Chronic Pelvic Pain SyndromeNCT07042555
Efficacy of Cognitive Behavior Therapy for Treatment of Chronic Pelvic Pain in Women
A study testing CBT-cp, Pelvic Floor Therapy and Pharmacotherapy in people with Chronic Pelvic Pain Syndrome, run by Islamia University of Bahawalpur.
Trial summary
The study will employ 4 treatment arms and 1 placebo arm to compare efficacy of CBT, PFT, Pharmacotherapy, Integrated CBT and PFT modalities in the management of chronic pelvic pain in women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Pelvic Pain Syndrome
- What is being tested?
- CBT-cp, Pelvic Floor Therapy and Pharmacotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of reproductive age, Women with CPP having no pathological or anatomical causes, Women with Overactive Bladder Syndrome Women with Vulvodynia.
Who cannot join
- Women experiencing per-menopause or menopause, Women with medical, or gynecological or hormonal abnormalities, Women with mental disorders, Women who use substances.
About this study
Official title: Efficacy of Cognitive Behavior Therapy, Pelvic Floor Therapy and Pharmacotherapy in the Treatment of Chronic Pelvic Pain in Women: A Comparative Study
The study will employ 4 treatment arms and 1 placebo arm to compare efficacy of CBT, PFT, Pharmacotherapy, Integrated CBT and PFT modalities in the management of chronic pelvic pain in women.
- Conditions
- Chronic Pelvic Pain Syndrome
- Being tested
- CBT-cp, Pelvic Floor Therapy, Pharmacotherapy, CBT-cp+PFT, Placebo
- Keywords
- Chronic Pelvic Pain, Pelvic Pain, Women
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-cpBehavioural
The participants in CBT-cp arm will receive weekly sessions of Cognitive Behavior Therapy for Chronic Pain.
Pelvic Floor TherapyOther
The participants in PFT arm will receive weekly sessions of pelvic floor therapy.
PharmacotherapyDrug
The participants in Pharmacotherapy arm will receive prescription and non prescription pain medication.
CBT-cp+PFTCombination product
The participants in integrated arm will receive weekly sessions of both CBT-cp and PFT.
PlaceboOther
The participants in placebo arm will receive sham drug.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy for Chronic Pain (CBT-cp) | Experimental | Not described Receives: Behavioral: CBT-cp |
| Pelvic Floor Therapy (PFT) | Experimental | Not described Receives: Other: Pelvic Floor Therapy |
| Pharmacotherapy | Experimental | Not described Receives: Drug: Pharmacotherapy |
| Integrated CBT-cp and PFT | Experimental | Not described Receives: Combination Product: CBT-cp+PFT |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start10 Jul 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Islamia University of Bahawalpur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bushra Akram, Islamia University of Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042555
- Sponsor's protocol ID
- IslUB
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akram B, Bilal A. Efficacy of Cognitive Behavior Therapy, Pelvic Floor Therapy, Integrated Therapy, and Pharmacotherapy in the Treatment of Chronic Pelvic Pain in Women: A Randomized Controlled Trial. Pak J Med Sci. 2026 Sep;42(9):2487-2496. doi: 10.12669/pjms.42.9.16890.
PubMed 42825061
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cognitive Behavior Therapy, Pelvic Floor Therapy and Pharmacotherapy in the Treatment of Chronic Pelvic Pain in Women: A Comparative Study
- ClinicalTrials.gov ID
- NCT07042555
- Acronym / sponsor ID
- IslUB
- Conditions
- Chronic Pelvic Pain Syndrome
- Keywords
- Chronic Pelvic Pain, Pelvic Pain, Women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Islamia University of BahawalpurUniversity, hospital or other
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 Jun 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 study will employ 4 treatment arms and 1 placebo arm to compare efficacy of CBT, PFT, Pharmacotherapy, Integrated CBT and PFT modalities in the management of chronic pelvic pain in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy for Chronic Pain (CBT-cp) | Experimental | Behavioral: CBT-cp |
| Pelvic Floor Therapy (PFT) | Experimental | Other: Pelvic Floor Therapy |
| Pharmacotherapy | Experimental | Drug: Pharmacotherapy |
| Integrated CBT-cp and PFT | Experimental | Combination Product: CBT-cp+PFT |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women of reproductive age, Women with CPP having no pathological or anatomical causes, Women with Overactive Bladder Syndrome Women with Vulvodynia.
Key exclusion criteria (1 listed)
- Women experiencing per-menopause or menopause, Women with medical, or gynecological or hormonal abnormalities, Women with mental disorders, Women who use substances.
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 |
|---|---|---|
| CBT-cpThe participants in CBT-cp arm will receive weekly sessions of Cognitive Behavior Therapy for Chronic Pain. | Behavioural | Cognitive Behavior Therapy for Chronic Pain (CBT-cp) |
| Pelvic Floor TherapyThe participants in PFT arm will receive weekly sessions of pelvic floor therapy. | Other | Pelvic Floor Therapy (PFT) |
| PharmacotherapyThe participants in Pharmacotherapy arm will receive prescription and non prescription pain medication. | Drug | Pharmacotherapy |
| CBT-cp+PFTThe participants in integrated arm will receive weekly sessions of both CBT-cp and PFT. | Combination product | Integrated CBT-cp and PFT |
| PlaceboThe participants in placebo arm will receive sham drug. | Other | Placebo |
Primary outcome
The Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Derived from this study: PubMed 42825061Akram B, Bilal A. Efficacy of Cognitive Behavior Therapy, Pelvic Floor Therapy, Integrated Therapy, and Pharmacotherapy in the Treatment of Chronic Pelvic Pain in Women: A Randomized Controlled Trial. Pak J Med Sci. 2026 Sep;42(9):2487-2496. doi: 10.12669/pjms.42.9.16890.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-cp, Pelvic Floor Therapy and Pharmacotherapy in people with Chronic Pelvic Pain Syndrome, run by Islamia University of Bahawalpur.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
The Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ) (time frame: Up to 12 weeks). 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 NCT07042555, which also lists 1 linked publication.
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 29 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.