Incontinence StressULP-USLNCT07384117
Long-term Outcomes of Urethral and Uterosacral Ligament Plication
A study testing uterosacral ligament plication, urethral ligament plication in people with Incontinence Stress and Incontinence, Urge, run by Alev Esercan at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the long-term success and outcomes of urethral ligament plication surgeries in patients with stress incontinence and uterosacral ligament plication surgeries in patients with urge incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Incontinence Stress, Incontinence, Urge
- What is being tested?
- uterosacral ligament plication, urethral ligament plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 10 Jul 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over with urinary incontinence (stress or urge incontinence, or both)
- Agreement to undergo surgery
- No contraindications for anesthesia for surgery
Who cannot join
- Pregnancy
- Being under 18 years of age
- Suspicion of malignancy
- Urinary incontinence due to neurogenic bladder
- Presence of intrinsic sphincter (urethral) insufficiency
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sanliurfa Education and Training Hospital
Sanliurfa
About this study
Official title: Long-term Outcomes of Urethral Ligament Plication and Uterosacral Ligament Plication: a Multicenter Prospective Study
The aim of this study is to determine the long-term success and outcomes of urethral ligament plication surgeries in patients with stress incontinence and uterosacral ligament plication surgeries in patients with urge incontinence.
Read the detailed description
For patients experiencing stress urinary incontinence during coughing and sneezing, which increases the intra-abdominal pressure, urethral ligament (pubourethral ligament/external urethral ligament) surgery will be performed. For patients with urge incontinence (inability to hold urine immediately) and posterior compartment syndrome (nocturia, constipation/fecal incontinence), uterosacral ligament plication surgery will be performed. For patients with both types of urinary incontinence, both surgeries will be performed, and the 2-year postoperative results will be evaluated.
This study will be a double-blind, prospective experimental study. Patients with stress urinary incontinence will undergo preoperative examination using an integral theory questionnaire to assess their symptoms and complaints anatomically and physiologically. The surgeon will always be the same person (Esercan A), and patients will be called for a follow-up examination two years after surgery (routine postoperative check-ups will be performed, but our study will focus on the results at the end of the second year). This examination will be conducted by the same surgeon, different from those who performed the surgery and published the findings, and the integral theory questionnaire will be used again for evaluation. Integral theory was defined in the literature by Professor Peter Emanuel Papa Petros from our research team, and he also provided the integral theory questionnaire. We already use this questionnaire in routine practice. Additionally, any postoperative complications will be recorded in detail.
- Conditions
- Incontinence Stress, Incontinence, Urge
- Being tested
- uterosacral ligament plication, urethral ligament plication
- Keywords
- stress urinary incontinence, urge urinary incontinence
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterosacral ligament plication, urethral ligament plicationProcedure or surgery
Urethral ligament plication: With an 18-inch French Foley catheter inserted, a vertical incision of approximately 3 cm is made in the sulcus of the anterior-lateral vaginal wall, 2 cm laterally on each side of the midline, ensuring the urethral meatus remains midline. The external urethral ligaments are located inferolateral to the urethra on both sides, the urethral portion of the pubourethral ligament (PUL) is located midline, and the lateral portion of the PUL is located laterally. Using 2-0 polyester sutures, the ligaments are sutured separately on both sides to form a loop. The incised anterior vaginal tissue is then closed individually with 2-0 rapid polyglactin sutures.
Uterosacral ligament plication: A 18F Foley catheter inserted, in the lithotomy position; the posterior cervical lip is grasped with a tenaculum, and elevated outwards and upwards. Leaving rectovaginal fascia and rectum posterior; suturing the both uterosacral ligament by 2-0 polyester sutures in the midline.
| Study group | Role | What they receive |
|---|---|---|
| Urinary incontinent patients will have surgeries according to their incontinence type "stress" | Experimental | Urethral plication surgery (ULP) will be done for stress incontinence Receives: Procedure: uterosacral ligament plication, urethral ligament plication |
| Urinary incontinent patients will have surgeries according to their incontinence type "urge" | Experimental | USL for urge urinary incontinence will be done. Receives: Procedure: uterosacral ligament plication, urethral ligament plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success (continence) rates after the operations
Urinary incontinence status will be evaluated by Integral Theory Questionnaire and examinations at postoperative first and second year
Measured: At postoperative first and second year
Secondary outcomes (1)
The complications
Any complication seen after until postoperative second year
Measured: At second postoperative year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Feb 2026
- Primary completion1 Jul 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence StressStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alev Esercan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Alev Esercan, Sanliurfa Education and Research Hospital
- Investigators
- Peter Emanuel Papa Petros, Prof., Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384117
- Sponsor's protocol ID
- SEAH-USL/ULP
- Acronym
- ULP-USL
- Status last verified
- Apr 2026
- First submitted
- 18 Jan 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected during the study will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Urethral Ligament Plication and Uterosacral Ligament Plication: a Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT07384117
- Acronym / sponsor ID
- ULP-USL / SEAH-USL/ULP
- Conditions
- Incontinence Stress, Incontinence, Urge
- Keywords
- stress urinary incontinence, urge urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Alev EsercanOther government
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 3 Feb 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.
The aim of this study is to determine the long-term success and outcomes of urethral ligament plication surgeries in patients with stress incontinence and uterosacral ligament plication surgeries in patients with urge incontinence.
Detailed description
For patients experiencing stress urinary incontinence during coughing and sneezing, which increases the intra-abdominal pressure, urethral ligament (pubourethral ligament/external urethral ligament) surgery will be performed. For patients with urge incontinence (inability to hold urine immediately) and posterior compartment syndrome (nocturia, constipation/fecal incontinence), uterosacral ligament plication surgery will be performed. For patients with both types of urinary incontinence, both surgeries will be performed, and the 2-year postoperative results will be evaluated.
This study will be a double-blind, prospective experimental study. Patients with stress urinary incontinence will undergo preoperative examination using an integral theory questionnaire to assess their symptoms and complaints anatomically and physiologically. The surgeon will always be the same person (Esercan A), and patients will be called for a follow-up examination two years after surgery (routine postoperative check-ups will be performed, but our study will focus on the results at the end of the second year). This examination will be conducted by the same surgeon, different from those who performed the surgery and published the findings, and the integral theory questionnaire will be used again for evaluation. Integral theory was defined in the literature by Professor Peter Emanuel Papa Petros from our research team, and he also provided the integral theory questionnaire. We already use this questionnaire in routine practice. Additionally, any postoperative complications will be recorded in detail.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary incontinent patients will have surgeries according to their incontinence type "stress" | Experimental | Procedure: uterosacral ligament plication, urethral ligament plicationUrethral plication surgery (ULP) will be done for stress incontinence |
| Urinary incontinent patients will have surgeries according to their incontinence type "urge" | Experimental | Procedure: uterosacral ligament plication, urethral ligament plicationUSL for urge urinary incontinence will be done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 and over with urinary incontinence (stress or urge incontinence, or both)
Key exclusion criteria (5 listed)
- Pregnancy
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 |
|---|---|---|
| uterosacral ligament plication, urethral ligament plicationUrethral ligament plication: With an 18-inch French Foley catheter inserted, a vertical incision of approximately 3 cm is made in the sulcus of the anterior-lateral vaginal wall, 2 cm laterally on each side of the midline, ensuring the urethral meatus remains midline. The external urethral ligaments are located inferolateral to the urethra on both sides, the urethral portion of the pubourethral ligament (PUL) is located midline, and the lateral portion of the PUL is located laterally. Using 2-0 polyester sutures, the ligaments are sutured separately on both sides to form a loop. The incised anterior vaginal tissue is then closed individually with 2-0 rapid polyglactin sutures. Uterosacral ligament plication: A 18F Foley catheter inserted, in the lithotomy position; the posterior cervical lip is grasped with a tenaculum, and elevated outwards and upwards. Leaving rectovaginal fascia and rectum posterior; suturing the both uterosacral ligament by 2-0 polyester sutures in the midline. | Procedure or surgery | Urinary incontinent patients will have surgeries according to their incontinence type "stress", Urinary incontinent patients will have surgeries according to their incontinence type "urge" |
Primary outcome
The success (continence) rates after the operations
Time frame: At postoperative first and second year
Urinary incontinence status will be evaluated by Integral Theory Questionnaire and examinations at postoperative first and second year
1 secondary outcome
The complications
Time frame: At second postoperative year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD collected during the study will be shared.
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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.
Peter Emanuel Papa Petros, Prof. study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uterosacral ligament plication, urethral ligament plication in people with Incontinence Stress and Incontinence, Urge, run by Alev Esercan 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The success (continence) rates after the operations (time frame: At postoperative first and second year). 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 9 Sep 2026.