Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence

Quality of Life Clinical Trial

Official title:

Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04251923
• Other study ID #: IRC/1536/019
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2020
• Est. completion date: July 2021

Study information

• Verified date: January 2020
• Source: B.P. Koirala Institute of Health Sciences
• Contact: baburam Dixit (Thapa), MD/MS
• Phone: 977-9842352481
• Email: baburamdixit[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prevalence of pelvic organ prolapsed is high in Nepal. After prolapse surgery many patients are affected with incontinence. Incontinence has physical, social and mental effect to the individual. This study is designed to know the role for mid urethral sling during vaginal prolapse surgery to decrease the rate of incontinence after the surgery.

Description:

Aim: To de termine the effect of mid urethral sling in reducing postoperative incontinence after vaginal prolapse surgery.

General Objectives: To compare the risk of de novo postoperative incontinence between prolapsed surgery with mid urethral sling versus no sling.

Specific Objectives: to compare the change in score of BFLUTS-SF (Bristol Female lower urinary tract symptoms- sexual function) and UDI-6 (Urinary distress inventory-6) pre and post surgery between the two groups.

Research Hypothesis: The use of mid urethral sling after vaginal prolapse surgery has role in reduction of postoperative incontinence.

Materials & Methods:

1. Whether study involves humans/animals or both : Humans

2. Population/ participants: Patients with pelvic organ prolapse who are planned for vaginal prolapse surgery in BPKIHS (BP Koirala Institute of Health and Sciences).

3. Type of study design: a randomized controlled trial

(e) Expected sample size: 54 Sample size calculation: Previous study done by Control groups:

Patient undergoing vaginal prolapse surgery only without mid urethral sling. There will be small incision in the suprapubic region that mimics the TVT incision.

(f) Probable duration of study: one and half year (g) Setting: BPKIHS, Department of Obstetrics and Gynecology (h) Parameter/Variables to be applied/ measured: Age, BMI, POPQ (Pelvic organ prolapse quantification) stage, menopause, ESST (Empty supine stress test).

(i) Outcome measures: LUTS score, UDI-6 score, SUI (stress urinary incontinence), Voiding dysfunction, dyspareunia, satisfaction, Complications like bladder injury, hemorrhage.

(j) Rationale for statistical methods to be employed: attached (k) Ethical clearance: Study will be started after getting clearance from the IRC (Institutional review committee) of BPKIHS .

(l) Permission to use copyright questionnaire/Proforma: Pre designed Proforma and questionnaire will be used to collect the data. The internationally valid questionnaire in English will be validated in Nepali language first and then it will be used.

(m) Maintain the confidentiality of subject: The confidentiality of the patients will be maintained throughout the research.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical POP-Q stage 3 or more

• Must have cell phone

Exclusion Criteria:

• Patient with POPQ stage less than stage 3

• Patient not giving consent

• Patient with previous pelvic and spine surgery

• Patient having positive cough stress test on examination

Related Conditions & MeSH terms

• Prolapse
• Quality of Life
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress
• Uterine Prolapse
• Vaginal Hysterectomy

Intervention

Device:
• Retro pubic sling
patient after hysterectomy will undergo retropubic sling surgery in the same setting. Retropubic sling will be inserted vaginally in the retropubic area following standard protocol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress urinary incontinence	The primary outcome of the study will be the presence of stress urinary incontinence in post operative at 3 months follow up. During follow up patient will be asked about the urinary incontinence on coughing, sneezing, heavy work and will examined in comfortably full bladder and cough stress test will be done to confirm the diagnosis of stress urinary incontinence.	3 months
Primary	stress urinary incontinence	The primary outcome of the study will be the presence of stress urinary incontinence in post operative at 6 months follow up. During follow up patient will be asked about the urinary incontinence on coughing, sneezing, heavy work and will examined in comfortably full bladder and cough stress test will be done to confirm the diagnosis of stress urinary incontinence.	6 months
Secondary	1) BFLUTS-FS (frequency symptoms), VS(voiding symptoms), IS (Irritable symptoms), Sex symptoms , QoL (Quality of life) score 2) UDI-6 (Urinary distress inventory-6) score 3) Complications during surgery 4) Dyspareunia 5) Pelvic pain	The main two questionnaires used in this study are BFLUTS-SF and UDI-6. BFLUTS-SF has five different section; BFLUTS- FS: frequency symptoms and score ranges from 0-15, VS: voiding symptoms and score is from 0-12 IS: irritable bladder symptoms and score is from 0-20. . sex: sexual symptoms and score is from 0-6. QoL: quality of life due to bladder symptoms and score is from 0-18.; UDI-6 score: quality of life due to bladder symptoms. Score range from 0-18. Severity increases as score increases in each section. High score denotes patient are highly affected due to bladder problems.; Complications are noted hemorrhage, bladder injury, prolonged catheterization, urinary retention, need of mesh removal Remote complications: mesh erosion, Dyspareunia, pelvic pain, these complications will be noted. For pelvic pain visual analogue scale will be used, score having 1-10; 0, being least to 10 being the maximum.	3 months
Secondary	1) BFLUTS-FS (frequency symptoms), VS(voiding symptoms), IS (Irritable symptoms), Sex symptoms , QoL (Quality of life) score 2) UDI-6 (Urinary distress inventory-6) score 3) Complications during surgery 4) Dyspareunia 5) Pelvic pain	The main two questionnaires used in this study are BFLUTS-SF and UDI-6. BFLUTS-SF has five different section; BFLUTS- FS: frequency symptoms and score ranges from 0-15, VS: voiding symptoms and score is from 0-12 IS: irritable bladder symptoms and score is from 0-20. . sex: sexual symptoms and score is from 0-6. QoL: quality of life due to bladder symptoms and score is from 0-18.; UDI-6 score: quality of life due to bladder symptoms. Score range from 0-18. Severity increases as score increases in each section. High score denotes patient are highly affected due to bladder problems.; Complications are noted hemorrhage, bladder injury, prolonged catheterization, urinary retention, need of mesh removal Remote complications: mesh erosion, Dyspareunia, pelvic pain, these complications will be noted. For pelvic pain visual analogue scale will be used, score having 1-10; 0, being least to 10 being the maximum.	6 months