Stress Incontinence, FemaleNCT05768607
Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension
A study testing Quality of Life QUESTIONNAIRE (SF36), INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) and UROGENITAL DISTRESS INVENTORY (UDI - 6) in people with Stress Incontinence, Female, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Urinary incontinence is a very common problem in women and can be seen at any age. Laparoscopic burch operation has been shown to be an effective, convenient and safe method in women with stress incontinence. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Incontinence, Female
- What is being tested?
- Quality of Life QUESTIONNAIRE (SF36), INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) and UROGENITAL DISTRESS INVENTORY (UDI - 6)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2023to 30 Jul 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having stress urinary incontinence
Who cannot join
- having any kind of urogynecological surgery history
- having pelvic mass
- having endometrial or myometrial pathology
- having uterine prolapsus grater than grade 2
- benign obese
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa Training and Research Hospital
Istanbul
Suleyman Salman, +905059345470, sleymansalman@gmail.com
Fatma Ketenci Gencer, +905416116469, fathma_k@hotmail.com
About this study
Official title: Evaluation of the Results of Laparoscopic Extraperitoneal ( Modified) Burch
Urinary incontinence is a very common problem in women and can be seen at any age. Laparoscopic burch operation has been shown to be an effective, convenient and safe method in women with stress incontinence. Laparoscopic Burch operation is less invasive because it is advantageous in terms of hospitalization time, blood loss, pain and recovery time, but the disadvantage is the procedure time. Modified extraperitoneal technique may be a good method for lowering the procedure time.
Read the detailed description
In the research; The pre- and postoperative urodynamics of patients who underwent laparoscopic extraperitoneal (modified) burch operation in the Gynecology and Obstetrics Clinic of Istanbul Health Sciences University Gaziosmanpasa Training and Research Hospital will be compared. Surgical outcomes together with complications will also be assessed.
In addition, the QUALITY OF LIFE (SF36), which determines the quality of life of the patients related to the urinary system functions, and the UROGENITAL DISTRESS INVENTORY (UDI - 6), INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) questionnaires that determine the effects of urinary incontinence, will be assessed preoperatively and postoperative 6 months of the patients.
- Conditions
- Stress Incontinence, Female
- Being tested
- Quality of Life QUESTIONNAIRE (SF36), INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7), UROGENITAL DISTRESS INVENTORY (UDI - 6)
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life QUESTIONNAIRE (SF36)Procedure or surgery
Units of a scale of the patients will be compared pre and postoperatively by using SF36
INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)Procedure or surgery
Units of a scale of the patients will be compared pre and postoperatively by using IIQ-7
UROGENITAL DISTRESS INVENTORY (UDI - 6)Procedure or surgery
Units of a scale of the patients will be compared pre and postoperatively by using UDI - 6
| Study group | Role | What they receive |
|---|---|---|
| Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension | Other | Not described Receives: Procedure: Quality of Life QUESTIONNAIRE (SF36); Procedure: INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7); Procedure: UROGENITAL DISTRESS INVENTORY (UDI - 6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical outcomes
Operation time in minutes
Measured: 1 year
Surgical outcomes
Bleeding volume in milliliter
Measured: 1 year
Preoperative and postoperative urodynamic result
First sensation of fluid filled in bladder in milliliter will be compared.
Measured: 1 year
Preoperative and postoperative urodynamic result
First urge sensation due to fluid filled in bladder in milliliter will be compared.
Measured: 1 year
Preoperative and postoperative urodynamic result
Maximum cystometric capacity in milliliter will be compared.
Measured: 1 year
Preoperative and postoperative urodynamic result
Compliance in milliliter/cmH2O will be compared.
Measured: 1 year
Preoperative and postoperative urodynamic result
Q max in milliliter/second will be compared.
Measured: 1 year
Preoperative and postoperative urodynamic result
Voided volume of the patients in milliliter will be compared.
Measured: 1 year
Preoperative and postoperative Quality of life Questionnaire
The domains assessed were pain, diet, speech, recreation, anxiety, mood, and overall QoL. Patients were asked to choose a Likert scale response (for example, 1 = no pain to 5 = severe pain) to a question on each domain and higher score represents better health. overall score ranges from 6 to 30. Pre and postoperative values will be compared.
Measured: 1 year
Preoperative and postoperative UROGENITAL DISTRESS INVENTORY
Score ranges from zero to 18 and higher scores indicate more severe symptoms and INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) in which SCORES RANGES FROM 0 TO 21 AND a higher score indicates more severe symptoms and lower quality of life. Pre and postoperative values will be compared.
Measured: 1 year
Preoperative and postoperative INCONTINENCE IMPACT QUESTIONNAIRE
Scores ranges from 0 to 21 AND a higher score indicates more severe symptoms and lower quality of life. Pre and postoperative values will be compared.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start17 Jan 2023
- Primary completion17 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Incontinence, FemaleStudies 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
- Model description
- Normally patients with stress urinary incontinence undergoes laparoscopic burch operation if transvaginal sling surgery was not planned. Here in our study group the assigned surgery type applied to study group is extraperitoneal ( modified) burch operation which is performed by not interfering with the abdominal cavity. By the way our study is an interventional study and it is planned to discuss both the anatomic and functional results of this technique.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Süleyman Salman, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768607
- Sponsor's protocol ID
- GaziosmanpasaTREHz
- Status last verified
- Jun 2023
- First submitted
- 27 Jan 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Results of Laparoscopic Extraperitoneal ( Modified) Burch
- ClinicalTrials.gov ID
- NCT05768607
- Acronym / sponsor ID
- GaziosmanpasaTREHz
- Conditions
- Stress Incontinence, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 17 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 14 Mar 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.
Urinary incontinence is a very common problem in women and can be seen at any age. Laparoscopic burch operation has been shown to be an effective, convenient and safe method in women with stress incontinence. Laparoscopic Burch operation is less invasive because it is advantageous in terms of hospitalization time, blood loss, pain and recovery time, but the disadvantage is the procedure time. Modified extraperitoneal technique may be a good method for lowering the procedure time.
Detailed description
In the research; The pre- and postoperative urodynamics of patients who underwent laparoscopic extraperitoneal (modified) burch operation in the Gynecology and Obstetrics Clinic of Istanbul Health Sciences University Gaziosmanpasa Training and Research Hospital will be compared. Surgical outcomes together with complications will also be assessed.
In addition, the QUALITY OF LIFE (SF36), which determines the quality of life of the patients related to the urinary system functions, and the UROGENITAL DISTRESS INVENTORY (UDI - 6), INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) questionnaires that determine the effects of urinary incontinence, will be assessed preoperatively and postoperative 6 months of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Normally patients with stress urinary incontinence undergoes laparoscopic burch operation if transvaginal sling surgery was not planned. Here in our study group the assigned surgery type applied to study group is extraperitoneal ( modified) burch operation which is performed by not interfering with the abdominal cavity. By the way our study is an interventional study and it is planned to discuss both the anatomic and functional results of this technique.
| Arm | Type | Receives |
|---|---|---|
| Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension | Other | Procedure: Quality of Life QUESTIONNAIRE (SF36), Procedure: INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7), Procedure: UROGENITAL DISTRESS INVENTORY (UDI - 6) |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- having stress urinary incontinence
Key exclusion criteria (5 listed)
- having any kind of urogynecological surgery history
- having pelvic mass
- having endometrial or myometrial pathology
- having uterine prolapsus grater than grade 2
- benign obese
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 |
|---|---|---|
| Quality of Life QUESTIONNAIRE (SF36)Units of a scale of the patients will be compared pre and postoperatively by using SF36 | Procedure or surgery | Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension |
| INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7)Units of a scale of the patients will be compared pre and postoperatively by using IIQ-7 | Procedure or surgery | Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension |
| UROGENITAL DISTRESS INVENTORY (UDI - 6)Units of a scale of the patients will be compared pre and postoperatively by using UDI - 6 | Procedure or surgery | Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension |
Primary outcome
Surgical outcomes
Time frame: 1 year
Operation time in minutes
Surgical outcomes
Time frame: 1 year
Bleeding volume in milliliter
Preoperative and postoperative urodynamic result
Time frame: 1 year
First sensation of fluid filled in bladder in milliliter will be compared.
Preoperative and postoperative urodynamic result
Time frame: 1 year
First urge sensation due to fluid filled in bladder in milliliter will be compared.
Preoperative and postoperative urodynamic result
Time frame: 1 year
Maximum cystometric capacity in milliliter will be compared.
Preoperative and postoperative urodynamic result
Time frame: 1 year
Compliance in milliliter/cmH2O will be compared.
Preoperative and postoperative urodynamic result
Time frame: 1 year
Q max in milliliter/second will be compared.
Preoperative and postoperative urodynamic result
Time frame: 1 year
Voided volume of the patients in milliliter will be compared.
Preoperative and postoperative Quality of life Questionnaire
Time frame: 1 year
The domains assessed were pain, diet, speech, recreation, anxiety, mood, and overall QoL. Patients were asked to choose a Likert scale response (for example, 1 = no pain to 5 = severe pain) to a question on each domain and higher score represents better health. overall score ranges from 6 to 30. Pre and postoperative values will be compared.
Preoperative and postoperative UROGENITAL DISTRESS INVENTORY
Time frame: 1 year
Score ranges from zero to 18 and higher scores indicate more severe symptoms and INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) in which SCORES RANGES FROM 0 TO 21 AND a higher score indicates more severe symptoms and lower quality of life. Pre and postoperative values will be compared.
Preoperative and postoperative INCONTINENCE IMPACT QUESTIONNAIRE
Time frame: 1 year
Scores ranges from 0 to 21 AND a higher score indicates more severe symptoms and lower quality of life. Pre and postoperative values will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of Life QUESTIONNAIRE (SF36), INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) and UROGENITAL DISTRESS INVENTORY (UDI - 6) in people with Stress Incontinence, Female, run by Gaziosmanpasa Research and Education Hospital 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 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: status not confirmed, as of the sponsor's last update on 5 Jun 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 Suleyman Salman (+905059345470, sleymansalman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical outcomes (time frame: 1 year). The study lists 11 primary outcomes in all. 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 5 Jun 2023.