NCT07042555

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 20, 2025

Last Update Submit

June 20, 2025

Conditions

Chronic Pelvic Pain Syndrome

Keywords

Chronic Pelvic Pain, Pelvic Pain, Women

Outcome Measures

Primary Outcomes (1)

  • The Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)

    Up to 12 weeks

Study Arms (5)

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

Interventions

CBT-cpBEHAVIORAL

The participants in CBT-cp arm will receive weekly sessions of Cognitive Behavior Therapy for Chronic Pain.

Cognitive Behavior Therapy for Chronic Pain (CBT-cp)
Pelvic Floor TherapyOTHER

The participants in PFT arm will receive weekly sessions of pelvic floor therapy.

Pelvic Floor Therapy (PFT)
PharmacotherapyDRUG

The participants in Pharmacotherapy arm will receive prescription and non prescription pain medication.

Pharmacotherapy
CBT-cp+PFTCOMBINATION_PRODUCT

The participants in integrated arm will receive weekly sessions of both CBT-cp and PFT.

Integrated CBT-cp and PFT
PlaceboOTHER

The participants in placebo arm will receive sham drug.

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women of reproductive age, Women with CPP having no pathological or anatomical causes, Women with Overactive Bladder Syndrome Women with Vulvodynia.

You may not qualify if:

  • Women experiencing per-menopause or menopause, Women with medical, or gynecological or hormonal abnormalities, Women with mental disorders, Women who use substances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic Pain

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Scholar

Study Record Dates

First Submitted

June 20, 2025

First Posted

June 29, 2025

Study Start

July 10, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06