| CTRI Number |
CTRI/2023/01/049082 [Registered on: 18/01/2023] Trial Registered Prospectively |
| Last Modified On: |
19/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To observe the urinary problems and quality of life in women who have undergone hysterectomy for benign gynecological conditions, |
|
Scientific Title of Study
|
Quality of Life and Lower Urinary Tract Symptoms in Women following Hysterectomy for Benign Gynecological Conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohan Damani |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of OBG,KMC Manipal, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7002957572 |
| Fax |
|
| Email |
damanirohan1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deeksha Pandey |
| Designation |
Additional Professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of OBG,KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9241216016 |
| Fax |
|
| Email |
deekshiiiobg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeksha Pandey |
| Designation |
Additional Professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of OBG,KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9241216016 |
| Fax |
|
| Email |
deekshiiiobg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohan Damani |
Kasturba Hospital, Manipal |
Department of OBG,Women and Child Block, KH, Manipal
Udupi
KARNATAKA |
7002957572
damanirohan1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
All women who have undergone hysterectomies for benign causes at Kasturba Hospital and are consenting to participate in the study |
|
| ExclusionCriteria |
| Details |
-Hysterectomy done for malignancies
-Known case of preoperative urinary incontinence or retention
-Neurological or spinal cord injury affecting bladder function
-History of prior bladder surgery
-Any comorbidities which may affect the general well being after surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A score based on UDI-6 questionnaire and a score based on WHO
QOL questionnaire is calculated and which is further analyzed to compare the QOL among
various approaches of hysterectomy [Abdominal (laparotomy and laparoscopy) ; Vaginal (with
pelvic floor repairs, without repairs)] for benign gynaecological conditions. To compare the
Lower Urinary tract symptoms in patients who have undergone different types of
hysterectomies.
|
At 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="2398"
Sample Size from India="2398"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Urinary complaints can be physically, socially and psychologically debilitating for a lady post hysterectomy. It will be helpful to find out the incidence and severity of the same with various modes of hysterectomy that will help in counselling patients preoperatively and managing these issues effectively. The following proposal will address the same and the quality of life of the patients who may present with such an issue. So the patients emotional health and social life can be maintained. |