Laparoscopic Extraperitoneal ( Modified) Burch Colposuspension

NCT05768607 | Unknown

• 1 other identifier: GaziosmanpasaTREHz
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stress Incontinence, Female

Outcome Measures

Primary Outcomes (11)

• Surgical outcomes

  Operation time in minutes

  1 year

• Surgical outcomes

  Bleeding volume in milliliter

  1 year

• Preoperative and postoperative urodynamic result

  First sensation of fluid filled in bladder in milliliter will be compared.

  1 year

• Preoperative and postoperative urodynamic result

  First urge sensation due to fluid filled in bladder in milliliter will be compared.

  1 year

• Preoperative and postoperative urodynamic result

  Maximum cystometric capacity in milliliter will be compared.

  1 year

• Preoperative and postoperative urodynamic result

  Compliance in milliliter/cmH2O will be compared.

  1 year

• Preoperative and postoperative urodynamic result

  Q max in milliliter/second will be compared.

  1 year

• Preoperative and postoperative urodynamic result

  Voided volume of the patients in milliliter will be compared.

  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.

  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.

  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.

  1 year

Study Arms (1)

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)

Interventions

Quality of Life QUESTIONNAIRE (SF36) PROCEDURE

Units of a scale of the patients will be compared pre and postoperatively by using SF36

Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension

INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) PROCEDURE

Units of a scale of the patients will be compared pre and postoperatively by using IIQ-7

Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension

UROGENITAL DISTRESS INVENTORY (UDI - 6) PROCEDURE

Units of a scale of the patients will be compared pre and postoperatively by using UDI - 6

Patients undergone Laparoscopic Extraperitoneal Burch Colposuspension

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having stress urinary incontinence

You may not qualify if:

• having any kind of urogynecological surgery history
• having pelvic mass
• having endometrial or myometrial pathology
• having uterine prolapsus grater than grade 2
• benign obese

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Suleyman Salman

CONTACT

+905059345470; sleymansalman@gmail.com

Fatma Ketenci Gencer

CONTACT

05416116469; fathma_k@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: March 14, 2023
• Study Start: January 17, 2023
• Primary Completion: July 17, 2023
• Study Completion: July 30, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)