Urinary Incontinence, StressNCT04994041
Adductor Strengthening and Pelvic Floor Muscle Strengthening Exercises on Stress Incontinence in Gym Females
A study testing Pelvic floor muscle plus adductor strengthening and Pelvic floor muscle exercises in people with Urinary Incontinence, Stress, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stress incontinence is common form of urinary incontinence in females. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. Group A: with pelvic floor muscle strengthening plus adductor is strengthening. Group B: with pelvic floor muscle strengthening. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Pelvic floor muscle plus adductor strengthening and Pelvic floor muscle exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2021to 10 Aug 2021
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 25-45 years of age
- Engaged in gym exercises
- Fulfilling signs and symptoms of stress incontinence
Who cannot join
- Pregnant females
- Females having any history of trauma
- Any neurological disorders affecting bowl bladder
- Any malignancy in lower abdominal area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Adductor Strengthening and Pelvic Floor Muscle Strengthening Exercises on Stress Incontinence in Gym Females
Stress incontinence is common form of urinary incontinence in females. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. Group A: with pelvic floor muscle strengthening plus adductor is strengthening. Group B: with pelvic floor muscle strengthening.
Read the detailed description
Stress incontinence is common form of urinary incontinence in females. When it develops in gym doing women, it badly affects their performance and result in psychosocial problems in addition to the barriers that already have been resulted from incontinence. This study combines simple regime of hip adductor a strengthening with pelvic floor muscles. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. If this comes out to be effective, this can be great contribution to gym doing females to improve their urinary incontinence related impairments. Woman would be encouraged to continue regular exercise. This will be randomized clinical trial. There are two groups for the compression of adductors strengthening and pelvic floor muscle strengthening. Group A: with pelvic floor muscle strengthening plus adductor is strengthening. Group B: with pelvic floor muscle strengthening. The collected data will be entered in Statistical Package for the Social Sciences 20.0, Descriptive and Inferential statists will be applied. Results and conclusion will be drawn.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- Pelvic floor muscle plus adductor strengthening, Pelvic floor muscle exercises
- Keywords
- Urinary Incontinence, Pelvic Floor Exercises
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle plus adductor strengtheningOther
20 sessions of pelvic floor muscle strengthening plus adductor is strengthening
Pelvic floor muscle exercisesOther
20 sessions of pelvic floor muscle strengthening
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle plus adductor strengthening | Experimental | pelvic floor muscle plus adductor strengthening Receives: Other: Pelvic floor muscle plus adductor strengthening |
| Pelvic floor muscle exercises | Active comparator | pelvic floor muscle exercises Receives: Other: Pelvic floor muscle exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Distress Inventory (UDI-6)
It is 6 point scale No= 0, Not at all= 1, Somewhat= 2, Moderately= 3, Quite a bit= 4.
Add all scores and multiply by 6 then multiply by 25 for the scale score
The UDI-6 Total Score of 33.33 was determined to be the optimal cutoff for distinguishing between symptomatic and asymptomatic women.
For UDI-6 scores more than 33.33 indicate higher distress caused by urinary incontinence symptoms.
Measured: 8 weeks
The Revised Urinary Incontinence Scale (RUIS)
It is a 5 point scale with each point contain 3 to 4option.
Possible score range of 0 - 16
A score of less than 4 indicates that the patient has no urinary incontinence
a score of 4-8 is considered mild.
a score of 9-12 is considered moderate.
a score of 13 or above is considered severe.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start10 Jan 2021
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, StressStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Sanaullah, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994041
- Sponsor's protocol ID
- REC/Lhr/21/0415 Irum
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schneeweiss J, Koch M, Umek W. The human urinary microbiome and how it relates to urogynecology. Int Urogynecol J. 2016 Sep;27(9):1307-12. doi: 10.1007/s00192-016-2944-5. Epub 2016 Jan 25.
PubMed 26811114Al-Mukhtar Othman J, Akervall S, Milsom I, Gyhagen M. Urinary incontinence in nulliparous women aged 25-64 years: a national survey. Am J Obstet Gynecol. 2017 Feb;216(2):149.e1-149.e11. doi: 10.1016/j.ajog.2016.09.104. Epub 2016 Oct 6.
PubMed 27720862Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
PubMed 28977091Pizzoferrato AC, Fauconnier A, Fritel X, Bader G, Dompeyre P. Urethral Closure Pressure at Stress: A Predictive Measure for the Diagnosis and Severity of Urinary Incontinence in Women. Int Neurourol J. 2017 Jun;21(2):121-127. doi: 10.5213/inj.1732686.343. Epub 2017 Jun 21.
PubMed 28673060de Mattos Lourenco TR, Matsuoka PK, Baracat EC, Haddad JM. Urinary incontinence in female athletes: a systematic review. Int Urogynecol J. 2018 Dec;29(12):1757-1763. doi: 10.1007/s00192-018-3629-z. Epub 2018 Mar 19.
PubMed 29552736Diokno AC, Newman DK, Low LK, Griebling TL, Maddens ME, Goode PS, Raghunathan TE, Subak LL, Sampselle CM, Boura JA, Robinson AE, McIntyre D, Burgio KL. Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1333-1341. doi: 10.1001/jamainternmed.2018.3766.
PubMed 30193294Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adductor Strengthening and Pelvic Floor Muscle Strengthening Exercises on Stress Incontinence in Gym Females
- ClinicalTrials.gov ID
- NCT04994041
- Acronym / sponsor ID
- REC/Lhr/21/0415 Irum
- Conditions
- Urinary Incontinence, Stress
- Keywords
- Urinary Incontinence, Pelvic Floor Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 6 Aug 2021 (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.
Stress incontinence is common form of urinary incontinence in females. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. Group A: with pelvic floor muscle strengthening plus adductor is strengthening. Group B: with pelvic floor muscle strengthening.
Detailed description
Stress incontinence is common form of urinary incontinence in females. When it develops in gym doing women, it badly affects their performance and result in psychosocial problems in addition to the barriers that already have been resulted from incontinence. This study combines simple regime of hip adductor a strengthening with pelvic floor muscles. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. If this comes out to be effective, this can be great contribution to gym doing females to improve their urinary incontinence related impairments. Woman would be encouraged to continue regular exercise. This will be randomized clinical trial. There are two groups for the compression of adductors strengthening and pelvic floor muscle strengthening. Group A: with pelvic floor muscle strengthening plus adductor is strengthening. Group B: with pelvic floor muscle strengthening. The collected data will be entered in Statistical Package for the Social Sciences 20.0, Descriptive and Inferential statists will be applied. Results and conclusion will be drawn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle plus adductor strengthening | Experimental | Other: Pelvic floor muscle plus adductor strengtheningpelvic floor muscle plus adductor strengthening |
| Pelvic floor muscle exercises | Active comparator | Other: Pelvic floor muscle exercisespelvic floor muscle exercises |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 25-45 years of age
- Engaged in gym exercises
- Fulfilling signs and symptoms of stress incontinence
Key exclusion criteria (4 listed)
- Pregnant females
- Females having any history of trauma
- Any neurological disorders affecting bowl bladder
- Any malignancy in lower abdominal area
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 |
|---|---|---|
| Pelvic floor muscle plus adductor strengthening20 sessions of pelvic floor muscle strengthening plus adductor is strengthening | Other | Pelvic floor muscle plus adductor strengthening |
| Pelvic floor muscle exercises20 sessions of pelvic floor muscle strengthening | Other | Pelvic floor muscle exercises |
Primary outcome
Urinary Distress Inventory (UDI-6)
Time frame: 8 weeks
It is 6 point scale No= 0, Not at all= 1, Somewhat= 2, Moderately= 3, Quite a bit= 4. Add all scores and multiply by 6 then multiply by 25 for the scale score The UDI-6 Total Score of 33.33 was determined to be the optimal cutoff for distinguishing between symptomatic and asymptomatic women. For UDI-6 scores more than 33.33 indicate higher distress caused by urinary incontinence symptoms.
The Revised Urinary Incontinence Scale (RUIS)
Time frame: 8 weeks
It is a 5 point scale with each point contain 3 to 4option. Possible score range of 0 - 16 A score of less than 4 indicates that the patient has no urinary incontinence a score of 4-8 is considered mild. a score of 9-12 is considered moderate. a score of 13 or above is considered severe.
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 30 Aug 2021.
- Background: PubMed 26811114Schneeweiss J, Koch M, Umek W. The human urinary microbiome and how it relates to urogynecology. Int Urogynecol J. 2016 Sep;27(9):1307-12. doi: 10.1007/s00192-016-2944-5. Epub 2016 Jan 25.
- Background: PubMed 27720862Al-Mukhtar Othman J, Akervall S, Milsom I, Gyhagen M. Urinary incontinence in nulliparous women aged 25-64 years: a national survey. Am J Obstet Gynecol. 2017 Feb;216(2):149.e1-149.e11. doi: 10.1016/j.ajog.2016.09.104. Epub 2016 Oct 6.
- Background: PubMed 28977091Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
- Background: PubMed 28673060Pizzoferrato AC, Fauconnier A, Fritel X, Bader G, Dompeyre P. Urethral Closure Pressure at Stress: A Predictive Measure for the Diagnosis and Severity of Urinary Incontinence in Women. Int Neurourol J. 2017 Jun;21(2):121-127. doi: 10.5213/inj.1732686.343. Epub 2017 Jun 21.
- Background: PubMed 29552736de Mattos Lourenco TR, Matsuoka PK, Baracat EC, Haddad JM. Urinary incontinence in female athletes: a systematic review. Int Urogynecol J. 2018 Dec;29(12):1757-1763. doi: 10.1007/s00192-018-3629-z. Epub 2018 Mar 19.
- Background: PubMed 30193294Diokno AC, Newman DK, Low LK, Griebling TL, Maddens ME, Goode PS, Raghunathan TE, Subak LL, Sampselle CM, Boura JA, Robinson AE, McIntyre D, Burgio KL. Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1333-1341. doi: 10.1001/jamainternmed.2018.3766.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
- 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.
Muhammad Sanaullah, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle plus adductor strengthening and Pelvic floor muscle exercises in people with Urinary Incontinence, Stress, 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 3 inclusion and 4 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 30 Aug 2021. 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?
Urinary Distress Inventory (UDI-6) (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT04994041, which also lists 7 linked publications.
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 30 Aug 2021.