Urinary IncontinenceNCT05733052
Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence
A study testing Polyester suture in people with Urinary Incontinence and Pelvic Floor Disorders, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
To test efficacy and safety at six months of the proposed Pubourethral Plication Procedure (PPP) for cure of stress urinary incontinence - reinforcing pubourethral ligaments (PUL) with large diameter polyester sutures. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Pelvic Floor Disorders
- What is being tested?
- Polyester suture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urine loss on coughing controlled by hemostat behind symphysis
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Muğla Training and Research Hospital
Muğla
Burcu Harmandar, Assoc.Prof., burucuharmandar@gmail.com
About this study
Official title: Pubourethral Plication Procedure (PPP) Cures Stress Urinary Incontinence Without Tapes- First Report.
To test efficacy and safety at six months of the proposed Pubourethral Plication Procedure (PPP) for cure of stress urinary incontinence - reinforcing pubourethral ligaments (PUL) with large diameter polyester sutures.
Read the detailed description
Full thickness vaginal incisions will be made in the suburethral sulci extending from bladder neck to urethral meatus. The operation space is 2.5cm2 space. A No2 or 3 polyester suture will be inserted into PUL, immediately lateral to midurethra, into PUL origin, external urethral ligament, laterally into m.pubococcygeus, then will be tied, but not tightly. The vaginal incisions will be closed with vicryl sutures. All women will be discharged on day of surgery. During the regular follow ups the healing at stress urinary incontinence will be evaluated
- Conditions
- Urinary Incontinence, Pelvic Floor Disorders
- Being tested
- Polyester suture
- Medical subject headings
- Urinary Incontinence, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyester sutureOther
A No2 polyester suture will be used for tying special anatomical structures fr telieving the symptom. of stress urinary incontinence
| Study group | Role | What they receive |
|---|---|---|
| Polyester suture arm | Experimental | A No 3 polyester suture will be inserted into the external urethral ligament, into the uurethral part of pubourethral ligament and into the pubic part of the pubourethral lgament then will be tied, but not tightly. The interventions will be carried on either side of the urethra that will be opened up by an 2.5 cm incision in the periurethral sulci. Receives: Other: Polyester suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curing effect of the suturation
The plication of pubourethral ligaments with a polyester suture will lead to a neoligament formation; so that the pubourethral ligaments will get strenghened. If the pubourethral ligaments get strengthened woman will not loose urine upon stressful activities such as coughing. Hence the stress test will be negative. And the rate of negative stress test within the cohort will show us the efficinecy of operation in curing urinary incontinence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMET AKIN SIVASLIOĞLU, Muğla Sıtkı Koçman University
- Investigators
- AHMET AKIN SIVASLIOGLU, Prof, Principal investigator, Mugla SITKI KOÇMAN UNİVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733052
- Sponsor's protocol ID
- 11/VII
- Status last verified
- Feb 2023
- First submitted
- 27 Dec 2022
- Last updated
- 17 Feb 2023
- Results posted
- 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 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pubourethral Plication Procedure (PPP) Cures Stress Urinary Incontinence Without Tapes- First Report.
- ClinicalTrials.gov ID
- NCT05733052
- Acronym / sponsor ID
- 11/VII
- Conditions
- Urinary Incontinence, Pelvic Floor Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 17 Feb 2023 (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.
To test efficacy and safety at six months of the proposed Pubourethral Plication Procedure (PPP) for cure of stress urinary incontinence - reinforcing pubourethral ligaments (PUL) with large diameter polyester sutures.
Detailed description
Full thickness vaginal incisions will be made in the suburethral sulci extending from bladder neck to urethral meatus. The operation space is 2.5cm2 space. A No2 or 3 polyester suture will be inserted into PUL, immediately lateral to midurethra, into PUL origin, external urethral ligament, laterally into m.pubococcygeus, then will be tied, but not tightly. The vaginal incisions will be closed with vicryl sutures. All women will be discharged on day of surgery. During the regular follow ups the healing at stress urinary incontinence will be evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polyester suture arm | Experimental | Other: Polyester sutureA No 3 polyester suture will be inserted into the external urethral ligament, into the uurethral part of pubourethral ligament and into the pubic part of the pubourethral lgament then will be tied, but not tightly. The interventions will be carried on either side of the urethra that will be opened up by an 2.5 cm incision in the periurethral sulci. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Urine loss on coughing controlled by hemostat behind symphysis
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Polyester sutureA No2 polyester suture will be used for tying special anatomical structures fr telieving the symptom. of stress urinary incontinence | Other | Polyester suture arm |
Primary outcome
Curing effect of the suturation
Time frame: 6 months
The plication of pubourethral ligaments with a polyester suture will lead to a neoligament formation; so that the pubourethral ligaments will get strenghened. If the pubourethral ligaments get strengthened woman will not loose urine upon stressful activities such as coughing. Hence the stress test will be negative. And the rate of negative stress test within the cohort will show us the efficinecy of operation in curing urinary incontinence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- 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.
AHMET AKIN SIVASLIOGLU, Prof principal investigator
Mugla SITKI KOÇMAN UNİVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyester suture in people with Urinary Incontinence and Pelvic Floor Disorders, run by Muğla Sıtkı Koçman 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: status not confirmed, as of the sponsor's last update on 17 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AHMET AKIN SIVASLIOGLU, Prof. (+905322770618, akinsivaslioglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Curing effect of the suturation (time frame: 6 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 17 Feb 2023.