urinary diary

    changes in the mean number of nocturia episodes per night(waking up in the middle of the night to void) as measured by a self-administered three-day voiding diary

    Time frame: baseline to 1, 2, 3,6,9 and 12 months

  4. Changes in number of incontinence episodes on three-day urinary diary

    Changes in number of incontinence episodes per day (involuntary leakage of urine) as measured by a self administered three-day urinary diary

    Time frame: form baseline to 1,2,3,6,9 and 12 months

  5. changes in International Consultation on Incontinence Questionnaire- Urinary Incontinence-Short Form (ICIQ-UI-SF) score

    self administered questionnaire with minimum score of 0 and maximum score of 21, the higher score, the worse the symptoms

    Time frame: form baseline to 1,2,3,6,9 and 12 months

  6. changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)

    self administered questionnaire with minimum score of 25 and maximum score of 160 , higher score indicated worse effect on the quality of life

    Time frame: from baseline to 1,2,3,6,9 and 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Jun 2027, 19 months after the start.

Of 42 non-industry phase 4 interventional studies under Urinary Bladder, Overactive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's planned 19 months is below that.

Counting every sponsor, half of 54 studies reached it within 23 months; a quarter within 15 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 27, 2025
First posted
Mar 16, 2026
StartActual
Nov 11, 2025
Primary completionEst.
Jun 2027
CompletionEst.
Dec 2027
Last update
Mar 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07473310
Responsible party
Sponsor
First posted
Mar 16, 2026
Start date
Nov 11, 2025
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Mar 16, 2026

Study contacts

Yahya H Elmorsy
Contact
Hossam.Yahya@yahoo.com
00201100311999

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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