Pelvic Floor DysfunctionNCT06875635
Pelvic Floor Dysfunction and Quality of Life in Patient Undergoing Gynecological Surgery
A study testing Pre and Post op pelvic floor muscle training, Only post op pelvic floor muscle training and Routine medical care in people with Pelvic Floor Dysfunction, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of the study is to assess the pelvic floor dysfunction and quality of life in patient undergoing gynecological surgery.Common gynecological surgeries done for prolapse, fibroids, and cervical abnormality and also for Gynecological cancer.Early physiotherapy after gynecological surgery improves recovery by… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Dysfunction
- What is being tested?
- Pre and Post op pelvic floor muscle training, Only post op pelvic floor muscle training and Routine medical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Apr 2025to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age:40 -60yrs
- undergoing vaginal or laparoscopic-assisted vaginal surgery for either POP repair (primary or recurrent), and/or hysterectomy
Who cannot join
- Emergency Surgery
- Chronic Illness
- Unstable Mental State
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pelvic Floor Muscle Training on Pelvic Floor Dysfunction and Quality of Life in Patient Undergoing Gynecological Surgery
The purpose of the study is to assess the pelvic floor dysfunction and quality of life in patient undergoing gynecological surgery.Common gynecological surgeries done for prolapse, fibroids, and cervical abnormality and also for Gynecological cancer.Early physiotherapy after gynecological surgery improves recovery by managing pain, restoring movement, and strengthening muscles, especially the pelvic floor.Conservative treatments like pelvic floor muscle exercises, biofeedback, and lifestyle changes can help with pelvic symptoms, including urinary incontinence and mild to moderate prolapse.
Read the detailed description
This is a randomized control trial to see the effects of pelvic floor training on pelvic floor dysfunction and quality of life in patient undergoing gynecological surgery. Females meeting the inclusion and exclusion criteria will be divided into three groups by convenient sampling technique. A sample size of 48 females with 16 females in each group. Group A will be treated four weeks pre and 8 weeks post op pelvic floor training exercises, group B will be treated only 8 weeks post op pelvic floor training exercises and group C will receive basic post op nursing care. Group A and B will have three treatment sessions per week Assessment will be done at 0 week (1month prior to surgery), 1 day before surgery, 2nd , 4th, 6th and 8th week after surgery. Females will be screened by Pelvic organ distress inventory (PFDI-20) and Pelvic floor impact questionnaire (PFIQ-7).
- Conditions
- Pelvic Floor Dysfunction
- Being tested
- Pre and Post op pelvic floor muscle training, Only post op pelvic floor muscle training, Routine medical care
- Keywords
- pelvic floor training ,, gynecological surgery,, quality of life,, strength of pelvic floor muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre and Post op pelvic floor muscle trainingOther
pre op exercises: Breathing exercise ,Kegel exercise ,Abdominals exercise include pelvic tilt ,knee rolling with abdominal contraction post op exercise :breathing exercise, circulatory exercise i.e ankle pump and heel slides, and bed mobility along with pre op exercise
Only post op pelvic floor muscle trainingOther
post op exercise :breathing exercise, circulatory exercise i.e ankle pump and heel slides, and bed mobility along with pre op protocol
Routine medical careOther
Circulatory exercise Breathing exercise Administrating analgesic Nursing care
| Study group | Role | What they receive |
|---|---|---|
| Prepost PFMT Group | Experimental | Routine medical care and pre \& post-op - op protocol of pelvic floor muscle training .1 month prior and 8 weeks post op protocol in patient undergoing gynecological surgery Receives: Other: Pre and Post op pelvic floor muscle training |
| Post PFMT Group | Experimental | Only Post-op pelvic floor muscle training for 8 weeks along with Routine medical care Receives: Other: Only post op pelvic floor muscle training |
| Control | Other | Routine medical care was given Receives: Other: Routine medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic organ distress inventory (PFDI-20)
Pelvic floor Distress inventory questionnaire is comprised of 3 Sections, including pelvic organ prolapse distress inventory (POPDI-6) from question 1 to 6, urinary distress inventory (UDI-6) from questions 7-12 and colorectal anal distress inventory (CRADI-8) from questions 13-20.
The total score ranges from 0 to 300, with higher scores indicating greater distress.the ICC value of the tool is 0.93
Measured: From Baseline to 1 day prior to surgery, 2nd,4th,6th and 8th week of intervention
Pelvic floor impact questionnaire (PFIQ-7)
The pelvic floor impact questionnaire is used for quality of life assessment. it has 3 sections, including Urinary impact questions, Colorectal anal impact questions, and Pelvic organ prolapse impact questionnaire. The total score ranges from 0-300. The ICC value of PFIQ is 0.77
Measured: From Baseline to 1 day prior to surgery, 2nd,4th,6th and 8th week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start25 Apr 2025
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be comparison between 3 groups.Two intervention group and 1 control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PhD, Principal investigator, Riphah International University, Islamabad, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875635
- Sponsor's protocol ID
- Majida zaffar
- Status last verified
- Nov 2025
- First submitted
- 9 Mar 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic Floor Muscle Training on Pelvic Floor Dysfunction and Quality of Life in Patient Undergoing Gynecological Surgery
- ClinicalTrials.gov ID
- NCT06875635
- Acronym / sponsor ID
- Majida zaffar
- Conditions
- Pelvic Floor Dysfunction
- Keywords
- pelvic floor training ,, gynecological surgery,, quality of life,, strength of pelvic floor muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the pelvic floor dysfunction and quality of life in patient undergoing gynecological surgery.Common gynecological surgeries done for prolapse, fibroids, and cervical abnormality and also for Gynecological cancer.Early physiotherapy after gynecological surgery improves recovery by managing pain, restoring movement, and strengthening muscles, especially the pelvic floor.Conservative treatments like pelvic floor muscle exercises, biofeedback, and lifestyle changes can help with pelvic symptoms, including urinary incontinence and mild to moderate prolapse.
Detailed description
This is a randomized control trial to see the effects of pelvic floor training on pelvic floor dysfunction and quality of life in patient undergoing gynecological surgery. Females meeting the inclusion and exclusion criteria will be divided into three groups by convenient sampling technique. A sample size of 48 females with 16 females in each group. Group A will be treated four weeks pre and 8 weeks post op pelvic floor training exercises, group B will be treated only 8 weeks post op pelvic floor training exercises and group C will receive basic post op nursing care. Group A and B will have three treatment sessions per week Assessment will be done at 0 week (1month prior to surgery), 1 day before surgery, 2nd , 4th, 6th and 8th week after surgery. Females will be screened by Pelvic organ distress inventory (PFDI-20) and Pelvic floor impact questionnaire (PFIQ-7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- There will be comparison between 3 groups.Two intervention group and 1 control group
| Arm | Type | Receives |
|---|---|---|
| Prepost PFMT Group | Experimental | Other: Pre and Post op pelvic floor muscle trainingRoutine medical care and pre \& post-op - op protocol of pelvic floor muscle training .1 month prior and 8 weeks post op protocol in patient undergoing gynecological surgery |
| Post PFMT Group | Experimental | Other: Only post op pelvic floor muscle trainingOnly Post-op pelvic floor muscle training for 8 weeks along with Routine medical care |
| Control | Other | Other: Routine medical careRoutine medical care was given |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women age:40 -60yrs
- undergoing vaginal or laparoscopic-assisted vaginal surgery for either POP repair (primary or recurrent), and/or hysterectomy
Key exclusion criteria (3 listed)
- Emergency Surgery
- Chronic Illness
- Unstable Mental State
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre and Post op pelvic floor muscle trainingpre op exercises: Breathing exercise ,Kegel exercise ,Abdominals exercise include pelvic tilt ,knee rolling with abdominal contraction post op exercise :breathing exercise, circulatory exercise i.e ankle pump and heel slides, and bed mobility along with pre op exercise | Other | Prepost PFMT Group |
| Only post op pelvic floor muscle trainingpost op exercise :breathing exercise, circulatory exercise i.e ankle pump and heel slides, and bed mobility along with pre op protocol | Other | Post PFMT Group |
| Routine medical careCirculatory exercise Breathing exercise Administrating analgesic Nursing care | Other | Control |
Primary outcome
Pelvic organ distress inventory (PFDI-20)
Time frame: From Baseline to 1 day prior to surgery, 2nd,4th,6th and 8th week of intervention
Pelvic floor Distress inventory questionnaire is comprised of 3 Sections, including pelvic organ prolapse distress inventory (POPDI-6) from question 1 to 6, urinary distress inventory (UDI-6) from questions 7-12 and colorectal anal distress inventory (CRADI-8) from questions 13-20. The total score ranges from 0 to 300, with higher scores indicating greater distress.the ICC value of the tool is 0.93
Pelvic floor impact questionnaire (PFIQ-7)
Time frame: From Baseline to 1 day prior to surgery, 2nd,4th,6th and 8th week of intervention
The pelvic floor impact questionnaire is used for quality of life assessment. it has 3 sections, including Urinary impact questions, Colorectal anal impact questions, and Pelvic organ prolapse impact questionnaire. The total score ranges from 0-300. The ICC value of PFIQ is 0.77
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Riaz, PhD principal investigator
Riphah International University, Islamabad, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre and Post op pelvic floor muscle training, Only post op pelvic floor muscle training and Routine medical care in people with Pelvic Floor Dysfunction, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic organ distress inventory (PFDI-20) (time frame: From Baseline to 1 day prior to surgery, 2nd,4th,6th and 8th week of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.