Pelvic Organ Prolapse Clinical Trial
Official title:
A Multicenter, Randomized, Prospective, Controlled Study Comparing Uterine Preserving Laparoscopic Lateral Suspension With Mesh Versus Laparoscopic Sacrocervicopexy in the Treatment of Uterine Prolapse: A Randomized Controlled Trial
NCT number | NCT03421457 |
Other study ID # | RCTPOPS |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 24, 2018 |
Est. completion date | March 14, 2019 |
Verified date | March 2019 |
Source | Fatih Sultan Mehmet Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is aimed to compare the efficiency of two uterus-preserving laparoscopic methods to treat uterine prolapse in a randomized controlled trial. Laparoscopic lateral suspension with mesh (LLSM) will be compared with laparoscopic sacrohysteropexy (LS). Both procedures are known as sufficient uterus preserving methods. LLSM was introduced to be an alternative to others with avoiding dissection of promontory and therefore being safer, faster and feasible technique.
Status | Completed |
Enrollment | 44 |
Est. completion date | March 14, 2019 |
Est. primary completion date | March 14, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - >18 years old - > Symptomatic prolapse of central compartment with a Pelvic Organ Prolapse Quantitative (POP-Q) stage 2 associated or not with anterior or posterior compartment prolapse. - Patients who are not comfortable with using or refusing pessary - Wish to preserve the uterus Exclusion Criteria: - Any cue for gynecologic oncological condition - Patients who approves Le Fort colpocleisis among who does not have any sexual intercourse |
Country | Name | City | State |
---|---|---|---|
Turkey | Fatih Sultan Mehmet Training and Research Hospital, Sancaktepe Campus | Istanbul | Sancaktepe |
Turkey | Sisli Hamidiye Etfal Training and Research Hospital | Istanbul | Sisli |
Lead Sponsor | Collaborator |
---|---|
Fatih Sultan Mehmet Training and Research Hospital | Sisli Hamidiye Etfal Training and Research Hospital |
Turkey,
Veit-Rubin N, Dubuisson JB, Gayet-Ageron A, Lange S, Eperon I, Dubuisson J. Patient satisfaction after laparoscopic lateral suspension with mesh for pelvic organ prolapse: outcome report of a continuous series of 417 patients. Int Urogynecol J. 2017 Nov;28(11):1685-1693. doi: 10.1007/s00192-017-3327-2. Epub 2017 Apr 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline POP-Q measurements (mm) at 12th month. | Prolapse degree; Point Ba/C/Bp | 12 months for each participant | |
Secondary | Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at 12th month. | Validated into Turkish language form will be used to compare preoperative and postoperative period. The FSFI is a multiple-trait scoring, self-report document used to assess female sexual function. It consists of 19 items that encompass six separate domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The maximum score is 36 points and the minimum score is 2 points. After completion of the questionnaire, the total SF score was calculated as follows: no sexual dysfunction (SD) (= 30 points) , mild SD (between <29 and > 23 points), and severe SD (= 22 points). | 12 months for each participant | |
Secondary | Subjective Success - Change from baseline Michigan Incontinence Severity Index (M-ISI) to measure urinary incontinence at 12th month. | Validated into Turkish language form will be used to compare preoperative and postoperative period. It has ten items, consisting of a total M-ISI domain (the sum of items 1-8) and a distinct Bother domain (the sum of items 9 and 10). The total M-ISI score consists of three subdomains (items 1-3 for stress urinary incontinence [SUI], items 4-6 for UUI, and items 7 and 8 for PU). The responses for each item range from 0 to 4 on a Likert-type scale, with higher values representing greater symptoms and greater bother. The total M-ISI domain ranges from 0 to 32, the Bother domain ranges from 0 to 8, the SUI and UUI subdomains range from 0 to 12, and the PU subdomain ranges from 0 to 8. Total domain and subdomain scores are obtained by simply adding the respective answers. The minimally important difference has been determined for the following domains/subdomains: total M-ISI (4 points), SUI (2 points), UUI (2 points), and PU (1 point). | 12 months for each participant | |
Secondary | Subjective Success - Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse at 12th month. | Validated into Turkish language form will be used to compare preoperative and postoperative period. he questionnaire included 20 questions grouped in sections (domains) related to a particular aspect of quality of life. A total of nine domains covering general health, prolapse impact, role limitations, physical and social limitations, personal relationships, emotional problems, sleep/energy disturbance as well as severity symptoms measurements were defined. Questions regarding bladder, bowel and sexual function were also separately included and validated for reproducibility and internal consistency. Responses ranged from 'none/not at all', through 'slightly/a little' and 'moderately' to 'a lot' to produce a four-point scoring system for each item. Scores in each domain ranged between 0 and 100 with a high total score indicating a greater impairment of quality of life. | 12 months for each participant | |
Secondary | Subjective Success - Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse at 12th month. | Validated into Turkish language form will be used to compare preoperative and postoperative period. Total range scores: 28 (min:0, max:28). Higher values represent a worse outcome. | 12 months for each participant | |
Secondary | Subjective Success - Change from baseline Visual Analog Score (VAS) for pain at 12th month. | Participant describes the pain related to the mesh. The respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain with a format of a horizontal bar. | 12 months for each participant | |
Secondary | Change from baseline Pelvic Hiatus measurements (mm) at 12th month. | Anteroposterior hiatal length (mm) | 12 months for each participant | |
Secondary | Change from baseline Pelvic biometry measurements at 12th month. | Prolapse degree over symphysis pubis (mm) Anterior compartment over 10mm, Posterior compartment over 15 mm are clinically relevant | 12 months for each participant | |
Secondary | Change from baseline bladder neck mobility measurements at 12th month. | Urethral rotation (degree) between rest and valsalva maneuver states | 12 months for each participant | |
Secondary | Failure (%) | Failure is defined by any recurrence of prolapse, mesh erosion and need for additional surgery | 12 months for each participant | |
Secondary | Complications | Perioperative and postoperative complications including Severe bleeding, hematoma, bladder injury, bowel injury, ureter injury, vascular injury, nerve injury, abscess, lower urinary tract infections, mesh extrusion, mesh exposure, prolapse recurrence, De novo SUI/OAB, dyspareunia, pelvic pain | 12 months for each participant | |
Secondary | Operation time | Duration of the operation between the first skin incision and suturing the skin of the trocar entries | Operation time will noted for each participant at the same day of the operation. Operation time will be determined with using a chronometer,from the time of first skin incision until the suturing the skin of the trocar entry, assessed up to 52 weeks. |
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