| CTRI Number |
CTRI/2026/03/107194 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pelvic Floor and Pilates Exercises for Improving Muscle Strength and Quality of Life in Postmenopausal Women with Early Uterine Prolapse |
|
Scientific Title of Study
|
Effectiveness of Pelvic Floor Muscle Training and Pilates Exercise Program on Pelvic Muscle Strength and Quality of Life in Postmenopausal Women with Stage I and II Uterine Prolapse: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Gohere |
| Designation |
PhD scholar |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Greater Noida, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201302
India |
| Phone |
7905327742 |
| Fax |
|
| Email |
goherepriyanka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr. V Krishna Reddy |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Greater Noida, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201302
India |
| Phone |
7905327742 |
| Fax |
|
| Email |
krishnareddympt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Gohere |
| Designation |
PhD scholar |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Greater Noida, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201302
India |
| Phone |
7905327742 |
| Fax |
|
| Email |
goherepriyanka@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Government Institute of Medical Sciences (GIMS), Kasna, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, 201310, India |
|
|
Primary Sponsor
|
| Name |
Priyanka Gohere |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Greater Noida, Uttar Pradesh – 201310, India |
| Type of Sponsor |
Other [Self] |
|
|
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 V Krishna Reddy |
Galgotias University |
Department Of Physiotherapy, School Of Allied Health Sciences, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
7799233734
krishnareddympt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Galgotias University School Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N814||Uterovaginal prolapse, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pelvic Floor Muscle Training (PFMT) |
Structured pelvic floor muscle training including Kegel exercises endurance holds and quick contractions. Includes supervised sessions with sEMG biofeedback and daily home exercise program. Duration 6 weeks 3 supervised sessions per week plus home exercises |
| Intervention |
Pilates Exercise Program |
Supervised Pilates-based exercise program focusing on core stabilization breathing control and pelvic floor activation. Exercises include pelvic tilts bridging, leg stretches abdominal stabilization and spinal mobility exercises. Duration 6 weeks 3 sessions per week 40 minutes per session |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Postmenopausal women (less than or equal to 1 year since last menstruation)
2. Clinically diagnosed with Stage I or II uterine prolapse using POP-Q staging system
3. Able to understand and perform exercise protocol
4. Willing to participate and provide written informed consent
5. Not currently undergoing pelvic floor physiotherapy or structured exercise program |
|
| ExclusionCriteria |
| Details |
1 History of pelvic surgery within the last 6 months
2 History of hysterectomy within last 6 months.
3 Severe musculoskeletal or neurological conditions affecting mobility.
4 Use of vaginal pessary or pelvic floor physiotherapy within the last 3 months.
5 Cognitive impairment preventing exercise compliance.
6 Active vaginal or urinary tract infection.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pelvic floor muscle strength assessed using surface electromyography (sEMG), expressed in microvolts (µV) |
Baseline (before intervention)
6 weeks (end of intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of life assessed using Pelvic Floor Distress Inventory (PFDI-20) at baseline and 6 weeks
Quality of life assessed using Pelvic Floor Impact Questionnaire (PFIQ 7) at baseline and 6 weeks |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
01/05/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate and compare the effectiveness of Pelvic Floor Muscle Training (PFMT) and a Pilates exercise program in improving pelvic floor muscle strength and quality of life in postmenopausal women with stages I and II uterine prolapse. Pelvic organ prolapse is a common condition in postmenopausal women that leads to reduced pelvic support, functional limitations, and decreased quality of life. Exercise-based physiotherapy interventions are considered first-line management for early-stage prolapse. A total of 106 eligible participants will be randomly allocated into two groups: PFMT and a Pilates exercise program, each administered for 6 weeks. Pelvic floor muscle strength will be assessed using surface electromyography (sEMG), and quality of life will be evaluated using validated questionnaires (PFDI-20 and PFIQ-7) at baseline and post-intervention. The study hypothesizes that the Pilates exercise program will be more effective than PFMT in improving pelvic floor muscle strength and quality of life in postmenopausal women with uterine prolapse. |